Low-dose enoximone improves exercise capacity in chronic heart failure

Brian D. Lowes, Michael Higginbotham, Lawrence Petrovich, Marcus A. DeWood, Mark A. Greenberg, Peter S. Rahko, G. William Dec, Thierry H. LeJemtel, Robert L. Roden, Margo M. Schleman, Alastair D. Robertson, Richard J. Gorczynski, Michael R. Bristow

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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. (C) 2000 by the American College of Cardiology.

Original languageEnglish (US)
Pages (from-to)501-508
Number of pages8
JournalJournal of the American College of Cardiology
Volume36
Issue number2
DOIs
StatePublished - 2000
Externally publishedYes

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Enoximone
Heart Failure
Exercise
Placebos
Cardiac Arrhythmias
Ambulatory Electrocardiography
Phosphodiesterase Inhibitors
Dyspnea
Multicenter Studies

ASJC Scopus subject areas

  • Nursing(all)

Cite this

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. Journal of the American College of Cardiology, 36(2), 501-508. https://doi.org/10.1016/S0735-1097(00)00759-2

Low-dose enoximone improves exercise capacity in chronic heart failure. / Lowes, Brian D.; Higginbotham, Michael; Petrovich, Lawrence; DeWood, Marcus A.; Greenberg, Mark A.; Rahko, Peter S.; Dec, G. William; LeJemtel, Thierry H.; Roden, Robert L.; Schleman, Margo M.; Robertson, Alastair D.; Gorczynski, Richard J.; Bristow, Michael R.

In: Journal of the American College of Cardiology, Vol. 36, No. 2, 2000, p. 501-508.

Research output: Contribution to journalArticle

Lowes, BD, Higginbotham, M, Petrovich, L, DeWood, MA, Greenberg, MA, Rahko, PS, Dec, GW, LeJemtel, TH, Roden, RL, Schleman, MM, Robertson, AD, Gorczynski, RJ & Bristow, MR 2000, 'Low-dose enoximone improves exercise capacity in chronic heart failure', Journal of the American College of Cardiology, vol. 36, no. 2, pp. 501-508. https://doi.org/10.1016/S0735-1097(00)00759-2
Lowes, Brian D. ; Higginbotham, Michael ; Petrovich, Lawrence ; DeWood, Marcus A. ; Greenberg, Mark A. ; Rahko, Peter S. ; Dec, G. William ; LeJemtel, Thierry H. ; Roden, Robert L. ; Schleman, Margo M. ; Robertson, Alastair D. ; Gorczynski, Richard J. ; Bristow, Michael R. / Low-dose enoximone improves exercise capacity in chronic heart failure. In: Journal of the American College of Cardiology. 2000 ; Vol. 36, No. 2. pp. 501-508.
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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. (C) 2000 by the American College of Cardiology.",
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AU - Lowes, Brian D.

AU - Higginbotham, Michael

AU - Petrovich, Lawrence

AU - DeWood, Marcus A.

AU - Greenberg, Mark A.

AU - Rahko, Peter S.

AU - Dec, G. William

AU - LeJemtel, Thierry H.

AU - Roden, Robert L.

AU - Schleman, Margo M.

AU - Robertson, Alastair D.

AU - Gorczynski, Richard J.

AU - Bristow, Michael R.

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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. (C) 2000 by the American College of Cardiology.

AB - 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. (C) 2000 by the American College of Cardiology.

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