Efficacy and safety of fluvastatin in patients with non-insulin-dependent diabetes mellitus and hyperlipidemia: preliminary report

Abstract

This randomized, double-blind, placebo-controlled study was designed to evaluate the effect of fluvastatin on the lipid profiles of patients with hypertriglyceridemia resulting from non-insulin-dependent diabetes mellitus (NIDDM). Sixty-six NIDDM patients (24 men, 42 women) with low density lipoprotein cholesterol (LDL-C) levels > 3.36 mmol/liter (130 mg/dL) and triglyceride (TG) levels of 2.3-11.3 mmol/liter (200-1,000 mg/dL) after an 8-week period of Step I diet were given fluvastatin, 20 mg every PM for 6 weeks followed by 20 mg twice daily for an additional 6 weeks, or placebo. By weeks 9-12, fluvastatin decreased plasma LDL-C levels by 24.3% (p < 0.001) and plasma TG by 15.3% (p < 0.01). High density lipoprotein cholesterol levels increased by 4.6% over the same interval (p < 0.05). Fluvastatin treatment was not associated with abnormalities in the indices of glycemic control or clinically important abnormalities in laboratory values. Fluvastatin is an effective treatment of combined elevations of TG and LDL-C in NIDDM.