New indication approved for Zocor

Drug Store News, Sept 27, 1999

The FDA has approved a supplemental indication for Merck's Zocor (simvastatin) for increasing HCL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. The broadened indication is based on data from four studies, including a study of patients with combined hyperlipidemia.

In this study, 130 patients (LDL greater than 130 mg/dL and triglycerides 300 to 700 mg/dL) were treated with placebo, Zocor 40 mg/day or Zocor 80 mg/day for six weeks. In a dose-dependent manner, Zocor 40 mg/day and Zocor 80 mg/day, respectively, decreased mean LDL by 29 percent and 36 percent, and median TG levels by 28 percent and 33 percent, while increasing mean HDL by 13 percent and 16 percent.