Watanabe Luis A, Wei Meng, Sun Ningling, Kim Dongsoo, Chiang Chern-En, Ke Yuannan, Tseng Chuen-Den, Coloma Ricardo, Vala M, Massaad R, Feig P, Guptha S
Clínica San Felipe, Jesús María, Lima, Peru.
Curr Med Res Opin. 2006 Oct;22(10):1955-64. doi: 10.1185/030079906X132514.
An open-label, multicentre study was conducted to evaluate the antihypertensive efficacy of a 4-week course of losartan 50 mg plus hydrochlorothiazide 12.5 mg in Asian patients with essential hypertension whose blood pressure had previously been treated with but not controlled by valsartan 80 mg.
A total of 237 eligible patients with mean trough sitting diastolic blood pressure (SiDBP) 95-115 mmHg and a mean trough sitting systolic blood pressure (SiSBP) < 190 mmHg entered the baseline period of treatment with valsartan 80 mg/day for 4 weeks. Those (n = 165) whose SiDBP remained > 90 mmHg and who were not excluded for other reasons were then switched to a single-tablet formulation of losartan 50 mg/hydrochlorothiazide 12.5 mg combination once daily for a further 4 weeks.
Mean SiDBP (study primary endpoint) at the end of combination therapy was reduced to 86.9 mmHg from 95.2 mmHg. SiSBP (study secondary endpoint) was reduced to 132.6 mmHg from 140.7 mmHg. Mean reductions after switching from valsartan 80 mg to losartan 50 mg/hydrochlorothiazide 12.5 mg were thus 8.3 and 8.1 mmHg for SiDBP and SiSBP, respectively (p < or = 0.001 for both outcomes). The goal of SiDBP < or = 90 mmHg was attained in 72% of the patients previously not controlled to the same level by valsartan 80 mg/day. Combination therapy with losartan 50 mg/hydrochlorothiazide 12.5 mg was generally well tolerated. Mean compliance with the losartan 50 mg/hydrochlorothiazide 12.5 mg combination was > 99%.
These results demonstrate that in Asian patients who do not reach the goal of mean trough SiDBP < or = 90 mmHg with valsartan monotherapy at 80 mg once-daily, switching to a single-tablet combination of losartan 50 mg/hydrochlorothiazide 12.5 mg once-daily is well tolerated, provides effective control of blood pressure and is an excellent choice to achieve blood pressure reduction goals.
开展了一项开放标签、多中心研究，以评估氯沙坦50毫克加氢氯噻嗪12.5毫克为期4周的疗程对亚洲原发性高血压患者的降压疗效，这些患者之前接受过缬沙坦80毫克治疗但血压未得到控制。
共有237例符合条件的患者，其平均谷值坐位舒张压（SiDBP）为95 - 115毫米汞柱，平均谷值坐位收缩压（SiSBP）< 190毫米汞柱，进入为期4周的缬沙坦80毫克/天治疗的基线期。那些SiDBP仍> 90毫米汞柱且未因其他原因被排除的患者（n = 165），随后换用氯沙坦50毫克/氢氯噻嗪12.5毫克的单片复方制剂，每日一次，再治疗4周。
联合治疗结束时，平均SiDBP（研究主要终点）从95.2毫米汞柱降至86.9毫米汞柱。SiSBP（研究次要终点）从140.7毫米汞柱降至132.6毫米汞柱。因此，从缬沙坦80毫克换用氯沙坦50毫克/氢氯噻嗪12.5毫克后，SiDBP和SiSBP的平均降幅分别为8.3和8.1毫米汞柱（两个结果的p均≤0.001）。72%之前未被缬沙坦80毫克/天控制到相同水平的患者实现了SiDBP≤90毫米汞柱的目标。氯沙坦50毫克/氢氯噻嗪12.5毫克联合治疗总体耐受性良好。氯沙坦50毫克/氢氯噻嗪12.5毫克联合治疗的平均依从性> 99%。
这些结果表明，对于亚洲患者，若每日一次80毫克缬沙坦单药治疗未达到平均谷值SiDBP≤90毫米汞柱的目标，换用每日一次氯沙坦50毫克/氢氯噻嗪12.5毫克的单片复方制剂耐受性良好，能有效控制血压，是实现血压降低目标的极佳选择。
