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Author Notes:

Corresponding Author: Sonal Singh MD, MPH, University of Massachusetts Medical School 55 Lake Ave North, Worcester, MA 01655. sonal.singh@umassmemorial.org

All presenters had the opportunity to review the manuscript and provide comments.

The study authors acknowledge the contributions of Daniel E. Forman, MD, to the present manuscript.

The authors thank the following NIA and NHLBI staff for coordinating and participating in the workshop: Lawrence C. Fine, MD, NHLBI; Evan Hadley, MD, Sergei V. Romashkan MD, PhD, and Marcel Salive, MD, NIA.

We thank the following individuals whose presentations at the workshop, in addition to those of the coauthors, stimulated the development of this article: Lesley Curtis, PhD, Duke Clinical Research Institute; Michelle Oden, PhD, MS, Oregon State University; Eric D. Peterson, MD, Duke Clinical Research Institute; Paul M. Ridker, MD, Brigham and Women’s Hospital, Harvard School of Medicine; Janice B. Schwartz MD, University of California San Francisco; Mary Sano, PhD, Icahn School of Medicine; Paul D. Thompson, MD, Hartford HealthCare Heart & Vascular Institute

Dr. Singh reports giving expert testimony for plaintiffs’ attorneys in litigation involving a statin.

Dr. Go reports receiving a research grant through his institution from Sanofi.

Dr. Wenger reports research grants, contracts, trial steering committee, trial data safety and monitoring board involvement with Gilead Sciences, NHLBI, Pfizer, and Society for Women’s Health Research. She also reports consultancies with Amgen, AstraZeneca, Gilead Sciences, Janssen Pharmaceuticals, and Merck.

Dr. Zoungas reports past participation in advisory boards, educational meetings or research on behalf of Monash University (for work unrelated to this paper) with AstraZeneca Pty Ltd, Eli Lilly Australia Pty Ltd, Merck Sharp & Dohme (Australia) Pty Ltd, and Novo Nordisk Pty Ltd.

Dr. Gurwitz serves as a member of the UnitedHealthcare Pharmacy and Therapeutics Committee.

Subject:

Research Funding:

The National Institute on Aging (NIA) funded the “Opportunities for Trials on Effects of Statins in Primary Prevention in Older Adults” workshop, which was held in Bethesda, Maryland, July 31-August 1, 2017, with support and participation from representatives of the National Heart, Lung, and Blood Institute (NHLBI).

Funding for this work was also supported by R24AG045050 from the NIA (JG, SF, AG).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Geriatrics & Gerontology
  • Gerontology
  • statins
  • primary prevention
  • older adults
  • randomized clinical trial
  • benefits
  • risks
  • CARDIOVASCULAR-DISEASE
  • RISK
  • THERAPY
  • CHOLESTEROL
  • METAANALYSIS
  • EVENTS
  • INDIVIDUALS
  • SIMVASTATIN
  • MORTALITY
  • COGNITION

Statins for Primary Prevention in Older Adults-Moving Toward Evidence-Based Decision-Making

Tools:

Journal Title:

Journal of the American Geriatrics Society

Volume:

Volume 66, Number 11

Publisher:

, Pages 2188-2196

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Objectives: To determine the efficacy and safety of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) events in older adults, especially those aged 80 and older and with multimorbidity. Methods: The National Institute on Aging and the National Heart, Lung and Blood Institute convened A multidisciplinary expert panel from July 31 to August 1, 2017, to review existing evidence, identify knowledge gaps, and consider whether statin safety and efficacy data in persons aged 75 and older without ASCVD are sufficient; whether existing data can inform the feasibility, design, and implementation of future statin trials in older adults; and clinical trial options and designs to address knowledge gaps. This article summarizes the presentations and discussions at that workshop. Results: There is insufficient evidence regarding the benefits and harms of statins in older adults, especially those with concomitant frailty, polypharmacy, comorbidities, and cognitive impairment; a lack of tools to assess ASCVD risk in those aged 80 and older; and a paucity of evidence of the effect of statins on outcomes of importance to older adults, such as statin-associated muscle symptoms, cognitive function, and incident diabetes mellitus. Prospective, traditional, placebo-controlled, randomized clinical trials (RCTs) and pragmatic RCTs seem to be suitable options to address these critical knowledge gaps. Future trials have to consider greater representation of very old adults, women, underrepresented minorities, and individuals of differing health, cognitive, socioeconomic, and educational backgrounds. Feasibility analyses from existing large healthcare networks confirm appropriate power for death and cardiovascular outcomes for future RCTs in this area. Conclusion: Existing data cannot address uncertainties about the benefits and harms of statins for primary ASCVD prevention in adults aged 75 and older, especially those with comorbidities, frailty, and cognitive impairment. Evidence from 1 or more RCTs could address these important knowledge gaps to inform person-centered decision-making. J Am Geriatr Soc 66:2188–2196, 2018.

Copyright information:

© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society

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