TRYVIO demonstrated a well-tolerated safety profile in patients with uncontrolled BP despite the use of ≥3 antihypertensive medications. Dual ERA activity represents a novel therapeutic approach, targeting the endothelin pathway.1 The balanced antagonism of both ETA and ETB receptors produces less profound fluid retention compared with earlier selective ETA antagonists, while maintaining robust BP reduction.¹
In the Phase 3 PRECISION trial involving 724 patients with confirmed uncontrolled BP despite treatment with at least three antihypertensive medications, TRYVIO achieved clinically meaningful SiSBP reduction of 15.3-15.4 mm Hg at Week 4, with sustained effects through 48 weeks of follow-up.²
TRYVIO does not require dose adjustment for age. Of the total number of subjects in the PRECISION study of TRYVIO, 321 (44%) were 65 years and older, whereas 72 (10%) were 75 years and older. Elderly patients demonstrated greater early BP lowering in subgroup analyses. Edema/fluid retention was more common in elderly than younger patients.³
Fluid retention and peripheral edema are among the most common adverse effects associated with TRYVIO, occurring in 9.1% of patients receiving the approved 12.5 mg dose compared with 2.1% of placebo-treated patients during the 4-week double-blind phase of the PRECISION study.1 Older age and chronic kidney disease are established risk factors for edema and fluid retention with TRYVIO.
Hyperkalemia was not identified as a risk factor with TRYVIO. In the PRECISION trial, no treatment-emergent cases of hyperkalemia were reported, and across all treatment groups (aprocitentan 12.5 mg and 25 mg), adverse events occurring in ≥2% or more in any treatment group did not include any instance of hyperkalemia. These results indicate that TRYVIO does not share the hyperkalemia risk profile as RAAS inhibitors.3
BP = blood pressure; ERA = endothelin-1 receptor antagonist; RAAS = renin-angiotensin-aldosterone system; SiSBP = sitting systolic blood pressure.