Concerns about rosuvatstin (Crestor™) - AstraZeneca Response

In response to Dr. Wolfe's letter in The Lancet (v 363 p2189, 2004), AstraZeneca, maker of rosuvastatin, published a response in The Lancet (June 25, 2004).

First, they note that most of the problems that Dr. Wolfe relates are at the 80 mg dose, that is not marketed. To date, 2 million patients have been treated with rosuvastatin. Rhabdomyolysis is rarely evident, as it is with other statins. None of the cases have been fatal.

Concerning the issue of renal insufficiency, they state that it was "found to be transient, often resolved on continued treatment, and not predictive of acute or progressive renal disease". A published study (Cardiology, v 102, p52, 2004) of more than 10,000 patients treated with this drug up to 3.8 years, showed that renal function tended to improve slightly.

Our comment: The FDA estimates that 1 Million prescriptions for rosuvastatin have been dispensed. 18 cases of rhabdomyolysis in 2 million patients represent a much higher rate compared to other statins (1.2 per million for lovastatin, 0.8 for simvastatin, 0.3 for atorvastatin and none for fluvastatin - Pharmacoepidemiol Drug Safety v13, p417, 2004). If these numbers are correct, and this trend continues, there is a very small (10 per million approximately) risk for rhabdomyolysis that is unnecessary unless rosuvastatin has some unique properties that other statins do not.

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