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
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...
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| Veröffentlicht in: | The American heart journal 2007-11, Vol.154 (5), p.861-869 |
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| creator | Feldman, Arthur M., MD, PhD Oren, Ron M., MD Abraham, William T., MD Boehmer, John P., MD Carson, Peter E., MD Eichhorn, Eric, MD Gilbert, Edward M., MD Kao, Andrew, MD Leier, Carl V., MD Lowes, Brian D., MD Mathier, Michael A., MD McGrew, Frank A., MD Metra, Marco, MD Zisman, Lawrence S., MD Shakar, Simon F., MD Krueger, Steven K., MD Robertson, Alastair D., PhD White, Bill G., PhD Gerber, Michael J., MD Wold, Gwyn E., MSPH Bristow, Michael R., MD, PhD |
| description | 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. |
| doi_str_mv | 10.1016/j.ahj.2007.06.044 |
| format | Article |
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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.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2007.06.044</identifier><identifier>PMID: 17967591</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Administration, Oral ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiomyopathy ; Cardiotonic Agents - administration & dosage ; Cardiovascular ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug dosages ; Drug therapy ; Enoximone - administration & dosage ; Female ; Follow-Up Studies ; Heart ; Heart failure ; Heart Failure - drug therapy ; Heart Failure - mortality ; Heart Failure - physiopathology ; Heart failure, cardiogenic pulmonary edema, cardiac enlargement ; Humans ; Infusions, Intravenous ; Male ; Medical sciences ; Middle Aged ; Mortality ; Myocardial Contraction - drug effects ; Myocardial Contraction - physiology ; Retrospective Studies ; Survival Rate ; Treatment Outcome ; United States - epidemiology ; Ventricular Function, Left - drug effects ; Ventricular Function, Left - physiology</subject><ispartof>The American heart journal, 2007-11, Vol.154 (5), p.861-869</ispartof><rights>2007</rights><rights>2007 INIST-CNRS</rights><rights>Copyright Elsevier Limited Nov 2007</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-11cd6a11ad6a64ddd16faf5f819f799fc5d65913299f96410a8ee590f09d6dfe3</citedby><cites>FETCH-LOGICAL-c464t-11cd6a11ad6a64ddd16faf5f819f799fc5d65913299f96410a8ee590f09d6dfe3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870307005911$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=19236804$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17967591$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Feldman, Arthur M., MD, PhD</creatorcontrib><creatorcontrib>Oren, Ron M., MD</creatorcontrib><creatorcontrib>Abraham, William T., MD</creatorcontrib><creatorcontrib>Boehmer, John P., MD</creatorcontrib><creatorcontrib>Carson, Peter E., MD</creatorcontrib><creatorcontrib>Eichhorn, Eric, MD</creatorcontrib><creatorcontrib>Gilbert, Edward M., MD</creatorcontrib><creatorcontrib>Kao, Andrew, MD</creatorcontrib><creatorcontrib>Leier, Carl V., MD</creatorcontrib><creatorcontrib>Lowes, Brian D., MD</creatorcontrib><creatorcontrib>Mathier, Michael A., MD</creatorcontrib><creatorcontrib>McGrew, Frank A., MD</creatorcontrib><creatorcontrib>Metra, Marco, MD</creatorcontrib><creatorcontrib>Zisman, Lawrence S., MD</creatorcontrib><creatorcontrib>Shakar, Simon F., MD</creatorcontrib><creatorcontrib>Krueger, Steven K., MD</creatorcontrib><creatorcontrib>Robertson, Alastair D., PhD</creatorcontrib><creatorcontrib>White, Bill G., PhD</creatorcontrib><creatorcontrib>Gerber, Michael J., MD</creatorcontrib><creatorcontrib>Wold, Gwyn E., MSPH</creatorcontrib><creatorcontrib>Bristow, Michael R., MD, PhD</creatorcontrib><creatorcontrib>for the EMOTE Study Group</creatorcontrib><creatorcontrib>EMOTE Study Group</creatorcontrib><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</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>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.