Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale

PREVENTABLE Trial Research Group; Jacob Joseph; Nicholas M. Pajewski; Rowena J. Dolor; Mary Ann Sellers; Letitia H. Perdue; Sheronda R. Peeples; Adam M. Henrie; Nancy Woolard; W. Schuyler Jones; Catherine P. Benziger; Ariela R. Orkaby; Amanda S. Mixon; Jeffrey J. VanWormer; Michael D. Shapiro; Christine E. Kistler; Tamar S. Polonsky; Ranee Chatterjee; Alanna M. Chamberlain; Daniel E. Forman; Kirk U. Knowlton; Thomas M. Gill; L. Kristin Newby; Bradley G. Hammill; Mine S. Cicek; Neely A. Williams; Jake E. Decker; Jiafu Ou; Jack Rubinstein; Gaurav Choudhary; Raúl J. Gazmuri; Kenneth E. Schmader; Christianne L. Roumie; Camille P. Vaughan; Mark B. Effron; Rhonda M. Cooper-DeHoff; Mark A. Supiano; Raj C. Shah; Jeffrey C. Whittle; Adrian F. Hernandez; Walter T. Ambrosius; Jeff D. Williamson; Karen P. Alexander; Sergei Romashkan; Larry Fine; Mark Weiner; Rhonda Cooper-DeHoff; Schuyler Jones; Kate Callahan; Sara Espinoza; Jack Rubinstein; Heather Snyder; Maria Carrillo; Russell Rothman; Betsy Shenkman; Tom Carton; Beth Nauman; Kathleen McTique; Minnie Jefferson; John Wing; Shirley Bloodworth; Alva Owens; Linda Bordelon; Murray Heimberg; Jesse Massey; Miriam Gonzalez; Bob Brashears; Konrad Kaczkowski; Mark King; Kimberly Hoisington; Jeanette Lovato; Julissa Almonte; Jack White; Michael Gaziano; Laura Lovato; Krishna Poddar; Zachary Taylor; David Hunt; Jennifer Hervey; Michelle Kelsey; Renee Leverty; Bryan Batch; Al Richmond; Manda Hufstedler; Alain Chang; Joanne Hetzel; Melissa Laffey; Marco Pahor; Denise Houston; Dalane Kitzman; Steve Rapp; Bonnie Sachs; Scott Lang; Randy Nulph; Emily Rives; Susan Zieman; Anne Newman; Karina Kapitanovsky; David Reboussin; Mina Cicek; Katie Halverson; Sarah Gaussoin; Claire Dohner; Pamela Monds; Clint Alred; Jennifer Bowman; Julie Bunke; Nancie Deckard; Tammy Lowe; Ryan Thiel; Kyra VanDoren; Heidi Whiteside; David Reuben; Peter Peduzzi; Scott Solomon; Hermes Florez; John Breitner; Phil Greenland; Tom Travison; Russ Waitman; Michael Bancks; Katie Burnet; Andrew Telzak; Yessica Estrella Vanterpool; Sandra Oberembt; Irena Davies; Lindsay Shade; Kelsey Strout; Heather Kitzman; Meera Patel; Goutham Rao; Kelsey Ufholz; Sohail Rao; Esmeralda Cardoso; Jenifer Allen; Ambar Kulshreshtha; William Brown; Shanelle Cripps; Daniel Ford; Megan Gauvey-Kern; Angela Meilander; Diane Kohnhorst; Steven Rosas; Joshua Druckrey; Thomas Loepfe; Jodi Kaseno; Madeline Berendt; Richmond Akatue; Steven Houtschilt; Jeff Linder; Tiffany Brown; Lydia Bazzano; Shannon Williams; Seuli Brill; Matthew Jindra; Erin Yurko; Mehta Tapan; Leigh Kirkwood; Gohar Azhar; Amanda Pangle; Matthew Carlson; Jane Lu; Brandi Wells; Howard Gordon; Naomi Ashley; Michael Ernst; Kristin Grdinovac; Erica Lower; Jennifer Hart; Olveen Carrasquillo; Veronica Linares; Michael Hall; Lane Boyer; Kristin Hahn-Cover; Vickie Grieshaber; Alfred Fisher; Sarah Kirke; Jeannie Ake; Emily Klawson; Jessica Lee; Kim Johnson; Nicolas Musi; Kevin Brown; Craig Rubin; Gentina Thompson; Haddy Bah; Jennifer Wharton; Michele Wall; Ezequiel Zamora; Jesus Betancourt; Ellen Binder; Amy Young; Parag Goyal; Fernando Park; Aimee Almonte; Cynthia Carlsson; Hannah Zylstra; Andres Munoz; Ariana Tinker; Kyaw Soe; Jodie Ann Clarke

