Ernesto G Cardona-Muñoz1, Agustín López-Alvarado2, Ignacio Conde-Carmona3, Gerardo Sánchez-Mejorada4, Sara Pascoe-González5, Ramiro G Banda-Elizondo6, Armando García-Castillo7, Guillermo González-Gálvez8, Raúl G Velasco-Sánchez9, Maricela Vidrio-Velázquez10, José L Leiva-Pons11, Efraín Villeda-Espinosa12, Arturo Guerra-López13, Ramón M Esturau-Santalo14. 1. Investigación Clínica Especializada, Sociedad Civil, Guadalajara, Jalisco, Mexico; Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico. 2. Núcleo Médico La Paz, Guadalajara, Jalisco, Mexico. 3. Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico. Electronic address: Ignacio.conde@stendhalpharma.com. 4. Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico. 5. Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico. 6. Centro de Estudios Clínicos y Especialidades Médicas, Monterrey, Nuevo León, Mexico. 7. Cardiolink Clinical Trials, Monterrey, Nuevo León, Mexico. 8. Instituto Jalisciense de Investigación en Diabetes y Obesidad S.C., Guadalajara, Jalisco, Mexico. 9. Hospital Dr. Ángel Leaño, Zapopan, Jalisco, Mexico. 10. Consultorio Médico Privado, Colonia Americana, Guadalajara, Jalisco, Mexico. 11. Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosí, San Luis Potosí, Mexico. 12. Hospital de Jesús IAP, Ciudad de México, Mexico. 13. Centro Médico Excel, Tijuana, Baja California, Mexico. 14. Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.
Abstract
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.
RCT Entities:
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.
Keywords:
Angiotensin II Type 1 receptor blockers; Bloqueadores de receptor de angiotensina II de tipo 1; Drug therapy; Fimasartan; Fimasartán; Hipertensión; Hypertension; Mexico; México; Tratamiento farmacológico