Clinical effects of torasemide prolonged release in mild-to-moderate hypertension: a randomized noninferiority trial versus torasemide immediate release

Abstract

The efficacy of a new torasemide prolonged release (PR) formulation to torasemide immediate release (IR) was compared in a randomized noninferiority double-blind trial. Patients with newly diagnosed mild-to-moderate hypertension or unresponsive or poor tolerability to previous antihypertensive monotherapy received 5 mg/day of torasemide-PR (n = 219) or torasemide-IR (n = 223) for 12 weeks (uptitration to 10 mg/day if no response at 4 or 8 weeks). Mean diastolic blood pressure (DBP) reduction in the torasemide-PR group (11.6 +/- 7.1 mmHg, 95% confidence interval [CI] 10.6-12.5) versus torasemide-IR (11.3 +/- 7.5 mmHg, 95% CI 10.2-12.3) met the noninferiority criterion of a nonsided 97.5% CI lower than the preestablished margin of 2 mmHg. A significantly higher percentage of patients in the torasemide-PR group achieved adequate BP control after 8 and 12 weeks. Ambulatory 24-h BP monitoring (ABPM) measurements in a subset of 100 patients showed greater daytime SBP reductions in the torasemide-PR group (128.4 +/- 9.9 mmHg vs. 133.5 +/- 10.4 mmHg, P < 0.05). Safety and tolerability of both formulations were similar.