doi:10.1111/jgs.18312

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale

PREVENTABLE Trial Research Group, Jacob Joseph, Nicholas M. Pajewski, Rowena J. Dolor, Mary Ann Sellers, Letitia H. Perdue, Sheronda R. Peeples, Adam M. Henrie, Nancy Woolard, W. Schuyler Jones, Catherine P. Benziger, Ariela R. Orkaby, Amanda S. Mixon, Jeffrey J. VanWormer, Michael D. Shapiro, Christine E. Kistler, Tamar S. Polonsky, Ranee Chatterjee, Alanna M. Chamberlain, Daniel E. FormanKirk U. Knowlton, Thomas M. Gill, L. Kristin Newby, Bradley G. Hammill, Mine S. Cicek, Neely A. Williams, Jake E. Decker, Jiafu Ou, Jack Rubinstein, Gaurav Choudhary, Raúl J. Gazmuri, Kenneth E. Schmader, Christianne L. Roumie, Camille P. Vaughan, Mark B. Effron, Rhonda M. Cooper-DeHoff, Mark A. Supiano, Raj C. Shah, Jeffrey C. Whittle, Adrian F. Hernandez, Walter T. Ambrosius, Jeff D. Williamson, Karen P. Alexander, Sergei Romashkan, Larry Fine, Mark Weiner, Rhonda Cooper-DeHoff, Schuyler Jones, Kate Callahan, Sara Espinoza, Jack Rubinstein, Heather Snyder, Maria Carrillo, Russell Rothman, Betsy Shenkman, Tom Carton, Beth Nauman, Kathleen McTique, Minnie Jefferson, John Wing, Shirley Bloodworth, Alva Owens, Linda Bordelon, Murray Heimberg, Jesse Massey, Miriam Gonzalez, Bob Brashears, Konrad Kaczkowski, Mark King, Kimberly Hoisington, Jeanette Lovato, Julissa Almonte, Jack White, Michael Gaziano, Laura Lovato, Krishna Poddar, Zachary Taylor, David Hunt, Jennifer Hervey, Michelle Kelsey, Renee Leverty, Bryan Batch, Al Richmond, Manda Hufstedler, Alain Chang, Joanne Hetzel, Melissa Laffey, Marco Pahor, Denise Houston, Dalane Kitzman, Steve Rapp, Bonnie Sachs, Scott Lang, Randy Nulph, Emily Rives, Susan Zieman, Anne Newman, Karina Kapitanovsky, David Reboussin, Mina Cicek, Katie Halverson, Sarah Gaussoin, Claire Dohner, Pamela Monds, Clint Alred, Jennifer Bowman, Julie Bunke, Nancie Deckard, Tammy Lowe, Ryan Thiel, Kyra VanDoren, Heidi Whiteside, David Reuben, Peter Peduzzi, Scott Solomon, Hermes Florez, John Breitner, Phil Greenland, Tom Travison, Russ Waitman, Michael Bancks, Katie Burnet, Andrew Telzak, Yessica Estrella Vanterpool, Sandra Oberembt, Irena Davies, Lindsay Shade, Kelsey Strout, Heather Kitzman, Meera Patel, Goutham Rao, Kelsey Ufholz, Sohail Rao, Esmeralda Cardoso, Jenifer Allen, Ambar Kulshreshtha, William Brown, Shanelle Cripps, Daniel Ford, Megan Gauvey-Kern, Angela Meilander, Diane Kohnhorst, Steven Rosas, Joshua Druckrey, Thomas Loepfe, Jodi Kaseno, Madeline Berendt, Richmond Akatue, Steven Houtschilt, Jeff Linder, Tiffany Brown, Lydia Bazzano, Shannon Williams, Seuli Brill, Matthew Jindra, Erin Yurko, Mehta Tapan, Leigh Kirkwood, Gohar Azhar, Amanda Pangle, Matthew Carlson, Jane Lu, Brandi Wells, Howard Gordon, Naomi Ashley, Michael Ernst, Kristin Grdinovac, Erica Lower, Jennifer Hart, Olveen Carrasquillo, Veronica Linares, Michael Hall, Lane Boyer, Kristin Hahn-Cover, Vickie Grieshaber, Alfred Fisher, Sarah Kirke, Jeannie Ake, Emily Klawson, Jessica Lee, Kim Johnson, Nicolas Musi, Kevin Brown, Craig Rubin, Gentina Thompson, Haddy Bah, Jennifer Wharton, Michele Wall, Ezequiel Zamora, Jesus Betancourt, Ellen Binder, Amy Young, Parag Goyal, Fernando Park, Aimee Almonte, Cynthia Carlsson, Hannah Zylstra, Andres Munoz, Ariana Tinker, Kyaw Soe, Jodie Ann Clarke

