Anesiva, Inc. (Nasdaq: ANSV) today outlined the planned Phase 2/3 clinical trial program for the development of 4975, the company's long-acting, non-opioid drug candidate for the acute treatment of severe pain. After a successful meeting with the FDA, the company will be focusing its near-term development efforts of 4975 in two areas-post-surgical pain and osteoarthritis.
In initial Phase 2 studies, 4975 was shown to provide a statistically significant reduction in the pain associated with total knee replacement surgeries and osteoarthritis of the knee for weeks to months following a single application. Anesiva anticipates commencing a series of clinical trials during the first half of this year to confirm the safety and efficacy of 4975. Following is a list of trials that are planned for the company's post-surgical and osteoarthritis indications:
Post-surgical
-- A 50-patient Phase 2 trial evaluating a higher dose of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with hip replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with arthroscopic shoulder surgeries (Begin in 1H07)
-- A 450-patient Phase 3 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 2H07)
Osteoarthritis
-- A 200-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with osteoarthritis of the knee (Begin in 1H07)
"We are eager to begin the next phase of our development to confirm our earlier findings of 4975, which has shown significant potential to treat debilitating pain in a number of indications without the substantial side effects associated with current opioid pain medications," stated John P. McLaughlin, chief executive officer of Anesiva. "We believe our Phase 2/3 program will provide an overview of the efficacy and safety profile of 4975 to treat pain associated with surgery and osteoarthritis."
How 4975 May Address Need for Long-Duration, Well-Tolerated Pain Relief
4975 is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, 4975 does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure.
In clinical studies to date, 4975 has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated. Opioid drugs, such as morphine, which are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions, have significant side effects including sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use.
About Total Knee Replacement Surgery and Osteoarthritis of the Knee
Total knee replacement (also known as total knee arthroplasty) is performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life.
Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients' mobility and activities. Approximately 1.1 million patients are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.
There were an estimated 470,000 total knee replacement procedures performed in the United States in 2005, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgery projects that approximately 3.5 million of these procedures will be done each year by 2030.
Conference Call Details
Anesiva will conduct a webcast conference call with the investment community at 9:00 a.m. EST, today, January 8, 2007 to discuss the company's clinical trial plans for 4975. Interested parties can listen to the live audio webcast by dialing 877-266-9200 (international dial: 706-634-1538) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing 800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 5711122.
About Anesiva
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's most recent quarterly report on Form 10-Q.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Anesiva, Inc.
http://www.anesiva.com
April 16, 2007
April 15, 2007
Cephalon Announces Positive Results From Two Phase 3 Clinical Trials Of FENTORA(TM) In Breakthrough Pain
Cephalon, Inc. (Nasdaq: CEPH) today reported data from the first Phase 3 clinical trial to demonstrate positive results of FENTORA(TM) (fentanyl buccal tablet) [C-II] in opioid-tolerant patients with neuropathic pain. Onset of pain relief began in 10 minutes in this study as well as in a separate Phase 3 study in opioid- tolerant patients with cancer. The data from these studies will be submitted for presentation at a medical meeting in 2007.
One double-blind, placebo-controlled study assessed the efficacy of FENTORA in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p<0.0001). Statistically significant differences in pain relief compared with placebo were observed as early as 10 minutes (p<0.05), consistent with positive results from a previously announced study in opioid-tolerant patients with chronic low back pain. The medication was generally well tolerated with adverse events typical of opioids.
Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with FENTORA in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the FENTORA New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p<0.0001). The medication was generally well tolerated with adverse events typical of opioids.
"These new studies of FENTORA provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from FENTORA may be more rapid than indicated in the approved labeling."
FENTORA is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for FENTORA, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.
Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.
FENTORA
Approved to manage breakthrough pain in opioid-tolerant patients with cancer, FENTORA's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all FENTORA clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of FENTORA, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg-per-mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Full prescribing information about FENTORA, including a boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any expansion of the labeled indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients discussed above; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.com
One double-blind, placebo-controlled study assessed the efficacy of FENTORA in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p<0.0001). Statistically significant differences in pain relief compared with placebo were observed as early as 10 minutes (p<0.05), consistent with positive results from a previously announced study in opioid-tolerant patients with chronic low back pain. The medication was generally well tolerated with adverse events typical of opioids.
Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with FENTORA in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the FENTORA New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p<0.0001). The medication was generally well tolerated with adverse events typical of opioids.
"These new studies of FENTORA provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from FENTORA may be more rapid than indicated in the approved labeling."
FENTORA is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for FENTORA, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.
Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.
FENTORA
Approved to manage breakthrough pain in opioid-tolerant patients with cancer, FENTORA's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all FENTORA clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of FENTORA, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg-per-mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Full prescribing information about FENTORA, including a boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any expansion of the labeled indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients discussed above; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.com
Jefferson Cardiologists Fix Broken Heart, Potentially Fatal Complication Of Heart Attack
Unexplained chest pain after a heart attack might be more dangerous than many physicians originally think.
In a case study to be published in the January issue of the international journal Clinical Cardiology, physicians at Thomas Jefferson University Hospital in Philadelphia report on a seemingly healthy 55-year-old man who had a silent heart attack and subsequent unexplained chest pain.
Once he was admitted to the hospital, it was discovered that the man actually had a rarely diagnosed complication called subepicardial aneurysm, which, if not quickly treated, could be fatal.
"The chest pain was a rupture of the heart wall about to happen--the most feared complication of a heart attack," explains Michael Savage, M.D., director, Cardiac Catheterization Laboratory at Thomas Jefferson University Hospital. "The rupture occurs from a tear in the muscle that has already been damaged by a heart attack. The heart muscle breaks and the wall bursts usually causing cataclysmic death soon after."
The Jefferson researchers recommend that when a patient experiences unexplained pain after a heart attack, physicians should consider the possibility of a subepicardial aneurysm.
Diagnosis of a subepicardial aneurysm is extremely rare, says Dr. Savage, who is also associate professor of Medicine, Jefferson Medical College of Thomas Jefferson University. Only 20 cases have ever been reported in the medical literature and many patients were diagnosed after death. It is highly likely that many more patients have died from this complication but the cause of death was unrecognized.
According to lead researcher, Aaron Giltner, M.D., a cardiology fellow at Thomas Jefferson University Hospital, the man, who worked in construction, came to the Thomas Jefferson University Hospital emergency room with chest pain. A heart attack was initially considered and the emergency physicians called in the interventional cardiologists for a consult.
The cardiologists also initially suspected a heart attack. The patient was admitted to the hospital and was readied for a cardiac catheterization to check for blocked arteries.
The cardiac catheterization suggested a subepicardial aneurysm--an impending cardiac rupture--and the researchers arranged for a CT scan. This confirmed that the patient had a subepicardial aneurysm, a rarely diagnosed complication of a heart attack. Once the problem was identified, surgeons promptly repaired the heart, saving his life.
"As our study shows," Dr. Savage says, "CT imaging can be invaluable in establishing the diagnosis of a subepicardial aneurysm. Clinical recognition of this entity and the use of appropriate imaging modalities are imperative to facilitate life-saving surgical intervention."
###
Members of the Jefferson University team who conducted this study are: Aaron Giltner, M.D., Ethan J. Halpern, M.D., Daniel Marelli, M.D. and Michael P. Savage, M.D.
Contact: Nan Myers
Thomas Jefferson University
In a case study to be published in the January issue of the international journal Clinical Cardiology, physicians at Thomas Jefferson University Hospital in Philadelphia report on a seemingly healthy 55-year-old man who had a silent heart attack and subsequent unexplained chest pain.
