Clinical Effects of Torasemide Prolonged Release in Mild‐to‐Moderate Hypertension: A Randomized Noninferiority Trial Versus Torasemide Immediate Release

• Published in: Cardiovascular therapeutics Vol. 26; no. 2; pp. 91 - 100
• Main Authors: Roca‐Cusachs, Alex, Aracil‐Vilar, Joaquín, Calvo‐Gómez, Carlos, Vaquer‐Pérez, José‐Vicente, Laporta‐Crespo, Félix, Rojas‐Serrano, María‐José, Guglietta, Antonio, Gropper, Savion
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 2008; Wiley; Blackwell
• Subjects: Adult; Aged; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Blood and lymphatic vessels; Blood Pressure - drug effects; Blood Pressure Monitoring, Ambulatory; Cardiology. Vascular system; Cardiovascular system; Delayed-Action Preparations; Diuretic; Diuretics - adverse effects; Diuretics - therapeutic use; Double-Blind Method; Female; Humans; Hypertension; Hypertension - drug therapy; Hypertension - physiopathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Severity of Illness Index; Spain; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Time Factors; Toresamide; Toresamide prolonged released; Treatment Outcome; Urination - drug effects; Hypertension; Controlled release form; Cardiovascular disease; Diuretic; Toresamide prolonged released; Randomization; Sulfonamides; Dosage form; Comparative study; Release; Torasemide; Toresamide; Prolonged
• ISSN: 1755-5914; 1755-5922
• DOI: 10.1111/j.1527-3466.2008.00046.x

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.