Staessen J A, Thijs L, Fagard R H, Birkenhäger W H, Arabidze G, Babeanu S, Gil-Extremera B, Bulpitt C J, Davidson C, de Leeuw P W, Efstratopoulos A D, Fletcher A E, Fogari R, Jääskivi M, Kawecka-Jaszcz K, Nachev C, Petrie J C, Seux M L, Tuomilehto J, Webster J, Yodfat Y
Klinisch Laboratorium Hypertensie, Inwendige Geneeskunde-Cardiologie, UZ Gasthuisberg, Herestraat 49, B-3000 Leuven,Belgium.
Hypertension. 1998 Sep;32(3):410-6. doi: 10.1161/01.hyp.32.3.410.
In the double-blind Systolic Hypertension in Europe (Syst-Eur) Trial, active treatment was initiated with nitrendipine (10 to 40 mg/d) with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d) titrated or combined to reduce sitting systolic blood pressure by at least 20 mm Hg to <150 mm Hg. In the control group, matching placebos were used similarly. In view of persistent concerns about the use of calcium channel blockers as first-line antihypertensive drugs, this report explored to what extent nitrendipine, administered alone, prevented cardiovascular complications. Age at randomization averaged 70.2 years and systolic/diastolic blood pressure 173.8/85.5 mm Hg. Of 2398 actively treated patients, 1327 took only nitrendipine (average dose, 23.4 mg/d), and 1042 progressed to other treatments including nitrendipine (n=757; 35.7 mg/d), enalapril (n=783; 13.4 mg/d), and/or hydrochlorothiazide (n=294; 21.0 mg/d). Compared with the whole placebo group (n=2297), patients receiving monotherapy with nitrendipine had 25% (P=0.05) fewer cardiovascular end points, and those progressing to other active treatments showed decreases (P</=0. 01) in total mortality (40%), stroke (59%), and all cardiovascular end points (39%). Among the control patients, 863 used only the first-line placebo. Compared with this subgroup, patients receiving monotherapy with nitrendipine showed a nearly 50% (P</=0.004) reduction of all types of end points, including total and cardiovascular mortality. The full relative benefit from nitrendipine was seen as early as 6 months after randomization. To ascertain that the benefit conferred by the dihydropyridine was not due to selection bias, the 1327 patients remaining on monotherapy with nitrendipine were matched by gender, age, previous cardiovascular complications, and systolic blood pressure at entry with an equal number of placebo patients. In this analysis, nitrendipine reduced (P</=0.05) cardiovascular mortality by 41%, all cardiovascular end points by 33%, and fatal and nonfatal cardiac end points by 33%. Despite the limitations inherent in post hoc analyses, the present findings suggest that the calcium channel blocker nitrendipine, given as a single antihypertensive medication, prevents cardiovascular complications in older patients with isolated systolic hypertension.
在欧洲收缩期高血压（Syst-Eur）双盲试验中，积极治疗起始使用尼群地平（10至40毫克/天），可能加用依那普利（5至20毫克/天）和/或氢氯噻嗪（12.5至25毫克/天），通过滴定或联合用药使坐位收缩压至少降低20毫米汞柱至<150毫米汞柱。在对照组中，同样使用匹配的安慰剂。鉴于对将钙通道阻滞剂作为一线抗高血压药物使用一直存在担忧，本报告探讨了单独使用尼群地平在多大程度上可预防心血管并发症。随机分组时的平均年龄为70.2岁，收缩压/舒张压为173.8/85.5毫米汞柱。在2398例接受积极治疗的患者中，1327例仅服用尼群地平（平均剂量，23.4毫克/天），1042例进展至其他治疗，包括尼群地平（n = 757；35.7毫克/天）、依那普利（n = 783；13.4毫克/天）和/或氢氯噻嗪（n = 294；21.0毫克/天）。与整个安慰剂组（n = 2297）相比，接受尼群地平单药治疗的患者心血管终点事件减少25%（P = 0.05），进展至其他积极治疗的患者总死亡率（40%）、中风（59%）和所有心血管终点事件（39%）均有所下降（P≤0.01）。在对照患者中，863例仅使用一线安慰剂。与该亚组相比，接受尼群地平单药治疗的患者所有类型终点事件，包括总死亡率和心血管死亡率，均降低近50%（P≤0.004）。随机分组后最早在6个月时就可看到尼群地平带来的全部相对益处。为确定二氢吡啶类药物带来的益处并非由于选择偏倚，将继续接受尼群地平单药治疗的1327例患者按性别、年龄、既往心血管并发症和入组时的收缩压与同等数量的安慰剂患者进行匹配。在该分析中，尼群地平使心血管死亡率降低41%（P≤0.05），所有心血管终点事件降低33%以及致命和非致命心脏终点事件降低33%。尽管事后分析存在固有限制，但目前的研究结果表明钙通道阻滞剂尼群地平作为单一抗高血压药物，可预防老年单纯收缩期高血压患者的心血管并发症。
