Randomized Controlled Trial

. 2023 Jun;71(6):1701-1713.

doi: 10.1111/jgs.18312. Epub 2023 Apr 20.

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

Jacob Joseph¹, Nicholas M Pajewski², Rowena J Dolor³, Mary Ann Sellers³, Letitia H Perdue², Sheronda R Peeples⁴, Adam M Henrie⁵, Nancy Woolard², W Schuyler Jones³, Catherine P Benziger⁶, Ariela R Orkaby⁷, Amanda S Mixon⁸, Jeffrey J VanWormer⁹, Michael D Shapiro², Christine E Kistler¹⁰, Tamar S Polonsky¹¹, Ranee Chatterjee³, Alanna M Chamberlain¹², Daniel E Forman¹³, Kirk U Knowlton¹⁴, Thomas M Gill¹⁵, L Kristin Newby³, Bradley G Hammill³, Mine S Cicek¹², Neely A Williams¹⁶, Jake E Decker¹⁷, Jiafu Ou¹⁸, Jack Rubinstein¹⁹, Gaurav Choudhary²⁰, Raúl J Gazmuri²¹, Kenneth E Schmader²², Christianne L Roumie⁸, Camille P Vaughan²³, Mark B Effron²⁴, Rhonda M Cooper-DeHoff²⁵, Mark A Supiano²⁶, Raj C Shah²⁷, Jeffrey C Whittle²⁸, Adrian F Hernandez³, Walter T Ambrosius², Jeff D Williamson², Karen P Alexander³; PREVENTABLE Trial Research Group

Collaborators, Affiliations

Collaborators

PREVENTABLE Trial Research Group:
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, Kenny Vu, Christina Hy, Cathy Lee, Angela Zeng, Alexander Hallock, Karen Reuben-Hallock, Brian Malm, Kasey Spreyer, Enzo Yaksic, Pearl Lee, Carly Runge, Sudeshna Kundu, Kieu Chau, William Rodriguez-Cintron, Sara Fuentes-Medina, Socorro Marie White, Mark Liu, Iliana Romero, Amir Tavabi, William Penny, Melissa St John, Paul Eleazer, Stephen Thongsa, Sathya Krishnasamy, Jordan Ricks, James Walsh, Lauren Espique, Jyotika Fernandes, Taylor Willis, Adrianna Ricci, Brian Peek, Jessica Michael, Mechelle Lockhart, Dennis Hall, Cortny Withee, Alayne Markland, Donald Davis, Teresa Todela, Dennis Sullivan, Linda Sawyer, Julie Lorscheter, Ankur Gupta, Tiffany Castle, Julienne Reynolds, Holly Kramer, Corliss Taylor, Kent Kirchner, Anita Kaye Spencer, Michael Godschalk, Charmaine Taylor, Steven Atlas, Raynier Baez Guerrero, Manyank Kansal, Jose Tenorio, Vikas Singh, Shamsa Kiran, Marie Albert, Vanessa Knipping, Richard Childress, Brandon Beaverson, Leonardo Tamariz, Jennifer Denizard, Sriram Peruvemba, Julianna Venetucci, Vijay Shivaswamy, Ramesh Ramalingam

Affiliations

¹ VA Providence Healthcare System, Providence, Rhode Island, USA.
² Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
³ Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
⁴ VA Boston Healthcare System, Boston, Massachusetts, USA.
⁵ Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Albuquerque, New Mexico, USA.
⁶ Essentia Health, Duluth, Minnesota, USA.
⁷ New England Geriatric Research, Education, and Clinical Center (GRECC), VA Boston Healthcare System, and Division of Aging, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁸ Vanderbilt University Medical Center and Geriatric Research Education and Clinical Center (GRECC), VA Tennessee Valley Healthcare System, Nashville, Tennessee, USA.
⁹ Marshfield Clinical Research Institute, Marshfield, Wisconsin, USA.
¹⁰ Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, North Carolina, USA.
¹¹ University of Chicago Medicine, Chicago, Illinois, USA.
¹² Mayo Clinic, Rochester, Minnesota, USA.
¹³ Department of Medicine, Sections of Geriatrics and Cardiology, University of Pittsburgh, Pittsburgh GRECC, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.
¹⁴ Intermountain Healthcare, Salt Lake City, Utah, USA.
¹⁵ Yale School of Medicine, New Haven, Connecticut, USA.
¹⁶ TN CEAL, Nashville, Tennessee, USA.
¹⁷ Section of Primary Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
¹⁸ Cardiology Division, John Cochran VA Medical Center and Cardiology Division, Washington University School of Medicine, St. Louis, Missouri, USA.
¹⁹ Division of Cardiology, Cincinnati VAMC and Division of Cardiovascular Diseases, Department of Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
²⁰ Providence VA Medical Center, and Lifespan Cardiovascular Institute, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
²¹ Captain James A. Lovell Federal Health Care Center, Rosalind Franklin University of Medicine and Science, Chicago, Illinois, USA.
²² Duke University and GRECC, Durham VA Medical Center, Durham, North Carolina, USA.
²³ Birmingham/Atlanta Geriatric Research Education and Clinical Center (GRECC), Department of Veterans Affairs, and Division of Geriatrics & Gerontology, Department of Medicine, Emory University, Atlanta, Georgia, USA.
²⁴ John Ochsner Heart and Vascular Institute, The University of Queensland Ochsner Clinical School, New Orleans, Louisiana, USA.
²⁵ University of Florida, College of Pharmacy and College of Medicine, Gainesville, Florida, USA.
²⁶ The University of Utah, Salt Lake, Utah, USA.
²⁷ Family & Preventive Medicine and the Rush Alzheimer's Disease Center, Rush University, Chicago, Illinois, USA.
²⁸ Clement J Zablocki VA Medical Center, Milwaukee, Wisconsin, USA.

