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Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial

dc.rights.licenseopenen_US
dc.contributor.authorAEBI, Philipp Stefan
dc.contributor.authorADAM, Luise
dc.contributor.authorHALLER, Moa
dc.contributor.authorBARDOCZI, Julia Bianca
dc.contributor.authorGENCER, Baris
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
dc.contributor.authorBEER, Jurg-Hans
dc.contributor.authorCARBALLO, Sebastian
dc.contributor.authorCHRIST-CRAIN, Mirjam
dc.contributor.authorFELLER, Martin
dc.contributor.authorGABUTTI, Luca
dc.contributor.authorHAYNES, Alan G
dc.contributor.authorMOUTZOURI, Elisavet
dc.contributor.authorCHOCANO-BEDOYA, Patricia Orializ
dc.contributor.authorBASSETTI, Stefano
dc.contributor.authorESCHER, Robert
dc.contributor.authorEGGER, Martin
dc.contributor.authorPOORTVLIET, Rosalinde K E
dc.contributor.authorSCHUETZ, Philipp
dc.contributor.authorTRELLE, Sven
dc.contributor.authorWERTLI, Maria M
dc.contributor.authorZEKRY, Dina
dc.contributor.authorMEAN, Marie
dc.contributor.authorAUJESKY, Drahomir
dc.contributor.authorBAUER, Douglas
dc.contributor.authorBLUM, Manuel R
dc.contributor.authorRODONDI, Nicolas
dc.date.accessioned2025-07-08T10:57:48Z
dc.date.available2025-07-08T10:57:48Z
dc.date.issued2025-05-23
dc.identifier.issn2044-6055en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/207266
dc.description.abstractEnINTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: 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.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enCardiovascular Disease
dc.subject.enGeriatric Medicine
dc.subject.enLipid Disorders
dc.subject.enPatients
dc.subject.enPrimary Health Care
dc.subject.enPrimary Prevention
dc.title.enRationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial
dc.title.alternativeBMJ Openen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmjopen-2024-093833en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40409969en_US
bordeaux.journalBMJ Openen_US
bordeaux.pagee093833en_US
bordeaux.volume15en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue5en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
hal.identifierhal-05150654
hal.version1
hal.date.transferred2025-07-08T10:57:54Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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