Efficacy and safety of sacubitril/valsartan in Afro-descendant patients with resistant hypertension: a randomized controlled trial.

Abstract

Background: Sacubitril/valsartan (Sac-Val) has demonstrated blood pressure (BP)-lowering effects, but its role in resistant hypertension remains unclear. This study evaluated the efficacy and safety of Sac-Val compared to optimized angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI) therapy in Brazilian patients with resistant hypertension, predominantly Afro-descendant.

Methods: In this phase III, 8-week, single-center, randomized trial, 80 adults with resistant hypertension were assigned to Sac-Val (titrated to 200 mg with an optional increase to 400 mg if BP remained >140/90 mmHg) or standard therapy (ARB/ACEI combined with other antihypertensive agents). The primary endpoint was the proportion of patients achieving BP control (<140/90 mmHg). The co-primary endpoints included mean reductions in mean sitting SBP (msSBP), mean sitting DBP (msDBP), and mean sitting pulse pressure (msPP) at week 8. Secondary outcomes assessed dose-dependent BP reduction.

Results: BP control was achieved in 94.9% of patients in the Sac-Val group versus 69.2% in the control group (P = 0.03). Sac-Val significantly reduced msPP (-6.05 mmHg, P = 0.008) and showed a trend toward greater msSBP reduction (P = 0.06). The 400 mg dose resulted in the greatest BP reduction, particularly for msPP (P = 0.034). No deaths were reported.

Conclusion: Sac-Val was more effective than standard therapy in achieving BP control and reducing BP in resistant hypertension, with a dose-dependent trend favoring the 400 mg regimen. These findings support Sac-Val as a potential treatment alternative for high-risk Afro-descendant patients.