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Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support: results of the oral enoximone in intravenous inotrope-dependent subjects trial.
Am Heart J 2007; 154(5):861-9AH

Abstract

BACKGROUND

We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (i.v.) inotropic support. Chronic parenteral inotropic therapy in UA-HF is costly and requires an indwelling catheter. An effective and safe oral inotrope would have value.

METHODS

In this placebo-controlled study, 201 subjects with UA-HF requiring i.v. inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent i.v. inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous i.v. inotropes were administered 50 or 75 mg tid for 1 week, which was reduced to 25 or 50 mg tid. The ability of subjects to remain alive and free of inotropic therapy was assessed for up to 182 days.

RESULTS

Thirty days after weaning, 51 (51%) subjects on placebo and 62 (61.4%) subjects in the enoximone group were alive and free of i.v. inotropic therapy (unadjusted primary end point P = 0.14, adjusted for etiology P = .17). At 60 days, the wean rate was 30% in the placebo group and 46.5% in the enoximone group (unadjusted P = .016) Kaplan-Meier curves demonstrated a trend toward a decrease in the time to death or reinitiation of i.v. inotropic therapy over the 182-day study period (hazard ratio 0.76 [95% CI 0.55-1.04]) and a reduction at 60 days (0.62 [95% CI 0.43-0.89], P = .009) and 90 days (0.69 [95% CI 0.49-0.97], P = .031) after weaning in the enoximone group.

CONCLUSIONS

Although there was no benefit over placebo in weaning patients from i.v. inotropes from 0 to 30 days, the EMOTE data suggest that low-dose oral enoximone can be used to wean a modest percentage of subjects from i.v. inotropic support for up to 90 days after initiation of therapy.

Authors+Show Affiliations

Department of Medicine, Jefferson Medical College, Philadelphia, PA 19107, 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 availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17967591

Citation

Feldman, Arthur M., et al. "Low-dose Oral Enoximone Enhances the Ability to Wean Patients With Ultra-advanced Heart Failure From Intravenous Inotropic Support: Results of the Oral Enoximone in Intravenous Inotrope-dependent Subjects Trial." American Heart Journal, vol. 154, no. 5, 2007, pp. 861-9.
Feldman AM, Oren RM, Abraham WT, et al. Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support: results of the oral enoximone in intravenous inotrope-dependent subjects trial. Am Heart J. 2007;154(5):861-9.
Feldman, A. M., Oren, R. M., Abraham, W. T., Boehmer, J. P., Carson, P. E., Eichhorn, E., ... Bristow, M. R. (2007). Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support: results of the oral enoximone in intravenous inotrope-dependent subjects trial. American Heart Journal, 154(5), pp. 861-9.
Feldman AM, et al. Low-dose Oral Enoximone Enhances the Ability to Wean Patients With Ultra-advanced Heart Failure From Intravenous Inotropic Support: Results of the Oral Enoximone in Intravenous Inotrope-dependent Subjects Trial. Am Heart J. 2007;154(5):861-9. PubMed PMID: 17967591.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support: results of the oral enoximone in intravenous inotrope-dependent subjects trial. AU - Feldman,Arthur M, AU - Oren,Ron M, AU - Abraham,William T, AU - Boehmer,John P, AU - Carson,Peter E, AU - Eichhorn,Eric, AU - Gilbert,Edward M, AU - Kao,Andrew, AU - Leier,Carl V, AU - Lowes,Brian D, AU - Mathier,Michael A, AU - McGrew,Frank A, AU - Metra,Marco, AU - Zisman,Lawrence S, AU - Shakar,Simon F, AU - Krueger,Steven K, AU - Robertson,Alastair D, AU - White,Bill G, AU - Gerber,Michael J, AU - Wold,Gwyn E, AU - Bristow,Michael R, AU - ,, Y1 - 2007/09/06/ PY - 2006/09/14/received PY - 2007/06/22/accepted PY - 2007/10/31/pubmed PY - 2007/11/14/medline PY - 2007/10/31/entrez SP - 861 EP - 9 JF - American heart journal JO - Am. Heart J. VL - 154 IS - 5 N2 - BACKGROUND: We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (i.v.) inotropic support. Chronic parenteral inotropic therapy in UA-HF is costly and requires an indwelling catheter. An effective and safe oral inotrope would have value. METHODS: In this placebo-controlled study, 201 subjects with UA-HF requiring i.v. inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent i.v. inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous i.v. inotropes were administered 50 or 75 mg tid for 1 week, which was reduced to 25 or 50 mg tid. The ability of subjects to remain alive and free of inotropic therapy was assessed for up to 182 days. RESULTS: Thirty days after weaning, 51 (51%) subjects on placebo and 62 (61.4%) subjects in the enoximone group were alive and free of i.v. inotropic therapy (unadjusted primary end point P = 0.14, adjusted for etiology P = .17). At 60 days, the wean rate was 30% in the placebo group and 46.5% in the enoximone group (unadjusted P = .016) Kaplan-Meier curves demonstrated a trend toward a decrease in the time to death or reinitiation of i.v. inotropic therapy over the 182-day study period (hazard ratio 0.76 [95% CI 0.55-1.04]) and a reduction at 60 days (0.62 [95% CI 0.43-0.89], P = .009) and 90 days (0.69 [95% CI 0.49-0.97], P = .031) after weaning in the enoximone group. CONCLUSIONS: Although there was no benefit over placebo in weaning patients from i.v. inotropes from 0 to 30 days, the EMOTE data suggest that low-dose oral enoximone can be used to wean a modest percentage of subjects from i.v. inotropic support for up to 90 days after initiation of therapy. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/17967591/Low_dose_oral_enoximone_enhances_the_ability_to_wean_patients_with_ultra_advanced_heart_failure_from_intravenous_inotropic_support:_results_of_the_oral_enoximone_in_intravenous_inotrope_dependent_subjects_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(07)00591-1 DB - PRIME DP - Unbound Medicine ER -