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Rationale and design of the enoximone clinical trials program.
J Card Fail 2005; 11(9):659-69JC

Abstract

BACKGROUND

Chronic heart failure is a disease syndrome characterized in its advanced stages by a poor quality of life, frequent hospitalizations, and a high risk of mortality. In advanced and ultra-advanced chronic heart failure, many treatment options, such as cardiac transplantation and mechanical devices, are severely limited by availability and cost. Short-term Phase II clinical trials suggest that low-dose oral inotropic therapy with enoximone may improve hemodynamics and exercise capacity, without adversely affecting mortality, in selected subjects with advanced chronic heart failure. Based on these data, the ability of enoximone to deliver safe and efficacious palliative treatment of advanced/ultra-advanced chronic heart failure is being evaluated in Phase III clinical trials.

METHODS AND RESULTS

The Enoximone Clinical Trials Program is a series of 4 clinical trials designed to evaluate the safety and efficacy of oral enoximone in advanced chronic heart failure. ESSENTIAL I and II (The Studies of Oral Enoximone Therapy in Advanced Heart Failure) will investigate the effects of oral enoximone on all-cause mortality and cardiovascular hospitalization, submaximal exercise capacity, and quality of life in subjects with New York Heart Association Class III/IV chronic heart failure. EMOTE (Oral Enoximone in Intravenous Inotrope-Dependent Subjects) will evaluate the potential of oral enoximone to wean subjects with ultra-advanced chronic heart failure from chronic intravenous inotropic therapy to which they have been shown to be dependent. EMPOWER (Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure) will explore the potential of enoximone to increase the tolerability of continuous release metoprolol in subjects shown previously to be hemodynamically intolerant to beta-blocker treatment.

CONCLUSION

These studies are Phase III, multicenter, randomized, double-blinded, placebo-controlled trials designed to test the general hypothesis that chronic oral administration of low doses of enoximone can produce beneficial effects in subjects with advanced or ultra-advanced chronic heart failure.

Authors+Show Affiliations

University of Colorado Health Sciences Center, Denver, Colorado 80262, USA.No 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)

Journal Article

Language

eng

PubMed ID

16360960

Citation

Lowes, Brian D., et al. "Rationale and Design of the Enoximone Clinical Trials Program." Journal of Cardiac Failure, vol. 11, no. 9, 2005, pp. 659-69.
Lowes BD, Shakar SF, Metra M, et al. Rationale and design of the enoximone clinical trials program. J Card Fail. 2005;11(9):659-69.
Lowes, B. D., Shakar, S. F., Metra, M., Feldman, A. M., Eichhorn, E., Freytag, J. W., ... Bristow, M. R. (2005). Rationale and design of the enoximone clinical trials program. Journal of Cardiac Failure, 11(9), pp. 659-69.
Lowes BD, et al. Rationale and Design of the Enoximone Clinical Trials Program. J Card Fail. 2005;11(9):659-69. PubMed PMID: 16360960.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rationale and design of the enoximone clinical trials program. AU - Lowes,Brian D, AU - Shakar,Simon F, AU - Metra,Marco, AU - Feldman,Arthur M, AU - Eichhorn,Eric, AU - Freytag,J William, AU - Gerber,Michael J, AU - Liard,Jean-Francois, AU - Hartman,Craig, AU - Gorczynski,Rick, AU - Evans,Gwyn, AU - Linseman,Jennifer V, AU - Stewart,Jennifer, AU - Robertson,Alastair D, AU - Roecker,Ellen B, AU - Demets,David L, AU - Bristow,Michael R, PY - 2005/03/22/received PY - 2005/08/29/revised PY - 2005/10/27/accepted PY - 2005/12/20/pubmed PY - 2006/3/31/medline PY - 2005/12/20/entrez SP - 659 EP - 69 JF - Journal of cardiac failure JO - J. Card. Fail. VL - 11 IS - 9 N2 - BACKGROUND: Chronic heart failure is a disease syndrome characterized in its advanced stages by a poor quality of life, frequent hospitalizations, and a high risk of mortality. In advanced and ultra-advanced chronic heart failure, many treatment options, such as cardiac transplantation and mechanical devices, are severely limited by availability and cost. Short-term Phase II clinical trials suggest that low-dose oral inotropic therapy with enoximone may improve hemodynamics and exercise capacity, without adversely affecting mortality, in selected subjects with advanced chronic heart failure. Based on these data, the ability of enoximone to deliver safe and efficacious palliative treatment of advanced/ultra-advanced chronic heart failure is being evaluated in Phase III clinical trials. METHODS AND RESULTS: The Enoximone Clinical Trials Program is a series of 4 clinical trials designed to evaluate the safety and efficacy of oral enoximone in advanced chronic heart failure. ESSENTIAL I and II (The Studies of Oral Enoximone Therapy in Advanced Heart Failure) will investigate the effects of oral enoximone on all-cause mortality and cardiovascular hospitalization, submaximal exercise capacity, and quality of life in subjects with New York Heart Association Class III/IV chronic heart failure. EMOTE (Oral Enoximone in Intravenous Inotrope-Dependent Subjects) will evaluate the potential of oral enoximone to wean subjects with ultra-advanced chronic heart failure from chronic intravenous inotropic therapy to which they have been shown to be dependent. EMPOWER (Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure) will explore the potential of enoximone to increase the tolerability of continuous release metoprolol in subjects shown previously to be hemodynamically intolerant to beta-blocker treatment. CONCLUSION: These studies are Phase III, multicenter, randomized, double-blinded, placebo-controlled trials designed to test the general hypothesis that chronic oral administration of low doses of enoximone can produce beneficial effects in subjects with advanced or ultra-advanced chronic heart failure. SN - 1071-9164 UR - https://www.unboundmedicine.com/medline/citation/16360960/Rationale_and_design_of_the_enoximone_clinical_trials_program_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1071-9164(05)01335-7 DB - PRIME DP - Unbound Medicine ER -