Stimpel M, Koch B, Dickstein K
Department of Clinical Research, Schwarz Pharma AG, Monheim, Germany.
Cardiology. 1996 Jul-Aug;87(4):313-8. doi: 10.1159/000177112.
This double-blind study was conducted to investigate the efficacy, safety and tolerability of three dose levels of moexipril in comparison to placebo as add-on therapy to hydrochlorothiazide (HCTZ) in patients with moderate to severe hypertension. Two hundred patients who did not respond adequately to a 4-week monotherapy with HCTZ-sitting diastolic blood pressure between 95 and 114 mm Hg- entered the 8-week double-blind period. Patients were randomized to once daily placebo or moexipril 3.75, 7.5 or 15 mg as add-on therapy to open-label HCTZ 25 mg. At biweekly visits, blood pressure and heart rate measurements were obtained and the occurrence of adverse experiences was documented. At the 8-week endpoint, adjusted mean reductions from baseline were significantly (p = 0.003) greater in patients receiving moexipril 3.75, 7.5 and 15 mg compared to placebo (-8.4, -8.8 and -8.9 vs. -4.6 mm Hg). No significant differences between the three dose levels of moexipril could be observed. Moexipril was generally well tolerated. The most frequently reported adverse events for moexipril and placebo were headache, flu syndrome and dizziness (6, 7, 5 vs. 4, 0, 4%). The results indicate that the combination of moexipril and HCTZ is a clinically valuable combination in the treatment of patients with moderate to severe hypertension.
本双盲研究旨在调查与安慰剂相比，三种剂量水平的莫昔普利作为氢氯噻嗪（HCTZ）的附加疗法用于中重度高血压患者时的疗效、安全性和耐受性。200名对HCTZ进行4周单药治疗反应不佳（坐位舒张压在95至114 mmHg之间）的患者进入为期8周的双盲期。患者被随机分为每日一次服用安慰剂或莫昔普利3.75、7.5或15 mg作为开放标签HCTZ 25 mg的附加疗法。在每两周一次的访视中，测量血压和心率并记录不良事件的发生情况。在8周的终点，接受莫昔普利3.75、7.5和15 mg的患者与安慰剂组相比，从基线调整后的平均血压降低幅度显著更大（p = 0.003）（-8.4、-8.8和-8.9 vs. -4.6 mmHg）。未观察到莫昔普利三个剂量水平之间有显著差异。莫昔普利总体耐受性良好。莫昔普利和安慰剂最常报告的不良事件是头痛、流感样综合征和头晕（6%、7%、5% vs. 4%、0%、4%）。结果表明，莫昔普利与HCTZ联合使用在治疗中重度高血压患者方面是一种具有临床价值的联合疗法。
