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Comparative effects of losartan and enalapril on exercise capacity and clinical status in patients with heart failure. The Losartan Pilot Exercise Study Investigators.
J Am Coll Cardiol. 1997 Oct; 30(4):983-91.JACC

Abstract

OBJECTIVES

This study was designed to determine 1) whether 12-week oral administration of losartan, an angiotensin II receptor antagonist, in patients with heart failure is well tolerated; and 2) whether functional capacity and clinical status of patients with heart failure in whom treatment with an angiotensin-converting enzyme (ACE) inhibitor is replaced with losartan for 12 weeks will remain similar to that noted in patients in whom treatment with an ACE inhibitor is continued.

BACKGROUND

Losartan is a specific, nonpeptide angiotensin II receptor antagonist. Although specific receptor blockade with losartan has certain theoretic advantages over nonspecific ACE inhibition, definitive demonstration of comparable effects in patients with congestive heart failure is lacking.

METHODS

A double-blind, multicenter, randomized, parallel, enalapril-controlled study was conducted in 116 patients with congestive heart failure (New York Heart Association functional classes II to IV) and left ventricular ejection fraction < or = 45% previously treated with stable doses of ACE inhibitors and diuretic agents, with or without concurrent digitalis and other vasodilators. After a baseline exercise period, open-label ACE inhibitors were discontinued, and patients were randomly assigned to 12 weeks of therapy with losartan, 25 mg/day (n = 38); losartan, 50 mg/day (n = 40); or enalapril, 20 mg/day (n = 38). Drug efficacy was evaluated by changes in maximal treadmill exercise time (using a modified Naughton protocol), 6-min walk test, left ventricular ejection fraction and dyspnea-fatigue index. Safety was measured by the incidence of clinical and laboratory adverse experiences.

RESULTS

The treadmill exercise time and the 6-min walk test did not change significantly after replacement of ACE inhibitor therapy with losartan. Similarly, a significant change was not observed in either the dyspnea-fatigue index or left ventricular ejection fraction at the end of double-blind period relative to baseline.

CONCLUSIONS

Losartan was generally well tolerated and comparable to enalapril in terms of exercise tolerance in this short-term (12-week) study of patients with heart failure. The clinical effects of long-term angiotensin II receptor blockade compared with ACE inhibition remain to be studied.

Authors+Show Affiliations

University of Chicago Medical Center, Illinois 60637, USA. rlang@medicine.bsd.uchicagoNo 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
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9316528

Citation

Lang, R M., et al. "Comparative Effects of Losartan and Enalapril On Exercise Capacity and Clinical Status in Patients With Heart Failure. the Losartan Pilot Exercise Study Investigators." Journal of the American College of Cardiology, vol. 30, no. 4, 1997, pp. 983-91.
Lang RM, Elkayam U, Yellen LG, et al. Comparative effects of losartan and enalapril on exercise capacity and clinical status in patients with heart failure. The Losartan Pilot Exercise Study Investigators. J Am Coll Cardiol. 1997;30(4):983-91.
Lang, R. M., Elkayam, U., Yellen, L. G., Krauss, D., McKelvie, R. S., Vaughan, D. E., Ney, D. E., Makris, L., & Chang, P. I. (1997). Comparative effects of losartan and enalapril on exercise capacity and clinical status in patients with heart failure. The Losartan Pilot Exercise Study Investigators. Journal of the American College of Cardiology, 30(4), 983-91.
Lang RM, et al. Comparative Effects of Losartan and Enalapril On Exercise Capacity and Clinical Status in Patients With Heart Failure. the Losartan Pilot Exercise Study Investigators. J Am Coll Cardiol. 1997;30(4):983-91. PubMed PMID: 9316528.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative effects of losartan and enalapril on exercise capacity and clinical status in patients with heart failure. The Losartan Pilot Exercise Study Investigators. AU - Lang,R M, AU - Elkayam,U, AU - Yellen,L G, AU - Krauss,D, AU - McKelvie,R S, AU - Vaughan,D E, AU - Ney,D E, AU - Makris,L, AU - Chang,P I, PY - 1997/10/8/pubmed PY - 1997/10/8/medline PY - 1997/10/8/entrez SP - 983 EP - 91 JF - Journal of the American College of Cardiology JO - J Am Coll Cardiol VL - 30 IS - 4 N2 - OBJECTIVES: This study was designed to determine 1) whether 12-week oral administration of losartan, an angiotensin II receptor antagonist, in patients with heart failure is well tolerated; and 2) whether functional capacity and clinical status of patients with heart failure in whom treatment with an angiotensin-converting enzyme (ACE) inhibitor is replaced with losartan for 12 weeks will remain similar to that noted in patients in whom treatment with an ACE inhibitor is continued. BACKGROUND: Losartan is a specific, nonpeptide angiotensin II receptor antagonist. Although specific receptor blockade with losartan has certain theoretic advantages over nonspecific ACE inhibition, definitive demonstration of comparable effects in patients with congestive heart failure is lacking. METHODS: A double-blind, multicenter, randomized, parallel, enalapril-controlled study was conducted in 116 patients with congestive heart failure (New York Heart Association functional classes II to IV) and left ventricular ejection fraction < or = 45% previously treated with stable doses of ACE inhibitors and diuretic agents, with or without concurrent digitalis and other vasodilators. After a baseline exercise period, open-label ACE inhibitors were discontinued, and patients were randomly assigned to 12 weeks of therapy with losartan, 25 mg/day (n = 38); losartan, 50 mg/day (n = 40); or enalapril, 20 mg/day (n = 38). Drug efficacy was evaluated by changes in maximal treadmill exercise time (using a modified Naughton protocol), 6-min walk test, left ventricular ejection fraction and dyspnea-fatigue index. Safety was measured by the incidence of clinical and laboratory adverse experiences. RESULTS: The treadmill exercise time and the 6-min walk test did not change significantly after replacement of ACE inhibitor therapy with losartan. Similarly, a significant change was not observed in either the dyspnea-fatigue index or left ventricular ejection fraction at the end of double-blind period relative to baseline. CONCLUSIONS: Losartan was generally well tolerated and comparable to enalapril in terms of exercise tolerance in this short-term (12-week) study of patients with heart failure. The clinical effects of long-term angiotensin II receptor blockade compared with ACE inhibition remain to be studied. SN - 0735-1097 UR - https://www.unboundmedicine.com/medline/citation/9316528/Comparative_effects_of_losartan_and_enalapril_on_exercise_capacity_and_clinical_status_in_patients_with_heart_failure__The_Losartan_Pilot_Exercise_Study_Investigators_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735109797002532 DB - PRIME DP - Unbound Medicine ER -