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Low-dose enoximone improves exercise capacity in chronic heart failure. Enoximone Study Group.
J Am Coll Cardiol 2000; 36(2):501-8JACC

Abstract

OBJECTIVES

This study was designed to evaluate the effects of low-dose enoximone on exercise capacity.

BACKGROUND

At higher doses the phosphodiesterase inhibitor, enoximone, has been shown to increase exercise capacity and decrease symptoms in heart failure patients but also to increase mortality. The effects of lower doses of enoximone on exercise capacity and adverse events have not been evaluated.

METHODS

This is a prospective, double-blind, placebo-controlled, multicenter trial (nine U.S. centers) conducted in 105 patients with New York Heart Association class II to III, ischemic or nonischemic chronic heart failure (CHF). Patients were randomized to placebo or enoximone at 25 or 50 mg orally three times a day. Treadmill maximal exercise testing was done at baseline and after 4, 8 and 12 weeks of treatment, using a modified Naughton protocol. Patients were also evaluated for changes in quality of life and for increased arrhythmias by Holter monitoring.

RESULTS

By the protocol-specified method of statistical analysis (the last observation carried-forward method), enoximone at 50 mg three times a day improved exercise capacity by 117 s at 12 weeks (p = 0.003). Enoximone at 25 mg three times a day also improved exercise capacity at 12 weeks by 115 s (p = 0.013). No increases in ventricular arrhythmias were noted. There were four deaths in the placebo group and 2 and 0 deaths in the enoximone 25 mg three times a day and enoximone 50 mg three times a day groups, respectively. Effects on degree of dyspnea and patient and physician assessments of clinical status favored the enoximone groups.

CONCLUSIONS

Twelve weeks of treatment with low-dose enoximone improves exercise capacity in patients with CHF, without increasing adverse events.

Authors+Show Affiliations

Heart Failure Treatment Program, University of Colorado Health Sciences Center, Denver, USA. Brian.Lowes@uchsc.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 available

Pub Type(s)

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

Language

eng

PubMed ID

10933364

Citation

Lowes, B D., et al. "Low-dose Enoximone Improves Exercise Capacity in Chronic Heart Failure. Enoximone Study Group." Journal of the American College of Cardiology, vol. 36, no. 2, 2000, pp. 501-8.
Lowes BD, Higginbotham M, Petrovich L, et al. Low-dose enoximone improves exercise capacity in chronic heart failure. Enoximone Study Group. J Am Coll Cardiol. 2000;36(2):501-8.
Lowes, B. D., Higginbotham, M., Petrovich, L., DeWood, M. A., Greenberg, M. A., Rahko, P. S., ... Bristow, M. R. (2000). Low-dose enoximone improves exercise capacity in chronic heart failure. Enoximone Study Group. Journal of the American College of Cardiology, 36(2), pp. 501-8.
Lowes BD, et al. Low-dose Enoximone Improves Exercise Capacity in Chronic Heart Failure. Enoximone Study Group. J Am Coll Cardiol. 2000;36(2):501-8. PubMed PMID: 10933364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose enoximone improves exercise capacity in chronic heart failure. Enoximone Study Group. AU - Lowes,B D, AU - Higginbotham,M, AU - Petrovich,L, AU - DeWood,M A, AU - Greenberg,M A, AU - Rahko,P S, AU - Dec,G W, AU - LeJemtel,T H, AU - Roden,R L, AU - Schleman,M M, AU - Robertson,A D, AU - Gorczynski,R J, AU - Bristow,M R, PY - 2000/8/10/pubmed PY - 2000/8/19/medline PY - 2000/8/10/entrez SP - 501 EP - 8 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 36 IS - 2 N2 - OBJECTIVES: This study was designed to evaluate the effects of low-dose enoximone on exercise capacity. BACKGROUND: At higher doses the phosphodiesterase inhibitor, enoximone, has been shown to increase exercise capacity and decrease symptoms in heart failure patients but also to increase mortality. The effects of lower doses of enoximone on exercise capacity and adverse events have not been evaluated. METHODS: This is a prospective, double-blind, placebo-controlled, multicenter trial (nine U.S. centers) conducted in 105 patients with New York Heart Association class II to III, ischemic or nonischemic chronic heart failure (CHF). Patients were randomized to placebo or enoximone at 25 or 50 mg orally three times a day. Treadmill maximal exercise testing was done at baseline and after 4, 8 and 12 weeks of treatment, using a modified Naughton protocol. Patients were also evaluated for changes in quality of life and for increased arrhythmias by Holter monitoring. RESULTS: By the protocol-specified method of statistical analysis (the last observation carried-forward method), enoximone at 50 mg three times a day improved exercise capacity by 117 s at 12 weeks (p = 0.003). Enoximone at 25 mg three times a day also improved exercise capacity at 12 weeks by 115 s (p = 0.013). No increases in ventricular arrhythmias were noted. There were four deaths in the placebo group and 2 and 0 deaths in the enoximone 25 mg three times a day and enoximone 50 mg three times a day groups, respectively. Effects on degree of dyspnea and patient and physician assessments of clinical status favored the enoximone groups. CONCLUSIONS: Twelve weeks of treatment with low-dose enoximone improves exercise capacity in patients with CHF, without increasing adverse events. SN - 0735-1097 UR - https://www.unboundmedicine.com/medline/citation/10933364/Low_dose_enoximone_improves_exercise_capacity_in_chronic_heart_failure__Enoximone_Study_Group_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735109700007592 DB - PRIME DP - Unbound Medicine ER -