TY - JOUR
T1 - Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE)
T2 - Trial design and rationale
AU - PREVENTABLE Trial Research Group
AU - Joseph, Jacob
AU - Pajewski, Nicholas M.
AU - Dolor, Rowena J.
AU - Sellers, Mary Ann
AU - Perdue, Letitia H.
AU - Peeples, Sheronda R.
AU - Henrie, Adam M.
AU - Woolard, Nancy
AU - Jones, W. Schuyler
AU - Benziger, Catherine P.
AU - Orkaby, Ariela R.
AU - Mixon, Amanda S.
AU - VanWormer, Jeffrey J.
AU - Shapiro, Michael D.
AU - Kistler, Christine E.
AU - Polonsky, Tamar S.
AU - Chatterjee, Ranee
AU - Chamberlain, Alanna M.
AU - Forman, Daniel E.
AU - Knowlton, Kirk U.
AU - Gill, Thomas M.
AU - Newby, L. Kristin
AU - Hammill, Bradley G.
AU - Cicek, Mine S.
AU - Williams, Neely A.
AU - Decker, Jake E.
AU - Ou, Jiafu
AU - Rubinstein, Jack
AU - Choudhary, Gaurav
AU - Gazmuri, Raúl J.
AU - Schmader, Kenneth E.
AU - Roumie, Christianne L.
AU - Vaughan, Camille P.
AU - Effron, Mark B.
AU - Cooper-DeHoff, Rhonda M.
AU - Supiano, Mark A.
AU - Shah, Raj C.
AU - Whittle, Jeffrey C.
AU - Hernandez, Adrian F.
AU - Ambrosius, Walter T.
AU - Williamson, Jeff D.
AU - Alexander, Karen P.
AU - Romashkan, Sergei
AU - Fine, Larry
AU - Weiner, Mark
AU - Cooper-DeHoff, Rhonda
AU - Jones, Schuyler
AU - Callahan, Kate
AU - Fisher, Alfred
AU - Shivaswamy, Vijay
N1 - Publisher Copyright:
© 2023 The American Geriatrics Society. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.
PY - 2023/6
Y1 - 2023/6
N2 - Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.
AB - Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.
KW - cognition
KW - dementia
KW - healthy aging
KW - older adults
KW - statins
UR - http://www.scopus.com/inward/record.url?scp=85153705424&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85153705424&partnerID=8YFLogxK
U2 - 10.1111/jgs.18312
DO - 10.1111/jgs.18312
M3 - Article
C2 - 37082807
AN - SCOPUS:85153705424
SN - 0002-8614
VL - 71
SP - 1701
EP - 1713
JO - Journal of the American Geriatrics Society
JF - Journal of the American Geriatrics Society
IS - 6
ER -