Painkiller study looks at risk management

NEWS IN BRIEF — Posted Jan. 23, 2006

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Genetic makeup contributed about 30% to the variability with which individuals responded to the painkillers Vioxx and Celebrex, according to a recent study. Both of the COX-2 inhibitors now have been withdrawn from the market because of the risk they carried for heart attacks and stroke. The analysis of how people vary in their response to the drugs was published in the January issue of Gastroenterology.

Researchers at the University of Pennsylvania examined the variability, both within and between subjects, in response to rofecoxib, or Vioxx, and celecoxib, or Celebrex, in a randomized, double-blind, placebo-controlled trial.

Fifty healthy volunteers between ages 21 and 43 received a single dose of placebo, celecoxib and rofecoxib in random order. This was done to allow researchers a direct comparison of the responses to the drugs within the same subjects.

Approximately 30% of the variability found in patients was attributable to differences between individuals, suggesting the contribution of genetics to a variety of biomarkers of drug response. The study also illustrated that even healthy individuals without a recognized risk of disease respond quite differently to the drugs.

The authors said they hoped that their work would provide an impetus for the development of a science-based approach to risk management. Exploitation of variability in response can lead to tests that identify patients most likely to benefit or have harmful side effects caused by these drugs, they said.

Note: This item originally appeared at

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