Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial

Area of Science:

• Cardiology
• Clinical Trials
• Sex Differences in Medicine

Background:

• Women with heart failure with reduced ejection fraction (HFrEF) often receive suboptimal guideline-recommended therapy and report a lower quality of life compared to men.
• Existing research indicates potential disparities in treatment and outcomes for women with HFrEF.

Purpose of the Study:

• To investigate sex-based differences in baseline characteristics, clinical outcomes, and the efficacy and safety of omecamtiv mecarbil.
• To analyze how omecamtiv mecarbil's treatment effects vary between men and women in the GALACTIC-HF study.

Main Methods:

• The GALACTIC-HF study randomized patients with symptomatic HFrEF (EF ≤ 35%) to omecamtiv mecarbil or placebo.
• This analysis specifically compared baseline characteristics, clinical outcomes, and treatment effects of omecamtiv mecarbil between male and female participants.

Main Results:

• Women comprised 21.2% of the 8,232 analyzed patients and presented with worse symptoms (lower KCCQ-TSS) and less guideline-based therapy at baseline.
• Despite baseline differences, women experienced a 20% lower risk of the primary composite endpoint (cardiovascular death, heart failure event, or all-cause death) compared to men.
• Omecamtiv mecarbil's treatment effect was consistent across sexes, with no significant interaction (P=0.68), and women reported fewer serious adverse events.

Conclusions:

• Women in the GALACTIC-HF trial exhibited poorer quality of life and received less guideline-based therapy but demonstrated a reduced risk of major adverse cardiovascular events.
• The efficacy and safety profile of omecamtiv mecarbil were comparable between men and women, suggesting its benefit is not sex-dependent.
• These findings highlight the importance of addressing sex disparities in HFrEF management while confirming omecamtiv mecarbil's potential role across diverse patient populations.