Volume 3   Issue  37                        December   2004

Cholesterol-lowering Drugs Not For Older Diabetics

News 8, Austin November 30, 2004

"The contents of the muscle cell are released into the blood stream and the pigments that are inside muscle that give muscle its red color get filtered by the kidneys and can cause kidney failure," Dr. David Graham, of the Food and Drug Administration, said.

Graham and his colleagues at the FDA and five other research institutions wanted to know if other statins caused this muscle disorder. They studied health records of about 250,000 people treated for high cholesterol. Their findings appear in The Journal of the American Medical Association (JAMA).

"The three major statins that are used to treat elevated cholesterol in the United States, atorvastatin, pravastatin and simvastatin, had very similar, virtually identical risk of rhabdomyolysis, and this risk was very low," Graham said.

About one in every 23,000 patients per year treated with one of these statins could develop the muscle disorder. The study also looked at fibrates, another kind of cholesterol medication, which increased the risk of rhabdomyolysis by five-fold. But the biggest risk is for a particular group of patients.

"This is among older patients with diabetes who were taking both a statin and a fibrate together at the same time. What we saw with those patients is that their risk of rhabdomyolysis was increased to a rate of about one in 500 per year," Graham said.

But that's nothing compared to what happened when patients took cerivastatin, before it was recalled, in combination with fibrates.

"For the combination therapy of cerivastatin plus fibrate, the risk of rhabdomyolysis was increased over 1,400 fold. In fact, the risk of rhabdomyolysis for this particular combination was about one in 10 patients in a year," Graham said.

Graham said his study shows that the right drug was taken off the market, and that patients can consider these three statins to be safe.

Graham also said older diabetic patients on combination therapy for high cholesterol should talk to their doctors about the risk of developing a muscle disorder.

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