Second University of Naples, Naples, Italy.
J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.
the aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in hemodialysis patients with chronic heart failure (CHF) and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with angiotensin-converting enzyme inhibitors.
in hemodialysis patients, CHF is responsible for a high mortality rate, but presently very few data are available with regard to this population.
A 3-year randomized, double-blind, placebo-controlled, multicenter trial was performed involving 30 Italian clinics. Hemodialysis patients with CHF (New York Heart Association functional class II to III; LVEF ≤ 40%) were randomized to telmisartan or placebo in addition to angiotensin-converting enzyme inhibitor therapy. A total of 332 patients were enrolled (165 telmisartan, 167 placebo). Drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35.5 ± 8.5 months (median: 36 months; range: 2 to 40 months). Primary outcomes were: 1) all-cause mortality; 2) cardiovascular mortality; and 3) CHF hospital stay.
at 3 years, telmisartan significantly reduced all-cause mortality (35.1% vs. 54.4%; p < 0.001), cardiovascular death (30.3% vs. 43.7%; p < 0.001), and hospital admission for CHF (33.9% vs. 55.1%; p < 0.0001). With Cox proportional hazards analysis, telmisartan was an independent determinant of all-cause mortality (hazard ratio [HR]: 0.51; 95% confidence interval [CI]: 0.32 to 0.82; p < 0.01), cardiovascular mortality (HR: 0.42; 95% CI: 0.38 to 0.61; p < 0.0001), and hospital stay for deterioration of heart failure (HR: 0.38; 95% CI: 0.19 to 0.51; p < 0.0001). Adverse effects, mainly hypotension, occurred in 16.3% of the telmisartan group versus 10.7% in the placebo group.
addition of telmisartan to standard therapies significantly reduces all-cause mortality, cardiovascular death, and heart failure hospital stays in hemodialysis patients with CHF and LVEF ≤ 40%. (Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial; NCT00490958).
本研究旨在确定替米沙坦在添加血管紧张素转换酶抑制剂标准治疗后，是否可降低伴有慢性心力衰竭（CHF）和左心室射血分数（LVEF）降低的血液透析患者的全因死亡率和心血管发病率。
在血液透析患者中，CHF 死亡率很高，但目前针对该人群的数据非常有限。
进行了一项为期 3 年的随机、双盲、安慰剂对照、多中心试验，涉及 30 家意大利诊所。将伴有 CHF（纽约心脏协会功能分级 II 至 III 级；LVEF≤40%）的血液透析患者随机分为替米沙坦或安慰剂组，除血管紧张素转换酶抑制剂治疗外，还添加替米沙坦或安慰剂治疗。共纳入 332 例患者（替米沙坦组 165 例，安慰剂组 167 例）。药物剂量滴定至替米沙坦目标剂量 80mg 或安慰剂。平均随访时间为 35.5±8.5 个月（中位数：36 个月；范围：2 至 40 个月）。主要结局为：1）全因死亡率；2）心血管死亡率；3）CHF 住院率。
3 年后，替米沙坦显著降低了全因死亡率（35.1% vs. 54.4%；p<0.001）、心血管死亡（30.3% vs. 43.7%；p<0.001）和因 CHF 住院率（33.9% vs. 55.1%；p<0.0001）。Cox 比例风险分析显示，替米沙坦是全因死亡率（风险比[HR]：0.51；95%置信区间[CI]：0.32 至 0.82；p<0.01）、心血管死亡率（HR：0.42；95% CI：0.38 至 0.61；p<0.0001）和心力衰竭恶化住院率（HR：0.38；95% CI：0.19 至 0.51；p<0.0001）的独立决定因素。替米沙坦组不良反应（主要为低血压）发生率为 16.3%，安慰剂组为 10.7%。
替米沙坦添加到标准治疗中可显著降低伴有 CHF 和 LVEF≤40%的血液透析患者的全因死亡率、心血管死亡和心力衰竭住院率。
