Trial Comparison Will Help In Treatment Of Arthritis

Incidence of upper gastrointestinal clinical events in patients with arthritis on the COX-2 inhibitor etoricoxib are fewer than in those patients on the NSAID* diclofenac, according to an Article in this week's issue of The Lancet. This information will assist patients with arthritis and their physicians in making decisions about pain management.

NSAIDS are often taken long term by arthritis patients. However, they significantly increase the risk of upper gastrointestinal clinical events such as bleeding ulcers. The incidences of upper gastrointestinal clinical events have been shown to be significantly less with COX-2 than traditional NSAIDS. However, previous trials have not simulated standard clinical practice because gastrointestinal protective therapies - eg, proton pump inhibitors (PPIs) - were not allowed.

Loren Laine (University of Southern California Keck School of Medicine, Los Angeles, USA) and colleagues analyse data from three randomised trials from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme† to assess the effects of COX-2 inhibitors versus traditional NSAIDS on upper gastrointestinal outcomes in a setting that simulates real-world practice, in which patients with gastrointestinal risk factors were encouraged to use protective PPI therapy and those with cardiovascular risk were encouraged to take low-dose aspirin. Overall, upper gastrointestinal clinical events were significantly less common with etoricoxib than with diclofenac, but not in the more serious complicated events‡. The treatment effects did not differ significantly in individuals using PPIs or aspirin.

The authors conclude: "The results of the MEDAL programme provide new information about upper gastrointestinal clinical events and symptoms to assist arthritis patients and their physicians to make decisions regarding NSAID use."

In an accompanying Comment, Joost Drenth and Freek Verheugt (Radboud University Nijmegen, Netherlands) state: "Though eterocoxib reduced upper gastrointestinal events, the effect was only small as 259 patients need to be treated to prevent one uncomplicated gastrointestinal event. The alternative, addition of a PPI to standard NSAID might be less expensive, potentially less cardiotoxic, and advantageous in terms of reducing dyspepsia, but here confirmation needs a randomised trial." (Quote by email; not in published paper)

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Professor Loren Laine, University of Southern California Keck School of Medicine, Los Angeles, USA.

Comment Professor Joost Drenth, Radboud University Nijmegen, Netherlands. Contact: Joe Santangelo
Lancet