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预防中风:PRoFESS、ONTARGET及TRANSCEND试验项目

Preventing stroke: the PRoFESS, ONTARGET, and TRANSCEND trial programs.

作者信息

Diener Hans-Christoph

机构信息

Department of Neurology, University of Duisburg-Essen, Essen, Germany.

出版信息

J Hypertens Suppl. 2009 Jul;27(5):S31-6. doi: 10.1097/01.hjh.0000357906.60778.7f.

DOI:10.1097/01.hjh.0000357906.60778.7f
PMID:19587553
Abstract

Renin-angiotensin system blockers have been shown to reduce stroke risk, partly independent of their blood pressure-lowering effect. The PReventiOn regimen For Effectively avoiding Second Strokes (PRoFESS) trial, ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET) and Telmisartan Randomized AssessmeNt Study in aCE-iNtolerant subjects with cardiovascular Disease (TRANSCEND) recently showed potential benefits of the angiotensin II receptor blocker, telmisartan, in reducing secondary strokes. In PRoFESS, 20 332 ischemic stroke patients were randomized to telmisartan 80 mg versus placebo and to two antiplatelets in a 2 x 2 factorial design. After a mean exposure of 2 years, telmisartan showed a nonsignificant lower rate of recurrent stroke versus placebo [880 versus 934; hazard ratio 0.95; 95% confidence interval (CI) 0.86-1.04]. In a post-hoc analysis, from 6 months, telmisartan significantly reduced the number of strokes versus placebo (533 versus 608; hazard ratio 0.88; 95% CI 0.78-0.99; P = 0.042). In the stroke subgroup of ONTARGET, telmisartan 80 mg showed a trend toward reducing recurrent stroke versus ramipril 10 mg (hazard ratio 0.91; 95% CI 0.79-1.05). In the TRANSCEND study, 5926 patients who were intolerant to angiotensin-converting enzyme inhibitors were treated with 80 mg telmisartan or placebo. In a combined analysis of PRoFESS and TRANSCEND, the incidence of the composite of stroke, myocardial infarction, or vascular death was 12.8% for telmisartan versus 13.8% for placebo (hazard ratio 0.91; 95% CI 0.85-0.98; P = 0.013).

摘要

肾素-血管紧张素系统阻滞剂已被证明可降低中风风险,部分独立于其降压作用。预防有效避免二次中风(PRoFESS)试验、正在进行的替米沙坦单药及与雷米普利联合应用的全球终点试验(ONTARGET)以及替米沙坦在不耐受血管紧张素转换酶抑制剂的心血管疾病患者中的随机评估研究(TRANSCEND)最近显示,血管紧张素II受体阻滞剂替米沙坦在降低二次中风方面具有潜在益处。在PRoFESS试验中,20332例缺血性中风患者按2×2析因设计随机分为替米沙坦80mg组与安慰剂组,并分别给予两种抗血小板药物。平均暴露2年后,与安慰剂相比,替米沙坦复发性中风发生率略低但无统计学意义(880例对934例;风险比0.95;95%置信区间[CI]0.86 - 1.04)。在一项事后分析中,从6个月起,与安慰剂相比,替米沙坦显著减少了中风次数(533例对608例;风险比0.88;95%CI0.78 - 0.99;P = 0.042)。在ONTARGET试验的中风亚组中,80mg替米沙坦与10mg雷米普利相比,复发性中风有降低趋势(风险比0.91;95%CI0.79 - 1.05)。在TRANSCEND研究中,5926例不耐受血管紧张素转换酶抑制剂的患者接受了80mg替米沙坦或安慰剂治疗。在PRoFESS和TRANSCEND的联合分析中,替米沙坦组中风、心肌梗死或血管性死亡复合事件的发生率为12.8%,安慰剂组为13.8%(风险比0.91;95%CI0.85 - 0.98;P = 0.013)。

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