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Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale.
Joseph J, Pajewski NM, Dolor RJ, Sellers MA, Perdue LH, Peeples SR, Henrie AM, Woolard N, Jones WS, Benziger CP, Orkaby AR, Mixon AS, VanWormer JJ, Shapiro MD, Kistler CE, Polonsky TS, Chatterjee R, Chamberlain AM, Forman DE, Knowlton KU, Gill TM, Newby LK, Hammill BG, Cicek MS, Williams NA, Decker JE, Ou J, Rubinstein J, Choudhary G, Gazmuri RJ, Schmader KE, Roumie CL, Vaughan CP, Effron MB, Cooper-DeHoff RM, Supiano MA, Shah RC, Whittle JC, Hernandez AF, Ambrosius WT, Williamson JD, Alexander KP, PREVENTABLE Trial Research Group. Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale. Journal of the American Geriatrics Society. 2023 Jun 1; 71(6):1701-1713.
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.