PMID: 37082807
PMCID: PMC10258159
DOI: 10.1111/jgs.18312

Randomized Controlled Trial

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

Jacob Joseph et al. J Am Geriatr Soc. 2023 Jun.

. 2023 Jun;71(6):1701-1713.

doi: 10.1111/jgs.18312. Epub 2023 Apr 20.

Authors

Collaborators

PREVENTABLE Trial Research Group:
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, Kenny Vu, Christina Hy, Cathy Lee, Angela Zeng, Alexander Hallock, Karen Reuben-Hallock, Brian Malm, Kasey Spreyer, Enzo Yaksic, Pearl Lee, Carly Runge, Sudeshna Kundu, Kieu Chau, William Rodriguez-Cintron, Sara Fuentes-Medina, Socorro Marie White, Mark Liu, Iliana Romero, Amir Tavabi, William Penny, Melissa St John, Paul Eleazer, Stephen Thongsa, Sathya Krishnasamy, Jordan Ricks, James Walsh, Lauren Espique, Jyotika Fernandes, Taylor Willis, Adrianna Ricci, Brian Peek, Jessica Michael, Mechelle Lockhart, Dennis Hall, Cortny Withee, Alayne Markland, Donald Davis, Teresa Todela, Dennis Sullivan, Linda Sawyer, Julie Lorscheter, Ankur Gupta, Tiffany Castle, Julienne Reynolds, Holly Kramer, Corliss Taylor, Kent Kirchner, Anita Kaye Spencer, Michael Godschalk, Charmaine Taylor, Steven Atlas, Raynier Baez Guerrero, Manyank Kansal, Jose Tenorio, Vikas Singh, Shamsa Kiran, Marie Albert, Vanessa Knipping, Richard Childress, Brandon Beaverson, Leonardo Tamariz, Jennifer Denizard, Sriram Peruvemba, Julianna Venetucci, Vijay Shivaswamy, Ramesh Ramalingam

