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Obesity-Associated Cardiovascular Risk and Benefit From PCSK9 Inhibition: A Prespecified Analysis From FOURIER.

Yu Mi Kang1, Robert P Giugliano2, Anthony C Keech3

  • 1TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Journal of the American College of Cardiology
|December 10, 2025
PubMed
Summary
This summary is machine-generated.

Evolocumab significantly reduces cardiovascular risk in patients with atherosclerotic cardiovascular disease, with greater benefits observed in those with higher body mass index (BMI). This PCSK9 inhibitor therapy attenuates the elevated risk associated with obesity.

Keywords:
PCSK9evolocumabmajor adverse cardiovascular eventsobesity

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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Obesity Research

Background:

  • Evolocumab, a PCSK9 inhibitor, is proven to reduce major adverse cardiovascular events (MACE).
  • The impact of body mass index (BMI) on evolocumab's efficacy was previously unclear.

Purpose of the Study:

  • To investigate the relationship between BMI and MACE risk.
  • To determine how BMI influences the clinical benefit of evolocumab in patients with atherosclerotic cardiovascular disease.

Main Methods:

  • Analysis of the FOURIER trial data (27,564 patients) comparing evolocumab to placebo.
  • Examined BMI association with cardiovascular risk in the placebo group.
  • Assessed treatment effect modification by BMI using Cox models and interaction terms.

Main Results:

  • Higher BMI (≥30 kg/m²), particularly ≥35 kg/m², was associated with increased MACE risk in the placebo arm.
  • Evolocumab demonstrated progressively greater risk reduction for MACE with increasing BMI (P for interaction = 0.025).
  • Risk reductions ranged from 11% (BMI <30) to 29% (BMI ≥35), with absolute risk reductions of 1.4% to 5.7% respectively.

Conclusions:

  • Obesity in patients with atherosclerotic cardiovascular disease elevates MACE risk.
  • Evolocumab effectively reduces this heightened risk, offering greater absolute benefits to individuals with higher BMI.