Research output: Contribution to journal › Article › peer-review

28 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	1701-1713
Number of pages	13
Journal	Journal of the American Geriatrics Society
Volume	71
Issue number	6
DOIs	https://doi.org/10.1111/jgs.18312
State	Published - Jun 2023

Keywords

cognition
dementia
healthy aging
older adults
statins

Access to Document

10.1111/jgs.18312

Cite this

PREVENTABLE Trial Research Group, Joseph, J., Pajewski, N. M., Dolor, R. J., Sellers, M. A., Perdue, L. H., Peeples, S. R., Henrie, A. M., Woolard, N., Jones, W. S., Benziger, C. P., Orkaby, A. R., Mixon, A. S., VanWormer, J. J., Shapiro, M. D., Kistler, C. E., Polonsky, T. S., Chatterjee, R., Chamberlain, A. M., ... Clarke, J. A. (2023). Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale. Journal of the American Geriatrics Society, 71(6), 1701-1713. https://doi.org/10.1111/jgs.18312

@article{5c903f9f7a7c4363836d3a4e5e69003e,

title = "Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale",

abstract = "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.",

keywords = "cognition, dementia, healthy aging, older adults, statins",

author = "{PREVENTABLE Trial Research Group} and Jacob Joseph and Pajewski, {Nicholas M.} and Dolor, {Rowena J.} and Sellers, {Mary Ann} and Perdue, {Letitia H.} and Peeples, {Sheronda R.} and Henrie, {Adam M.} and Nancy Woolard and Jones, {W. Schuyler} and Benziger, {Catherine P.} and Orkaby, {Ariela R.} and Mixon, {Amanda S.} and VanWormer, {Jeffrey J.} and Shapiro, {Michael D.} and Kistler, {Christine E.} and Polonsky, {Tamar S.} and Ranee Chatterjee and Chamberlain, {Alanna M.} and Forman, {Daniel E.} and Knowlton, {Kirk U.} and Gill, {Thomas M.} and Newby, {L. Kristin} and Hammill, {Bradley G.} and Cicek, {Mine S.} and Williams, {Neely A.} and Decker, {Jake E.} and Jiafu Ou and Jack Rubinstein and Gaurav Choudhary and Gazmuri, {Ra{\'u}l J.} and Schmader, {Kenneth E.} and Roumie, {Christianne L.} and Vaughan, {Camille P.} and Effron, {Mark B.} and Cooper-DeHoff, {Rhonda M.} and Supiano, {Mark A.} and Shah, {Raj C.} and Whittle, {Jeffrey C.} and Hernandez, {Adrian F.} and Ambrosius, {Walter T.} and Williamson, {Jeff D.} and Alexander, {Karen P.