b uniquely increased risks of renal events (peripheral edema, renal dysfunction, hypertension) and arrhythmia events, with apparent adverse effects by the end of year 2000 and 2004, respectively," the researchers write. "However, the results did not show adverse effects of other COX-2 inhibitors on renal events and arrhythmia, indicating no overall evidence for a COX-2 inhibitor class effect."

In conclusion, the authors write: "Notably for policy and clinical decision making, our results also suggest that a time-cumulative meta-analytic approach for examining available trial safety data would have helped clarify apparently adverse effects several years earlier than the current report. The knowledge of all potential adverse effects is important and indeed time-sensitive, for physicians and patients both need complete information about risks and benefits to properly use COX-2 inhibitors and other clinical treatments." They continue, "future drug safety monitoring of emerging clinical treatments may benefit from continuous cumulative meta-analytic aggregation of safety data for all drug-approval applications and experimental agents." (JAMA. 2006; 296:doi:10.1001/jama.296.13.jrv60015. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Corresponding author Mr. Ding was supported by a grant from the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) and by an institutional training grant from the National Cancer Institute, National Institutes of Health. Dr. Song was supported by grants from the NIDDK, National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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In a related study, Patricia McGettigan, M.B.B.S., B.Pharm., F.R.A.C.P., Ph.D., and David Henry, M.B., Ch.B., F.R.C.P., from The University of Newcastl
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Contact: Todd Datz
617-432-3952
JAMA and Archives Journals
12-Sep-2006

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