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.
Formulary JournalClinical Pharmacology November 04, 2011
