NEW YORK -- An article in the Aug. 22 Journal of the American Medical Association reported patients taking Celebrex (celecoxib) and Vioxx (rofecoxib) may run a higher risk of getting cardiovascular disease, a charge each drug maker vehemently denies.
The contents of the JAMA article were picked up by many news organizations.
"Pharmacia and Pfizer believe the conclusions drawn by the analysis in the JAMA article were flawed and unsound," Pfizer, a co-marketer of Celebrex (celecoxib), reported in a statement issued the same day the study was published. "It contains no new clinical information and is based on an inappropriate re-analysis of several older clinical studies containing data that were not suitable for combination and comparison."
Merck reportedly agreed with some of the study's conclusions, but maintained that data exists that shows no increase in cardiovascular risk in patients taking its drug, Vioxx (rofecoxib). Celebrex and Vioxx, both used to treat arthritis, account for a combined $6 billion in annual prescription sales.
Dr. Eric J. Topol, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, used data from two major clinical trials each company had run previously in an attempt to demonstrate their respective stomach-safety profiles. In Topol's cardiac study, Merck's Vioxx fared slightly worse and had more cardiac problems associated with it than Pfizer/Pharmacia's Celebrex. Both Celebrex and Vioxx are cox-2 inhibitors.
"Our findings suggest a potential increase in cardiovascular event rates for the presently available cox-2 inhibitors," Topol wrote. "It is possible that concomitant use of aspirin may not fully offset the risk of selective cox-2 inhibitors. However, definitive evidence of such an adverse effect will require a prospective randomized clinical trial."
Topol acknowledged the limits of his study and even suggested cox-2s might alleviate atherosclerosis. "On the other hand, the inflammatory component of atherosclerosis has recently been emphasized and may be suppressible by cox-2 inhibitors," Topol said. Still, Topol said the "remarkable exposure and popularity" of cox-2 inhibitors should compel researchers to conduct a randomized trial of their long-term effect on cardiovascular health. "Until then," he said, "we urge caution in prescribing these agents to patients at risk for cardiovascular morbidity."
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