Cardona-Muñoz Ernesto G, López-Alvarado Agustín, Conde-Carmona Ignacio, Sánchez-Mejorada Gerardo, Pascoe-González Sara, Banda-Elizondo Ramiro G, García-Castillo Armando, González-Gálvez Guillermo, Velasco-Sánchez Raúl G, Vidrio-Velázquez Maricela, Leiva-Pons José L, Villeda-Espinosa Efraín, Guerra-López Arturo, Esturau-Santalo Ramón M
Investigación Clínica Especializada, Sociedad Civil, Guadalajara, Jalisco, Mexico; Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
Núcleo Médico La Paz, Guadalajara, Jalisco, Mexico.
Arch Cardiol Mex. 2017 Oct-Dec;87(4):316-325. doi: 10.1016/j.acmx.2017.01.001. Epub 2017 Feb 10.
To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population.
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.
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%).
Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.
评估60毫克和120毫克的替米沙坦（FMS）单独使用或与12.5毫克氢氯噻嗪（HCTZ）联合使用在墨西哥人群中的疗效和安全性。
对1-2级高血压患者进行了一项为期6个月的达标治疗开放性研究。受试者最初每日服用一次60毫克FMS。在第8周时，舒张压（DBP）<90mmHg的受试者在研究剩余时间内继续服用相同剂量的FMS，而DBP≥90mmHg的受试者被随机分为每日服用120毫克FMS或60毫克FMS + 12.5毫克HCTZ。在第12周时，DBP≥90mmHg的随机分组受试者接受120毫克FMS + 12.5毫克HCTZ，而达到目标的受试者继续接受分配的治疗直至研究结束。
60毫克FMS组（n = 272）的DBP和收缩压（SBP）分别降低了11.3±8.9（p<.0001）和16.0±14.1（p<.0001）mmHg，75.4%的受试者达到治疗目标。每日分配服用120毫克FMS、60毫克FMS + 12.5毫克HCTZ或120毫克FMS + 12.5毫克HCTZ的受试者，在接受分配的治疗后DBP和SBP均显著降低。在研究结束时，237/272名受试者（87.1%）的DBP<90mmHg且SBP<140mmHg。最常报告的不良反应包括头痛（3.7%）、口干（1.1%）、短暂性肝酶升高（1.1%）和头晕（0.7%）。
替米沙坦在患有1-2级原发性高血压的墨西哥受试者中安全有效。
