A randomized controlled trial comparing sacubitril/valsartan and telmisartan in patients with HFrEF: efficacy and safety evaluation
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20253374Keywords:
BNP, Heart failure therapy, HFrEF, LVEF, NYHA class, Sacubitril/valsartanAbstract
Background: Heart failure with reduced ejection fraction (HFrEF) is a progressive condition associated with high morbidity, mortality, and healthcare costs. Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), has demonstrated superior efficacy over traditional angiotensin receptor blockers (ARBs) in improving outcomes. This study compared the safety and efficacy of sacubitril/valsartan with telmisartan monotherapy in HFrEF patients.
Methods: A randomized, prospective, open-label, interventional study was conducted at a tertiary care center over six months. A total of 81 patients with HFrEF (EF ≤40%) were randomized into group A (telmisartan 40 mg daily) and group B (sacubitril/valsartan 200 mg twice daily). Outcomes assessed included NYHA class, left ventricular ejection fraction (LVEF), and serum BNP levels at baseline, 3 months, and 6 months. Safety was evaluated through adverse events and laboratory monitoring. Statistical analysis was conducted using SPSS, with significance set at p<0.05.
Results: Both groups showed significant improvement in LVEF and BNP levels. Sacubitril/valsartan demonstrated superior efficacy in reducing BNP levels (583.2±324.2 pg/ml versus 957.5±305.2 pg/ml, p<0.0001) and improving NYHA class (p=0.005). LVEF improved significantly in both groups, with no intergroup difference (p=0.130). No hospitalizations or mortality occurred during the study. One case of non-serious angioedema was reported in the sacubitril/valsartan group. Hematological and biochemical parameters remained stable, confirming comparable safety profiles.
Conclusions: Sacubitril/valsartan is more effective than telmisartan in improving NYHA class and reducing BNP levels in HFrEF patients, with a comparable safety profile. It should be considered a preferred treatment option in HFrEF management, particularly in patients with NYHA class II/III symptoms, as per ACC/AHA guidelines.
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