Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia

Abstract

Aim: To compare the safety and efficacy of once-daily pitavastatin (1, 2, and 4 mg) and pravastatin (10, 20, and 40 mg) in elderly patients (≥ 65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia.

Design: After a 6-8-week washout/dietary period, patients were randomized to six treatment groups (1, 2, or 4 mg pitavastatin vs. 10, 20, or 40 mg pravastatin) in a 12-week multicentre double-blind study. Patients (n = 942; men, 44.3%; Caucasian, 99.3%; mean age, 70 years; age range, 65-89 years) in all groups were well matched for duration of disease and diagnosis.

Results: Mean decreases in low-density lipoprotein cholesterol over 12 weeks were 31.4-44.3% with pitavastatin 1-4 mg and 22.4-34.0% with pravastatin 10-40 mg (p < 0.001 for all dose comparisons). Compared with pravastatin, pitavastatin provided greater decreases in total cholesterol and apolipoprotein B in all dose groups (p < 0.001) and triglycerides in the low-dose (p = 0.001) and higher-dose (p = 0.016) groups, and greater increases in high-density lipoprotein cholesterol in the intermediate-dose (p = 0.013) and higher-dose (p = 0.023) groups. The proportions of patients achieving the European Atherosclerosis Society target with pitavastatin and pravastatin, respectively, were: low doses, 59.9 and 37.9%; intermediate doses, 79.5 and 51.0%; higher doses, 88.1 and 65.7% (p < 0.001 for all comparisons). Both statins were well tolerated, with no reports of myopathy or rhabdomyolysis.

Conclusion: Pitavastatin provides superior efficacy and comparable tolerability to pravastatin in elderly patients.

Trial registration: ClinicalTrials.gov NCT00257686.