Aprocitentan Reduces Blood Pressure for Black Patients With Resistant Hypertension
The drug shows a decrease in proteinuria and is well tolerated and safe, including for Black patients with chronic kidney disease.
Aprocitentan (Tryvio) added to a combination of at least 3 antihypertensive drugs demonstrated clinically meaningful and sustained blood pressure reductions for Black patients with confirmed resistant hypertension. The drug also showed decreases in proteinuria for patients with proteinuria at baseline and was well tolerated and safe, including for Black patients with chronic kidney disease.1
The drug shows a decrease in proteinuria and is well tolerated and safe, including for Black patients with chronic kidney disease. | Image Credit: Prostock-studio - stock.adobe.com
“Black individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk,” Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA, a professor at the Tulane University School of Medicine, said in a news release.1 “This is possibly related to the activated endothelin system seen in patients prone to developing resistant hypertension, and this may explain why existing therapies that do not target the endothelin system have not shown optimal improvement for Black patients. Now, for the first time, we have an approved treatment targeting the endothelin system that may help fulfill an unmet need in Black patients with resistant hypertension.”
Investigators included patients from the PRECISION (NCT03541174) study who self-reported as Black. They aimed to determine if aprocitentan could decrease blood pressure for patients who remained hypertensive with at least 3 background antihypertensives within 1 year prior to screening and had a sitting systolic blood pressure of 140 mm Hg or greater. The screening period included patients switching from their individual antihypertensive treatments to the standard background therapy, but they remained on β-blockers if needed. Patients received either aprocitentan 12.5 mg, 25 mg, or the placebo once daily for the 4 weeks of part one. For the 32-week part 2 of the study, all patients received aprocitentan at 25 mg.2
Investigators included 82 Black patients in the study, and in part one, investigators reported that systolic blood pressure was similar for aprocitentan and the placebo, with the least-square mean changes being –11.3 mm Hg (12.5 mg), –11.19 mm Hg (25 mg), and –12.0 mm Hg (placebo). However, the investigators also reported that dose dependently decreased mean 24-hour systolic blood pressure at week 4 was –4.0 mm Hg, –8.6 mm Hg, and –0.7 mm Hg, respectively.2
During part 2, there were further decreases, with a mean reduction of 16.4 mm Hg from baseline to week 36. For micro- or macroalbuminuria, aprocitentan reduced UACR at week 4 by approximately 38% and 65% for the 12.5 and 25 mg dosages, respectively, and 13% for the placebo. This was sustained during part 2, according to the investigators. Furthermore, the drug was well-tolerated for Black patients, with 6 adverse events (AEs) leading to treatment discontinuation, with early occurring edema/fluid retention being the most frequently reported AE.2
The FDA has also approved an updated label for the drug, which determined that the Risk Evaluation and Mitigation Strategy was no longer necessary. This was due to the benefits of the drug outweighing the risk of embryo-fetal toxicity.3
“As shown in the phase 3 PRECISION study, Tryvio decreased systolic blood pressure by more than 15 mm Hg from baseline in patients with confirmed resistant hypertensive despite treatment with a combination of antihypertensives. The durable efficacy was achieved with a good safety and tolerability profile,” Michael Moye, President and General Manager of Idorsia US, said in a news release.3 “Decreasing blood pressure to such an extent in these high cardiovascular risk patients is known to markedly decrease the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions."
READ MORE: Cardiology Resource Center
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