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Soluble guanylate cyclase stimulators for heart failure: a network meta-analysis and subgroup analyses of reduced and
Mohamed T Abuelazm1, Abdelrahman Attia2, Mohamed Abdelnabi3
1Faculty of Medicine, Tanta University, Tanta, Egypt. Dr.mabuelazm@gmail.com.
Insights
Vericiguat 10 mg effectively reduced cardiovascular mortality and heart failure hospitalizations in heart failure with reduced ejection fraction (HFrEF) patients. However, it showed no significant benefit in heart failure with preserved ejection fraction (HFpEF) patients.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Soluble guanylate cyclase (sGC) stimulators are being explored for heart failure (HF) management.
- Their role in guidelines for heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) remains unclear.
Purpose of the Study:
- To conduct a network meta-analysis of randomized controlled trials (RCTs) on sGC stimulators for HF.
- To evaluate the efficacy and safety of vericiguat 10 mg in HFrEF and HFpEF.
Main Methods:
- Systematic search of five databases for RCTs up to January 24th, 2023.
- Network meta-analysis synthesizing data from 8 RCTs involving 7307 patients.
- Pooled dichotomous outcomes using risk ratio (RR) and confidence intervals (CI).
Main Results:
- Vericiguat 10 mg significantly reduced composite cardiovascular (CVS) mortality and HF hospitalization in HFrEF (RR: 0.87, 95% CI [0.78; 0.97]).
- No significant benefit was observed in HFpEF patients (RR: 0.69, 95% CI [0.15; 3.05]).
- Vericiguat 10 mg demonstrated no significant difference from placebo in all-cause mortality or adverse events.
Conclusions:
- Vericiguat 10 mg shows efficacy in reducing mortality and hospitalizations for HFrEF patients, with a favorable safety profile.
- Efficacy was not demonstrated in HFpEF patients, suggesting potential underpowered data for this subgroup and other sGC agents.
- Further large-scale RCTs are warranted to clarify vericiguat's role in HFrEF guidelines and explore sGC stimulators in HFpEF.
Background:
Soluble guanylate cyclase (sGC) stimulators have been investigated for heart failure (HF) in several randomized controlled trials (RCTs). However, its place in the management guidelines of either HFrEF or HfpEF is still inconclusive.
Methods:
We conducted a network meta-analysis synthesizing RCTs investigating sGC for HF management, which were retrieved by systematically searching five databases until January 24th, 2023. Dichotomous outcomes were pooled using risk ratio (RR) along with confidence interval (CI).
Results:
Eight RCTs with a total of 7307 patients were included. Vericiguat 10 mg significantly reduced the composite cardiovascular (CVS) mortality and HF hospitalization in HF (RR: 0.88, 95% CI [0.79; 0.98]) and in HFrEF (RR: 0.87, 95% CI [0.78; 0.97]); however, it was not effective in HFpEF (RR: 0.69, 95% CI [0.15; 3.05]). Also, vericiguat 10 mg showed no difference compared to placebo regarding the incidence of all-cause mortality (RR: 0.96, 95% CI [0.84; 1.10]), any adverse events (AEs) (RR: 0.94, 95% CI [0.83; 1.07]), any serious AEs (RR: 0.91, 95% CI [0.81; 1.01]), and any AEs leading to drug discontinuation (RR: 1.14, 95% CI [0.92; 1.40]).
Conclusion:
Vericiguat 10 mg was effective in reducing the composite CVS mortality and HF hospitalization, with an acceptable safety profile. This was only observed in HFrEF patients, but not in HFpEF patients. However, our data regarding other agents (riociguat and praliciguat) and HFpEF can be underpowered, warranting further RCTs to clarify vericiguat 10 mg place in HFrEF management guidelines and to investigate sGC stimulators for HFpEF in large-scale trials.
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