A study published in the January issue of the American Gastroenterological Association (AGA) journal Gastroenterology found a difference in how people responded to popular painkillers and that up to 30 percent of this variability can be attributed to an individual's genetic make-up. This variation can influence both how useful the drugs are in affording relief from pain and inflammation, and the number and severity of the adverse effects. This evaluation is perhaps the most rigorous look at how people vary in their response to drugs and was designed as part of a strategy to determine genetic and other markers that might help predict response and safety of these drugs, including susceptibility to cardiovascular complications.

The study looked at people taking two popular painkillers--rofecoxib (Vioxx, Merck) and celecoxib (Celebrex, Pfizer)--known as COX-2 inhibitors. During the past two years, evidence has emerged that COX-2s confer a risk of heart attack and stroke, resulting in two of the drugs in this class being withdrawn from the market and a black box warning being issued for a third drug.

"The use of any drug involves a mix of benefits and risks. The problems with COX-2 inhibitors were real, but involved less than 2 percent of patients who were taking them," said Garret A. FitzGerald, MD, study author from the University of Pennsylvania School of Medicine. "Because we often underestimate just how much people differ in their response to the same dose of the same drug, there is a need to develop diagnostic methods to identify those patients at an increased risk of cardiovascular events and explore this variability in drug response to move toward an individualized approach in drug development."

Researchers at the University of Pennsylvania examined the variability, both within and between subjects, in response to celecoxib and rofecoxib, in a randomized, double-blind, placebo controlled study. Screening, enrollment and f
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Contact: Kimberly Wise
media@gastro.org
301-941-2620
American Gastroenterological Association
4-Jan-2006

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