Aims: In the present study, we investigated the efficacy and safety of candesartan cilexetil (candesartan) as "add-on" treatment in congestive heart failure (CHF) in daily practice.
Methods and results: In this open-label, multicenter study 414 CHF outpatients (NYHA II/III) with left ventricular ejection fraction (LVEF) < or = 40% and plasma brain natriuretic peptide (BNP) levels > 200 pg/ml at baseline were enrolled. Patients were treated with standard therapy including at least one angiotensin converting enzyme inhibitor in addition to another CHF drug; 91% of the patients received beta-blockers. Candesartan was uptitrated to 32 mg/day (target dose if tolerated) during 6 weeks followed by constant dosing over 16 weeks. The primary endpoint plasma BNP was significantly reduced by 25% at week 22 (from 394 to 295 pg/ml, P < 0.0001 vs. baseline). Candesartan produced early and sustained improvements of plasma BNP/NT-pro-BNP, LVEF, and quality of life (SF-36) compared to baseline. Of patients on beta-blockers, 37% improved towards NYHA II/I at week 22 (P < 0.0001) and 53.5% of the patients in NYHA III at baseline improved into NYHA II/I at week 22 (n = 232, P < 0.0001). Candesartan was well tolerated; no unexpected findings were reported besides known adverse reactions including hypotension, hyperkalemia, and serum creatinine elevations.
Conclusion: Candesartan "add-on" treatment provides a good benefit/risk ratio in CHF outpatients in daily practice, although high-risk patients should be managed with frequent monitoring of BP, serum potassium, and renal function.