The treatment of hypercholesterolaemia and mixed/combined hyperlipidaemia with ezetimibe-containing medicines

Jonathan Henry Jacobsen, Elise Rochet, Ning Ma, Ross McLeod, Thomas Vreugdenburg
Record ID 32018001209
Authors' objectives: This report evaluates the clinical effectiveness, safety, cost and cost-effectiveness associated with ezetimibe (monotherapy and combination therapies) in patients with hypercholesterolaemia without atherosclerotic cardiovascular disease (ASCVD), hypercholesterolaemia with ASCVD, mixed/combined hyperlipidaemia (herein referred to as hyperlipidaemia) without ASCVD, and hyperlipidaemia with ASCVD. Legal, social, ethical and organisational issues are also considered.
Authors' results and conclusions: Clinical Evaluation The safety and clinical effectiveness of ezetimibe (monotherapy and combination therapies) was informed by 30 randomised controlled trials (RCTs) in patients with hypercholesterolaemia without ASCVD, 42 RCTs in patients with hypercholesterolaemia and ASCVD, and 5 RCTs in patients with hyperlipidaemia without ASCVD. There were no studies evaluating ezetimibe in patients with hyperlipidaemia and ASCVD. The included RCTs were of moderate to high quality with key concerns relating to incomplete data, uncertain applicability to the Swiss context, and general reliance on surrogate markers to infer clinical effectiveness (i.e. low density lipoprotein-cholesterol [LDL-c], high density lipoprotein-cholesterol [HDL-c], etc.). This summary presents MACE results and the absolute change in surrogate markers at 3 months (short-term) and 12/15 months (long-term). Hypercholesterolaemia without ASCVD There were no studies evaluating ezetimibe monotherapy beyond 3 months. The results for these comparisons were limited to surrogate markers. There were no studies using fenofibrate or ezetimibe plus fenofibrate. Ezetimibe vs placebo At 3 months, there were statistical differences in favour of ezetimibe with respect to the absolute change in LDL-c (mean difference [MD] -46.68mg/dL; 95% confidence interval [CI] -53.46, -39.90mg/dL; p
Project Status: Completed
Year Published: 2021
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Switzerland
MeSH Terms
  • Cardiovascular Diseases
  • Hypercholesterolemia
  • Cholesterol, LDL
  • Hyperlipidemias
  • Anticholesteremic Agents
  • Ezetimibe
  • Ezetimibe, Simvastatin Drug Combination
  • ezetimib
  • statins
  • fenofibrate
  • primary hypercholesterolaemia
  • mixed hyperlipidaemia
  • combined hyperlipidaemia
  • dyslipidaemia
  • artherosclerosis
  • cardiovascular disesase
  • PROMs
  • efficacy
  • effectiveness
  • safety
  • costs
  • economics
  • cost-effectiveness
  • budget impact
  • legal
  • social
  • ethical
  • organisational
Organisation Name: Swiss Federal Office of Public Health (FOPH)
Contact Address: Federal Office of Public Health, Schwarzenburgstrasse 157, CH-3003 Berne, Switzerland
Contact Name: Stephanie Vollenweider
Contact Email:
Copyright: Swiss Federal Office of Public Health
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.