Once he was admitted to the hospital, it was discovered that the man actually had a rarely diagnosed complication called subepicardial aneurysm, which, if not quickly treated, could be fatal.
"The chest pain was a rupture of the heart wall about to happen--the most feared complication of a heart attack," explains Michael Savage, M.D., director, Cardiac Catheterization Laboratory at Thomas Jefferson University Hospital. "The rupture occurs from a tear in the muscle that has already been damaged by a heart attack. The heart muscle breaks and the wall bursts usually causing cataclysmic death soon after."
The Jefferson researchers recommend that when a patient experiences unexplained pain after a heart attack, physicians should consider the possibility of a subepicardial aneurysm.
Diagnosis of a subepicardial aneurysm is extremely rare, says Dr. Savage, who is also associate professor of Medicine, Jefferson Medical College of Thomas Jefferson University. Only 20 cases have ever been reported in the medical literature and many patients were diagnosed after death. It is highly likely that many more patients have died from this complication but the cause of death was unrecognized.
According to lead researcher, Aaron Giltner, M.D., a cardiology fellow at Thomas Jefferson University Hospital, the man, who worked in construction, came to the Thomas Jefferson University Hospital emergency room with chest pain. A heart attack was initially considered and the emergency physicians called in the interventional cardiologists for a consult.
The cardiologists also initially suspected a heart attack. The patient was admitted to the hospital and was readied for a cardiac catheterization to check for blocked arteries.
The cardiac catheterization suggested a subepicardial aneurysm--an impending cardiac rupture--and the researchers arranged for a CT scan. This confirmed that the patient had a subepicardial aneurysm, a rarely diagnosed complication of a heart attack. Once the problem was identified, surgeons promptly repaired the heart, saving his life.
"As our study shows," Dr. Savage says, "CT imaging can be invaluable in establishing the diagnosis of a subepicardial aneurysm. Clinical recognition of this entity and the use of appropriate imaging modalities are imperative to facilitate life-saving surgical intervention."
###
Members of the Jefferson University team who conducted this study are: Aaron Giltner, M.D., Ethan J. Halpern, M.D., Daniel Marelli, M.D. and Michael P. Savage, M.D.
Contact: Nan Myers
Thomas Jefferson University
Caffeine Cuts Post-Workout Pain By Nearly 50 Percent, UGA Study Finds
Although it's too soon to recommend dropping by Starbucks before hitting the gym, a new study suggests that caffeine can help reduce the post-workout soreness that discourages some people from exercising.
In a study to be published in the February issue of The Journal of Pain, a team of University of Georgia researchers finds that moderate doses of caffeine, roughly equivalent to two cups of coffee, cut post-workout muscle pain by up to 48 percent in a small sample of volunteers.
Lead author Victor Maridakis, a researcher in the department of kinesiology at the UGA College of Education, said the findings may be particularly relevant to people new to exercise, since they tend to experience the most soreness.
"If you can use caffeine to reduce the pain, it may make it easier to transition from that first week into a much longer exercise program," he said.
Maridakis and his colleagues studied nine female college students who were not regular caffeine users and did not engage in regular resistance training. One and two days after an exercise session that caused moderate muscle soreness, the volunteers took either caffeine or a placebo and performed two different quadriceps (thigh) exercises, one designed to produce a maximal force, the other designed to generate a sub-maximal force. Those that consumed caffeine one-hour before the maximum force test had a 48 percent reduction in pain compared to the placebo group, while those that took caffeine before the sub-maximal test reported a 26 percent reduction in pain.
Caffeine has long been known to increase alertness and endurance, and a 2003 study led by UGA professor Patrick O'Connor found that caffeine reduces thigh pain during moderate-intensity cycling. O'Connor, who along with professors Kevin McCully and the late Gary Dudley co-authored the current study, explained that caffeine likely works by blocking the body's receptors for adenosine, a chemical released in response to inflammation.
Despite the positive findings in the study, the researchers say there are some caveats. First, the results may not be applicable to regular caffeine users, since they may be less sensitive to caffeine's effect. The researchers chose to study women to get a definitive answer in at least one sex, but men may respond differently to caffeine. And the small sample size of nine volunteers means that the study will have to be replicated with a larger study.
O'Connor said that despite these limitations, caffeine appears to be more effective in relieving post-workout muscle pain than several commonly used drugs. Previous studies have found that the pain reliever naproxen (the active ingredient in Aleve) produced a 30 percent reduction in soreness. Aspirin produced a 25 percent reduction, and ibuprofen has produced inconsistent results.
"A lot of times what people use for muscle pain is aspirin or ibuprofen, but caffeine seems to work better than those drugs, at least among women whose daily caffeine consumption is low," O'Connor said.
Still, the researchers recommend that people use caution when using caffeine before a workout. For some people, too much caffeine can produce side effects such as jitteriness, heart palpitations and sleep disturbances.
"It can reduce pain," Maridakis said, "but you have to apply some common sense and not go overboard."
###
Contact: Sam Fahmy
University of Georgia
In a study to be published in the February issue of The Journal of Pain, a team of University of Georgia researchers finds that moderate doses of caffeine, roughly equivalent to two cups of coffee, cut post-workout muscle pain by up to 48 percent in a small sample of volunteers.
Lead author Victor Maridakis, a researcher in the department of kinesiology at the UGA College of Education, said the findings may be particularly relevant to people new to exercise, since they tend to experience the most soreness.
"If you can use caffeine to reduce the pain, it may make it easier to transition from that first week into a much longer exercise program," he said.
Maridakis and his colleagues studied nine female college students who were not regular caffeine users and did not engage in regular resistance training. One and two days after an exercise session that caused moderate muscle soreness, the volunteers took either caffeine or a placebo and performed two different quadriceps (thigh) exercises, one designed to produce a maximal force, the other designed to generate a sub-maximal force. Those that consumed caffeine one-hour before the maximum force test had a 48 percent reduction in pain compared to the placebo group, while those that took caffeine before the sub-maximal test reported a 26 percent reduction in pain.
Caffeine has long been known to increase alertness and endurance, and a 2003 study led by UGA professor Patrick O'Connor found that caffeine reduces thigh pain during moderate-intensity cycling. O'Connor, who along with professors Kevin McCully and the late Gary Dudley co-authored the current study, explained that caffeine likely works by blocking the body's receptors for adenosine, a chemical released in response to inflammation.
Despite the positive findings in the study, the researchers say there are some caveats. First, the results may not be applicable to regular caffeine users, since they may be less sensitive to caffeine's effect. The researchers chose to study women to get a definitive answer in at least one sex, but men may respond differently to caffeine. And the small sample size of nine volunteers means that the study will have to be replicated with a larger study.
O'Connor said that despite these limitations, caffeine appears to be more effective in relieving post-workout muscle pain than several commonly used drugs. Previous studies have found that the pain reliever naproxen (the active ingredient in Aleve) produced a 30 percent reduction in soreness. Aspirin produced a 25 percent reduction, and ibuprofen has produced inconsistent results.
"A lot of times what people use for muscle pain is aspirin or ibuprofen, but caffeine seems to work better than those drugs, at least among women whose daily caffeine consumption is low," O'Connor said.
Still, the researchers recommend that people use caution when using caffeine before a workout. For some people, too much caffeine can produce side effects such as jitteriness, heart palpitations and sleep disturbances.
"It can reduce pain," Maridakis said, "but you have to apply some common sense and not go overboard."
###
Contact: Sam Fahmy
University of Georgia
As Former President George Bush Recuperates From Hip Replacement Surgery, Physical Therapy Will Play Key Role In Recovery
As former President George H. W. Bush recovers from last week's surgery at the Mayo Clinic to replace his right hip, periodic and progressive physical therapy will play a key role in his successful rehabilitation, says the American Physical Therapy Association (APTA).
