Efficacy and safety of coadministration of ezetimibe and statins in elderly patients with primary hypercholesterolaemia.
OBJECTIVE
To compare the efficacy and safety of statin (HMG-CoA reductase inhibitor) monotherapy versus ezetimibe 10mg plus statin in older and younger adults with primary hypercholesterolaemia.


METHODS
Four multicentre, randomised, double-blind, placebo-controlled, balanced parallel-group trials were pooled for analysis. After washout and placebo run-in period, men and women >/=18 years of age (n = 1861) with primary hypercholesterolaemia (plasma low-density lipoprotein-cholesterol [LDL-C] level from >/=3.76 to </=6.48 mmol/L and triglycerides </=3.95 mmol/L) were randomised to either placebo, statin monotherapy (lovastatin or pravastatin 10, 20 or 40 mg, simvastatin or atorvastatin 10, 20, 40 or 80 mg) or ezetimibe plus statin for 12 weeks. For each study, the primary efficacy endpoint was the percentage reduction in LDL-C from baseline to study endpoint. In the present study, age subset analyses on data pooled across these four trials were carried out to determine whether coadministration of ezetimibe and statin was equally efficacious across specific age groupings: age <65 versus >/=65 years; age <75 versus >/=75 years.


RESULTS
Across age groupings, coadministration of ezetimibe and statin produced significant incremental reductions in LDL-C compared with statin monotherapy. The beneficial effects of ezetimibe plus statin on LDL-C, triglycerides and high-density lipoprotein-cholesterol (HDL-C) were overall independent of age groupings. Ezetimibe plus statin therapy was generally well tolerated, with similar incidence of adverse events, serious adverse events and changes in liver function and muscle enzymes in the given age groups compared with statin therapy alone.


CONCLUSIONS
The beneficial effects of ezetimibe coadministered with statins on LDL-C, triglycerides and HDL-C were similar between older and younger hypercholesterolaemic patients, with a favourable safety profile across all patient age groups.
Lipka
Leslie
L
Schering-Plough Research Institute, Kenilworth, New Jersey 07033-1300, USA.
Sager
Philip
P
Strony
John
J
Yang
Bo
B
Suresh
Ramachandran
R
Veltri
Enrico
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000502:physiology; D000410:Alanine Transaminase / Q000097:blood; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001384:Azetidines / Q000009:adverse effects / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000069438:Ezetimibe