Efficacy and safety of oral candesartan cilexetil in patients with congestive heart failure

Background: Candesartan cilexetil is a new angiotensin 11 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 was well tolerated. Conclusion: Candesartan cilexetil, 8 mg/day, significantly reduced the progression of CHF when compared with placebo. (C) 2003 European Society of Cardiology. Published by Elsevier B.V. All rights reserved.