Risk of NSAIDs May Be Overstated

A new epidemiologic study based on detailed patient surveys rather than administrative databases suggests not only that non-aspirin, nonsteroidal, anti-inflammatory drugs (NANSAIDs) that are inhibitors of cyclooxygenase (COX) may not harm patients but, on the contrary, may have a protective effect against heart attack.

Previous studies have shown that aspirin, a nonsteroidal anti-inflammatory drug (NSAID), reduces the risk of heart attack and stroke. However, in the wake of problems found with some other COX inhibitors such as Vioxx, recent studies of NANSAIDs have shown an increased risk, some have shown no association between NANSAIDs and heart attack, and some have suggested a lower risk of heart attack.

The prior studies used prescription records from billing data or electronic databases. Then a February 2005 study by Stephen E. Kimmel, M.D., associate professor of medicine at the University of Pennsylvania and associate professor of epidemiology in the department of biostatics and epidemiology (Philadelphia, USA), suggested a benefit of nonselective NANSAIDS. In this study, data were collected from study participants instead of relying on limited information from electronic databases. The research showed that of all the nonsteroids used, 80% were over-the-counter drugs and mostly ibuprofen.

In the new study, participants were asked about their use of both prescription and over-the-counter nonsteroidal and aspirin use and about several risk factors for heart attacks that are typically unavailable or incomplete in administrative databases. When each category of bias was removed, NANSAIDs showed a stronger protective association with heart attack. The findings of the study were reported in the August 2005 issue of Pharmacoepidemiology and Drug Safety.

"As you add into the model more and more useful and relevant information, the association between nonsteroidals and heart attacks changes, and it changes in the direction of showing more benefit,” explained Dr. Kimmel. "We are not saying we know the whole answer, but our data suggest there might be beneficial effects of nonsteroidals and there are clearly limitations to interpreting the epidemiologic studies that are now out there.”