Holwerda N J, Fogari R, Angeli P, Porcellati C, Hereng C, Oddou-Stock P, Heath R, Bodin F
St Elizabeth Hospital, Tilburg, The Netherlands.
J Hypertens. 1996 Sep;14(9):1147-51. doi: 10.1097/00004872-199609000-00016.
To compare the antihypertensive efficacy and systemic tolerability of valsartan, a new angiotensin II receptor antagonist, with placebo and with an angiotensin converting enzyme (ACE) inhibitor, enalapril.
A total of 348 adult outpatients with mild-to-moderate uncomplicated essential hypertension participated in this double-blind, parallel, study. Patients were allocated randomly in a ratio of 2:2:1 to receive 80 mg valsartan once a day, 20 mg enalapril once a day, or placebo for 8 weeks in general practice. Patients were assessed at 4 and 8 weeks of therapy.
The primary efficacy variable was the change from baseline in mean sitting diastolic blood pressure (SDBP) after 8 weeks of therapy. Secondary variables included the change in sitting systolic blood pressure (SSBP) and response rates at 8 weeks.
Valsartan and enalapril produced statistically significant reductions in diastolic and systolic blood pressures compared with placebo. Similar falls were found in both of the active treatment groups with mean changes in SDBP at 8 weeks of -9.5 mmHg for valsartan and -9.4 mmHg for enalapril (-4.5 mmHg for placebo). No significant differences between valsartan and enalapril were found for reductions in SDBP or SSBP. Response rates at 8 weeks were significantly greater for valsartan (54%) and enalapril (58%) than for placebo (20%), with no significant difference between the two active treatments. Both valsartan and enalapril demonstrated a consistent antihypertensive effect over time, with 90% of patients with a response at 4 weeks responding at 8 weeks. Both of the treatments were tolerated well. Although the incidence of coughing was generally low in the study, more cases were reported with enalapril (three) than with valsartan (one) or placebo (none).
The data show 80 mg valsartan once a day to be as effective as 20 mg enalapril once a day in the treatment of mild-to-moderate hypertension. Valsartan is tolerated well and does not appear to be associated with any increase in the incidence of coughing.
比较新型血管紧张素II受体拮抗剂缬沙坦与安慰剂及血管紧张素转换酶（ACE）抑制剂依那普利的降压疗效和全身耐受性。
共有348例轻至中度无并发症原发性高血压成年门诊患者参与了这项双盲、平行研究。患者按2:2:1的比例随机分配，在一般医疗实践中接受每日一次80毫克缬沙坦、每日一次20毫克依那普利或安慰剂治疗8周。在治疗4周和8周时对患者进行评估。
主要疗效变量为治疗8周后平均坐位舒张压（SDBP）相对于基线的变化。次要变量包括坐位收缩压（SSBP）的变化和8周时的有效率。
与安慰剂相比，缬沙坦和依那普利使舒张压和收缩压有统计学意义的降低。两个活性治疗组的血压下降情况相似，缬沙坦8周时SDBP的平均变化为-9.5 mmHg，依那普利为-9.4 mmHg（安慰剂为-4.5 mmHg）。缬沙坦和依那普利在降低SDBP或SSBP方面未发现显著差异。缬沙坦（54%）和依那普利（58%）8周时的有效率显著高于安慰剂（20%），两种活性治疗之间无显著差异。缬沙坦和依那普利随时间均显示出持续的降压作用，4周时有反应的患者中90%在8周时仍有反应。两种治疗耐受性均良好。尽管研究中咳嗽发生率总体较低，但依那普利报告的病例（3例）多于缬沙坦（1例）或安慰剂（无）。
数据表明，每日一次80毫克缬沙坦在治疗轻至中度高血压方面与每日一次20毫克依那普利效果相当。缬沙坦耐受性良好，且似乎与咳嗽发生率的增加无关。
