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The Efficacy and Safety of Sacubitril/Valsartan Compared to Valsartan in Patients with Heart Failure and Mildly
Sharath Kommu1,2, Richard L Berg3
1Department of Hospital Medicine, Marshfield Clinic Health System, Rice Lake, WI 54868, USA.
Journal of Clinical Medicine
|March 28, 2024
Summary
Sacubitril/valsartan improved heart failure outcomes in patients with mildly reduced or preserved ejection fraction, enhancing quality of life and reducing hospitalizations. However, it increased the risk of hypotension without affecting mortality.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Sacubitril/valsartan is established for heart failure with reduced ejection fraction (HFrEF).
- Evidence for its use in heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF) is inconsistent.
- This meta-analysis evaluates sacubitril/valsartan versus valsartan in HFmrEF and HFpEF patients.
Purpose of the Study:
- To assess the efficacy of sacubitril/valsartan compared to valsartan in HFmrEF and HFpEF.
- To evaluate the safety profile of sacubitril/valsartan in this patient population.
Main Methods:
- A meta-analysis of four randomized controlled trials (RCTs).
- Included 3375 patients in the sacubitril/valsartan group and 3362 in the valsartan group.
- Searched MEDLINE and ClinicalTrials.gov for relevant RCTs.
Main Results:
- Sacubitril/valsartan significantly improved Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) and New York Heart Association (NYHA) class.
- A composite outcome of heart failure hospitalizations and cardiovascular death was reduced by sacubitril/valsartan.
- No significant benefit was observed for cardiovascular death or all-cause mortality.
- Hypotension risk increased with sacubitril/valsartan; hyperkalemia and renal function risks were not elevated.
Conclusions:
- Sacubitril/valsartan offers benefits in KCCQ CSS, NYHA class, and HF hospitalizations/cardiovascular death for HFmrEF/HFpEF patients.
- The primary safety concern is an increased risk of hypotension.
- No increased risk of hyperkalemia or worsening renal function was detected.
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