"Following hip replacement surgery, physical therapy is routinely used, either in a home health, out-patient, or a rehabilitation setting," says Dale Avers, PT, DPT, PhD, a professor in physical therapy at SUNY Upstate Medical University in Syracuse, NY. Avers, who has been conducting research regarding exercise for aging adults, including those with hip replacements, warns that residual weakness, which can include balance impairment, may become evident even years following hip replacement surgery if not properly addressed.
"Physical therapy, not necessarily on a continuous basis, is now recommended for patients with hip replacements," says Avers. "Starting around 4 months, physical therapy, which includes strength training, mobility and balance exercises, is recommended for optimal results."
The leading indicator for hip replacement is pain and impaired mobility, not age, notes Avers, very often associated with osteoarthritis. Physical therapists can improve mobility and decrease pain through manual therapy and strengthening exercises. Hip replacement surgery is recommended as a last resort, when the pain becomes unbearable and interferes with mobility.
For President Bush, Senator Elizabeth Dole, and other patients with hip replacements, physical therapy starts immediately in the hospital following surgery, beginning with gentle mobility exercises and activities, says Avers. Gradually, the exercises are progressed as healing takes place. Avers said that once the immediate post-op rehabilitation is complete, patients should return to physical therapy for continued strength and balance training. "As healing progresses, they need the guidance of a physical therapist to achieve optimal results and to return to full function in the activities they enjoy," Avers said.
"Successful hip replacement surgery is the first step in President Bush's recovery and to enjoying his normal activities," says Avers. "Physical therapy is the finishing touch."
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as other physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org
"Following hip replacement surgery, physical therapy is routinely used, either in a home health, out-patient, or a rehabilitation setting," says Dale Avers, PT, DPT, PhD, a professor in physical therapy at SUNY Upstate Medical University in Syracuse, NY. Avers, who has been conducting research regarding exercise for aging adults, including those with hip replacements, warns that residual weakness, which can include balance impairment, may become evident even years following hip replacement surgery if not properly addressed.
"Physical therapy, not necessarily on a continuous basis, is now recommended for patients with hip replacements," says Avers. "Starting around 4 months, physical therapy, which includes strength training, mobility and balance exercises, is recommended for optimal results."
The leading indicator for hip replacement is pain and impaired mobility, not age, notes Avers, very often associated with osteoarthritis. Physical therapists can improve mobility and decrease pain through manual therapy and strengthening exercises. Hip replacement surgery is recommended as a last resort, when the pain becomes unbearable and interferes with mobility.
For President Bush, Senator Elizabeth Dole, and other patients with hip replacements, physical therapy starts immediately in the hospital following surgery, beginning with gentle mobility exercises and activities, says Avers. Gradually, the exercises are progressed as healing takes place. Avers said that once the immediate post-op rehabilitation is complete, patients should return to physical therapy for continued strength and balance training. "As healing progresses, they need the guidance of a physical therapist to achieve optimal results and to return to full function in the activities they enjoy," Avers said.
"Successful hip replacement surgery is the first step in President Bush's recovery and to enjoying his normal activities," says Avers. "Physical therapy is the finishing touch."
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as other physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org
Novel Shingles Pain Treatment Lauched In The UK
GrГјnenthal announced today that it has been granted a UK licence for its new product Versatis(R) (5% lidocaine medicated plaster). Versatis is licensed for the treatment of neuropathic pain associated with previous herpes zoster (shingles) infection, also known as post-herpetic neuralgia (PHN)1.
Versatis offers a topical and non-systemic approach for the treatment of localised neuropathic pain symptoms associated with PHN, often described as burning, shooting or stabbing. It is an innovative combination of the local anaesthetic lidocaine and a soft hydrogel plaster, combining efficacious treatment and simple handling with a proven tolerability and safety profile1.
The plaster offers rapid and continuous pain relief 30 minutes after application2. Following a once daily 12 hours-on/12 hours-off application schedule, up to three plasters can be used at one time. It can be used as monotherapy or in combination with patient's existing analgesia, and clinical trials have shown no clinically relevant drug interactions1.
The launch of Versatis coincides with the announcement of a new survey that shows the impact of PHN on quality of life. Conducted by the Barts Pain Research Group, the survey reveals that over 80% of respondents felt that PHN had negatively affected their ability to enjoy life, whilst almost 50% felt suicidal or depressed as a result of PHN3. Apart from the psychological impact of PHN, the condition has a significant impact on day-to-day activities, such as work, sleep and even getting dressed with one in three people not being able to participate in any day-to-day activities prior to treatment3. In addition, 92% of patients continued to suffer pain even whilst on treatment and over two thirds are dissatisfied with existing treatment options3.
"Versatis offers clinicians an effective and well-tolerated new treatment option for people suffering the debilitating shooting, stabbing and burning pain symptoms following shingles," said Professor Richard Langford, Professor of Anaesthesia & Pain Medicine at St Bartholomew's Hospital London. "It is generally older people who develop post-herpetic neuralgia after shingles and hence with their multiple morbidities and medications, the very low systemic level of lidocaine during Versatis use, minimises concerns about contraindications and drug interactions."
More than one million patients have been treated with the lidocaine plaster since 1999 in the US4. Marketed as Lidoderm(R) by Endo Pharmaceuticals its use demonstrates improved quality of life5 and better pain relief6 compared to their other treatments.В
GrГјnenthal researches, develops and produces high therapeutic value medicines and markets them throughout the world. GrГјnenthal is an expert in drugs for pain therapy and gynaecology and a leader in the field of intelligent, user-friendly drug delivery technologies. GrГјnenthal is an independent, family-owned company with a long history of international co-operations. The company was founded in 1946 and has its headquarters in Germany. We supply our markets from seven production sites around the world and have affiliates in 27 countries. GrГјnenthal employs about 1,900 people in Germany and about 4,700 world-wide. Sales in 2005 amounted to approximately 777 million Euro.
-- Post-herpetic Neuralgia (PHN) is a prolonged neuropathic or nerve pain that follows an acute attack of shingles.
-- Shingles or herpes zoster is an acute infection caused by the reactivation of the latent varicella-zoster virus (chickenpox). After a childhood chicken pox infection the virus lies dormant in the dorsal root ganglia of the spinal cord. An acute shingles rash occurs when the virus is reactivated7.
-- PHN affects approximately 200,000 people in the UK8.
-- Older age is the risk factor most strongly associated with developing PHN and people aged 50 years or older are almost 15 times more likely to have pain 30 days after developing a shingles rash increasing to 27 times more likely after 60 days8.
References
1. Versatis Summary of Product Characteristics
2. Rowbotham MC et al. Pain 1996; 65: 39-44
3. The Barts Pain Research Group. Post-herpetic Neuralgia: The patient's voice.
4. GrГјnenthal data on file (Patient exposure)
5. Gammaitoni AR et al. Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review of the Literature. J Clin Pharmacol 2003;43: 111-117
6. Katz NP et al. Lidocaine Patch 5% Reduces Pain Intensity and Interference with Quality of Life in Patients With Postherpetic Neuralgia. Pain Med 2002; 3(4) 324-332
7. Prodigy Guidance: Shingles and post-herpetic neuralgia
8. Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderlyl
Versatis offers a topical and non-systemic approach for the treatment of localised neuropathic pain symptoms associated with PHN, often described as burning, shooting or stabbing. It is an innovative combination of the local anaesthetic lidocaine and a soft hydrogel plaster, combining efficacious treatment and simple handling with a proven tolerability and safety profile1.
