Clinical evaluation of simvastatin in patients with severe hypercholesterolemia. An Italian open study

Simvastatin, a new semisynthetic inhibitor of hydroxymethylglutaryl coenzyme A reductase, was tested in an open study in 131 Italian patients, most of whom had familial hypercholesterolemia (mean starting cholesterol levels, 370.5 ± 56.7 mg/dl). Triglycerides were generally within normal limits (mean, 170.9 ± 106.5 mg/dl). The open protocol, which was followed up for six months, allowed the physicians to raise the dosage from the starting level of 10 mg/day to 20 mg/day and eventually to 40 mg/day. In 15 patients the 10-mg dose proved sufficient to lower total cholesterol by 33% and low-density lipoprotein cholesterol by 42%. In 35 patients, with similar levels of cholesterol but with more significant elevations of triglycerides and lower high-density lipoprotein levels, it was necessary to raise the dosage to 20 mg/day, but results were similar to those found in the previous series. Finally, in 79 patients with marked elevations of cholesterol (mean, 388 ± 74 mg), the dose was raised ...