Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.

Autor:	Cardona-Muñoz EG; Investigación Clínica Especializada, Sociedad Civil, Guadalajara, Jalisco, Mexico; Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico., López-Alvarado A; Núcleo Médico La Paz, Guadalajara, Jalisco, Mexico., Conde-Carmona I; Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico. Electronic address: Ignacio.conde@stendhalpharma.com., Sánchez-Mejorada G; Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico., Pascoe-González S; Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico., Banda-Elizondo RG; Centro de Estudios Clínicos y Especialidades Médicas, Monterrey, Nuevo León, Mexico., García-Castillo A; Cardiolink Clinical Trials, Monterrey, Nuevo León, Mexico., González-Gálvez G; Instituto Jalisciense de Investigación en Diabetes y Obesidad S.C., Guadalajara, Jalisco, Mexico., Velasco-Sánchez RG; Hospital Dr. Ángel Leaño, Zapopan, Jalisco, Mexico., Vidrio-Velázquez M; Consultorio Médico Privado, Colonia Americana, Guadalajara, Jalisco, Mexico., Leiva-Pons JL; Hospital Central 'Dr. Ignacio Morones Prieto', San Luis Potosí, San Luis Potosí, Mexico., Villeda-Espinosa E; Hospital de Jesús IAP, Ciudad de México, Mexico., Guerra-López A; Centro Médico Excel, Tijuana, Baja California, Mexico., Esturau-Santalo RM; Hospital Civil de Guadalajara 'Fray Antonio Alcalde', Guadalajara, Jalisco, Mexico.
Jazyk:	angličtina
Zdroj:	Archivos de cardiologia de Mexico [Arch Cardiol Mex] 2017 Oct - Dec; Vol. 87 (4), pp. 316-325. Date of Electronic Publication: 2017 Feb 10.
DOI:	10.1016/j.acmx.2017.01.001
Abstrakt:	Objective: To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population. Methods: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90mmHg were randomised to either 120mg FMS or 60mg FMS + 12.5mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90mmHg received 120mg FMS+12.5mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. Results: FMS 60mg (n=272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3±8.9 (p<.0001) and 16.0±14.1 (p<.0001)mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120mg, FMS 60mg+HCTZ 12.5mg, or FMS 120mg+HCTZ 12.5mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP<90mmHg and an SBP<140mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). Conclusion: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension. (Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.)
Databáze:	MEDLINE
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