Affiliations

¹ VA Providence Healthcare System, Providence, Rhode Island, USA.
² Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
³ Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
⁴ VA Boston Healthcare System, Boston, Massachusetts, USA.
⁵ Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Albuquerque, New Mexico, USA.
⁶ Essentia Health, Duluth, Minnesota, USA.
⁷ New England Geriatric Research, Education, and Clinical Center (GRECC), VA Boston Healthcare System, and Division of Aging, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁸ Vanderbilt University Medical Center and Geriatric Research Education and Clinical Center (GRECC), VA Tennessee Valley Healthcare System, Nashville, Tennessee, USA.
⁹ Marshfield Clinical Research Institute, Marshfield, Wisconsin, USA.
¹⁰ Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, North Carolina, USA.
¹¹ University of Chicago Medicine, Chicago, Illinois, USA.
¹² Mayo Clinic, Rochester, Minnesota, USA.
¹³ Department of Medicine, Sections of Geriatrics and Cardiology, University of Pittsburgh, Pittsburgh GRECC, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.
¹⁴ Intermountain Healthcare, Salt Lake City, Utah, USA.
¹⁵ Yale School of Medicine, New Haven, Connecticut, USA.
¹⁶ TN CEAL, Nashville, Tennessee, USA.
¹⁷ Section of Primary Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
¹⁸ Cardiology Division, John Cochran VA Medical Center and Cardiology Division, Washington University School of Medicine, St. Louis, Missouri, USA.
¹⁹ Division of Cardiology, Cincinnati VAMC and Division of Cardiovascular Diseases, Department of Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
²⁰ Providence VA Medical Center, and Lifespan Cardiovascular Institute, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
²¹ Captain James A. Lovell Federal Health Care Center, Rosalind Franklin University of Medicine and Science, Chicago, Illinois, USA.
²² Duke University and GRECC, Durham VA Medical Center, Durham, North Carolina, USA.
²³ Birmingham/Atlanta Geriatric Research Education and Clinical Center (GRECC), Department of Veterans Affairs, and Division of Geriatrics & Gerontology, Department of Medicine, Emory University, Atlanta, Georgia, USA.
²⁴ John Ochsner Heart and Vascular Institute, The University of Queensland Ochsner Clinical School, New Orleans, Louisiana, USA.
²⁵ University of Florida, College of Pharmacy and College of Medicine, Gainesville, Florida, USA.
²⁶ The University of Utah, Salt Lake, Utah, USA.
²⁷ Family & Preventive Medicine and the Rush Alzheimer's Disease Center, Rush University, Chicago, Illinois, USA.
²⁸ Clement J Zablocki VA Medical Center, Milwaukee, Wisconsin, USA.

PMID: 37082807
PMCID: PMC10258159
DOI: 10.1111/jgs.18312

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.

Trial registration: ClinicalTrials.gov NCT04262206.

Keywords: cognition; dementia; healthy aging; older adults; statins.

PubMed Disclaimer

Conflict of interest statement

Thomas M. Gill is supported by P30AG021342 and 5UL1TR001863. Dr. Pajewski is supported by P30AG021332, R01HL155396, and R01AG071807. Dr Roumie is supported in part by CX000570-10 and the Center for Diabetes Translation Research P30DK092986.

Daniel E. Forman is supported by NIH awards R01AG060499, R01AG058883, and P30AG02482, and VHA MERIT award I01HX003518.

L. Kristin Newby reports research funding from NHLBI, NIA, NICHD, NC DHHS, BioKier, Roche Diagnostics; Consulting/advisory board for CSL-Behring, Medtronic, Beckman-Coulter, NHLBI; Non-funded “other” for BOD DHMRI, BOT AZ Healthcare Foundation.

Jacob Joseph reports research funding from NIH, Veterans Health Administration, Amgen, Kowa, and Alnylam.

Kenneth Schmader reports support from the Duke Pepper Older Americans Independence Center (NIA P30AG028716).

Michael Shapiro reports scientific advisory boards: Amgen, Novartis, NovoNordisk; Consulting: Ionis, Regeneron.

W. Schuyler Jones reports research grants from Bayer Boehringer Ingelheim, Merck, National Institutes of Health, Patient-Centered Outcomes Research Institute; Honoraria/Advisory Committees from Bayer, Bristol-Myers Squibb, Janssen Pharmaceuticals.

Catherine P. Benzinger reports site PI for studies funded by Department of Defense (WARRIOR), Amgen (VESALIUS), Novartis (INCLISIRAN), but are not relevant to the current study (does not receive financial support).

Raj C. Shah reports being the site principal investigator or sub-investigator for Alzheimer’s disease clinical trials for which his institution (Rush University Medical Center) is compensated (Amylyx Pharmaceuticals, Inc., Athira Pharma, Inc., Edgewater NEXT, Eli Lilly & Co., Inc., and Genentech, Inc.).

Christine E. Kistler reports serving as a consultant to a pharmacogenomics company, Base10, Inc. and on a pharmacogenomics advisory board for Baptist Health, FL.

Ariela R. Orkaby reports Veterans Affairs CSR&D CDA-2 award IK2-CX001800; consulting for Anthos Therapeutics.

Rowena J. Dolor reports grant funding from NIA paid to the institution for this project; PCORI, honorarium (less than $5000), as a member of the PCORI Clinical Trials Advisory Panel; Einstein-Montefiore, honorarium (less than $5000), as a member of their CTSA External Advisory Board; Veterans Administration, honorarium (less than $5000), as a consultant to the Women’s Health Practice-Based Research Network.

Karen P. Alexander reports grant funding from NIA to the institution for this project.

All other authors have nothing to report.

Figures

**Figure 2.**
PREVENTABLE pragmatism on PRECIS-2

See this image and copyright information in PMC

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

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

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