Aebi Philipp Stefan, Adam Luise, Haller Moa, Bardoczi Julia Bianca, Gencer Baris, Bonnet Fabrice, Beer Jürg-Hans, Carballo Sebastian, Christ-Crain Mirjam, Feller Martin, Gabutti Luca, Haynes Alan G, Moutzouri Elisavet, Chocano-Bedoya Patricia Orializ, Bassetti Stefano, Escher Robert, Egger Martin, Poortvliet Rosalinde K E, Schuetz Philipp, Trelle Sven, Wertli Maria M, Zekry Dina, Méan Marie, Aujesky Drahomir, Bauer Douglas, Blum Manuel R, Rodondi Nicolas
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
BMJ Open. 2025 May 23;15(5):e093833. doi: 10.1136/bmjopen-2024-093833.
Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy <1 year. Therefore, the present RCT aims to assess the safety and potential benefits of statin discontinuation in primary prevention for the ever-growing population of multimorbid older adults.
This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.
The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.
Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158- IDRCB 2022-A02481-42.
他汀类药物是使用最为广泛的药物之一。虽然它们对中年人心血管疾病的一级和二级预防有效，但其对无心血管疾病的老年人（年龄≥70岁）预防的益处尚不确定，尤其是对那些患有多种疾病的老年人。他汀类药物的副作用和药物相互作用在老年患者中很常见，可能会对生活质量产生负面影响。迄今为止，唯一一项研究老年人停用他汀类药物的随机对照试验表明，两组生存率无差异，但确实注意到停用他汀类药物的患者生活质量有小幅改善。然而，该试验仅纳入了预期寿命<1年的患者。因此，本随机对照试验旨在评估在一级预防中，停用他汀类药物对日益增多的患有多种疾病的老年人的安全性和潜在益处。
本研究是一项多中心、随机、非劣效性试验，在瑞士、法国和荷兰的住院和门诊环境中进行，目标是使用他汀类药物进行一级预防的患者。1800名参与者按1:1随机分配至停用（干预组）或继续（对照组）他汀类药物治疗。主要目标是比较对照组和干预组在长达48个月的随访期内主要心血管事件（非致命性心肌梗死或非致命性缺血性中风）和全因死亡的主要复合终点。我们假设停用他汀类药物不会导致无事件生存期缩短，在2年观察期内非劣效性界值设定为5.2周。次要目标是比较以患者为中心的结局（健康相关生活质量、肌肉疼痛症状、跌倒和肌肉减少症）以及全因死亡、非心血管死亡、主要心血管事件和冠状动脉及外周动脉血运重建。该研究为开放标签，主要终点采用盲法结局判定。
试验方案已获得瑞士、法国和荷兰当地伦理委员会的批准。结果将发表在同行评审期刊上。
Clinicaltrials.gov：NCT05178420；瑞士伦理委员会（BASEC）：2021-01513；瑞士国家门户网站（FOPH）：SNCTP000005172；荷兰试验注册：NL83907.058.23；法国试验注册：22.04747.000158 - IDRCB 2022 - A02481 - 42。
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