Malacco Ettore, Omboni Stefano
Internal Medicine III, L. Sacco Hospital, University of Milan, Milan, Italy.
Adv Ther. 2007 Sep-Oct;24(5):1006-15. doi: 10.1007/BF02877705.
This study was undertaken to compare the antihypertensive efficacy of zofenopril 30 mg + hydrochlorothiazide 12.5 mg fixed combination versus zofenopril alone in patients with essential hypertension with and without the metabolic syndrome, according to National Cholesterol Education Program-Adult Treatment Panel III criteria. After a 4-wk placebo washout period, 463 patients with mild to moderate essential hypertension (diastolic blood pressure [DBP] 95-115 mm Hg) aged 18 to 75 y were randomly assigned 2:1:1 to treatment with zofenopril+hydrochlorothiazide, zofenopril, or hydrochlorothiazide for 12 wk in an international, multicenter, double-blind, parallel-group study. DBP and systolic blood pressure changes with treatment were calculated. The first 12 wk of treatment were followed by a 24-wk open-label period during which only safety was assessed. Reported here is a subanalysis of the main study results, performed in patients with and without metabolic syndrome, limited to a zofenopril+hydrochlorothiazide versus zofenopril comparison. The antihypertensive effect of zofenopril+hydrochlorothiazide or zofenopril was similar in patients with (77%) and without metabolic syndrome. In patients with and without metabolic syndrome, however, DBP and systolic blood pressure reductions were significantly greater with zofenopril+hydrochlorothiazide (with metabolic syndrome: 14+/-8/21+/-14 mm Hg; without metabolic syndrome: 15+/-7/23+/-14 mm Hg) than with zofenopril alone (with metabolic syndrome: 10+/-9/11+/-15; without metabolic syndrome: 12+/-10/14+/-18 mm Hg). The safety of the 2 treatments was similar in patients with and without metabolic syndrome. The fixed combination of zofenopril+hydrochlorothiazide improved the efficacy of zofenopril alone. This effect was particularly evident in patients with metabolic syndrome, in whom blood pressure control is more difficult to achieve and who are at greater risk for cardiovascular events.
本研究旨在根据美国国家胆固醇教育计划成人治疗小组第三次报告的标准，比较佐芬普利30毫克+氢氯噻嗪12.5毫克固定复方制剂与单用佐芬普利对伴有和不伴有代谢综合征的原发性高血压患者的降压疗效。在为期4周的安慰剂洗脱期后，463例年龄在18至75岁之间、患有轻度至中度原发性高血压（舒张压[DBP]95 - 115毫米汞柱）的患者，在一项国际多中心双盲平行组研究中，按2:1:1随机分配接受佐芬普利+氢氯噻嗪、佐芬普利或氢氯噻嗪治疗12周。计算治疗期间DBP和收缩压的变化。治疗的前12周之后是为期24周的开放标签期，在此期间仅评估安全性。本文报告的是对主要研究结果的亚分析，该分析在伴有和不伴有代谢综合征的患者中进行，仅限于佐芬普利+氢氯噻嗪与佐芬普利的比较。佐芬普利+氢氯噻嗪或佐芬普利对伴有代谢综合征（77%）和不伴有代谢综合征的患者的降压效果相似。然而，在伴有和不伴有代谢综合征的患者中，佐芬普利+氢氯噻嗪使DBP和收缩压的降低幅度（伴有代谢综合征：14±8/21±14毫米汞柱；不伴有代谢综合征：15±7/23±14毫米汞柱）显著大于单用佐芬普利（伴有代谢综合征：10±9/11±15；不伴有代谢综合征：12±10/14±18毫米汞柱）。两种治疗方法在伴有和不伴有代谢综合征的患者中的安全性相似。佐芬普利+氢氯噻嗪固定复方制剂提高了单用佐芬普利的疗效。这种效果在代谢综合征患者中尤为明显，这类患者血压控制更难实现，且发生心血管事件的风险更高。
