Pravastatin and risk factor modification in patients with moderate primary hypercholesterolaemia

Abstract

Aim: To evaluate the efficacy and safety of pravastatin 20mg at night, versus placebo, in combination with dietary, smoking cessation, and other lifestyle advice in general practice.

Methods: This was a multicentre, randomised double blind placebo controlled trial carried out in thirty general practices in three New Zealand centres. Patients with moderate primary hypercholesterolaemia (5.2-6.7 mmol/L) and two or more risk factors for coronary heart disease were enrolled. After a minimum of 6 weeks lifestyle changes, 95 patients (aged 18-70 years) were randomised to active or placebo therapy. They continued to receive advice and encouragement in maintaining dietary, exercise or smoking cessation changes.

Results: Seventy eight patients, pravastatin (n = 39) and placebo (n = 39), completed the treatment phase of the study. After 6 weeks on 20 mg pravastatin, total cholesterol decreased by 18% (0.9 mmol/L, p < 0.0001), triglycerides decreased by 6% (0.1 mmol/L ns), LDL-cholesterol decreased by 23% (1.1 mmol/L, p < 0.0001), and HDL-cholesterol increased by 8% (0.1 mmol/L, ns). A similar effect was also observed after 26 weeks of therapy. These effects were also significant when compared with the placebo group. In 61% of patients treated with pravastatin there was a reduction in cholesterol to less than 5.2 mmol/L, and no real change in lipid levels in patients receiving placebo. No significant differences were observed between the active and placebo groups with regard to patient withdrawal, compliance, or adverse reactions.

Conclusions: In general practice pravastatin is a well tolerated and safe drug that induces a favourable effect on lipid profile in patients with primary moderate hypercholesterolaemia and two or more other risk factors for coronary artery disease.