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


METHODS
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.


CONCLUSIONS
Pitavastatin provides superior efficacy and comparable tolerability to pravastatin in elderly patients.
Department of Clinical Biochemistry, Gentofte University Hospital, University of Copenhagen, Hellerup, Denmark. stst@geh.regionh.dk
Steen
S
Stender
Dragos
D
Budinski
Masahiko
M
Gosho
Neil
N
Hounslow
D000368:Aged; D000369:Aged, 80 and over; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D004311:Double-Blind Method; D004361:Drug Tolerance; D050171:Dyslipidemias / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy*; D008297:Male; D017035:Pravastatin / Q000008:administration & dosage* / Q000009:adverse effects; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D017035:Pravastatin; C108475:pitavastatin