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Studies provide new evidence on risks associated with Cox-2 inhibitors and NSAIDs

Two new review studies evaluating the safety of the pain-relieving medications selective cyclooxygenase 2 (COX-2) inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) find increased cardiovascular and kidney risks. The studies and an accompanying editorial were posted online today by JAMA because of the public health implications of the findings. The articles will appear in the October 4 print issue of JAMA.

"It is estimated that more than 30 million people worldwide take nonsteroidal anti-inflammatory drugs (NSAIDs) daily for treatment of pain and inflammation," according to background information provided in one of the articles. Adverse effects of some conventional NSAIDs include toxic gastrointestinal (GI) effects, as well as adverse renal (kidney) effects. "Overall, an estimated 2.5 million individuals in the United States annually experience adverse renal effects caused by use of NSAIDs," the authors write. "With decreased risk of adverse GI effects, a class of drugs that selectively inhibits COX-2 enzyme was introduced for analgesia (pain relief) and the treatment of arthritis." According to the authors, the adverse renal effects of selective COX-2 inhibition are unclear. Evidence is accumulating on the potential class effect of COX-2 inhibitors on cardiovascular risk. Two COX-2 inhibitors have already been withdrawn from the market: rofecoxib (marketed as Vioxx) and valdecoxib (marketed as Bextra).

Jingjing Zhang, M.D., Ph.D., from Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues evaluated the adverse risks of renal events and arrhythmia (disturbance of the normal heart rhythm) events in patients prescribed COX-2 inhibitors from a systematic review of the medical literature to determine if these negative side-effects involve every drug in this class.

"In this comprehensive meta-analysis of 114 randomized trials of COX-2 inhibitors comprised of 116,094 participants, rofecoxi
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Contact: Todd Datz
617-432-3952
JAMA and Archives Journals
12-Sep-2006


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