The plaster offers rapid and continuous pain relief 30 minutes after application2. Following a once daily 12 hours-on/12 hours-off application schedule, up to three plasters can be used at one time. It can be used as monotherapy or in combination with patient's existing analgesia, and clinical trials have shown no clinically relevant drug interactions1.
The launch of Versatis coincides with the announcement of a new survey that shows the impact of PHN on quality of life. Conducted by the Barts Pain Research Group, the survey reveals that over 80% of respondents felt that PHN had negatively affected their ability to enjoy life, whilst almost 50% felt suicidal or depressed as a result of PHN3. Apart from the psychological impact of PHN, the condition has a significant impact on day-to-day activities, such as work, sleep and even getting dressed with one in three people not being able to participate in any day-to-day activities prior to treatment3. In addition, 92% of patients continued to suffer pain even whilst on treatment and over two thirds are dissatisfied with existing treatment options3.
"Versatis offers clinicians an effective and well-tolerated new treatment option for people suffering the debilitating shooting, stabbing and burning pain symptoms following shingles," said Professor Richard Langford, Professor of Anaesthesia & Pain Medicine at St Bartholomew's Hospital London. "It is generally older people who develop post-herpetic neuralgia after shingles and hence with their multiple morbidities and medications, the very low systemic level of lidocaine during Versatis use, minimises concerns about contraindications and drug interactions."
More than one million patients have been treated with the lidocaine plaster since 1999 in the US4. Marketed as Lidoderm(R) by Endo Pharmaceuticals its use demonstrates improved quality of life5 and better pain relief6 compared to their other treatments.В
GrГјnenthal researches, develops and produces high therapeutic value medicines and markets them throughout the world. GrГјnenthal is an expert in drugs for pain therapy and gynaecology and a leader in the field of intelligent, user-friendly drug delivery technologies. GrГјnenthal is an independent, family-owned company with a long history of international co-operations. The company was founded in 1946 and has its headquarters in Germany. We supply our markets from seven production sites around the world and have affiliates in 27 countries. GrГјnenthal employs about 1,900 people in Germany and about 4,700 world-wide. Sales in 2005 amounted to approximately 777 million Euro.
-- Post-herpetic Neuralgia (PHN) is a prolonged neuropathic or nerve pain that follows an acute attack of shingles.
-- Shingles or herpes zoster is an acute infection caused by the reactivation of the latent varicella-zoster virus (chickenpox). After a childhood chicken pox infection the virus lies dormant in the dorsal root ganglia of the spinal cord. An acute shingles rash occurs when the virus is reactivated7.
-- PHN affects approximately 200,000 people in the UK8.
-- Older age is the risk factor most strongly associated with developing PHN and people aged 50 years or older are almost 15 times more likely to have pain 30 days after developing a shingles rash increasing to 27 times more likely after 60 days8.
References
1. Versatis Summary of Product Characteristics
2. Rowbotham MC et al. Pain 1996; 65: 39-44
3. The Barts Pain Research Group. Post-herpetic Neuralgia: The patient's voice.
4. GrГјnenthal data on file (Patient exposure)
5. Gammaitoni AR et al. Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review of the Literature. J Clin Pharmacol 2003;43: 111-117
6. Katz NP et al. Lidocaine Patch 5% Reduces Pain Intensity and Interference with Quality of Life in Patients With Postherpetic Neuralgia. Pain Med 2002; 3(4) 324-332
7. Prodigy Guidance: Shingles and post-herpetic neuralgia
8. Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderlyl
AspenBio Pharma's Human Appendicitis Blood Test Shows Strong Preliminary Results As Clinical Diagnostic Aid
AspenBio Pharma, Inc. (OTC Bulletin Board: APNB) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, today reported on the development status of the company's human appendicitis blood test and positive results from preliminary clinical trials. The company also reported that U.S. federal trademark applications have been filed for AppyScore and AppyScreen for the planned commercialization of two new human appendicitis blood tests.
AspenBio Pharma continues to make exciting progress in the development and testing of its two first-generation blood-based human diagnostic tests designed to rapidly help diagnose or rule out appendicitis in patients complaining of abdominal pain. AspenBio has created and optimized a specialized assay test to detect a marker in the blood associated with appendicitis and has tested this assay in several on-going research trials involving hundreds of human patients.
Preliminary results indicate that the company's first-generation triage test is highly effective in identifying patients with acute appendicitis. This marker demonstrates a linear (or direct) correlation to the histopathologic severity of appendicitis. The test is especially accurate in patients 30 years of age and under, which is also the age group most commonly afflicted with appendicitis.
As a result of these positive developments, the company's R&D team is designing two separate appendicitis triage blood test systems. The primary test is the AppyScore system which is based on a blood test result scoring system designed to be used as an initial appendicitis triage test for patients entering an Emergency Room /urgent care facility complaining of abdominal pain. The scoring system is designed to quantify the blood marker level, which guides the physician in determining not only the presence but also the stage of appendicitis. Determining the stage of appendicitis helps the physician assess the level of possible danger and the potential for the appendix to burst causing complications of a life-threatening perforation.
The AppyScreen system is a second appendicitis screening test which is being developed as a point-of-care test designed specifically for use in a physician's office. This rapid-screen qualitative blood test would be used by a primary care doctor to quickly screen and identify potential appendicitis patients -- especially children and young adults -- who should immediately go to the emergency room for further appropriate care that may include a more quantitative AppyScore test.
Appendicitis can advance rapidly. Delays in the diagnosis and care of appendicitis are associated with serious complications. After basic tests and examination, a CT scan is the most commonly used emergency room diagnostic method for ruling out appendicitis for patients with abdominal pain. Costing $1,500 to $3,000 per procedure, an estimated $4.5 to $9.0 billion is spent annually in the US on CT scans for this purpose. The scans can take more than four hours to complete and expose patients to ionizing radiation. While CT scans are still the current medical standard, CT diagnostic error rates are estimated to range between 15% and 40%, and a high percentage of CT scan results are simply inconclusive. The present approach contributes to a significantly large number of unnecessary appendicitis surgeries due to diagnostic errors.
Every year in the United States alone, approximately 6 million patients enter emergency rooms complaining of abdominal pain. About 700,000 of these patients are diagnosed with appendicitis and have emergency surgery to remove the appendix. However, due to diagnostic errors some 100,000 of these patients (or approximately one out of seven) who undergo this emergency surgery end up having a normal appendix removed.
In addition to involving other risks, hospital charges for such unnecessary (negative) appendectomies are estimated to give rise to hospital charges of approximately $1.5 billion annually in the US alone. Additionally, about 95,000 patients are not diagnosed correctly in time and suffer a potentially life-threatening perforation of the appendix requiring immediate and more complex emergency surgery. This also results in a more lengthy hospital stay, a longer recovery or treatment period, and substantially increased cost.
"When we first started our investigations to develop this blood test, our main goal was to be able to more accurately identify patients with appendicitis," said Dr. John Bealer, a pediatric surgeon based in Denver Colorado and co-inventor of the test. "In initial clinical studies of patients with appendicitis, AppyScore has been impressively accurate at detecting appendicitis. False-negative results for AppyScore have been exceedingly rare and to date seen only in those cases with minimal histological evidence of appendicitis. This finding opens up the potential of two different roles for AppyScore in treating patients. For some patients, AppyScore could potentially be a stand-alone diagnostic test of appendicitis. For others, it could also be useful as a triage tool by determining which abdominal-pain patients are the best candidates for CT scanning. By both adding new diagnostic information and supplementing standard diagnostic methods, AppyScore could become very important for the 6 million patients annually who enter emergency rooms with abdominal pain."
Appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages usually presenting as abdominal pain. While this first-generation test can be falsely-positive in some patients with other specific inflammatory diseases, these diseases are infrequent in people less than 30 years of age and generally are less of a diagnostic challenge than appendicitis.
