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Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors.
Am Heart J 2000; 139(4):609-17AH

Abstract

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.

Authors+Show Affiliations

Duke Clinical Research Institute, Durham, NC 27710, USA. grang001@mc.duke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10740141

Citation

Granger, C B., et al. "Randomized Trial of Candesartan Cilexetil in the Treatment of Patients With Congestive Heart Failure and a History of Intolerance to Angiotensin-converting Enzyme Inhibitors." American Heart Journal, vol. 139, no. 4, 2000, pp. 609-17.
Granger CB, Ertl G, Kuch J, et al. Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors. Am Heart J. 2000;139(4):609-17.
Granger, C. B., Ertl, G., Kuch, J., Maggioni, A. P., McMurray, J., Rouleau, J. L., ... Pfeffer, M. A. (2000). Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors. American Heart Journal, 139(4), pp. 609-17.
Granger CB, et al. Randomized Trial of Candesartan Cilexetil in the Treatment of Patients With Congestive Heart Failure and a History of Intolerance to Angiotensin-converting Enzyme Inhibitors. Am Heart J. 2000;139(4):609-17. PubMed PMID: 10740141.
* Article titles in AMA citation format should be in sentence-case
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,C B, AU - Ertl,G, AU - Kuch,J, AU - Maggioni,A P, AU - McMurray,J, AU - Rouleau,J L, AU - Stevenson,L W, AU - Swedberg,K, AU - Young,J, AU - Yusuf,S, AU - Califf,R M, AU - Bart,B A, AU - Held,P, AU - Michelson,E L, AU - Sellers,M A, AU - Ohlin,G, AU - Sparapani,R, AU - Pfeffer,M A, PY - 2000/3/31/pubmed PY - 2000/6/3/medline PY - 2000/3/31/entrez SP - 609 EP - 17 JF - American heart journal JO - Am. Heart J. VL - 139 IS - 4 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. SN - 0002-8703 UR - https://www.unboundmedicine.com/medline/citation/10740141/Randomized_trial_of_candesartan_cilexetil_in_the_treatment_of_patients_with_congestive_heart_failure_and_a_history_of_intolerance_to_angiotensin_converting_enzyme_inhibitors_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(00)90037-1 DB - PRIME DP - Unbound Medicine ER -