Reappraisal of statin primary prevention trials: implications for identification of the statin-eligible primary prevention patient

作者：G.B. John Mancini, Arnold Ryomoto, Eunice Yeoh, Iulia Iatan, Liam R. Brunham, Robert A. Hegele · 发表于：European Journal of Preventive Cardiology · 年份：2025 · DOI：10.1093/eurjpc/zwaf048 · 被引用次数：10 · 研究领域：Lipoproteins and Cardiovascular Health、Diabetes, Cardiovascular Risks, and Lipoproteins、Health Promotion and Cardiovascular Prevention

AIMS: Identification of patients eligible for primary prevention statin therapy is complex, often relying upon risk algorithms that diverge internationally. Our goal was to develop a simpler global definition of statin-eligible primary prevention patients. METHODS AND RESULTS: Randomized clinical trials (RCTs) cited in North American and European dyslipidaemia guidelines justifying primary prevention statins for cardiovascular risk reduction were critically reappraised according to eligibility criteria and characteristics of actual enrollees. Statin-eligibility based on meeting minimal enrolment criteria vs. risks calculated using the Framingham risk score, the pooled cohort equation, and the systematic coronary risk estimate two were contrasted. Patient scenarios meeting minimal RCT eligibility criteria seldom attained high enough 10 year risk of events according to the algorithms tested and thus would not be eligible for statin therapy. Overall, enrollees were 63.9 ± 8.9 years (mean ± SD) with low density lipoprotein-cholesterol (LDL-C) 3.53 ± 0.91 mmol/L. Enrollees in trials studying the lowest LDL-C levels were generally older and had additional risk factors. CONCLUSION: Results of primary prevention RCTs justify treatment of more subjects and lower risk subjects than current risk algorithm-based guidelines. Based on a synthesis of RCT inclusion/exclusion criteria and the characteristics of enrollees, we propose that a statin-indicated primary prevention subject is one wh...