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Spotlight Session - ASPEN

Session: Spotlight Poster Session C

(CSPOT16) Association Between Sacubitril/Valsartan and Risk of Dementia in Heart Failure Patients: A Nationwide Cohort Study

Wednesday, August 28, 2024
8:00 AM – 1:30 PM CEST
Location: Foyer 3

    Presenting Author(s)

  • Kyungyeon Jung, PharmD

    PhD student
    Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea
    GYEONGGI-DO, Republic of Korea

    • Co-Author(s)

  • Ju Hwan Kim, PharmD, PhD

    Research Assistant Professor
    School of Pharmacy, Sungkyunkwan University, Suwon, South Korea
    Suwon, Republic of Korea

  • Sungho Bea, PharmD, PhD

    Postdoctoral fellow
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States

  • HK

    Hwa Yeon Ko, PharmD

    PhD student
    School of Pharmacy, Sungkyunkwan University, Suwon, South Korea, Republic of Korea

  • SY

    Seng Chan You, MD

    Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, South Korea, Republic of Korea

  • EC

    Eue-Keun Choi, MD

    Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea, Republic of Korea

  • Ju-Young Shin, PhD

    Associate Professor
    School of Pharmacy, Sungkyunkwan University, Suwon, South Korea
    Suwon, Republic of Korea

Background: Due to concerns that sacubitril may contribute to the accumulation of amyloid-β peptides in the central nervous system, the U.S. Food and Drug Administration required a randomized controlled trial as a post-marketing requirement to identify the risk of dementia related to sacubitril/valsartan.

Objectives: To evaluate the risk of incident dementia associated with sacubitril/valsartan in patients with heart failure

Methods: We conducted a retrospective cohort study using the National Health Insurance Database from January 1, 2003 and March 31, 2023, in South Korea. Patients diagnosed with heart failure and prescribed either sacubitril/valsartan or angiotensin-converting-enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) within 90 days of their first diagnosis of heart failure between October 2017 and December 2020 were included in our study. The primary outcome was incident dementia, categorized into Alzheimer’s dementia and vascular dementia. Patients were followed up after 1 year from their first prescription date of sacubitril/valsartan or ACEI/ARB until the earliest occurrence of dementia, death, or end of study period (March 2023). After 1:4 propensity score matching based on patients’ characteristics, hazard ratio (HR) with 95% confidence interval (CI) for dementia was estimated using Cox’s proportional hazards model.

Results: There were 6,930 users of sacubitril/valsartan (mean [SD] age, 61.7 [14.6] years; 4,916 [70.9%] male) matched on propensity score to 27,720 users of ACEI/ARB (mean [SD] age, 61.7 [15.8] years; 19,722 (71.1%) male). During a mean follow-up period of 2.2 years and 2.3 years, dementia events were observed in 200 (2.9%) and 980 (3.5%) patients prescribed sacubitril/valsartan and ACEI/ARB, respectively. Sacubitril/valsartan was associated with a 16% lower risk of dementia compared with ACEI/ARB (HR 0.84; 95% CI 0.72-0.98).

Conclusions: Despite the plausible biological mechanism, we found no association between sacubitril/valsartan and risk of dementia in real-world clinical settings. Our study findings may alleviate concerns about the risk of dementia and support the ongoing use of sacubitril/valsartan as a first-line treatment for heart failure.