Low-Dose Simvastatin in the Treatment of Mild to Moderate Hypercholesterolaemia

Abstract

HMG CoA reductase inhibitors have been shown to be effective agents in lowering cholesterol in patients with primary hypercholesterolaemia. The aim of this study was to determine whether simvastatin at a low dose of 5mg given once in the evening was also effective in lowering cholesterol. In a multicentre, randomised, placebo-controlled study, 86 subjects (64 males, 22 females) with a mean age of 61 ± 13.1 years and serum total cholesterol concentrations of 5.2 to 7.0 mmol/L were investigated. After an initial 10 weeks of a standard lipid-lowering diet, the last 4 weeks on placebo, participants were randomised to receive either simvastatin 5mg or matching placebo to be taken in the evening. After 6 weeks, study participants not achieving a target cholesterol of ≤ 5.2 mmol/L were titrated to simvastatin 10mg or matching placebo for a further 6 weeks. At 6 weeks, 77% of the simvastatin-treated group had achieved a cholesterol level of ≤ 5.2 mmol/L compared with only 5% of the placebo-treated group (p < 0.01). Simvastatin 5mg decreased total cholesterol by 17.7%, low-density lipoprotein cholesterol by 25.4% and triglyceride by 5.8%; high-density lipoprotein cholesterol rose by 8.7%. Increasing simvastatin to 10mg in 23% of subjects did not significantly alter the lipid levels. Clinical and biochemical adverse experiences were few and were similar in the simvastatin and placebo groups. This study demonstrated that simvastatin at a low dose of 5mg is a well tolerated and effective lipid-lowering agent in subjects with mild to moderate hypercholesterolaemia.