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

Arthur M. Feldman, Ron M. Oren, William T. Abraham, John Boehmer, Peter E. Carson, Eric Eichhorn, Edward M. Gilbert, Andrew Kao, Carl V. Leier, Brian D. Lowes, Michael A. Mathier, Frank A. McGrew, Marco Metra, Lawrence S. Zisman, Simon F. Shakar, Steven K. Krueger, Alastair D. Robertson, Bill G. White, Michael J. Gerber, Gwyn E. WoldMichael R. Bristow

Research output: Contribution to journalArticle

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Abstract

Background: We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (IV) 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 IV inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent IV inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous IV 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 IV 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 IV 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 IV 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 IV inotropic support for up to 90 days after initiation of therapy.

Original languageEnglish (US)
Pages (from-to)861-869
Number of pages9
JournalAmerican Heart Journal
Volume154
Issue number5
DOIs
StatePublished - Nov 1 2007

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Enoximone
Heart Failure
Placebos
Weaning
Therapeutics
Indwelling Catheters

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Feldman, Arthur M. ; Oren, Ron M. ; Abraham, William T. ; Boehmer, John ; Carson, Peter E. ; Eichhorn, Eric ; Gilbert, Edward M. ; Kao, Andrew ; Leier, Carl V. ; Lowes, Brian D. ; Mathier, Michael A. ; McGrew, Frank A. ; Metra, Marco ; Zisman, Lawrence S. ; Shakar, Simon F. ; Krueger, Steven K. ; Robertson, Alastair D. ; White, Bill G. ; Gerber, Michael J. ; Wold, Gwyn E. ; Bristow, Michael R. / 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. In: American Heart Journal. 2007 ; Vol. 154, No. 5. pp. 861-869.
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title = "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",
abstract = "Background: We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (IV) 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 IV inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent IV inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous IV 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 IV 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 IV 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 IV 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 IV inotropic support for up to 90 days after initiation of therapy.",
author = "Feldman, {Arthur M.} and Oren, {Ron M.} and Abraham, {William T.} and John Boehmer and Carson, {Peter E.} and Eric Eichhorn and Gilbert, {Edward M.} and Andrew Kao and Leier, {Carl V.} and Lowes, {Brian D.} and Mathier, {Michael A.} and McGrew, {Frank A.} and Marco Metra and Zisman, {Lawrence S.} and Shakar, {Simon F.} and Krueger, {Steven K.} and Robertson, {Alastair D.} and White, {Bill G.} and Gerber, {Michael J.} and Wold, {Gwyn E.} and Bristow, {Michael R.}",
year = "2007",
month = "11",
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doi = "10.1016/j.ahj.2007.06.044",
language = "English (US)",
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pages = "861--869",
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Feldman, AM, Oren, RM, Abraham, WT, Boehmer, J, Carson, PE, Eichhorn, E, Gilbert, EM, Kao, A, Leier, CV, Lowes, BD, Mathier, MA, McGrew, FA, Metra, M, Zisman, LS, Shakar, SF, Krueger, SK, Robertson, AD, White, BG, Gerber, MJ, Wold, GE & Bristow, MR 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, vol. 154, no. 5, pp. 861-869. https://doi.org/10.1016/j.ahj.2007.06.044

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. / Feldman, Arthur M.; Oren, Ron M.; Abraham, William T.; Boehmer, John; Carson, Peter E.; Eichhorn, Eric; Gilbert, Edward M.; Kao, Andrew; Leier, Carl V.; Lowes, Brian D.; Mathier, Michael A.; McGrew, Frank A.; Metra, Marco; Zisman, Lawrence S.; Shakar, Simon F.; Krueger, Steven K.; Robertson, Alastair D.; White, Bill G.; Gerber, Michael J.; Wold, Gwyn E.; Bristow, Michael R.

In: American Heart Journal, Vol. 154, No. 5, 01.11.2007, p. 861-869.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support

T2 - 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

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.

PY - 2007/11/1

Y1 - 2007/11/1

N2 - Background: We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (IV) 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 IV inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent IV inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous IV 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 IV 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 IV 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 IV 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 IV inotropic support for up to 90 days after initiation of therapy.

AB - Background: We determined whether low-dose oral enoximone could wean patients with ultra-advanced heart failure (UA-HF) from intravenous (IV) 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 IV inotropic therapy were randomized to enoximone or placebo. Subjects receiving intermittent IV inotropes were administered study medication of 25 or 50 mg 3 times a day (tid). Subjects receiving continuous IV 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 IV 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 IV 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 IV 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 IV inotropic support for up to 90 days after initiation of therapy.

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