Steen Stender1, Dragos Budinski, Neil Hounslow. 1. Department of Clinical Biochemistry, Gentofte University Hospital, University of Copenhagen, Hellerup, Denmark. stst@geh.regionh.dk
Abstract
AIMS: To assess the long-term efficacy, safety and tolerability of pitavastatin (2 and 4 mg) in elderly patients (≥ 65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. DESIGN:Patients (n = 545) who had completed a 12-week double-blind comparative study (core study) ofpitavastatin and pravastatin entered a 60-week, open-label, multicentre extension study of pitavastatin. The initial daily dose was 2 mg, increasing to 4 mg after 8 weeks if necessary to achieve treatment targets. The proportion of patients attaining European Atherosclerosis Society (EAS) and National Cholesterol Education Program Adult Treatment Plan III (NCEP ATP III) targets for low-density lipoprotein cholesterol (LDL-C) was determined. RESULTS: Of the patients enrolled, 539 received at least one dose of pitavastatin (safety population: men, 45.5%; Caucasian, 99.1%; mean age, 70.3 years; range, 65-89 years). Only 17% of patients required up-titration to pitavastatin 4 mg. After 60 weeks, NCEP ATP III and EAS targets were attained by 93.8% and 89.0% of patients, respectively. Plasma LDL-C declined by 43.4% and high-density lipoprotein cholesterol increased by 9.6% versus core-study baseline values. Pitavastatin was well tolerated: the most common treatment-emergent adverse events were nasopharyngitis, mild/moderate myalgia and hypertension. There were no cases of severe myalgia, myopathy, myositis or rhabdomyolysis, and no significant findings on urinalysis, vital signs or 12-lead ECG. CONCLUSION: Long-term pitavastatin treatment (2 and 4 mg) is effective in lowering LDL-C levels and has a good safety and tolerability profile in elderly patients.
RCT Entities:
AIMS: To assess the long-term efficacy, safety and tolerability of pitavastatin (2 and 4 mg) in elderly patients (≥ 65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. DESIGN:Patients (n = 545) who had completed a 12-week double-blind comparative study (core study) of pitavastatin and pravastatin entered a 60-week, open-label, multicentre extension study of pitavastatin. The initial daily dose was 2 mg, increasing to 4 mg after 8 weeks if necessary to achieve treatment targets. The proportion of patients attaining European Atherosclerosis Society (EAS) and National Cholesterol Education Program Adult Treatment Plan III (NCEP ATP III) targets for low-density lipoprotein cholesterol (LDL-C) was determined. RESULTS: Of the patients enrolled, 539 received at least one dose of pitavastatin (safety population: men, 45.5%; Caucasian, 99.1%; mean age, 70.3 years; range, 65-89 years). Only 17% of patients required up-titration to pitavastatin 4 mg. After 60 weeks, NCEP ATP III and EAS targets were attained by 93.8% and 89.0% of patients, respectively. Plasma LDL-C declined by 43.4% and high-density lipoprotein cholesterol increased by 9.6% versus core-study baseline values. Pitavastatin was well tolerated: the most common treatment-emergent adverse events were nasopharyngitis, mild/moderate myalgia and hypertension. There were no cases of severe myalgia, myopathy, myositis or rhabdomyolysis, and no significant findings on urinalysis, vital signs or 12-lead ECG. CONCLUSION: Long-term pitavastatin treatment (2 and 4 mg) is effective in lowering LDL-C levels and has a good safety and tolerability profile in elderly patients.