} and Sergei Romashkan and Larry Fine and Mark Weiner and Rhonda Cooper-DeHoff and Schuyler Jones and Kate Callahan and Sara Espinoza and Jack Rubinstein and Heather Snyder and Maria Carrillo and Russell Rothman and Betsy Shenkman and Tom Carton and Beth Nauman and Kathleen McTique and Minnie Jefferson and John Wing and Shirley Bloodworth and Alva Owens and Linda Bordelon and Murray Heimberg and Jesse Massey and Miriam Gonzalez and Bob Brashears and Konrad Kaczkowski and Mark King and Kimberly Hoisington and Jeanette Lovato and Julissa Almonte and Jack White and Michael Gaziano and Laura Lovato and Krishna Poddar and Zachary Taylor and David Hunt and Jennifer Hervey and Michelle Kelsey and Renee Leverty and Bryan Batch and Al Richmond and Manda Hufstedler and Alain Chang and Joanne Hetzel and Melissa Laffey and Marco Pahor and Denise Houston and Dalane Kitzman and Steve Rapp and Bonnie Sachs and Scott Lang and Randy Nulph and Emily Rives and Susan Zieman and Anne Newman and Karina Kapitanovsky and David Reboussin and Mina Cicek and Katie Halverson and Sarah Gaussoin and Claire Dohner and Pamela Monds and Clint Alred and Jennifer Bowman and Julie Bunke and Nancie Deckard and Tammy Lowe and Ryan Thiel and Kyra VanDoren and Heidi Whiteside and David Reuben and Peter Peduzzi and Scott Solomon and Hermes Florez and John Breitner and Phil Greenland and Tom Travison and Russ Waitman and Michael Bancks and Katie Burnet and Andrew Telzak and Vanterpool, {Yessica Estrella} and Sandra Oberembt and Irena Davies and Lindsay Shade and Kelsey Strout and Heather Kitzman and Meera Patel and Goutham Rao and Kelsey Ufholz and Sohail Rao and Esmeralda Cardoso and Jenifer Allen and Ambar Kulshreshtha and William Brown and Shanelle Cripps and Daniel Ford and Megan Gauvey-Kern and Angela Meilander and Diane Kohnhorst and Steven Rosas and Joshua Druckrey and Thomas Loepfe and Jodi Kaseno and Madeline Berendt and Richmond Akatue and Steven Houtschilt and Jeff Linder and Tiffany Brown and Lydia Bazzano and Shannon Williams and Seuli Brill and Matthew Jindra and Erin Yurko and Mehta Tapan and Leigh Kirkwood and Gohar Azhar and Amanda Pangle and Matthew Carlson and Jane Lu and Brandi Wells and Howard Gordon and Naomi Ashley and Michael Ernst and Kristin Grdinovac and Erica Lower and Jennifer Hart and Olveen Carrasquillo and Veronica Linares and Michael Hall and Lane Boyer and Kristin Hahn-Cover and Vickie Grieshaber and Alfred Fisher and Sarah Kirke and Jeannie Ake and Emily Klawson and Jessica Lee and Kim Johnson and Nicolas Musi and Kevin Brown and Craig Rubin and Gentina Thompson and Haddy Bah and Jennifer Wharton and Michele Wall and Ezequiel Zamora and Jesus Betancourt and Ellen Binder and Amy Young and Parag Goyal and Fernando Park and Aimee Almonte and Cynthia Carlsson and Hannah Zylstra and Andres Munoz and Ariana Tinker and Kyaw Soe and Clarke, {Jodie Ann}",

note = "Publisher Copyright: {\textcopyright} 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.",

