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Findings culled from a new method for aggregating and making sense of data in the FDA’s Adverse Event Reporting System (AERS) present a surprising glimpse at the postmarketing adverse event data for statins.

The study found a class-wide variation in muscle-related adverse event reports. The results linked rosuvastatin (Crestor, AstraZeneca) with the highest percentage risk in 6 categories, including myopathy (general), myalgia, myositis, rhabdomyolysis, joints and tendons, muscle atrophy and injury, and muscle coordination and weakness. Pravastatin (Pravachol, Bristol-Myers Squibb) and lovastatin (Mevacor, Merck) demonstrated the best muscle-related safety profile.

“The results were surprising because in the literature it’s generally regarded that Crestor is very safe ... and Crestor, across the board, seemed to be linked to more adverse events in the categories that we searched than the other statin drugs” said Keith Hoffman, PhD, vice president, Scientific Affairs, AdverseEvents, Inc.

Through RxFilter, the company identified more than 150,000 muscle-related adverse event reports in 6 categories linked to statins between January 1, 2004 and March 31, 2011. The drugs included atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), fluvastatin (Lescol), as well as generic equivalents and foreign designations. Percent risk calculations were determined based on the number of primary suspect adverse events linked to each statin, divided by an estimated number of patients exposed to the drugs during the study period. A ranked risk measure was used to calculate within-drug comparisons.

The results indicated that Crestor had the highest percent risk in each of 6 adverse event categories examined, while Pravachol and Mevacor appeared to have the least.

The company’s database is now online at www.adverseevents.com.   November 04, 2011

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