</description><subject>Administration, Oral</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Cardiomyopathy</subject><subject>Cardiotonic Agents - administration & dosage</subject><subject>Cardiovascular</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Enoximone - administration & dosage</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Heart failure</subject><subject>Heart Failure - drug therapy</subject><subject>Heart Failure - mortality</subject><subject>Heart Failure - physiopathology</subject><subject>Heart failure, cardiogenic pulmonary edema, cardiac enlargement</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Myocardial Contraction - drug effects</subject><subject>Myocardial Contraction - physiology</subject><subject>Retrospective Studies</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>United States - epidemiology</subject><subject>Ventricular Function, Left - drug effects</subject><subject>Ventricular Function, Left - physiology</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kt2q1DAUhYsonvHoA3gjAdG7jjudNG09IMjBPzgg-HMdMs0Ok9ppapLOOK_pE7nrDAwM4k27C99aWd0rWfaUw5IDl6-6pd50ywKgWoJcghD3sgWHpsplJcT9bAEARV5XsLrKHsXY0acsavkwu-JVI6uy4Yvs953f58ZHZD7onuHgf7mtH5CmjR5ajCxtkOm16106sOTZHvXARp0cDimyvUsbNvUp6Fyb3SwwbIM6JGa166eAzAa_ZW4gYkfmU6TZp-BH17I4jaMP6TX7gpE8IvP272kXSdzwLz3mBkccDMUgo3WHLRmk4HT_OHtgdR_xyel9nX1__-7b7cf87vOHT7dv7_JWSJFyzlsjNeeanlIYY7i02pa25o2tmsa2pZG0olVBcyMFB10jlg1YaIw0FlfX2cuj7xj8zwljUlsXW-x7PSAFVbIWoilFQeDzC7DzUxgom-IlCMmlEEAUP1Jt8DEGtGoMbqvDQXFQc92qU1S3mutWIBXVTZpnJ-dpvUVzVpz6JeDFCdCx1b0NVJGLZ64pVrKG2ejmyCEtbOcwqNhSw1SnC7RZZbz7b4w3F-q2d4OjA3_gAeP5b1UsFKiv872cryVUAJSSr_4A5rPjDw</recordid><startdate>20071101</startdate><enddate>20071101</enddate><creator>Feldman, Arthur M., MD, PhD</creator><creator>Oren, Ron M., MD</creator><creator>Abraham, William T., MD</creator><creator>Boehmer, John P., MD</creator><creator>Carson, Peter E., MD</creator><creator>Eichhorn, Eric, MD</creator><creator>Gilbert, Edward M., MD</creator><creator>Kao, Andrew, MD</creator><creator>Leier, Carl V., MD</creator><creator>Lowes, Brian D., MD</creator><creator>Mathier, Michael A., MD</creator><creator>McGrew, Frank A., MD</creator><creator>Metra, Marco, MD</creator><creator>Zisman, Lawrence S., MD</creator><creator>Shakar, Simon F., MD</creator><creator>Krueger, Steven K., MD</creator><creator>Robertson, Alastair D., PhD</creator><creator>White, Bill G., PhD</creator><creator>Gerber, Michael J., MD</creator><creator>Wold, Gwyn E., MSPH</creator><creator>Bristow, Michael R., MD, PhD</creator><general>Mosby, Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20071101</creationdate><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</title><author>Feldman, Arthur M., MD, PhD ; Oren, Ron M., MD ; Abraham, William T., MD ; Boehmer, John P., MD ; Carson, Peter E., MD ; Eichhorn, Eric, MD ; Gilbert, Edward M., MD ; Kao, Andrew, MD ; Leier, Carl V., MD ; Lowes, Brian D., MD ; Mathier, Michael A., MD ; McGrew, Frank A., MD ; Metra, Marco, MD ; Zisman, Lawrence S., MD ; Shakar, Simon F., MD ; Krueger, Steven K., MD ; Robertson, Alastair D., PhD ; White, Bill G., PhD ; Gerber, Michael J., MD ; Wold, Gwyn E., MSPH ; Bristow, Michael R., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-11cd6a11ad6a64ddd16faf5f819f799fc5d65913299f96410a8ee590f09d6dfe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Administration, Oral</topic><topic>Biological and medical sciences</topic><topic>Cardiology. Vascular system</topic><topic>Cardiomyopathy</topic><topic>Cardiotonic Agents - administration & dosage</topic><topic>Cardiovascular</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Enoximone - administration & dosage</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Heart failure</topic><topic>Heart Failure - drug therapy</topic><topic>Heart Failure - mortality</topic><topic>Heart Failure - physiopathology</topic><topic>Heart