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Tuesday, February 14, 2006

According to a meta-analysis reported by Dr. Lee Simon, Associate Clinical Professor of Medicine at Harvard Medical School, the COX-2 specific inhibitor Celebrex (celecoxib) is not associated with an increased risk of serious cardiovascular thrombotic events compared to placebo or NSAIDs. This meta-analysis, which covered 41 clinical studies involving 44,308 patients, evaluated the cardiovascular safety of Celebrex versus both placebo and nonselective NSAIDs ("ns-NSAIDs").

In summary, the meta-analysis showed that patients taking Celebrex had no more risk for heart attack, stroke, or CV death combined than those given placebo or ns-NSAIDs.

Dr. Simon presented his report about the meta-analysis at the American College of Rheumatology (ACR) 2005 Annual Scientific Meeting, held in mid-November at San Diego, California. Some of his findings included:
“There were no cardiovascular signals that were any different to the active comparators. [Celebrex] was no different to non selective drugs in terms of cardiovascular risk,” Dr. Simon said. Comparators included placebo, naproxen, diclofenac, ibuprofen, loxoprofen, acetaminophen and ketoprofen.
“In this large meta-analysis comprising studies of two weeks to three years duration involving patients with chronic conditions, [Celebrex] at doses of 200mg or more total daily dose was not associated with an increased risk of serious CV thromboembolic events compared with placebo or nonselective NSAIDs,” Dr Simon concluded.

Dr. Simon is a former Division Director of the Arthritis, Analgesic & Ophthalmologic Drug Product Division at the FDA's Center for Drug Evaluation and Research.

This meta-analysis was reportedly funded by the drug company Pfizer, which makes Celebrex. Dr. Gail Cawkwell, a Senior Medical Director at Pfizer, said that this meta-analysis presented by Dr. Simon at the 2005 ACR meeting was being prepared for publication in a peer-reviewed journal. Further, Dr. Cawkwell said the new meta-analysis data had been shared with the FDA as well as European Union regulators.


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