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April 2, 2002Circulation231 citations

Metoprolol CR/XL in Female Patients With Heart Failure

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JGJalal K. GhaliIPIleana L. PiñaSGStephen S. Gottlieb

Key Result

Treatment with metoprolol CR/XL in women with heart failure reduced the combined end point of all-cause mortality and all-cause hospitalizations by 21% (P=0.044).

Key Points

  • This study aims to assess the impact of metoprolol CR/XL on heart failure outcomes specifically in women.
  • Randomized, placebo-controlled trial with 3991 patients with heart failure and LVEF ≤0.40.
  • Post hoc analysis included 898 women, focusing on outcomes including all-cause mortality and hospitalizations.
  • Compared outcomes in women with severe heart failure (n=183) and overall female cohort.
  • Metoprolol CR/XL led to a 21% reduction in the primary endpoint of mortality/hospitalizations (P=0.044).
  • Cardiovascular hospitalizations decreased by 29% (P=0.013), and worsening heart failure hospitalizations decreased by 42% (P=0.021).
  • In severe heart failure, cardiovascular hospitalizations reduced by 57% (P=0.005), and worsening heart failure hospitalizations reduced by 72% (P=0.0004).

Study Design

Type

RCT (n=898)

Randomization

Randomized

Structured PICO

Does metoprolol CR/XL reduce all-cause mortality and hospitalizations in women with heart failure and reduced LVEF?

P
Population
898 women with heart failure (NYHA class II-IV, LVEF ≤0.40), including a subgroup of 183 women with severe heart failure (NYHA class III/IV and LVEF <0.25), from the MERIT-HF trial.
I
Intervention
Metoprolol controlled-release/extended-release (CR/XL)
C
Comparator
Placebo
O
Outcome
Combined end point of all-cause mortality/all-cause hospitalizationscomposite

Metoprolol CR/XL significantly reduces the composite of all-cause mortality and hospitalizations in women with heart failure and reduced ejection fraction, including those with severe disease.

Main Result

Effect estimate: 21% reduction

p-value: p=0.044

Limitations

  • post hoc analysis

Abstract

Background — Underrepresentation of women in heart failure clinical trials has limited conclusions regarding the effect of various management strategies on survival in women with heart failure and decreased left ventricular ejection fraction (LVEF). Methods and Results — MERIT-HF (Metoprolol Extended-Release Randomized Intervention Trial in Heart Failure) was a randomized, placebo-controlled study, the purpose of which was to evaluate the effect of metoprolol controlled-release/extended-release (CR/XL) in 3991 patients with New York Heart Association class II to IV heart failure and LVEF ≤0.40. We performed a post hoc analysis to evaluate the effect of metoprolol CR/XL on outcome in women (n=898), including the outcome in 183 women with severe heart failure (New York Heart Association class III/IV and LVEF <0.25). Treatment with metoprolol CR/XL in women resulted in a 21% reduction in the primary combined end point of all-cause mortality/all-cause hospitalizations (164 versus 137 patients; P =0.044). The number of cardiovascular hospitalizations was reduced by 29% (164 versus 120; P =0.013), and hospitalization for worsening heart failure was reduced by 42% (95 versus 56; P =0.021). Similar results were noted in the subgroup of women with severe heart failure, with a 57% reduction in cardiovascular hospitalizations (63 versus 30; P =0.005) and a 72% reduction in hospitalization due to worsening heart failure (46 versus 14; P =0.0004). A pooling of mortality results from MERIT-HF, the Cardiac Insufficiency Bisoprolol Study (CIBIS II), and the Carvedilol Prospective Randomized Cumulative Survival Study (COPERNICUS) showed very similar survival benefits in women and men. Conclusions — The beneficial effects of metoprolol CR/XL extend to women with heart failure, including women with clinically stable severe heart failure.

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Cite This Study

Ghali et al. (2002) conducted an RCT in Heart failure (n=898). Metoprolol controlled-release/extended-release (CR/XL) vs. Placebo was evaluated on All-cause mortality/all-cause hospitalizations (21% reduction, p=0.044). Treatment with metoprolol CR/XL in women with heart failure reduced the combined end point of all-cause mortality and all-cause hospitalizations by 21% (P=0.044).

synapsesocial.com/papers/6a090953bee8d5ab8a92dc92https://doi.org/10.1161/01.cir.0000012546.20194.33
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