failure, cardiogenic pulmonary edema, cardiac enlargement</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Myocardial Contraction - drug effects</topic><topic>Myocardial Contraction - physiology</topic><topic>Retrospective Studies</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>United States - epidemiology</topic><topic>Ventricular Function, Left - drug effects</topic><topic>Ventricular Function, Left - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Feldman, Arthur M., MD, PhD</creatorcontrib><creatorcontrib>Oren, Ron M., MD</creatorcontrib><creatorcontrib>Abraham, William T., MD</creatorcontrib><creatorcontrib>Boehmer, John P., MD</creatorcontrib><creatorcontrib>Carson, Peter E., MD</creatorcontrib><creatorcontrib>Eichhorn, Eric, MD</creatorcontrib><creatorcontrib>Gilbert, Edward M., MD</creatorcontrib><creatorcontrib>Kao, Andrew, MD</creatorcontrib><creatorcontrib>Leier, Carl V., MD</creatorcontrib><creatorcontrib>Lowes, Brian D., MD</creatorcontrib><creatorcontrib>Mathier, Michael A., MD</creatorcontrib><creatorcontrib>McGrew, Frank A., MD</creatorcontrib><creatorcontrib>Metra, Marco, MD</creatorcontrib><creatorcontrib>Zisman, Lawrence S., MD</creatorcontrib><creatorcontrib>Shakar, Simon F., MD</creatorcontrib><creatorcontrib>Krueger, Steven K., MD</creatorcontrib><creatorcontrib>Robertson, Alastair D., PhD</creatorcontrib><creatorcontrib>White, Bill G., PhD</creatorcontrib><creatorcontrib>Gerber, Michael J., MD</creatorcontrib><creatorcontrib>Wold, Gwyn E., MSPH</creatorcontrib><creatorcontrib>Bristow, Michael R., MD, PhD</creatorcontrib><creatorcontrib>for the EMOTE Study Group</creatorcontrib><creatorcontrib>EMOTE Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest research library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Feldman, Arthur M., MD, PhD</au><au>Oren, Ron M., MD</au><au>Abraham, William T., MD</au><au>Boehmer, John P., MD</au><au>Carson, Peter E., MD</au><au>Eichhorn, Eric, MD</au><au>Gilbert, Edward M., MD</au><au>Kao, Andrew, MD</au><au>Leier, Carl V., MD</au><au>Lowes, Brian D., MD</au><au>Mathier, Michael A., MD</au><au>McGrew, Frank A., MD</au><au>Metra, Marco, MD</au><au>Zisman, Lawrence S., MD</au><au>Shakar, Simon F., MD</au><au>Krueger, Steven K., MD</au><au>Robertson, Alastair D., PhD</au><au>White, Bill G., PhD</au><au>Gerber, Michael J., MD</au><au>Wold, Gwyn E., MSPH</au><au>Bristow, Michael R., MD, PhD</au><aucorp>for the EMOTE Study Group</aucorp><aucorp>EMOTE Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2007-11-01</date><risdate>2007</risdate><volume>154</volume><issue>5</issue><spage>861</spage><epage>869</epage><pages>861-869</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><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.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>17967591</pmid><doi>10.1016/j.ahj.2007.06.044</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2007-11, Vol.154 (5), p.861-869 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_68449542 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Administration, Oral Biological and medical sciences Cardiology. Vascular system Cardiomyopathy Cardiotonic Agents - administration & dosage Cardiovascular Dose-Response Relationship, Drug Drug Administration Schedule Drug dosages Drug therapy Enoximone - administration & dosage Female Follow-Up Studies Heart Heart failure Heart Failure - drug therapy Heart Failure - mortality Heart Failure - physiopathology Heart failure, cardiogenic pulmonary edema, cardiac enlargement Humans Infusions, Intravenous Male Medical sciences Middle Aged Mortality Myocardial Contraction - drug effects Myocardial Contraction - physiology Retrospective Studies Survival Rate Treatment Outcome United States - epidemiology Ventricular Function, Left - drug effects Ventricular Function, Left - physiology |
| 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 |
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