The FDA has approved a 0.4-mg dose of Bayer Corporation's cerivastatin (Baycol) for patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, the statin was approved to reduce triglycerides and apolipoprotein B (apo B) in patients with primary hypercholesterolemia and mixed dyslipidemia. Cerivastatin was initially approved at 0.2-mg and 0.3-mg strengths. Cerivastatin was previously approved as an adjunct to diet for the reduction of elevated total cholesterol and lowdensity lipoprotein cholesterol (LDLC) in patients with hypercholesterolemia and mixed dyslipidemia when the response to dietary restriction of saturated fat and cholesterol and other nonpharmacologic measures was inadequate.
Clinical data from two large trials of patients with hypercholesterolemia showed that patients taking the 0.4-mg dose of cerivastatin each day for 8 weeks (in conjunction with dietary therapy) achieved mean reductions in LDL-C and total cholesterol of 34% and 24%, respectively. Reductions in apo B of 26% were observed. Pooled data from seven studies of patients treated with cerivastatin 0.4 mg for 8 weeks found a median triglyceride reduction from baseline of 30%.
Liver function tests are recommended before treatment with cerivastatin, at 6 and 12 weeks after beginning therapy or elevating the dose, and periodically thereafter, the labeling states. The drug should not be used in patients with active liver disease or unexplained and persistent elevations of serum transaminase, in women during pregnancy, and in breast-feeding women.
Copyright Springhouse Corporation Aug 1999
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