Muscle wasting risk low for three statins
Risk of rhabdomyolysis, a muscle wasting disorder associated with statin use, is low for atorvastatin, pravastatin and simvastatin when used as monotherapy, according to David Graham, a doctor with the US Food and Drug Administration, and colleagues (JAMA 2004;292:2585).
The US researchers examined incidence rates for this rare adverse event
for the three statins and compared them with those for a fourth — cerivastatin,
which was withdrawn from the market in 2001.
In 252,460 patients treated with lipid-lowering agents, the researchers
found 24 cases of rhabdomyolysis that resulted in admission to hospital.
Average incidence per 10,000 person-years for atorvastatin, pravastatin
and simvastatin was 0.44 (95 per cent confidence interval, 0.20-0.84).
Cerivastatin had a higher risk of rhabdomyolysis — incidence per
10,000 person-years for monotherapy was 5.34 (CI 1.46-13.68).
The risk was increased when statin treatment was combined with a fibrate,
especially in older patients with diabetes. Cerivastatin combined with
a fibrate conferred a risk of approximately one in 10 treated patients
per year, the researchers calculate (incidence per 10,000 person-years
1,035, CI 389-2117).
Dr Graham raised the issue of statin safety at a recent US Senate inquiry
into the FDA approval and subsequent withdrawal of rofecoxib (Vioxx)
by Merck. In his evidence he identified five drugs with safety concerns — rosuvastatin
(Crestor), valdecoxib (Bextra), sibutramine (Reductil), isotretinoin
(Roaccutane) and salmeterol (Serevent). The FDA has issued a statement
pointing out that Dr Graham’s comments do not reflect the views
of the agency.
A UK spokesman for AstraZeneca, manufacturer of Crestor, said that rosuvastatin
had a safety profile in line with other statin therapies currently on
the market and that he did not know why this agent had been singled out.
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