Beckett Nigel S, Peters Ruth, Fletcher Astrid E, Staessen Jan A, Liu Lisheng, Dumitrascu Dan, Stoyanovsky Vassil, Antikainen Riitta L, Nikitin Yuri, Anderson Craig, Belhani Alli, Forette Françoise, Rajkumar Chakravarthi, Thijs Lutgarde, Banya Winston, Bulpitt Christopher J
Care of the Elderly, Division of Medicine, Imperial College London, United Kingdom.
N Engl J Med. 2008 May 1;358(18):1887-98. doi: 10.1056/NEJMoa0801369. Epub 2008 Mar 31.
Whether the treatment of patients with hypertension who are 80 years of age or older is beneficial is unclear. It has been suggested that antihypertensive therapy may reduce the risk of stroke, despite possibly increasing the risk of death.
We randomly assigned 3845 patients from Europe, China, Australasia, and Tunisia who were 80 years of age or older and had a sustained systolic blood pressure of 160 mm Hg or more to receive either the diuretic indapamide (sustained release, 1.5 mg) or matching placebo. The angiotensin-converting-enzyme inhibitor perindopril (2 or 4 mg), or matching placebo, was added if necessary to achieve the target blood pressure of 150/80 mm Hg. The primary end point was fatal or nonfatal stroke.
The active-treatment group (1933 patients) and the placebo group (1912 patients) were well matched (mean age, 83.6 years; mean blood pressure while sitting, 173.0/90.8 mm Hg); 11.8% had a history of cardiovascular disease. Median follow-up was 1.8 years. At 2 years, the mean blood pressure while sitting was 15.0/6.1 mm Hg lower in the active-treatment group than in the placebo group. In an intention-to-treat analysis, active treatment was associated with a 30% reduction in the rate of fatal or nonfatal stroke (95% confidence interval [CI], -1 to 51; P=0.06), a 39% reduction in the rate of death from stroke (95% CI, 1 to 62; P=0.05), a 21% reduction in the rate of death from any cause (95% CI, 4 to 35; P=0.02), a 23% reduction in the rate of death from cardiovascular causes (95% CI, -1 to 40; P=0.06), and a 64% reduction in the rate of heart failure (95% CI, 42 to 78; P<0.001). Fewer serious adverse events were reported in the active-treatment group (358, vs. 448 in the placebo group; P=0.001).
The results provide evidence that antihypertensive treatment with indapamide (sustained release), with or without perindopril, in persons 80 years of age or older is beneficial. (ClinicalTrials.gov number, NCT00122811 [ClinicalTrials.gov].).
80岁及以上高血压患者的治疗是否有益尚不清楚。有人提出,抗高血压治疗可能会降低中风风险,尽管可能会增加死亡风险。
我们将来自欧洲、中国、澳大拉西亚和突尼斯的3845名80岁及以上且收缩压持续在160mmHg或更高的患者随机分配,使其接受利尿剂吲达帕胺(缓释,1.5mg)或匹配的安慰剂。如有必要,添加血管紧张素转换酶抑制剂培哚普利(2或4mg)或匹配的安慰剂,以达到150/80mmHg的目标血压。主要终点是致命性或非致命性中风。
活性治疗组(1933例患者)和安慰剂组(1912例患者)匹配良好(平均年龄83.6岁;坐位平均血压173.0/90.8mmHg);11.8%有心血管疾病史。中位随访时间为1.8年。2年时,活性治疗组的坐位平均血压比安慰剂组低15.0/6.1mmHg。在意向性分析中,活性治疗与致命性或非致命性中风发生率降低30%相关(95%置信区间[CI],-1至51;P=0.06),中风死亡发生率降低39%(95%CI,1至62;P=0.05),任何原因导致的死亡发生率降低21%(95%CI,4至35;P=0.02),心血管原因导致的死亡发生率降低23%(95%CI,-1至40;P=0.06),心力衰竭发生率降低64%(95%CI,42至78;P<0.001)。活性治疗组报告的严重不良事件较少(358例,安慰剂组为448例;P=0.001)。
结果提供了证据,表明80岁及以上人群使用吲达帕胺(缓释)进行抗高血压治疗,无论是否联用培哚普利,都是有益的。(临床试验注册号,NCT00122811 [ClinicalTrials.gov]。)