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首页> 外文期刊>Clinical drug investigation >Zofenopril versus Lisinopril in the Treatment of Essential Hypertension in Elderly Patients A Randomised, Double-Blind, Multicentre Study
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Zofenopril versus Lisinopril in the Treatment of Essential Hypertension in Elderly Patients A Randomised, Double-Blind, Multicentre Study

机译：佐非诺普利与利诺普利治疗老年原发性高血压的一项随机，双盲，多中心研究

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Background: Angiotensin-converting enzyme inhibitors have been proposed as first-choice drugs for antihypertensive therapy in elderly subjects because of their demonstrated efficacy and safety. However, no information is currently available on the use of zofenopril in elderly hypertensive patients.Objective: To assess the efficacy and safety of zofenopril (30 or 60mg once daily) compared with lisinopril (10 or 20mg once daily).Patients and methods: Patients aged >65 years with mild to moderate essential hypertension (sitting diastolic blood pressure [DBP] >90mm Hg and <=110mm Hg) were included in the study. They were randomised to receive either zofenopril 30mg or lisinopril l0mg. Blood pressure and heart rate were measured at baseline and after 4 and 12 weeks of treatment. Patients underwent electrocardiography and evaluation of laboratory parameters at baseline and after 12 weeks. Ambulatory blood pressure monitoring (ABPM) was also performed at baseline and after 12 weeks. After 4 weeks drug doses were doubled in patients whose sitting DBP was >90mm Hg. The primary endpoint was to achieve sitting DBP values <90mm Hg or a reduction of sitting DBP >10mm Hg after 12 weeks of treatment.Results: 181 patients were randomised to treatment and 164 patients completed the study. Thirty-three patients were included in the analysis of 24-hour blood pressure monitoring. The percentage of patients with normalised sitting DBP (<90mm Hg) and the rate of treatment responders (reduction of sitting DBP >10mm Hg) were not significantly different between the two treatment groups (normalised: zofenopril 81.3% vs lisinopril 76.7%; responders: zofenopril 74.7% vs lisinopril 77.8%). At the end of the treatment sitting DBP was not significantly different between the two treatment groups (zofenopril 82.2(+-)6.6mm Hg vs lisinopril 82.0(+-)7.8mm Hg). Eight percent of patients experienced adverse events in the zofenopril group and 9% in the lisinopril group. A small percentage of adverse events (4%) was related to treatment and reported in the zofenopril group. Conclusions: In elderly hypertensive patients, treatment with zofenopril was effective and well tolerated. Efficacy and safety were comparable with those of lisinopril.
机译：背景：血管紧张素转换酶抑制剂已被证明是老年患者抗高血压治疗的首选药物，因为它们具有明显的功效和安全性。然而，目前尚无有关老年高血压患者使用佐芬普利的信息。目的：评估佐芬普利（每日30或60毫克）与赖诺普利（每日10或20毫克）相比的疗效和安全性。患者和方法：患者年龄大于65岁的轻度至中度原发性高血压（舒张压[DBP]> 90mm Hg和<= 110mm Hg）被纳入研究。他们被随机分配接受zofenopril 30mg或赖诺普利10mg。在基线以及治疗4周和12周后测量血压和心率。患者在基线和12周后接受心电图检查和实验室参数评估。在基线时和12周后也进行了动态血压监测（ABPM）。 4周后，坐位DBP> 90mm Hg的患者的药物剂量加倍。主要终点是治疗12周后达到坐位DBP值<90mm Hg或坐位DBP降低> 10mm Hg。结果：181名患者被随机分配接受治疗，164名患者完成了研究。 33例患者被纳入24小时血压监测分析中。在两个治疗组之间，坐位DBP（<90mm Hg）正常的患者百分比和治疗反应率（坐位DBP减少> 10mm Hg）没有显着差异（标准化：佐非普利81.3％vs赖诺普利76.7％;响应者：佐芬普利74.7％vs赖诺普利77.8％）。在治疗结束时，两个治疗组的坐位DBP无显着差异（佐芬普利82.2（+/-）6.6mm Hg与赖诺普利82.0（+/-）7.8mm Hg）。 zofenopril组有8％的患者经历了不良事件，而赖诺普利组有9％的患者经历了不良事件。一小部分不良事件（4％）与治疗有关，并在zofenopril组中报告。结论：在老年高血压患者中，佐芬普利治疗有效且耐受性良好。疗效和安全性与赖诺普利相当。

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