Aprocitentan for Blood Pressure Reduction in Black Patients
- PMID: 39840441
- DOI: 10.1161/HYPERTENSIONAHA.124.24142
Aprocitentan for Blood Pressure Reduction in Black Patients
Abstract
Background: Black individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk. We investigated the blood pressure (BP)-lowering effect of the dual endothelin receptor antagonist aprocitentan in Black individuals enrolled in the PRECISION study (Parallel-Group, Phase 3 Study with Aprocitentan in Subjects with Resistant Hypertension).
Methods: Patients with confirmed resistant hypertension were randomized to aprocitentan 12.5 mg, 25 mg, or placebo for 4 weeks (part 1). They subsequently received aprocitentan 25 mg for 32 weeks (part 2) before re-randomization to aprocitentan 25 mg or placebo (part 3).
Results: Eighty-two patients randomized in the PRECISION study were Black individuals. At week 4, aprocitentan 12.5 and 25 mg reduced office trough systolic BP (-11.3 and -11.9 mm Hg) to a similar degree as placebo (-12.0 mm Hg). Using 24-hour ambulatory BP monitoring, the placebo effect was minimal (-0.7 mm Hg), and aprocitentan reduced systolic BP by 4.0 and 8.6 mm Hg. During part 2, office BP continued to decrease (-16.4 mm Hg at week 36). In part 3, office and ambulatory systolic BP increased on placebo (+9.9 and +8.1 mm Hg, respectively), whereas the BP-lowering effect was maintained with aprocitentan. Aprocitentan markedly reduced albuminuria during the study. The most frequent adverse event was peripheral edema, occurring in 3 patients (10%) receiving aprocitentan 25 mg versus none receiving aprocitentan 12.5 mg or placebo.
Conclusions: Aprocitentan reduced BP and albuminuria in Black individuals with resistant hypertension. The BP-lowering efficacy was similar to that of the overall PRECISION population. Aprocitentan may represent an important addition to the often difficult-to-control hypertension in Black individuals.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03541174.
Keywords: aprocitentan; blood pressure; edema; endothelin receptor antagonists; hypertension.
Conflict of interest statement
J.M. Flack has received consulting fees from AstraZeneca, Janssen, ReCor, Teva, and Idorsia; payment for a lecture at a CME event from Janssen; and research grant support from SoniVie, Mineralys, ReCor, Idorsia, and AstraZeneca. M.P. Schlaich has received research support, funding, travel support, and honoraria from Idorsia, Medtronic, Abbott, Merck, Novartis, Mineralys, ReCor, and AstraZeneca. M.A. Weber has received travel support from Idorsia to attend a scientific meeting. M. Sassi-Sayadi is an employee of Idorsia Pharmaceuticals, Ltd. M. Clozel, R.F. Dreier, and P. Danaietash are employees of Idorsia Pharmaceuticals, Ltd and hold stock or stock options in Idorsia Pharmaceuticals, Ltd. K. Narkiewicz has received speaker and consulting honoraria from Adamed, Bausch, Berlin-Chemie/Menarini, Egis, Eli Lilly, Idorsia, Gedeon Richter, Janssen, Krka, Novo Nordisk, Polpharma, Promed, Recordati, Sandoz, Servier, and Zentiva. J.G. Wang has received grants from Huawei, Novartis, and Omron, and lecture and consulting fees from Huawei, Idorsia, Medtronic, Nova Nordisk, Novartis, Servier, Skylabs, and Viatris. K.C. Ferdinand is a consultant for Eli Lilly, Boehringer Ingelheim, Janssen, Amgen, and Medtronic. Medical writing and editorial support for this article were provided by Idorsia Pharmaceuticals, Ltd. The other authors report no conflicts.
Comment in
-
Endothelin Antagonism: A New Era for Resistant Hypertension?Hypertension. 2025 Apr;82(4):611-614. doi: 10.1161/HYPERTENSIONAHA.125.24606. Epub 2025 Mar 19. Hypertension. 2025. PMID: 40106534 No abstract available.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Medical
