New Reviews Shed Light on Vioxx Cardiovascular Risks

Same risks not seen with other cox-2 inhibitors, including Celebrex

WEDNESDAY, Sept. 13 (HealthDay News) -- Two new meta-analyses confirm that the cyclooxygenase-2 inhibitor rofecoxib (Vioxx) is indeed associated with an increased risk of cardiovascular problems, renal events, and arrhythmia, but similar risks were not seen with other cox-2 inhibitors, including celecoxib (Celebrex). The findings were released early online Sept. 12 in Journal of the American Medical Association.

In the first study, David Henry, M.B. Ch.B., and Patricia McGettigan, M.D., from the University of Newcastle in New South Wales, Australia, performed a review and meta-analysis of 23 studies examining cardiovascular risks and use of non-steroidal anti-inflammatory drugs or cox-2 inhibitors. They found an elevated risk with the use of rofecoxib (relative risk 1.33 or 2.19, depending on dose) and diclofenac (RR 1.4), but no increased risk with celecoxib, naproxen, piroxicam, and ibuprofen.

In the second study, Eric L. Ding, B.A., and colleagues from Harvard University in Boston, performed a meta-analysis of 114 studies examining the risk of renal events and arrhythmia after treatment with selective cox-2 inhibitors. They found that only rofecoxib was associated with an increased risk of arrhythmia (RR 2.90) and composite renal events (RR 1.53), while celecoxib was associated with a decreased risk of renal dysfunction (RR 0.61) and hypertension (RR 0.83).

The findings suggest that Vioxx increases the risk of acute myocardial infarction at either low or high doses, and that Celebrex does so at high doses (above 200 mg/d), with the risk at low doses unclear. "For most patients with arthritis or other conditions who require chronic pain relief, naproxen appears to be the safest NSAID choice from a cardiovascular perspective," according to an editorial by David J. Graham, M.D. M.P.H., of the U.S. Food and Drug Administration in Silver Spring, Md. "For patients at high risk of NSAID-related gastrointestinal tract complications, naproxen plus a proton pump inhibitor is less costly and as effective, and probably safer, than low-dose celecoxib."

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