Hall W D, Weber M A, Ferdinand K, Flamenbaum W, Marbury T, Jain A K, Weidler D, Weiss R, Herron J, Codispoti J
Hypertension Research Centre, Emory University School of Medicine, Decatur, GA 30030.
J Hum Hypertens. 1994 Aug;8(8):571-5.
Indapamide (Lozol), an indoline antihypertensive drug with diuretic and vasodilating activities, was evaluated in 195 patients with mild to moderate essential hypertension (sitting DBP between 95 and 110 mmHg) in a multicentre, randomised, double-blind, parallel-group design trial. A four week single-blind placebo wash-out period was followed by an eight week double-blind period. Patients were randomised to indapamide 1.25 mg/day or to placebo. The primary efficacy endpoint was the mean change in sitting DBP from baseline to week 8. Ninety patients in the placebo group (93%) and 82 patients (84%) in the indapamide group completed the eight weeks of double-blind therapy. Indapamide produced a mean (SE) decrease in sitting DBP of 7.4 (0.63) mmHg (from 100.1 to 92.8 mmHg) compared with a decrease of 3.6 (0.75) mmHg (from 99.6 to 95.8 mmHg) produced by placebo (p < 0.0001). Indapamide and placebo also produced mean decreases in standing DBP of 6.8 (0.75) and 2.8 (0.77) mmHg, respectively (p = 0.0002), in sitting SBP of 11.1 (1.18) and 3.2 (1.35) mmHg, respectively (p = 0.0001) and in standing SBP of 11.4 (1.29) and 4.0 (1.43) mmHg, respectively (P = 0.0002). Reduction in BP of > or = 10 mmHg or to a DBP of < or = 90 mmHg was more frequent (P = 0.0005) among indapamide (46.6%) compared with placebo (23.7%) treated patients. During the eight week double-blind treatment period, incidence rates for all adverse experiences and for drug-related adverse experiences were similar between the two treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)
吲达帕胺(洛沙坦)是一种具有利尿和血管舒张活性的吲哚类抗高血压药物,在一项多中心、随机、双盲、平行组设计试验中,对195例轻度至中度原发性高血压患者(坐位舒张压在95至110 mmHg之间)进行了评估。在为期四周的单盲安慰剂洗脱期后,进入为期八周的双盲期。患者被随机分为每日服用1.25 mg吲达帕胺组或安慰剂组。主要疗效终点是从基线到第8周坐位舒张压的平均变化。安慰剂组90例患者(93%)和吲达帕胺组82例患者(84%)完成了八周的双盲治疗。与安慰剂使坐位舒张压降低3.6(0.75)mmHg(从99.6降至95.8 mmHg)相比,吲达帕胺使坐位舒张压平均(SE)降低7.4(0.63)mmHg(从100.1降至92.8 mmHg)(p<0.0001)。吲达帕胺和安慰剂使立位舒张压分别平均降低6.8(0.75)和2.8(0.77)mmHg(p = 0.0002),坐位收缩压分别平均降低11.1(1.18)和3.2(1.35)mmHg(p = 0.0001),立位收缩压分别平均降低11.4(1.29)和4.0(1.43)mmHg(P = 0.0002)。与安慰剂治疗的患者(23.7%)相比,吲达帕胺治疗的患者(46.6%)血压降低≥10 mmHg或舒张压≤90 mmHg更为常见(P = 0.0005)。在为期八周的双盲治疗期间,两个治疗组的所有不良事件和与药物相关的不良事件发生率相似。(摘要截短于250字)