year = "2023",

month = jun,

doi = "10.1111/jgs.18312",

language = "English",

volume = "71",

pages = "1701--1713",

journal = "Journal of the American Geriatrics Society",

issn = "0002-8614",

number = "6",

}

PREVENTABLE Trial Research Group, 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, Romashkan, S, Fine, L, Weiner, M, Cooper-DeHoff, R, Jones, S, Callahan, K, Espinoza, S, Rubinstein, J, Snyder, H, Carrillo, M, Rothman, R, Shenkman, B, Carton, T, Nauman, B, McTique, K, Jefferson, M, Wing, J, Bloodworth, S, Owens, A, Bordelon, L, Heimberg, M, Massey, J, Gonzalez, M, Brashears, B, Kaczkowski, K, King, M, Hoisington, K, Lovato, J, Almonte, J, White, J, Gaziano, M, Lovato, L, Poddar, K, Taylor, Z, Hunt, D, Hervey, J, Kelsey, M, Leverty, R, Batch, B, Richmond, A, Hufstedler, M, Chang, A, Hetzel, J, Laffey, M, Pahor, M, Houston, D, Kitzman, D, Rapp, S, Sachs, B, Lang, S, Nulph, R, Rives, E, Zieman, S, Newman, A, Kapitanovsky, K, Reboussin, D, Cicek, M, Halverson, K, Gaussoin, S, Dohner, C, Monds, P, Alred, C, Bowman, J, Bunke, J, Deckard, N, Lowe, T, Thiel, R, VanDoren, K, Whiteside, H, Reuben, D, Peduzzi, P, Solomon, S, Florez, H, Breitner, J, Greenland, P, Travison, T, Waitman, R, Bancks, M, Burnet, K, Telzak, A, Vanterpool, YE, Oberembt, S, Davies, I, Shade, L, Strout, K, Kitzman, H, Patel, M, Rao, G, Ufholz, K, Rao, S, Cardoso, E, Allen, J, Kulshreshtha, A, Brown, W, Cripps, S, Ford, D, Gauvey-Kern, M, Meilander, A, Kohnhorst, D, Rosas, S, Druckrey, J, Loepfe, T, Kaseno, J, Berendt, M, Akatue, R, Houtschilt, S, Linder, J, Brown, T, Bazzano, L, Williams, S, Brill, S, Jindra, M, Yurko, E, Tapan, M, Kirkwood, L, Azhar, G, Pangle, A, Carlson, M, Lu, J, Wells, B, Gordon, H, Ashley, N, Ernst, M, Grdinovac, K, Lower, E, Hart, J, Carrasquillo, O, Linares, V, Hall, M, Boyer, L, Hahn-Cover, K, Grieshaber, V, Fisher, A, Kirke, S, Ake, J, Klawson, E, Lee, J, Johnson, K, Musi, N, Brown, K, Rubin, C, Thompson, G, Bah, H, Wharton, J, Wall, M, Zamora, E, Betancourt, J, Binder, E, Young, A, Goyal, P, Park, F, Almonte, A, Carlsson, C, Zylstra, H, Munoz, A, Tinker, A, Soe, K & Clarke, JA 2023, 'Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale', Journal of the American Geriatrics Society, vol. 71, no. 6, pp. 1701-1713. https://doi.org/10.1111/jgs.18312

