Messerli F, Frishman W H, Elliott W J
Division of Hypertension, Ochsner Medical Institutions, New Orleans, Louisiana 70155, USA.
Am J Hypertens. 1998 Mar;11(3 Pt 1):322-7. doi: 10.1016/s0895-7061(97)00466-4.
The combination of an angiotensin converting enzyme inhibitor with a calcium antagonist has become a common way of treating patients with essential hypertension who respond insufficiently to monotherapy. This double-blind, randomized, parallel, placebo-controlled, multicenter, outpatient study evaluated the antihypertensive efficacy and safety of a calcium antagonist (verapamil SR) and an angiotensin converting enzyme inhibitor (trandolapril) in patients with mild-to-moderate (stages I and II) essential hypertension. Six hundred thirty-one patients were enrolled in this 10-week study. After a 4-week single-blind placebo phase, patients received one of the following daily dosage regimens in a double-blind fashion for 6 weeks: placebo, 4 mg of trandolapril, 240 mg of verapamil SR, or a combination of 4 mg of trandolapril and 240 mg of verapamil SR. Trough sitting diastolic blood pressure was lowered by 4.5 mm Hg, 4.3 mm Hg, and 8.1 mm Hg more than placebo in the trandolapril, verapamil SR, and combination groups, respectively. In the combination group, sitting diastolic blood pressure was significantly lowered (P < .01) by 3.6 mm Hg more than in the trandolapril group and by 3.8 mm Hg more than in the verapamil SR group. An analysis of the trough-to-peak ratio for sitting diastolic blood pressure revealed values of 0.75 and 0.67, for the 4-mg trandolapril and the combination groups, respectively, at end point. The overall incidence of adverse reactions was similar for all treatment groups. In this study the combination of an angiotensin converting enzyme inhibitor and calcium antagonist was well tolerated and more effective than either agent administered alone for the treatment of mild-to-moderate essential hypertension.
血管紧张素转换酶抑制剂与钙拮抗剂联合使用已成为治疗原发性高血压患者的常用方法，这些患者对单一疗法反应不足。这项双盲、随机、平行、安慰剂对照、多中心门诊研究评估了钙拮抗剂（缓释维拉帕米）和血管紧张素转换酶抑制剂（群多普利）对轻至中度（I期和II期）原发性高血压患者的降压疗效和安全性。631名患者参加了这项为期10周的研究。在为期4周的单盲安慰剂阶段后，患者以双盲方式接受以下每日剂量方案之一，为期6周：安慰剂、4毫克群多普利、240毫克缓释维拉帕米，或4毫克群多普利与240毫克缓释维拉帕米的组合。群多普利组、缓释维拉帕米组和联合治疗组的卧位舒张压谷值分别比安慰剂组降低了4.5毫米汞柱、4.3毫米汞柱和8.1毫米汞柱。在联合治疗组中，卧位舒张压比群多普利组显著降低（P < .01）3.6毫米汞柱，比缓释维拉帕米组显著降低3.8毫米汞柱。对卧位舒张压谷峰比的分析显示，在终点时，4毫克群多普利组和联合治疗组的值分别为0.75和0.67。所有治疗组的不良反应总发生率相似。在本研究中，血管紧张素转换酶抑制剂和钙拮抗剂联合使用耐受性良好，比单独使用任何一种药物治疗轻至中度原发性高血压更有效。
