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Popularity uncovers COX-2 inhibitor side effects

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An ecological study seems to suggest that cyclo-oxygenase (COX)-2 inhibitors result in adverse drug reactions at population level, even though they are judged safer than previous non-steroidal anti-inflammatory drugs (NSAIDs) for individual patients.

Doctors in Canada performed a cross sectional time series study with data from administrative healthcare databases covering 1.3 million Ontario residents aged 66 years and over and compared the prevalences of NSAIDs use and upper gastrointestinal bleeding needing hospital admission.

A 41% increase in use of COX-2 inhibitors during 1994–2002 was mirrored by a 10% increase in hospital admission rates. Plotting the prevalences over time showed a parallel rise after COX-2 inhibitors were introduced in April 2000 and March 2001. NSAIDs use after COX-2 inhibitors were introduced rose from a prevalence of 14% to 19.8%, representing 90 000 extra users a year of COX-2 inhibitors, and admissions for bleeding rose significantly, from 15.4 to 17/10 000 population, representing 650 extra bleeds. The researchers are confident that the time trends indicate a strong direct link, and they found no evidence for other explanations. What they cannot say, though, is whether increased pain relief afforded by COX-2 inhibitors offset the disbenefits of the side effects.

COX-2 inhibitors carry less risk of gastrointestinal bleeding than non-selective NSAIDs, according to recent evidence, but it was uncertain whether this was true with the wider use of these newer drugs and greater exposure at the population level.

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