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Titolo Effects of Telmisartan Added to Angiotensin-Converting Enzyme Inhibitors on Mortality and Morbidity in Hemodialysis Patients With Chronic Heart Failure A Double-Blind, Placebo-Controlled Trial
Autore Gennaro Cice, MD,* Attilio Di Benedetto, MD,† Salvatore D?Isa, MD,*± Antonello D?Andrea, MD,* Daniele Marcelli, MD,§ Emanuele Gatti, MD,§ Raffaele Calabrò, MD* - Naples and Rome, Italy; and Bad Homburg, Germany
Referenza J Am Coll Cardiol 2010; 56 (21): 1701-1708
Contenuto Objectives 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. Background In hemodialysis patients, CHF is responsible for a high mortality rate, but presently very few data are available with regard to this population. Methods 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. Results 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. Conclusions 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).
Data 24.01.2011
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