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

Alex Roca-Cusachs, Joaquín Aracil-Vilar, Carlos Calvo-Gómez, José Vicente Vaquer-Pérez, Félix Laporta-Crespo, María José Rojas-Serrano, Antonio Guglietta, Savion Gropper, Nadezhda Alexeeva, Pedro Aranda, Josep Lluis Ballvé, Andrei Baranovsky, Svetlana Boldueva, Carles Brotons, Angel Cano, Svetlana Churina, Antoni Coca, Luis De Teresa, Juan Antonio Divisón, Yanis DumpisXavier Farrés, Ángela Felip, Juan García, Blas Gil, Boris Goloschekin, Pablo Gómez, Victor Kostenko, Enrique López De Coca, Manuel Luque, Emili Marco, Joan Martorell, Viktor Milyagin, Alexander Orlov-Morozov, Vladimir Parfenov, Elena Pavlysh, Jaume Plana, Miguel Ángel Prieto, Montserrat Pujol, José Carlos Rodríguez, Alexander Sherenkov, Javier Sobrino, Lev Sorokin, Joaquim Vilà, Irina Zobenko, Konstantin Zrazhesvsky

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Resum

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. © 2008 The Authors.
Idioma originalAnglès
Pàgines (de-a)91-100
RevistaCardiovascular Therapeutics
Volum26
Número2
DOIs
Estat de la publicacióPublicada - 14 de jul. 2008

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