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An Analysis of Rosuvastatin's Safety Record

Results are in from a postmarketing analysis of adverse-event reports to the FDA.

In 2003 the FDA approved the cholesterol-lowering drug rosuvastatin (Crestor), after determining that the drug's myotoxic potential per LDL-lowering efficacy (at a maximum dose of 40 mg) was similar to that of other approved statins. A consumer-advocacy group filed a petition with the FDA in 2004 to withdraw rosuvastatin because it considered the drug's myotoxic and renal risks to be too high, even at approved doses. The FDA has answered this petition in a letter that outlines extensively the risks and benefits of rosuvastatin and concludes that the drug should not be withdrawn.

Now, researchers in Boston have analyzed rosuvastatin-associated adverse-event reports (AERs) to the FDA from October 2003 through September 2004. They compared these reports with AERs for atorvastatin, simvastatin, and pravastatin during this period. The rate of the researchers' primary combined endpoint — rhabdomyolysis, proteinuria, nephropathy, or renal failure — was significantly higher with rosuvastatin (28 AERs per million prescriptions) than with the other statins examined (range, 3–13 AERs per million prescriptions). When AERs during each drug's first year of marketing were compared, the difference remained significant between rosuvastatin and the other statins (except simvastatin, which showed a nonsignificant trend toward fewer AERs than rosuvastatin did). Notably, the rate of AERs during the first year of marketing was dramatically higher with the now-withdrawn cerivastatin (Baycol) than with any other statin examined, including rosuvastatin.

Comment: Patients who are taking rosuvastatin should not be alarmed, given this study's methodologic limitations (e.g., no controls, very different adverse events combined in the primary endpoint, potential over-reporting of adverse events with rosuvastatin because of heightened attention to the drug in 2004). Patients who still find the current findings unsettling should know that they may be able to reach their target LDL levels with a statin whose safety record is not being questioned. Although this study does not substantially increase my concern about rosuvastatin, starting a patient on a statin that has a longer safety record and also has been proven to save lives might be prudent. With alternatives available, the case for using rosuvastatin as first-line therapy is not clear — and this study has done nothing to change that fact.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology June 10, 2005

Citation(s):

Alsheikh-Ali AA et al. The safety of rosuvastatin as used in common clinical practice: A postmarketing analysis. Circulation 2005 Jun 14; 111:3051-7.

• Original article (Subscription may be required)
• Medline abstract (Free)

Grundy SM. The issue of statin safety: Where do we stand? Circulation 2005 Jun 14; 111:3016-9.

• Original article (Subscription may be required)
• Medline abstract (Free)