Akira Matsumori1. 1. Kyoto University Graduate School of Medicine, 54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan. amat@kuhp.kyoto-u.ac.jp
Abstract
BACKGROUND:Candesartan cilexetil is a new angiotensin II receptor blocker with a high affinity for the angiotensin II-subtype 1 receptor. AIMS: This 6-month study examined the safety and efficacy of candesartan cilexetil, 8 mg once daily, to prevent the progression of congestive heart failure (CHF). METHODS: This randomised, double-blind, placebo-controlled study enrolled 305 patients with CHF who were not receiving ACE inhibitor therapy. The composite primary efficacy endpoint was progression of CHF or addition or dose escalation of CHF medications. The secondary endpoints were incidence of cardiovascular events and changes in left ventricular function. RESULTS: The study was prematurely terminated after the second interim safety analysis. The incidence of confirmed progression of CHF was significantly lower in the candesartan group (7.4%) than in the placebo group (22.2%), with a risk reduction of 66.7% and a risk difference of -14.8% (95% CI: -22.8 to -6.8%, P<0.001). Cardiovascular events were also significantly lower during treatment with candesartan than with placebo (10.8% vs. 22.9%) with a risk reduction of 52.8% and a risk difference of -12.1% (95% CI: -20.6 to -3.6%, P<0.01). The actively treated group had a significant improvement in hemodynamics. Candesartan cilexetil was well tolerated. CONCLUSION:Candesartan cilexetil, 8 mg/day, significantly reduced the progression of CHF when compared with placebo.
RCT Entities:
BACKGROUND:Candesartancilexetil is a new angiotensin II receptor blocker with a high affinity for the angiotensin II-subtype 1 receptor. AIMS: This 6-month study examined the safety and efficacy of candesartancilexetil, 8 mg once daily, to prevent the progression of congestive heart failure (CHF). METHODS: This randomised, double-blind, placebo-controlled study enrolled 305 patients with CHF who were not receiving ACE inhibitor therapy. The composite primary efficacy endpoint was progression of CHF or addition or dose escalation of CHF medications. The secondary endpoints were incidence of cardiovascular events and changes in left ventricular function. RESULTS: The study was prematurely terminated after the second interim safety analysis. The incidence of confirmed progression of CHF was significantly lower in the candesartan group (7.4%) than in the placebo group (22.2%), with a risk reduction of 66.7% and a risk difference of -14.8% (95% CI: -22.8 to -6.8%, P<0.001). Cardiovascular events were also significantly lower during treatment with candesartan than with placebo (10.8% vs. 22.9%) with a risk reduction of 52.8% and a risk difference of -12.1% (95% CI: -20.6 to -3.6%, P<0.01). The actively treated group had a significant improvement in hemodynamics. Candesartancilexetil was well tolerated. CONCLUSION:Candesartancilexetil, 8 mg/day, significantly reduced the progression of CHF when compared with placebo.
Authors: Daniel G Kramer; Thomas A Trikalinos; David M Kent; George V Antonopoulos; Marvin A Konstam; James E Udelson Journal: J Am Coll Cardiol Date: 2010-07-27 Impact factor: 24.094