Appendicitis is especially difficult to diagnose in children and young adults using a CT scan because of their low body fat. This lack of body fat results in very poor tissue differentiation on the CT scan. AspenBio Pharma's new triage/diagnostic tests also have the potential to enhance overall safety by reducing the amount of radiation exposure in children from unnecessary CT scans. Adds Bealer, "Given these factors, we are particularly excited about what this triage test could mean for helping to diagnose or rule out the disease in the highest-risk appendicitis population of children and young adults."
Based upon a potential annual emergency room/urgent care usage of 6 million tests and management's estimates of a sales price of a few hundred dollars per test, the annual U.S. market potential for AppyScore and AppyScreen systems could exceed several hundred million dollars, with the international market potential at a multiple of that of the U.S.
"We believe that these two first generation triage tests will prove to be very cost-effective and welcomed innovations for emergency room physicians who must quickly and correctly diagnose or rule out appendicitis," said Richard Donnelly, AspenBio Pharma's president and CEO. "Rarely do you find a new healthcare technology that is faster, more accurate, and much less expensive than current techniques. These blood-based tests can potentially save the US healthcare system and insurance providers billions of dollars in reduced numbers of CT scans alone. Consequently, the AppyScore and AppyScreen tests have legitimate blockbuster sales potential in the human medical markets worldwide."
Beginning in 2004, AspenBio commenced the establishment of an intellectual property portfolio for the appendicitis testing technology and products. The company has filed for worldwide patent coverage related to several aspects of the initial discovery and various test applications. Further enhancement and expansion of the proprietary patent position is ongoing with respect to the scope of protection for the company's first generation and future generation versions of tests. Strong scientific and technical progress remain the basis for these innovative efforts.
Clinical studies will continue, while activities for securing an international licensing partner to support FDA approval, distribution, and marketing will commence in the near future. The company anticipates submitting an FDA regulatory filing for approval of the tests during the third quarter of 2007.
About AspenBio Pharma, Inc.
AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to the discovery, development, manufacture, and marketing of novel proprietary products, including those that enhance the reproductive efficiency of animals and that have large worldwide market potential. The company was originally formed to produce purified proteins for diagnostic applications and has become a leading supplier of human hormones to many of the nation's largest medical diagnostic companies and research institutions. The company has successfully leveraged this foundational science and technology expertise to rapidly develop an enviable late-stage pipeline of several novel reproduction hormone analogs for wide-ranging therapeutic use initially in bovine and equine species. For more information, please visit: http://www.aspenbiopharma.com.
Forward Looking Statements
This news release includes "forward looking statements" of AspenBio Pharma, Inc. ("APNB") as defined by the Securities and Exchange Commission (the "SEC"). All statements, other than statements of historical fact, included in the press release that address activities, events or developments that APNB believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors APNB believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of APNB. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including the ability to successfully complete the development of new products and produce them economically, secure intellectual property positions including valid and enforceable patent and trademark rights, execute agreements required to successfully advance the company's objectives, retain the scientific management team to advance the products, obtain additional funding as and if needed, adverse changes in market conditions and the regulatory environment, fluctuations in sales volumes, and realization of intangible assets. Furthermore, APNB does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this news release should be considered in conjunction with the warnings and cautionary statements contained in APNB's recent filings with the SEC.
AspenBio Pharma, Inc.
http://www.aspenbiopharma.com
AspenBio Pharma continues to make exciting progress in the development and testing of its two first-generation blood-based human diagnostic tests designed to rapidly help diagnose or rule out appendicitis in patients complaining of abdominal pain. AspenBio has created and optimized a specialized assay test to detect a marker in the blood associated with appendicitis and has tested this assay in several on-going research trials involving hundreds of human patients.
Preliminary results indicate that the company's first-generation triage test is highly effective in identifying patients with acute appendicitis. This marker demonstrates a linear (or direct) correlation to the histopathologic severity of appendicitis. The test is especially accurate in patients 30 years of age and under, which is also the age group most commonly afflicted with appendicitis.
As a result of these positive developments, the company's R&D team is designing two separate appendicitis triage blood test systems. The primary test is the AppyScore system which is based on a blood test result scoring system designed to be used as an initial appendicitis triage test for patients entering an Emergency Room /urgent care facility complaining of abdominal pain. The scoring system is designed to quantify the blood marker level, which guides the physician in determining not only the presence but also the stage of appendicitis. Determining the stage of appendicitis helps the physician assess the level of possible danger and the potential for the appendix to burst causing complications of a life-threatening perforation.
The AppyScreen system is a second appendicitis screening test which is being developed as a point-of-care test designed specifically for use in a physician's office. This rapid-screen qualitative blood test would be used by a primary care doctor to quickly screen and identify potential appendicitis patients -- especially children and young adults -- who should immediately go to the emergency room for further appropriate care that may include a more quantitative AppyScore test.
Appendicitis can advance rapidly. Delays in the diagnosis and care of appendicitis are associated with serious complications. After basic tests and examination, a CT scan is the most commonly used emergency room diagnostic method for ruling out appendicitis for patients with abdominal pain. Costing $1,500 to $3,000 per procedure, an estimated $4.5 to $9.0 billion is spent annually in the US on CT scans for this purpose. The scans can take more than four hours to complete and expose patients to ionizing radiation. While CT scans are still the current medical standard, CT diagnostic error rates are estimated to range between 15% and 40%, and a high percentage of CT scan results are simply inconclusive. The present approach contributes to a significantly large number of unnecessary appendicitis surgeries due to diagnostic errors.
Every year in the United States alone, approximately 6 million patients enter emergency rooms complaining of abdominal pain. About 700,000 of these patients are diagnosed with appendicitis and have emergency surgery to remove the appendix. However, due to diagnostic errors some 100,000 of these patients (or approximately one out of seven) who undergo this emergency surgery end up having a normal appendix removed.
In addition to involving other risks, hospital charges for such unnecessary (negative) appendectomies are estimated to give rise to hospital charges of approximately $1.5 billion annually in the US alone. Additionally, about 95,000 patients are not diagnosed correctly in time and suffer a potentially life-threatening perforation of the appendix requiring immediate and more complex emergency surgery. This also results in a more lengthy hospital stay, a longer recovery or treatment period, and substantially increased cost.
"When we first started our investigations to develop this blood test, our main goal was to be able to more accurately identify patients with appendicitis," said Dr. John Bealer, a pediatric surgeon based in Denver Colorado and co-inventor of the test. "In initial clinical studies of patients with appendicitis, AppyScore has been impressively accurate at detecting appendicitis. False-negative results for AppyScore have been exceedingly rare and to date seen only in those cases with minimal histological evidence of appendicitis. This finding opens up the potential of two different roles for AppyScore in treating patients. For some patients, AppyScore could potentially be a stand-alone diagnostic test of appendicitis. For others, it could also be useful as a triage tool by determining which abdominal-pain patients are the best candidates for CT scanning. By both adding new diagnostic information and supplementing standard diagnostic methods, AppyScore could become very important for the 6 million patients annually who enter emergency rooms with abdominal pain."
Appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages usually presenting as abdominal pain. While this first-generation test can be falsely-positive in some patients with other specific inflammatory diseases, these diseases are infrequent in people less than 30 years of age and generally are less of a diagnostic challenge than appendicitis.
Appendicitis is especially difficult to diagnose in children and young adults using a CT scan because of their low body fat. This lack of body fat results in very poor tissue differentiation on the CT scan. AspenBio Pharma's new triage/diagnostic tests also have the potential to enhance overall safety by reducing the amount of radiation exposure in children from unnecessary CT scans. Adds Bealer, "Given these factors, we are particularly excited about what this triage test could mean for helping to diagnose or rule out the disease in the highest-risk appendicitis population of children and young adults."
