FDA Clears New Dosage of Cholesterol Drug

The U.S. Food and Drug Administration has approved the marketing of Baycol (cerivastatin) by Bayer Corp. in a new 0.8 mg dosage. Baycol is indicated for the treatment of primary hypercholesterolemia and mixed dyslipidemia, along with an additional indication for raising high-density lipoprotein cholesterol.

Baycol is one of the newest statins to be released in the United States, according to a company news release. The 0.8 mg dosage provides further efficacy as a titration dose for patients who need additional low-density lipoprotein cholesterol lowering.

In one randomized double-blind trial, patients exhibited a mean LDL cholesterol reduction of 42% after eight weeks of treatment with Baycol 0.8 mg. Reductions of LDL cholesterol in the study ranged from 24% to 58%. Patients with elevated baseline triglycerides greater than 250 mg/dL to 400 mg/dL exhibited a reduction in triglycerides by an average of 30% and showed an average increase in HDL cholesterol of 13%.

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