Heidbreder D, Froer K L, Bauer B, Cairns V, Breitstadt A, Bender N
Hoechst AG, Frankfurt, Germany.
Clin Cardiol. 1993 Jan;16(1):47-52. doi: 10.1002/clc.4960160111.
In an open, multicenter extension of a short-term study, 159 patients with mild to moderate hypertension were treated with either ramipril monotherapy or a combination of ramipril and hydrochlorothiazide for up to 1 year. Patients started with either 5 mg ramipril once daily (responders in the short-term study) or a combination of ramipril 5 mg plus hydrochlorothiazide 25 mg once daily. The dose could be adjusted and nonresponders to ramipril monotherapy could have hydrochlorothiazide added. In the 38 patients treated with ramipril monotherapy, the largest drop in mean blood pressure (BP) had already occurred in the previous short-term study; from Week 2 in the long-term study, the BP remained stable with means below 150/90 mmHg. In the 83 patients treated with the combination for 50 weeks or more, mean BP continued to decrease until around Week 10 in the long-term study while therapy was being adjusted. Thereafter, it also remained stable with means below 150/85 mmHg. Both treatment groups showed good mean reductions at end point, as did the group of 38 patients treated with the combination for less than 50 weeks. High response rates (84-95%) were seen in all groups at end point. The combination was well tolerated and the efficacy of ramipril in combination with hydrochlorothiazide was maintained over the 1-year period of investigation.
在一项短期研究的开放性多中心扩展研究中,159例轻至中度高血压患者接受雷米普利单药治疗或雷米普利与氢氯噻嗪联合治疗长达1年。患者起始剂量为每日一次5毫克雷米普利(短期研究中的应答者)或每日一次雷米普利5毫克加氢氯噻嗪25毫克的联合用药。剂量可进行调整,对雷米普利单药治疗无反应者可加用氢氯噻嗪。在接受雷米普利单药治疗的38例患者中,平均血压(BP)的最大降幅已出现在之前的短期研究中;在长期研究的第2周起,血压保持稳定,平均值低于150/90 mmHg。在83例接受联合治疗50周或更长时间的患者中,在长期研究中直至第10周左右进行治疗调整时,平均血压持续下降。此后,血压也保持稳定,平均值低于150/85 mmHg。两个治疗组在终点时平均血压均有良好降幅,接受联合治疗少于50周的38例患者组也是如此。所有组在终点时均观察到高应答率(84 - 95%)。联合用药耐受性良好,在为期1年的研究期间,雷米普利与氢氯噻嗪联合用药的疗效得以维持。