Based upon a potential annual emergency room/urgent care usage of 6 million tests and management's estimates of a sales price of a few hundred dollars per test, the annual U.S. market potential for AppyScore and AppyScreen systems could exceed several hundred million dollars, with the international market potential at a multiple of that of the U.S.
"We believe that these two first generation triage tests will prove to be very cost-effective and welcomed innovations for emergency room physicians who must quickly and correctly diagnose or rule out appendicitis," said Richard Donnelly, AspenBio Pharma's president and CEO. "Rarely do you find a new healthcare technology that is faster, more accurate, and much less expensive than current techniques. These blood-based tests can potentially save the US healthcare system and insurance providers billions of dollars in reduced numbers of CT scans alone. Consequently, the AppyScore and AppyScreen tests have legitimate blockbuster sales potential in the human medical markets worldwide."
Beginning in 2004, AspenBio commenced the establishment of an intellectual property portfolio for the appendicitis testing technology and products. The company has filed for worldwide patent coverage related to several aspects of the initial discovery and various test applications. Further enhancement and expansion of the proprietary patent position is ongoing with respect to the scope of protection for the company's first generation and future generation versions of tests. Strong scientific and technical progress remain the basis for these innovative efforts.
Clinical studies will continue, while activities for securing an international licensing partner to support FDA approval, distribution, and marketing will commence in the near future. The company anticipates submitting an FDA regulatory filing for approval of the tests during the third quarter of 2007.
About AspenBio Pharma, Inc.
AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to the discovery, development, manufacture, and marketing of novel proprietary products, including those that enhance the reproductive efficiency of animals and that have large worldwide market potential. The company was originally formed to produce purified proteins for diagnostic applications and has become a leading supplier of human hormones to many of the nation's largest medical diagnostic companies and research institutions. The company has successfully leveraged this foundational science and technology expertise to rapidly develop an enviable late-stage pipeline of several novel reproduction hormone analogs for wide-ranging therapeutic use initially in bovine and equine species. For more information, please visit: http://www.aspenbiopharma.com.
Forward Looking Statements
This news release includes "forward looking statements" of AspenBio Pharma, Inc. ("APNB") as defined by the Securities and Exchange Commission (the "SEC"). All statements, other than statements of historical fact, included in the press release that address activities, events or developments that APNB believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors APNB believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of APNB. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including the ability to successfully complete the development of new products and produce them economically, secure intellectual property positions including valid and enforceable patent and trademark rights, execute agreements required to successfully advance the company's objectives, retain the scientific management team to advance the products, obtain additional funding as and if needed, adverse changes in market conditions and the regulatory environment, fluctuations in sales volumes, and realization of intangible assets. Furthermore, APNB does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this news release should be considered in conjunction with the warnings and cautionary statements contained in APNB's recent filings with the SEC.
AspenBio Pharma, Inc.
http://www.aspenbiopharma.com
Potential Linkages Between Two Serious Problems Facing The Elderly Examined
Dementia, including Alzheimer's disease, is one of the most devastating conditions of older age. Currently affecting nearly 7 million individuals in the U.S. and 24 million worldwide, dementia leads to total loss of memory and the ability to function independently - making it one of people's greatest fears of aging.
Delirium is an acute confusional state, a common and serious complication in older individuals that often follows surgery or serious illness. Sometimes accompanied by disorientation, paranoia and hallucinations, delirium develops in 14 to 56 percent of all hospitalized seniors, complicating hospital stays for over 4 million older individuals in the U.S. each year.
For the most part, dementia and delirium have been viewed as separate and distinct conditions. But a special section of The Journal of Gerontology: Medical Sciences, appearing in January 2007, looks at their interface, asking: Can delirium itself lead to the development of a cognitive disorder? Do delirium and dementia represent opposite ends of the same spectrum of disease, rather than two separate conditions?
"I have been studying delirium for 20 years," says Sharon Inouye, MD, MPH, a geriatrician at Beth Israel Deaconess Medical Center and Director of the Aging Brain Center at the Institute for Aging Research, Hebrew SeniorLife. "And the more cases I encounter, the more linkages I see with dementia. For a large proportion of older patients, the problem [of delirium] is never resolved. I routinely hear from patients' families, 'They went into the hospital, they became very confused, and they never recovered.'"
Inouye, a professor of medicine at Harvard Medical School, together with Luigi Ferrucci, MD, PhD, Chief of the Longitudinal Studies Section of the National Institute on Aging and Editor-in-Chief of the journal, which is published by the Gerontological Society of America, examined the relationship between these two widespread conditions during the "Aging Brain Center Scientific Symposium: The Interface of Delirium and Dementia," held last spring.
"Better understanding of delirium may represent a new window of opportunity for the prevention of dementia," explains Ferrucci. "We, therefore, decided to approach the subject from a multidisciplinary perspective, exploring delirium and dementia from a number of vantage points." Findings spawned from the symposium make up the five articles featured in the special issue of the journal, including:
* Biomarkers. "There is currently no way of identifying delirium save for the observations of an astute clinician," notes Inouye. In this review article, BIDMC geriatrician Edward Marcantonio, MD, examines a number of promising biomarkers for delirium, including serum chemistries,genetic markers, serum anticholinergic activity, neurotransmitters, inflammatory markers and cortisol.
* Role of neuroimaging. Physicist David Alsop, PhD, of BIDMC's Department of Radiology, describes major advances in neuroimaging - including advanced methods using magnetic resonance (MR) imaging, positron emission tomography (PET) and single photo emission computed tomography (SPECT) -- which offer the possibility of using highly sensitive imaging techniques to detect changes in the brain following episodes of delirium and thereby investigate the mechanisms and networks involved in its onset and consequences.
* Use of SPECT scanning to assess cerebral perfusion changes in patients with delirium. Led by Tamara Fong, MD, of BIDMC's Department of Neurology, this paper describes the results of a study examining a group of hospitalized patients, which shows that frontal or parietal cerebral perfusion abnormalities occur in cases of delirium. These results suggest localized involvement in the brain's frontal and parietal lobes with delirium, which may correlate with the clinical findings and long-term outcomes.
* The link between anesthesia and development of long-term delirium. Zhongcong Xie, MD, together with senior author Rudolph Tanzi, MD, of the Genetics and Aging Research Unit, Massachusetts General Institute for Neurodegenerative Disease, demonstrate that the commonly used anesthetic isoflurane results in neuronal cell death, and enhancement of A-beta oligomerization, for the first time, providing a direct link between the acute effects of inhalational anesthetics (recognized risk factors for delirium) and the hallmark mechanisms of Alzheimer's disease neuropathogenesis.
* The potential role for cognitive reserve. Inouye, together with BIDMC gerontologist Richard Jones, ScD, an investigator in the Institute for Aging Research at Hebrew SeniorLife, report their findings showing that hospitalized older persons with lower levels of education may be at increased risk for delirium relative to older persons with more education. "People have varying degrees of cognitive reserve, the capability to withstand insults and stresses to their system [such as might occur in a hospital setting]," explains Inouye. "Our study shows that amount of education correlates with brain resiliency, perhaps by building greater numbers of neuronal pathways."
Delirium is a tremendous expense to the country's medical system, amounting to more than $7 billion per year in hospital expenses and more than $100 billion a year when rehabilitation, institutionalization and long-term care is factored in.
In a 1999 study in The New England Journal of Medicine, Inouye demonstrated that delirium can be decreased by 40 percent by implementing a number of straightforward interventions while patients are hospitalized. These include making sure that patients are oriented and hydrated, that they are up and walking, that they are using their hearing aids and vision aids, and that they avoid the use of sleep medications.
