Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension

Background: Aldosterone dysregulation contributes to hypertension. Lorundrostat is an aldosterone synthase inhibitor, but data on its efficacy and safety in patients with hypertension are limited.

Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, participants with uncontrolled hypertension (24-hour ambulatory BP ≥130/80 mm Hg) received placebo, lorundrostat (50 mg daily), or lorundrostat (50 mg, adjustable to 100 mg). The primary endpoint was the change in 24-hour systolic BP at 12 weeks.

Results: At 12 weeks, placebo-adjusted reductions in systolic BP were −7.9 mm Hg (97.5% CI, −13.3 to −2.6) with stable-dose lorundrostat and −6.5 mm Hg (97.5% CI, −11.8 to −1.2) with dose-adjusted lorundrostat. Hyperkalemia (>6.0 mmol/L) occurred in 5–7% of lorundrostat-treated participants.

Conclusions: Lorundrostat significantly reduced BP in patients with uncontrolled hypertension, with safety concerns including hyperkalemia and eGFR decline.

Background: Aldosterone dysregulation contributes to hypertension. Lorundrostat is an aldosterone synthase inhibitor, but data on its efficacy and safety in patients with hypertension are limited.

Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, participants with uncontrolled hypertension (24-hour ambulatory BP ≥130/80 mm Hg) received placebo, lorundrostat (50 mg daily), or lorundrostat (50 mg, adjustable to 100 mg). The primary endpoint was the change in 24-hour systolic BP at 12 weeks.

Results: At 12 weeks, placebo-adjusted reductions in systolic BP were −7.9 mm Hg (97.5% CI, −13.3 to −2.6) with stable-dose lorundrostat and −6.5 mm Hg (97.5% CI, −11.8 to −1.2) with dose-adjusted lorundrostat. Hyperkalemia (>6.0 mmol/L) occurred in 5–7% of lorundrostat-treated participants.

Conclusions: Lorundrostat significantly reduced BP in patients with uncontrolled hypertension, with safety concerns including hyperkalemia and eGFR decline.