Abstract
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.
Patients and 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 40mg, simvastatin or atorvastatin 10, 20, 40 or 80mg) 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.
Conclusion
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.
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Acknowledgements
The investigators who participated in the four studies upon which this analysis was based have been listed in the original publications. Funding for these clinical trials was provided by Merck/Schering-Plough Pharmaceuticals, North Wales, PA, USA. The authors would also like to thank Drs Michael J. Davies and Jennifer Rotonda for assistance with the preparation of this manuscript.
All authors are (John Strony, Bo Yang, Ramachandran Suresh, Enrico Veltri) or were (Leslie Lipka, Philip Sager) employees of Schering Plough Research Institute, Kenilworth, NJ, USA when studies were conducted and may hold stock in the company.
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Lipka, L., Sager, P., Strony, J. et al. Efficacy and Safety of Coadministration of Ezetimibe and Statins in Elderly Patients with Primary Hypercholesterolaemia. Drugs Aging 21, 1025–1032 (2004). https://doi.org/10.2165/00002512-200421150-00005
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DOI: https://doi.org/10.2165/00002512-200421150-00005