"Our goal now is to better understand the fundamental changes that cause delirium and determine whether they result in permanent injury to the brain, in order to better devise ways to intervene and prevent this injury," explains Inouye. "Knowing that our population is rapidly aging, these figures are only going to increase unless we do something now. We hope to eventually be able to identify at-risk individuals before they develop delirium, so that we can intervene before it escalates to a chronic condition."
###
In addition to Inouye, coauthors include: BIDMC investigators Edward Marcantonio, MD, and David Alsop, PhD, and Brigham and Women's Hospital investigators James Rudolph, MD, Deborah Culley, MD, and Gregory Crosby, MD, for "Serum Biomarkers for Delirium."
David Alsop, Michael Fearing, PhD, of Hebrew SeniorLife, Keith Johnson, MD, of Massachusetts General Hospital, Reisa Sperling, MD, of Brigham and Women's Hospital, and Tamara Fong, MD, of BIDMC for "The Role of Neuroimaging in Elucidating Delirium Pathophysiology."
Tamara Fong, MD, Sidney Bogardus, Jr., MD, Linda Leo-Summers, Aditya Daftary, MD, and Hal Blumenfeld, MD, and John Seibyl, MD, of Yale University School of Medicine; Eliza Auerbach, MD, of Columbia School of Medicine; Sharada Modur of Ohio State University, for "Cerebral Perfusion Changes in Older Delirious Patients Using 99mTc HMPAO SPECT."
Zhongcong Xie, PhD, Yuanlin Dong, Uta Maeda, Robert Moir, and Rudolph Tanzi, PhD, of Mass General Institute for Neurodegenerative Disease, MGH; Deborah Culley, MD, and Gregory Crosby, MD, of Brigham and Women's Hospital for "Isofluorane-Induced Apoptosis: A Potential Pathogenic Link Between Delirium and Dementia."
Richard Jones, ScD, Frances Yang, PhD, Ying Zhang, MD, MPH, Dan Kiely, MPH, MA, and Edward Marcantonio, MD, of the Institute for Aging Research, Hebrew SeniorLife for "Does Educational Attainment Contribute to Risk for Delirium? A Potential Role for Cognitive Reserve."
Funding for the studies and article was provided, in part, by grants from the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, the Alzheimer's Association and the Donaghue Medical Research Foundation.
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and ranks third among independent hospitals nationwide in National Institutes of Health (NIH) funding. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu/.
The Aging Brain Center is housed within Hebrew SeniorLife's Institute for Aging Research, the country's largest geriatric research facility in an applied setting. It is located at Hebrew Rehabilitation Center in Boston, which is also a major teaching site for the Harvard Medical School Multi-Campus Fellowship in Geriatric Medicine. IFAR is distinguished by the multidisciplinary nature of its faculty, which includes both social and medical research scientists.
Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center
Delirium is an acute confusional state, a common and serious complication in older individuals that often follows surgery or serious illness. Sometimes accompanied by disorientation, paranoia and hallucinations, delirium develops in 14 to 56 percent of all hospitalized seniors, complicating hospital stays for over 4 million older individuals in the U.S. each year.
For the most part, dementia and delirium have been viewed as separate and distinct conditions. But a special section of The Journal of Gerontology: Medical Sciences, appearing in January 2007, looks at their interface, asking: Can delirium itself lead to the development of a cognitive disorder? Do delirium and dementia represent opposite ends of the same spectrum of disease, rather than two separate conditions?
"I have been studying delirium for 20 years," says Sharon Inouye, MD, MPH, a geriatrician at Beth Israel Deaconess Medical Center and Director of the Aging Brain Center at the Institute for Aging Research, Hebrew SeniorLife. "And the more cases I encounter, the more linkages I see with dementia. For a large proportion of older patients, the problem [of delirium] is never resolved. I routinely hear from patients' families, 'They went into the hospital, they became very confused, and they never recovered.'"
Inouye, a professor of medicine at Harvard Medical School, together with Luigi Ferrucci, MD, PhD, Chief of the Longitudinal Studies Section of the National Institute on Aging and Editor-in-Chief of the journal, which is published by the Gerontological Society of America, examined the relationship between these two widespread conditions during the "Aging Brain Center Scientific Symposium: The Interface of Delirium and Dementia," held last spring.
"Better understanding of delirium may represent a new window of opportunity for the prevention of dementia," explains Ferrucci. "We, therefore, decided to approach the subject from a multidisciplinary perspective, exploring delirium and dementia from a number of vantage points." Findings spawned from the symposium make up the five articles featured in the special issue of the journal, including:
* Biomarkers. "There is currently no way of identifying delirium save for the observations of an astute clinician," notes Inouye. In this review article, BIDMC geriatrician Edward Marcantonio, MD, examines a number of promising biomarkers for delirium, including serum chemistries,genetic markers, serum anticholinergic activity, neurotransmitters, inflammatory markers and cortisol.
* Role of neuroimaging. Physicist David Alsop, PhD, of BIDMC's Department of Radiology, describes major advances in neuroimaging - including advanced methods using magnetic resonance (MR) imaging, positron emission tomography (PET) and single photo emission computed tomography (SPECT) -- which offer the possibility of using highly sensitive imaging techniques to detect changes in the brain following episodes of delirium and thereby investigate the mechanisms and networks involved in its onset and consequences.
* Use of SPECT scanning to assess cerebral perfusion changes in patients with delirium. Led by Tamara Fong, MD, of BIDMC's Department of Neurology, this paper describes the results of a study examining a group of hospitalized patients, which shows that frontal or parietal cerebral perfusion abnormalities occur in cases of delirium. These results suggest localized involvement in the brain's frontal and parietal lobes with delirium, which may correlate with the clinical findings and long-term outcomes.
* The link between anesthesia and development of long-term delirium. Zhongcong Xie, MD, together with senior author Rudolph Tanzi, MD, of the Genetics and Aging Research Unit, Massachusetts General Institute for Neurodegenerative Disease, demonstrate that the commonly used anesthetic isoflurane results in neuronal cell death, and enhancement of A-beta oligomerization, for the first time, providing a direct link between the acute effects of inhalational anesthetics (recognized risk factors for delirium) and the hallmark mechanisms of Alzheimer's disease neuropathogenesis.
* The potential role for cognitive reserve. Inouye, together with BIDMC gerontologist Richard Jones, ScD, an investigator in the Institute for Aging Research at Hebrew SeniorLife, report their findings showing that hospitalized older persons with lower levels of education may be at increased risk for delirium relative to older persons with more education. "People have varying degrees of cognitive reserve, the capability to withstand insults and stresses to their system [such as might occur in a hospital setting]," explains Inouye. "Our study shows that amount of education correlates with brain resiliency, perhaps by building greater numbers of neuronal pathways."
Delirium is a tremendous expense to the country's medical system, amounting to more than $7 billion per year in hospital expenses and more than $100 billion a year when rehabilitation, institutionalization and long-term care is factored in.
In a 1999 study in The New England Journal of Medicine, Inouye demonstrated that delirium can be decreased by 40 percent by implementing a number of straightforward interventions while patients are hospitalized. These include making sure that patients are oriented and hydrated, that they are up and walking, that they are using their hearing aids and vision aids, and that they avoid the use of sleep medications.
"Our goal now is to better understand the fundamental changes that cause delirium and determine whether they result in permanent injury to the brain, in order to better devise ways to intervene and prevent this injury," explains Inouye. "Knowing that our population is rapidly aging, these figures are only going to increase unless we do something now. We hope to eventually be able to identify at-risk individuals before they develop delirium, so that we can intervene before it escalates to a chronic condition."