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 - Espinoza, Sara

AU - Rubinstein, Jack

AU - Snyder, Heather

AU - Carrillo, Maria

AU - Rothman, Russell

AU - Shenkman, Betsy

AU - Carton, Tom

AU - Nauman, Beth

AU - McTique, Kathleen

AU - Jefferson, Minnie

AU - Wing, John

AU - Bloodworth, Shirley

AU - Owens, Alva

AU - Bordelon, Linda

AU - Heimberg, Murray

AU - Massey, Jesse

AU - Gonzalez, Miriam

AU - Brashears, Bob

AU - Kaczkowski, Konrad

AU - King, Mark

AU - Hoisington, Kimberly

AU - Lovato, Jeanette

AU - Almonte, Julissa

AU - White, Jack

AU - Gaziano, Michael

AU - Lovato, Laura

AU - Poddar, Krishna

AU - Taylor, Zachary

AU - Hunt, David

AU - Hervey, Jennifer

AU - Kelsey, Michelle

AU - Leverty, Renee

AU - Batch, Bryan

AU - Richmond, Al

AU - Hufstedler, Manda

AU - Chang, Alain

AU - Hetzel, Joanne

AU - Laffey, Melissa

AU - Pahor, Marco

AU - Houston, Denise

AU - Kitzman, Dalane

AU - Rapp, Steve

AU - Sachs, Bonnie

AU - Lang, Scott

AU - Nulph, Randy

AU - Rives, Emily

AU - Zieman, Susan

AU - Newman, Anne

AU - Kapitanovsky, Karina

AU - Reboussin, David

AU - Cicek, Mina

AU - Halverson, Katie

AU - Gaussoin, Sarah

AU - Dohner, Claire

AU - Monds, Pamela

AU - Alred, Clint

AU - Bowman, Jennifer

AU - Bunke, Julie

AU - Deckard, Nancie

AU - Lowe, Tammy

AU - Thiel, Ryan

AU - VanDoren, Kyra

AU - Whiteside, Heidi

AU - Reuben, David

AU - Peduzzi, Peter

AU - Solomon, Scott

AU - Florez, Hermes

AU - Breitner, John

AU - Greenland, Phil

AU - Travison, Tom

AU - Waitman, Russ

AU - Bancks, Michael

AU - Burnet, Katie

AU - Telzak, Andrew

AU - Vanterpool, Yessica Estrella

AU - Oberembt, Sandra

AU - Davies, Irena

AU - Shade, Lindsay

AU - Strout, Kelsey

AU - Kitzman, Heather

AU - Patel, Meera

AU - Rao, Goutham

AU - Ufholz, Kelsey

AU - Rao, Sohail

AU - Cardoso, Esmeralda

AU - Allen, Jenifer

AU - Kulshreshtha, Ambar

AU - Brown, William

AU - Cripps, Shanelle

AU - Ford, Daniel

AU - Gauvey-Kern, Megan

AU - Meilander, Angela

AU - Kohnhorst, Diane

AU - Rosas, Steven

AU - Druckrey, Joshua

AU - Loepfe, Thomas

AU - Kaseno, Jodi

AU - Berendt, Madeline

AU - Akatue, Richmond

AU - Houtschilt, Steven

AU - Linder, Jeff

AU - Brown, Tiffany

AU - Bazzano, Lydia

AU - Williams, Shannon

AU - Brill, Seuli

AU - Jindra, Matthew

AU - Yurko, Erin

AU - Tapan, Mehta

AU - Kirkwood, Leigh

AU - Azhar, Gohar

AU - Pangle, Amanda

AU - Carlson, Matthew

AU - Lu, Jane

AU - Wells, Brandi

AU - Gordon, Howard

AU - Ashley, Naomi

AU - Ernst, Michael

AU - Grdinovac, Kristin

AU - Lower, Erica

AU - Hart, Jennifer

AU - Carrasquillo, Olveen

AU - Linares, Veronica

AU - Hall, Michael

AU - Boyer, Lane

AU - Hahn-Cover, Kristin

AU - Grieshaber, Vickie

AU - Fisher, Alfred

AU - Kirke, Sarah

AU - Ake, Jeannie

AU - Klawson, Emily

AU - Lee, Jessica

AU - Johnson, Kim

AU - Musi, Nicolas

AU - Brown, Kevin

AU - Rubin, Craig

AU - Thompson, Gentina

AU - Bah, Haddy

AU - Wharton, Jennifer

AU - Wall, Michele

AU - Zamora, Ezequiel

AU - Betancourt, Jesus

AU - Binder, Ellen

AU - Young, Amy

AU - Goyal, Parag

AU - Park, Fernando

AU - Almonte, Aimee

AU - Carlsson, Cynthia

AU - Zylstra, Hannah

AU - Munoz, Andres

AU - Tinker, Ariana

AU - Soe, Kyaw

AU - Clarke, Jodie Ann

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

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 -

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale

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