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Pitavastatin demonstrates long-term efficacy, safety and tolerability in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia.
MedLine Citation:
PMID:  22345687     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Steen Stender; Dragos Budinski; Neil Hounslow
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-1-23
Journal Detail:
Title:  European journal of preventive cardiology     Volume:  -     ISSN:  2047-4881     ISO Abbreviation:  Eur J Prev Cardiolog     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-2-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101564430     Medline TA:  Eur J Prev Cardiolog     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Clinical Biochemistry, Gentofte University Hospital, University of Copenhagen, Hellerup, Denmark.
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