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Statin study points to link between side effects, gene
By Alicia Chang
Associated Press
Jul 24, 2008
Scientists may have found a way to test for and possibly avoid a serious side effect of cholesterol-lowering statin drugs, one of the world's top-selling medicines. In rare cases, statins can cause muscle pain and weakness. Researchers have identified a genetic variation that seems to predict more than half of these cases. People on statins who have the variant were about five to 17 times more likely to develop muscle problems, a serious side effect that can lead to muscle breakdown, kidney failure and death.
The finding raises hope that a test could be developed to screen heart patients to find out who is at greatest risk. Normally, muscle weakness caused by statins affects 1 out of 10,000 patients a year.
"It could become a very simple check," said Rory Collins of the University of Oxford, who cowrote the study published in today's New England Journal of Medicine.
But doctors say having this knowledge does not mean the millions taking statins should be tested, especially those who are having no problem.
Statins are mostly prescribed to prevent heart attacks in people with clogged arteries and work by lowering LDL, or "bad cholesterol." Last year, global sales for statins topped $14.8 billion, according to the drug-research firm IMS Health.
The genetic analyses drew from two studies that were in part funded by Merck & Co., which makes the cholesterol blockbuster Zocor, now available as the generic simvastatin.
The first involved 85 statin users with muscle weakness and 90 controls taken from a sample of 12,000 people. The participants took higher-than-normal doses of simvastatin, or Zocor.
Using DNA samples, researchers found a gene variation in more than 60 percent of those with muscle weakness. The variant makes a protein less effective at carrying statins into the liver, where the drug has the greatest effect.
Muscle weakness was mild and reversible if people stopped taking statins. Researchers confirmed the results in a second separate study involving people who took a lower dose. It is unclear if the results hold true for other cholesterol drugs.
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