Sacubitril/valsartan and the risk of incident dementia in heart failure: a nationwide propensity-matched cohort study

Clin Res Cardiol. 2024 Jun;113(6):875-883. doi: 10.1007/s00392-023-02322-0. Epub 2023 Oct 31.

Abstract

Background: Sacubitril acts to inhibit neprilysin and as neprilysin is involved in amyloid-beta degradation in the central nervous system, and there is concern that sacubitril/valsartan may increase the risk of dementia. We aimed to compare the risk of incident dementia associated with sacubitril/valsartan and angiotensin II receptor blockers (ARBs).

Methods: Patients with heart failure with reduced ejection fraction treated with either sacubitril/valsartan or ARB, identified from the Korean National Health Insurance Service database, were matched in a 1:2 ratio using propensity scores (6789 on sacubitril/valsartan and 13,578 on ARBs) and followed up for incident dementia.

Results: During a mean follow-up of 2.5 years, 526 (2.6%) patients were newly diagnosed with dementia: Alzheimer dementia in 282, vascular dementia in 8, and other dementia in 236. There was no significant difference in the risk of overall dementia (hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.70-1.01), Alzheimer dementia (HR 0.85, 95% CI 0.67-1.10), vascular dementia (HR 0.98, 95% CI 0.23-4.11), and all other dementias (HR 0.81, 95% CI 0.62-1.07) between sacubitril/valsartan users and ARB users. These results were consistent regardless of initial sacubitril/valsartan dose and subgroups including old age, previous mild cognitive impairment, previous stroke, and concomitant antiplatelet or anticoagulation. Sensitivity analysis with a 1-year lag period for dementia assessment confirmed the main analysis. Meanwhile, risk of incident stroke was lower in sacubitril/valsartan users compared to ARBs users.

Conclusions: In a nationwide propensity-matched cohort of patients with heart failure, sacubitril/valsartan was not associated with an increased risk of incident dementia compared to ARBs.

Keywords: Adverse drug event; Dementia; Heart failure; Neprilysin.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aminobutyrates* / adverse effects
  • Aminobutyrates* / therapeutic use
  • Angiotensin Receptor Antagonists* / adverse effects
  • Angiotensin Receptor Antagonists* / therapeutic use
  • Biphenyl Compounds*
  • Dementia* / epidemiology
  • Drug Combinations*
  • Female
  • Follow-Up Studies
  • Heart Failure* / epidemiology
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Neprilysin
  • Propensity Score*
  • Republic of Korea / epidemiology
  • Retrospective Studies
  • Risk Assessment / methods
  • Risk Factors
  • Stroke Volume
  • Tetrazoles* / adverse effects
  • Valsartan*

Substances

  • sacubitril and valsartan sodium hydrate drug combination