title: Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.
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%).
  
  
  CONCLUSIONS
  Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.
authors.affiliation: Investigación Clínica Especializada, Sociedad Civil, Guadalajara, Jalisco, Mexico; Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
authors.forename: Ernesto G
authors.initials: EG
authors.lastname: Cardona-Muñoz
authors.affiliation: Núcleo Médico La Paz, Guadalajara, Jalisco, Mexico.
authors.forename: Agustín
authors.initials: A
authors.lastname: López-Alvarado
authors.affiliation: Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico. Electronic address: Ignacio.conde@stendhalpharma.com.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Conde-Carmona
authors.affiliation: Específicos Stendhal, S.A. de C.V., Ciudad de México, Mexico.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Sánchez-Mejorada
authors.affiliation: Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
authors.forename: Sara
authors.initials: S
authors.lastname: Pascoe-González
authors.affiliation: Centro de Estudios Clínicos y Especialidades Médicas, Monterrey, Nuevo León, Mexico.
authors.forename: Ramiro G
authors.initials: RG
authors.lastname: Banda-Elizondo
authors.affiliation: Cardiolink Clinical Trials, Monterrey, Nuevo León, Mexico.
authors.forename: Armando
authors.initials: A
authors.lastname: García-Castillo
authors.affiliation: Instituto Jalisciense de Investigación en Diabetes y Obesidad S.C., Guadalajara, Jalisco, Mexico.
authors.forename: Guillermo
authors.initials: G
authors.lastname: González-Gálvez
authors.affiliation: Hospital Dr. Ángel Leaño, Zapopan, Jalisco, Mexico.
authors.forename: Raúl G
authors.initials: RG
authors.lastname: Velasco-Sánchez
authors.affiliation: Consultorio Médico Privado, Colonia Americana, Guadalajara, Jalisco, Mexico.
authors.forename: Maricela
authors.initials: M
authors.lastname: Vidrio-Velázquez
authors.affiliation: Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosí, San Luis Potosí, Mexico.
authors.forename: José L
authors.initials: JL
authors.lastname: Leiva-Pons
authors.affiliation: Hospital de Jesús IAP, Ciudad de México, Mexico.
authors.forename: Efraín
authors.initials: E
authors.lastname: Villeda-Espinosa
authors.affiliation: Centro Médico Excel, Tijuana, Baja California, Mexico.
authors.forename: Arturo
authors.initials: A
authors.lastname: Guerra-López
authors.affiliation: Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.
authors.forename: Ramón M
authors.initials: RM
authors.lastname: Esturau-Santalo
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001713:Biphenyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D000075222:Essential Hypertension / Q000145:classification / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008800:Mexico; D008875:Middle Aged; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D011743:Pyrimidines; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C558933:fimasartan
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