###
In addition to Inouye, coauthors include: BIDMC investigators Edward Marcantonio, MD, and David Alsop, PhD, and Brigham and Women's Hospital investigators James Rudolph, MD, Deborah Culley, MD, and Gregory Crosby, MD, for "Serum Biomarkers for Delirium."
David Alsop, Michael Fearing, PhD, of Hebrew SeniorLife, Keith Johnson, MD, of Massachusetts General Hospital, Reisa Sperling, MD, of Brigham and Women's Hospital, and Tamara Fong, MD, of BIDMC for "The Role of Neuroimaging in Elucidating Delirium Pathophysiology."
Tamara Fong, MD, Sidney Bogardus, Jr., MD, Linda Leo-Summers, Aditya Daftary, MD, and Hal Blumenfeld, MD, and John Seibyl, MD, of Yale University School of Medicine; Eliza Auerbach, MD, of Columbia School of Medicine; Sharada Modur of Ohio State University, for "Cerebral Perfusion Changes in Older Delirious Patients Using 99mTc HMPAO SPECT."
Zhongcong Xie, PhD, Yuanlin Dong, Uta Maeda, Robert Moir, and Rudolph Tanzi, PhD, of Mass General Institute for Neurodegenerative Disease, MGH; Deborah Culley, MD, and Gregory Crosby, MD, of Brigham and Women's Hospital for "Isofluorane-Induced Apoptosis: A Potential Pathogenic Link Between Delirium and Dementia."
Richard Jones, ScD, Frances Yang, PhD, Ying Zhang, MD, MPH, Dan Kiely, MPH, MA, and Edward Marcantonio, MD, of the Institute for Aging Research, Hebrew SeniorLife for "Does Educational Attainment Contribute to Risk for Delirium? A Potential Role for Cognitive Reserve."
Funding for the studies and article was provided, in part, by grants from the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, the Alzheimer's Association and the Donaghue Medical Research Foundation.
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and ranks third among independent hospitals nationwide in National Institutes of Health (NIH) funding. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu/.
The Aging Brain Center is housed within Hebrew SeniorLife's Institute for Aging Research, the country's largest geriatric research facility in an applied setting. It is located at Hebrew Rehabilitation Center in Boston, which is also a major teaching site for the Harvard Medical School Multi-Campus Fellowship in Geriatric Medicine. IFAR is distinguished by the multidisciplinary nature of its faculty, which includes both social and medical research scientists.
Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center
Low-Dose Aspirin Lowers Risk Of Asthma Diagnosis
In a large, randomized, placebo-controlled study of 22,071 healthy male physicians, taking a low-dose of aspirin every other day lowered the risk of receiving an initial asthma diagnosis by 22 percent.
These findings, based on data from the double-blind Physicians' Health Study, appear in the second issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Tobias Kurth, M.D., Sc.D., of the Division of Aging at Brigham and Women's Hospital in Massachusetts, and five associates studied physicians, ages 40 to 84, over a period of 4.9 years. Among the 11,037 individuals who took aspirin, 113 new cases of asthma were diagnosed, as contrasted to 145 in the placebo group.
Asthma is a chronic inflammatory disease that causes potentially reversible obstructive lung problems. Breathing difficulties from asthma usually occur during "attacks," which involve narrowing of the airways, swelling of the lining, tightening of respiratory muscles and an increased secretion of mucus. In 2004, more than 20 million Americans were estimated to have asthma.
"Aspirin reduced the risk by 22 percent of newly-diagnosed adult-onset asthma," said Dr. Kurth. "These results suggest that aspirin may reduce the development of asthma in adults. They do not imply that aspirin improves symptoms in patients with asthma."
"Indeed, asthma can cause severe bronchospasm in some patients who have asthma," he continued. "Because asthma was not the primary endpoint of the U. S. Public Health Service study, additional randomized trials would be helpful to confirm the apparent reduction in asthma incidence caused by aspirin."
The Physicians Health Study, which began in 1982, was terminated after 4.9 years when results showed a 44-percent reduction in the risk of a first heart attack among those randomly assigned to aspirin.
"Physicians could self-report an asthma diagnosis on questionnaires at baseline, at six months and annually thereafter," said Dr. Kurth. "Asthma was not the original deductive endpoint of the trial."
According to the authors, the 22-percent lower risk of newly-diagnosed asthma among those assigned to the low-dose aspirin group was not affected by participant characteristics like smoking, body mass index or age.
They noted that aspirin-intolerant asthma, a problem in which aspirin exacerbates the disease, affects only a small minority of asthma patients. In three large population-based studies, that difficulty affected only four to 11 percent of the groups. In children, however, the proportion affected by aspirin intolerant asthma was significantly smaller.
###
Contact: Suzy Martin
American Thoracic Society
These findings, based on data from the double-blind Physicians' Health Study, appear in the second issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Tobias Kurth, M.D., Sc.D., of the Division of Aging at Brigham and Women's Hospital in Massachusetts, and five associates studied physicians, ages 40 to 84, over a period of 4.9 years. Among the 11,037 individuals who took aspirin, 113 new cases of asthma were diagnosed, as contrasted to 145 in the placebo group.
Asthma is a chronic inflammatory disease that causes potentially reversible obstructive lung problems. Breathing difficulties from asthma usually occur during "attacks," which involve narrowing of the airways, swelling of the lining, tightening of respiratory muscles and an increased secretion of mucus. In 2004, more than 20 million Americans were estimated to have asthma.
"Aspirin reduced the risk by 22 percent of newly-diagnosed adult-onset asthma," said Dr. Kurth. "These results suggest that aspirin may reduce the development of asthma in adults. They do not imply that aspirin improves symptoms in patients with asthma."
"Indeed, asthma can cause severe bronchospasm in some patients who have asthma," he continued. "Because asthma was not the primary endpoint of the U. S. Public Health Service study, additional randomized trials would be helpful to confirm the apparent reduction in asthma incidence caused by aspirin."
The Physicians Health Study, which began in 1982, was terminated after 4.9 years when results showed a 44-percent reduction in the risk of a first heart attack among those randomly assigned to aspirin.
"Physicians could self-report an asthma diagnosis on questionnaires at baseline, at six months and annually thereafter," said Dr. Kurth. "Asthma was not the original deductive endpoint of the trial."
According to the authors, the 22-percent lower risk of newly-diagnosed asthma among those assigned to the low-dose aspirin group was not affected by participant characteristics like smoking, body mass index or age.
They noted that aspirin-intolerant asthma, a problem in which aspirin exacerbates the disease, affects only a small minority of asthma patients. In three large population-based studies, that difficulty affected only four to 11 percent of the groups. In children, however, the proportion affected by aspirin intolerant asthma was significantly smaller.
###
Contact: Suzy Martin
American Thoracic Society
Narcotics Often Prescribed For Back Pain But Efficacy Data Are Poor And Chances For Abuse High
A review of studies on use of narcotics for chronic back pain found that they are commonly prescribed and may help for short-term pain relief but that substance abuse disorders are common, occurring in up to 24 percent of cases (Review, p. 116). But many of the studies are of poor quality and none evaluated relief of pain lasting 16 weeks or longer.
###
Tip sheet: Annals of Internal Medicine, Jan. 16, 2007, issue
NOTE: Annals of Internal Medicine is published by the American College of Physicians.
Contact: Susan Anderson
American College of Physicians
###
Tip sheet: Annals of Internal Medicine, Jan. 16, 2007, issue
NOTE: Annals of Internal Medicine is published by the American College of Physicians.
Contact: Susan Anderson
American College of Physicians
Subscribe to:
Posts (Atom)
