Pharmaceutical Business review

AstraZeneca’s Crestor proves least safe in Tufts study

The researchers compared the safety profiles of the three most commonly used statins, atorvastatin (Lipitor), simvastatin (Zocor), and pravastatin (Pravachol), versus the more recently introduced statin, rosuvastatin (Crestor). After reviewing a national database for adverse event reports, the study found rosuvastatin to have the poorest safety profile.

The most serious reactions resulted in damage to the kidney (proteinuria/nephropathy), and muscle (rhabdomyolysis), which frequently resulted in patients requiring hospitalization.

The researchers analyzed 145 rosuvastatin-associated adverse events reported to the FDA over its first year of marketing and compared the rates of such events with other statins simultaneously and during their respective first year of marketing. The review found that with either comparison, rosuvastatin (Crestor) was significantly more likely to be associated with rhabdomyolysis, proteinuria, nephropathy or kidney failure.

“This study raises concern about the safety of this drug at the range of doses currently used in common clinical practice in the general population,” said Dr Richard Karas, lead author and co-director of Tufts-NEMC’s Molecular Cardiology Research Center.

“I would advise healthcare providers to consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C lowering therapy, and to closely monitor patients for adverse events if rosuvastatin is used,” added Dr Karas.