The Study on cognition and prognosis in the elderly (SCOPE): principal results of a randomized double-blind intervention trial
The Study on cognition and prognosis in the elderly (SCOPE): principal results of a randomized double-blind intervention trial
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DOI：
10.1097/00004872-200305000-00011
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发表时间：
2003-05-01
影响因子：
4.9
通讯作者：
Zanchetti, A
中科院分区：
文献类型：
--
作者：
Lithell, H;Hansson, L;Zanchetti, A
背景：老年高血压患者降压治疗的预后益处在十多年前就已确立，但在轻度至中度血压升高的患者中尚不清楚。目的评估坎地沙坦类降压治疗是否能降低轻度至中度血压升高的老年患者的心血管事件、认知功能下降和痴呆。设计前瞻性、双盲、1997 - 2002年进行的随机、平行组研究。设置和参与者该研究包括4964名年龄在70-89岁的患者，收缩压为160 - 179 mmHg，和/或舒张压为90-99 mmHg，简易精神状态检查（MMSE）测试评分大于或等于24。共有15个国家的527个中心参与了这项研究。干预患者被随机分配接受血管紧张素受体阻滞剂坎地沙坦或安慰剂，并根据需要增加开放标签的活性抗高血压治疗。因此，对照组（84%的患者）广泛使用了积极的抗高血压治疗。平均随访时间为3.7年。主要结局指标主要结局指标为主要心血管事件，包括心血管死亡、非致命性卒中和非致命性心肌梗死。次要结局指标包括心血管死亡，非致命性和致命性中风和心肌梗死，认知功能测量的MMSE和demential.Results血压下降21.7/10.8毫米汞柱的坎地沙坦组和18.5/9.2毫米汞柱的对照组。242例坎地沙坦组患者和268例对照组患者发生首起主要心血管事件;坎地沙坦组风险降低10.9% [95%置信区间（CI），-6.0至25.1，P= 0.19]。坎地沙坦治疗使非致死性卒中减少27.8%（95% CI，1.3 - 47.2，P = 0.04），所有卒中减少23.6%（95% CI，-0.7-42.1，P = 0.056）。心肌梗死和心血管死亡率无显著差异。坎地沙坦组的平均MMSE评分从28.5降至28.0，对照组从28.5降至27.9（P = 0.20）。在老年高血压患者中，与对照组相比，坎地沙坦类药物治疗期间血压降低的效果略好，与主要心血管事件的减少和非致死性卒中的显著减少相关。在血压大幅降低的情况下，两个治疗组的认知功能均得到良好维持。两种治疗方案通常耐受良好。(C)2003年利平科特威廉姆斯威尔金斯。
Background The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago, but are less clear in those with mildly to moderately elevated blood pressure.Objective To assess whether candesartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events, cognitive decline and dementia.Design Prospective, double-blind, randomized, parallel-group study conducted in 1997 - 2002.Setting and participants The study was of 4964 patients aged 70-89 years, with systolic blood pressure 160179 mmHg, and/or diastolic blood pressure 90-99 mmHg, and a Mini Mental State Examination (MMSE) test score greater than or equal to 24. A total of 527 centres in 15 countries participated in the study.Intervention Patients were assigned randomly to receive the angiotensin receptor blocker candesartan or placebo, with open-label active antihypertensive therapy added as needed. As a consequence, active antihypertensive therapy was extensively used in the control group (84% of patients). Mean follow-up was 3.7 years.Main outcome measures The primary outcome measure was major cardiovascular events, a composite of cardiovascular death, non-fatal stroke and non-fatal myocardial infarction. Secondary outcome measures included cardiovascular death, non-fatal and fatal stroke and myocardial infarction, cognitive function measured by the MMSE and dementia.Results Blood pressure fell by 21.7/10.8 mmHg in the candesartan group and by 18.5/9.2 mmHg in the control group. A first major cardiovascular event occurred in 242 candesartan patients and in 268 control patients; risk reduction with candesartan was 10.9% [95% confidence interval (CI), -6.0 to 25.1, P= 0.19]. Candesartan-based treatment reduced non-fatal stroke by 27.8% (95% CI, 1.3 to 47.2, P = 0.04), and all stroke by 23.6% (95% CI, -0.7 to 42.1, P = 0.056). There were no significant differences in myocardial infarction and cardiovascular mortality. Mean MMSE score fell from 28.5 to 28.0 in the candesartan group and from 28.5 to 27.9 in the control group (P = 0.20). The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups.Conclusions In elderly hypertensive patients, a slightly more effective blood pressure reduction during candesartan-based therapy, compared with control therapy, was associated with a modest, statistically nonsignificant, reduction in major cardiovascular events and with a marked reduction in non-fatal stroke. Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions. Both treatment regimens were generally well tolerated. (C) 2003 Lippincott Williams Wilkins.