Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial

Residual cardiovascular risk persists despite statins, yet outcome studies of lipid‐targeted therapies beyond low‐density lipoprotein cholesterol (LDL‐C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High‐dose eicosapentaenoic ac...

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Veröffentlicht in:Clinical cardiology (Mahwah, N.J.) Jg. 40; H. 3; S. 138 - 148
Hauptverfasser: Bhatt, Deepak L., Steg, Ph. Gabriel, Brinton, Eliot A., Jacobson, Terry A., Miller, Michael, Tardif, Jean‐Claude, Ketchum, Steven B., Doyle, Ralph T., Murphy, Sabina A., Soni, Paresh N., Braeckman, Rene A., Juliano, Rebecca A., Ballantyne, Christie M.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: New York Wiley Periodicals, Inc 01.03.2017
John Wiley & Sons, Inc
Schlagworte:
Cardiovascular Diseases - drug therapy
Cardiovascular Diseases - epidemiology
Clinical trials
Dose-Response Relationship, Drug
Double-Blind Method
Eicosapentaenoic Acid - administration & dosage
Eicosapentaenoic Acid - analogs & derivatives
Female
Follow-Up Studies
France - epidemiology
General clinical cardiology/adult
Health risk assessment
Heart attacks
Humans
Incidence
Lipidology
Low density lipoprotein
Male
Middle Aged
Platelet Aggregation Inhibitors - administration & dosage
Prospective Studies
Quebec - epidemiology
Risk Factors
Time Factors
Treatment Outcome
Trial Designs
Triglycerides
United Kingdom - epidemiology
United States - epidemiology
Clinical trials
General clinical cardiology/adult
Lipidology
ISSN:0160-9289, 1932-8737, 1932-8737
Online-Zugang:Volltext
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Zusammenfassung:Residual cardiovascular risk persists despite statins, yet outcome studies of lipid‐targeted therapies beyond low‐density lipoprotein cholesterol (LDL‐C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High‐dose eicosapentaenoic acid (EPA) reduces triglyceride‐rich lipoproteins without raising LDL‐C. Omega‐3s have postulated pleiotropic cardioprotective benefits beyond triglyceride‐lowering. To date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes. The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE‐IT; NCT01492361) is a phase 3b randomized, double‐blinded, placebo‐controlled trial of icosapent ethyl, a highly purified ethyl ester of EPA, vs placebo. The main objective is to evaluate whether treatment with icosapent ethyl reduces ischemic events in statin‐treated patients with high triglycerides at elevated cardiovascular risk. REDUCE‐IT enrolled men or women age ≥45 years with established cardiovascular disease or age ≥50 years with diabetes mellitus and 1 additional risk factor. Randomization required fasting triglycerides ≥150 mg/dL and <500 mg/dL and LDL‐C >40 mg/dL and ≤100 mg/dL with stable statin (± ezetimibe) ≥4 weeks prior to qualifying measurements. The primary endpoint is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary endpoint is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Several secondary, tertiary, and exploratory endpoints will be assessed. Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow‐up will continue in this event‐driven trial until approximately 1612 adjudicated primary‐efficacy endpoint events have occurred.
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Funding information The trial is sponsored by Amarin Pharma Inc.
ISSN:0160-9289
1932-8737
1932-8737
DOI:10.1002/clc.22692