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Gene Variant Linked to Statin-Induced Side Effects

(HealthDay News)
by -- A. Agrawal, PhD
Updated: Oct 13th 2009

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TUESDAY, Oct. 13 (HealthDay News) -- Women and those with a variant of a liver-metabolizing enzyme have a higher risk of mild statin-associated side effects, particularly those associated with simvastatin, according to a study in the Oct. 20 issue of the Journal of the American College of Cardiology.

Deepak Voora, M.D., from Duke University Medical Center in Durham, N.C., and colleagues randomly assigned 509 patients with hypercholesterolemia to 10 mg atorvastatin for eight weeks followed by 80 mg atorvastatin for eight weeks, 20 mg simvastatin for eight weeks followed by 80 mg simvastatin for eight weeks, or 10 mg pravastatin for eight weeks followed by 40 mg pravastatin for eight weeks.

The researchers found that 99 patients had a composite adverse event (side effect, myalgia, or creatinine kinase elevation). Adverse events were more common in women (66 versus 50 percent), in those with the SLCO1B1*5 allele of cytochrome P450 associated with impaired statin clearance (37 versus 25 percent), and in those without significant creatinine kinase elevation. The percent of patients with adverse events increased with increasing numbers of copies of the SLCO1B1*5 allele, and the risk of adverse events was highest in patients treated with simvastatin.

"SLCO1B1*5 genotype and female sex were associated mild statin-induced side effects," Voora and colleagues conclude. "These results could have potential implications for clinical practice because the vast majority of patients who are intolerant of statins have mild symptoms without associated CK [creatinine kinase] elevations."

The trial was conducted by Genaissance Pharmaceuticals, which is now part of Clinical Data Inc. Two authors are employees of Clinical Data and one author reported unrestricted research funding from Medtronic.

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