Vaïsse B, Ghobrial H, Vaur L, Poncelet P, Asmar R, Herpin D, Mallion J M
CHU La Timone, Marseille.
Arch Mal Coeur Vaiss. 2001 Aug;94(8):907-12.
The aim of the study was to evaluate by ambulatory blood pressure measurement (ABPM) the 24 hours antihypertensive efficacy of the fixed combination therapy, valsartan 80 mg + hydrochlorothiazide 12.5 mg (V + H), once daily, after 6 weeks of treatment, in patients with mild to moderate hypertension.
It was a French, multicenter, double blind, randomized trial in parallel groups comparing V + H and placebo. After an initial two weeks placebo period, patients were assigned to receive either V + H or placebo for six weeks. Were eligible those with clinical arterial blood pressure, measured by sphygmomanometer, between 160/95 and 209/114 mmHg after monotherapy. A 26 hours ABPM, with Spacelabs 90,207, was done at J0 and J42 (one measurement every 15 minutes, in day time and at night). Responders were defined as a fall in day diastolic blood pressure > or = 5 mmHg and/or day diastolic blood pressure < 90 mmHg with ABPM.
123 of the 138 randomized patients had two interpretative measurements. Their average age was 59 + 10 years. 57% (78) of them were males and their average ABPM before treatment was 143 +/- 15/88 +/- 11 mmHg. With V + H, the reduction of the systolic and the diastolic blood pressure measured by ABPM, was significantly more important than with placebo (SBP: -15.4 +/- 10.9 mmHg versus -0.6 +/- 7.7 mmHg, p < 0.001; DBP: -9.1 +/- 7 mmHg versus -0.4 +/- 5.4 mmHg, p < 0.001). Pulse pressure (PP) was also significantly reduced with the combination therapy V + H, but it was not modified with placebo (-6.3 + 5.5 mmHg versus -0.2 + 4.1 mmHg, p < 0.001). ABPM responder rate was 73% with V + H versus 24% with placebo (p < 0.001). Trough/peak ratio was 80.3% for systolic blood pressure and 57.3% for diastolic blood pressure. The combination V + H was as well tolerated as placebo.
The fixed combination V + H used for treatment of hypertension, after failure of monotherapy, is very effective in reducing pulse pressure, systolic and diastolic blood pressure, over 24 hours, homogeneously, and is as well tolerated as placebo.
本研究旨在通过动态血压监测（ABPM）评估缬沙坦80毫克+氢氯噻嗪12.5毫克（V+H）固定复方疗法每日一次治疗6周后对轻度至中度高血压患者的24小时降压疗效。
这是一项法国的多中心、双盲、平行组随机试验，比较V+H与安慰剂。在最初两周的安慰剂期后，患者被分配接受V+H或安慰剂治疗六周。单药治疗后用血压计测量临床动脉血压在160/95至209/114毫米汞柱之间的患者符合入选标准。在J0和J42时使用Spacelabs 90,207进行26小时的ABPM（白天和夜间每15分钟测量一次）。根据ABPM，日间舒张压下降≥5毫米汞柱和/或日间舒张压<90毫米汞柱者被定义为有反应者。
138例随机分组患者中有123例进行了两次可解释测量。他们的平均年龄为59±10岁。其中57%（78例）为男性，治疗前平均ABPM为143±15/88±11毫米汞柱。使用V+H时，通过ABPM测量的收缩压和舒张压下降幅度明显大于安慰剂组（收缩压：-15.4±10.9毫米汞柱对-0.6±7.7毫米汞柱，p<0.001；舒张压：-9.1±7毫米汞柱对-0.4±5.4毫米汞柱，p<0.001）。联合治疗V+H也使脉压（PP）显著降低，但安慰剂组未改变（-6.3+5.5毫米汞柱对-0.2+4.1毫米汞柱，p<0.001）。V+H组的ABPM有反应率为73%，而安慰剂组为24%（p<0.001）。收缩压的谷峰比为80.3%，舒张压的谷峰比为57.3%。V+H联合用药的耐受性与安慰剂相当。
单药治疗失败后用于治疗高血压的固定复方V+H在24小时内均匀降低脉压、收缩压和舒张压方面非常有效，且耐受性与安慰剂相当。
