TY - JOUR
T1 - Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin- converting enzyme inhibitors
AU - Granger, Christopher B.
AU - Ertl, Georg
AU - Kuch, Jerzy
AU - Maggioni, Aldo P.
AU - McMurray, John
AU - Rouleau, Jean Lucien
AU - Stevenson, Lynn Warner
AU - Swedberg, Karl
AU - Young, James
AU - Yusuf, Salim
AU - Califf, Robert M.
AU - Bart, Bradley A.
AU - Held, Peter
AU - Michelson, Eric L.
AU - Sellers, Mary Ann
AU - Ohlin, Gunilla
AU - Sparapani, Rodney
AU - Pfeffer, Marc A.
PY - 2000
Y1 - 2000
N2 - Background: Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors. Methods: Patients with CHF, left ventricular ejection fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d; the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%). Results: The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant; the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16-mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%). Conclusions: Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.
AB - Background: Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors. Methods: Patients with CHF, left ventricular ejection fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d; the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%). Results: The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant; the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16-mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%). Conclusions: Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.
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U2 - 10.1016/S0002-8703(00)90037-1
DO - 10.1016/S0002-8703(00)90037-1
M3 - Article
C2 - 10740141
AN - SCOPUS:0034074905
SN - 0002-8703
VL - 139
SP - 609
EP - 617
JO - American Heart Journal
JF - American Heart Journal
IS - 4
ER -