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

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datacite.rightsopen.access
dc.contributor.authorAebi, Philipp Stefan
dc.contributor.authorAdam, Luise
dc.contributor.authorHaller, Moa
dc.contributor.authorBardoczi, Julia Bianca
dc.contributor.authorGencer, Baris
dc.contributor.authorBonnet, Fabrice
dc.contributor.authorBeer, Jürg-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.authorMéan, Marie
dc.contributor.authorAujesky, Drahomir
dc.contributor.authorBauer, Douglas
dc.contributor.authorBlum, Manuel R.
dc.contributor.authorRodondi, Nicolas
dc.date.accessioned2025-07-08T14:44:34Z
dc.date.available2025-07-08T14:44:34Z
dc.date.issued2025-05-23
dc.description.abstractIntroduction 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.description.numberOfPages9
dc.description.sponsorshipClinic of General Internal Medicine
dc.description.sponsorshipInstitute of General Practice and Primary Care (BIHAM)
dc.description.sponsorshipClinic of General Internal Medicine
dc.description.sponsorshipDepartment of Clinical Research (DCR) - Statistics & Methodology (Bütikofer)
dc.description.sponsorshipDepartment of Clinical Research, Clinical Trials Unit Bern
dc.description.sponsorshipBerner Institut für Hausarztmedizin (BIHAM) - SC-Team Feller
dc.description.sponsorshipBerner Institut für Hausarztmedizin (BIHAM) - Ageing
dc.description.sponsorshipAllgemeine Innere Medizin
dc.identifier.doi10.48620/89248
dc.identifier.pmid40409969
dc.identifier.publisherDOI10.1136/bmjopen-2024-093833
dc.identifier.urihttps://boris-portal.unibe.ch/handle/20.500.12422/211469
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.relation.fundingSwiss National Science Foundation
dc.relation.grantnoIICT 33IC30‐193052
dc.relation.ispartofBMJ Open
dc.relation.issn2044-6055
dc.subjectCardiovascular Disease
dc.subjectGERIATRIC MEDICINE
dc.subjectLipid disorders
dc.subjectPatients
dc.subjectPrimary Health Care
dc.subjectPrimary Prevention
dc.subject.ddc600 - Technology::610 - Medicine & health
dc.titleRationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial.
dc.typearticle
dspace.entity.typePublication
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oaire.citation.issue5
oaire.citation.startPagee093833
oaire.citation.volume15
oairecerif.author.affiliationClinic of General Internal Medicine
oairecerif.author.affiliationInstitute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliationInstitute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliationInstitute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliationInstitute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliationBerner Institut für Hausarztmedizin (BIHAM) - SC-Team Feller
oairecerif.author.affiliationDepartment of Clinical Research (DCR) - Statistics & Methodology (Bütikofer)
oairecerif.author.affiliationInstitute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliationBerner Institut für Hausarztmedizin (BIHAM) - Ageing
oairecerif.author.affiliationDepartment of Clinical Research, Clinical Trials Unit Bern
oairecerif.author.affiliationClinic of General Internal Medicine
oairecerif.author.affiliationClinic of General Internal Medicine
oairecerif.author.affiliationAllgemeine Innere Medizin
oairecerif.author.affiliationClinic of General Internal Medicine
oairecerif.author.affiliation2Institute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliation2Clinic of General Internal Medicine
oairecerif.author.affiliation2Institute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliation2Institute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliation2Institute of General Practice and Primary Care (BIHAM)
oairecerif.author.affiliation2Institute of General Practice and Primary Care (BIHAM)
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unibe.journal.abbrevTitleBMJ Open
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