A simple gene test may one day help doctors identify patients at risk for a rare, dangerous reaction to cholesterol-lowering drugs now taken by millions of people worldwide, researchers said.
Researchers analyzed 300,000 genetic markers in 85 patients who developed myopathy, a form of muscle weakness, and 90 patients who remained healthy after taking a high dose of Merck & Co.'s Zocor. Patients with variations in a single gene had a fourfold to 16-fold higher risk of the side effect, a known danger from cholesterol-lowering drugs known as statins.
``We provide compelling evidence that at least one common variant in the SLCO1B1 gene substantially alters the risk'' of myopathy caused by simvastatin, the generic name for Zocor, said the researchers led by Rory Collins, co-director of the University of Oxford's Clinical Trial Service Unit. ``These findings are likely to apply to other statins because myopathy is a class effect,'' they said.
Cholesterol-lowering drugs such as Zocor, Pfizer Inc.'s Lipitor and AstraZeneca Plc's Crestor generated $33.7 billion in worldwide sales in 2007, according to IMS Health, a Norwalk, Connecticut-based research firm.
It's too soon to start testing all patients for the genetic marker, the researchers said. The side effect is rare in patients taking a standard dose of the cholesterol-lowering drugs, occurring in about 1 in every 10,000 patients each year, and the chance of a person with the genetic variation developing myopathy remains small, they said in the study published in the New England Journal of Medicine.
More Serious Cases
A genetic test may be more helpful for patients who need high doses of the drugs or are simultaneously taking other medications that increase the risk, the researchers said.
Doctors may be able to eliminate nearly 60 percent of myopathy cases caused by statin drugs by not giving high doses to patients with the genetic variations, said Yusuke Nakamura, from the University of Tokyo's Human Genome Center, who was not involved in the research. More study is needed to see if the gene, which regulates the amount of drug in the liver, is also linked to rhabdomyolysis, a deadly breakdown of muscle linked to statin use, Nakamura wrote in an editorial.
Researchers analyzed 300,000 genetic markers in 85 patients who developed myopathy, a form of muscle weakness, and 90 patients who remained healthy after taking a high dose of Merck & Co.'s Zocor. Patients with variations in a single gene had a fourfold to 16-fold higher risk of the side effect, a known danger from cholesterol-lowering drugs known as statins.
``We provide compelling evidence that at least one common variant in the SLCO1B1 gene substantially alters the risk'' of myopathy caused by simvastatin, the generic name for Zocor, said the researchers led by Rory Collins, co-director of the University of Oxford's Clinical Trial Service Unit. ``These findings are likely to apply to other statins because myopathy is a class effect,'' they said.
Cholesterol-lowering drugs such as Zocor, Pfizer Inc.'s Lipitor and AstraZeneca Plc's Crestor generated $33.7 billion in worldwide sales in 2007, according to IMS Health, a Norwalk, Connecticut-based research firm.
It's too soon to start testing all patients for the genetic marker, the researchers said. The side effect is rare in patients taking a standard dose of the cholesterol-lowering drugs, occurring in about 1 in every 10,000 patients each year, and the chance of a person with the genetic variation developing myopathy remains small, they said in the study published in the New England Journal of Medicine.
More Serious Cases
A genetic test may be more helpful for patients who need high doses of the drugs or are simultaneously taking other medications that increase the risk, the researchers said.
Doctors may be able to eliminate nearly 60 percent of myopathy cases caused by statin drugs by not giving high doses to patients with the genetic variations, said Yusuke Nakamura, from the University of Tokyo's Human Genome Center, who was not involved in the research. More study is needed to see if the gene, which regulates the amount of drug in the liver, is also linked to rhabdomyolysis, a deadly breakdown of muscle linked to statin use, Nakamura wrote in an editorial.
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