Division of Hypertension and Cardiovascular Rehabilitation, Department of Cardiovascular Diseases, University of Leuven, Studies Coordinating Centre, Leuven, Belgium.
J Hypertens. 2010 Apr;28(4):865-74. doi: 10.1097/HJH.0b013e32833627c9.
The current literature supports the immediate use of combinations of antihypertensive drugs in terms of ease of use and adherence, but the key issue whether combination therapy is more effective than monotherapy in the prevention of cardiovascular complications remains unproven.
We analysed the double-blind (median follow-up 2.0 years) and open follow-up (6.0 years) phases of the Systolic Hypertension in Europe trial. Patients were 60 years or more with an entry systolic/diastolic blood pressure (BP) of 160-219/less than 95 mmHg. Antihypertensive treatment started immediately after randomization in the active-treatment group, but only after completion of the double-blind trial in control patients. Treatment consisted of nitrendipine (10-40 mg/day) with the possible addition of enalapril (5-20 mg/day). We adjusted our analyses for sex, age, history of cardiovascular complications, baseline systolic BP and previous antihypertensive treatment.
During the double-blind trial, adding enalapril to nitrendipine (n = 515), compared with the equivalent combination of placebos (n = 559), decreased systolic BP by a further 9.5 mmHg and reduced all cardiovascular events by 51% (P = 0.0035) and heart failure by 66% (P = 0.032), with similar trends for stroke (-51%; P = 0.066) and cardiac events (-44%; P = 0.075). Over the whole duration of follow-up, combination therapy (n = 871), compared with nitrendipine monotherapy (n = 1552), decreased systolic BP by 3.1 mmHg and reduced total mortality (-32%; P = 0.023), with similar trends for all cardiovascular events (-23%; P = 0.081) and stroke (-42%; P = 0.054).
Despite the limitations of a posthoc analysis, but congruent with the stronger BP reduction, our results suggest that combination therapy with nitrendipine plus enalapril might improve outcome over and beyond the benefits seen with nitrendipine monotherapy.
目前的文献支持在使用方便性和依从性方面立即使用降压药物联合治疗，但联合治疗在预防心血管并发症方面是否比单药治疗更有效这一关键问题仍未得到证实。
我们分析了欧洲收缩期高血压试验的双盲（中位随访 2.0 年）和开放随访（6.0 年）阶段。患者年龄在 60 岁及以上，入组时收缩压/舒张压（BP）为 160-219/小于 95mmHg。在活性治疗组中，随机分组后立即开始降压治疗，而在对照组中，只有在双盲试验完成后才开始降压治疗。治疗方案包括硝苯地平（10-40mg/天），可能加用依那普利（5-20mg/天）。我们根据性别、年龄、心血管并发症史、基线收缩压和先前的降压治疗对分析进行了调整。
在双盲试验期间，与等效的安慰剂联合治疗（n=559）相比，硝苯地平加用依那普利（n=515）进一步降低收缩压 9.5mmHg，使所有心血管事件减少 51%（P=0.0035），心力衰竭减少 66%（P=0.032），卒中减少 51%（P=0.066）和心脏事件减少 44%（P=0.075）也有类似趋势。在整个随访期间，与硝苯地平单药治疗（n=1552）相比，联合治疗（n=871）降低收缩压 3.1mmHg，总死亡率降低 32%（P=0.023），所有心血管事件降低 23%（P=0.081）和卒中降低 42%（P=0.054）也有类似趋势。
尽管这是一项事后分析，但与更强的血压降低一致，我们的结果表明，硝苯地平加用依那普利的联合治疗可能比硝苯地平单药治疗更能改善预后。
