Gomez H J
Cardiovascular Clinical Research Unit, CIBA-GEIGY Corporation, Summit, New Jersey 07901.
Clin Cardiol. 1991 Aug;14(8 Suppl 4):IV22-7; discussion IV51-5. doi: 10.1002/clc.4960141803.
The dose-response curve for benazepril, a new angiotensin-converting enzyme inhibitor, has been established from a systematic series of controlled clinical studies in patients with mild to moderate essential hypertension. The studies included a dose-ranging study, four dose-response studies (placebo-controlled or crossover), and four titration trials. The dose-response studies involved 803 patients and evaluated doses from 2 to 80 mg. Analysis of the data revealed the existence of a dose-response relationship over the dosage range of 10 to 80 mg given once daily. Efficacy of once-daily administration was shown by the persistence of significant blood pressure reduction over the 24-h dosing interval. In addition, the net trough-to-peak ratio (an indicator of net antihypertensive effect at the end of the dosing interval) was generally greater than 50%. The dose-determination studies with benazepril were conducted according to a well-designed strategy in which parameters were carefully defined. Based on these trials, the initial dosage for benazepril appears to be 10 mg once daily. Additional response may be observed at dosages up to 80 mg once daily.
新型血管紧张素转换酶抑制剂贝那普利的剂量反应曲线，是通过对轻至中度原发性高血压患者进行的一系列系统对照临床研究确定的。这些研究包括一项剂量范围研究、四项剂量反应研究（安慰剂对照或交叉研究）以及四项滴定试验。剂量反应研究涉及803名患者，评估剂量为2至80毫克。数据分析显示，在每日一次给予10至80毫克的剂量范围内存在剂量反应关系。每日一次给药的疗效表现为在24小时给药间隔内血压持续显著降低。此外，净谷峰比值（给药间隔结束时净降压效果的指标）一般大于50%。贝那普利的剂量确定研究是根据精心设计的策略进行的，其中参数经过仔细定义。基于这些试验，贝那普利的初始剂量似乎为每日一次10毫克。每日一次剂量高达80毫克时可能会观察到进一步的反应。
