EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension
Background Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage condi...
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| Veröffentlicht in: | The American heart journal 2014-02, Vol.167 (2), p.210-217 |
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| creator | Sitbon, Olivier, MD Delcroix, Marion, MD Bergot, Emmanuel, MD Boonstra, Anco B., MD Granton, John, MD Langleben, David, MD Subías, Pilar Escribano, MD Galiè, Nazzareno, MD Pfister, Thomas, PhD Lemarié, Jean-Christophe, MSc Simonneau, Gérald, MD |
| description | Background Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. Methods The EPITOME-2 trial was an open-label, prospective, multicenter, single-arm, phase IIIb study. Patients with pulmonary arterial hypertension on long-term, stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients (Flolan; GlaxoSmithKline, Durham, NC) to epoprostenol with arginine and sucrose excipients (Veletri; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland). Patients were followed up for 3 months, and dose adjustments were recorded. Efficacy measures included the 6-minute walk distance, hemodynamics assessed by right heart catheterization, and New York Heart Association functional class. Safety and tolerability of the transition were also evaluated. Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication. Results Forty-two patients enrolled in the study, and 1 patient withdrew consent before treatment; thus, 41 patients received treatment and completed the study. Six patients required dose adjustments. There were no clinically relevant changes from baseline to month 3 in any of the efficacy end points. Adverse events were those previously described with intravenous prostacyclin therapy. Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month 3 in the domain of treatment convenience. Conclusions Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy, raised no new safety or tolerability concerns, and provided patients with an increased sense of treatment convenience. |
| doi_str_mv | 10.1016/j.ahj.2013.08.007 |
| format | Article |
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However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. Methods The EPITOME-2 trial was an open-label, prospective, multicenter, single-arm, phase IIIb study. Patients with pulmonary arterial hypertension on long-term, stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients (Flolan; GlaxoSmithKline, Durham, NC) to epoprostenol with arginine and sucrose excipients (Veletri; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland). Patients were followed up for 3 months, and dose adjustments were recorded. Efficacy measures included the 6-minute walk distance, hemodynamics assessed by right heart catheterization, and New York Heart Association functional class. Safety and tolerability of the transition were also evaluated. Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication. Results Forty-two patients enrolled in the study, and 1 patient withdrew consent before treatment; thus, 41 patients received treatment and completed the study. Six patients required dose adjustments. There were no clinically relevant changes from baseline to month 3 in any of the efficacy end points. Adverse events were those previously described with intravenous prostacyclin therapy. Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month 3 in the domain of treatment convenience. Conclusions Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy, raised no new safety or tolerability concerns, and provided patients with an increased sense of treatment convenience.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2013.08.007</identifier><identifier>PMID: 24439982</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Antihypertensive Agents - administration & dosage ; Aqueous solutions ; Blood pressure ; Cardiac Catheterization ; Cardiovascular ; Dose-Response Relationship, Drug ; Drug therapy ; Epoprostenol - administration & dosage ; Exercise Tolerance - drug effects ; Familial Primary Pulmonary Hypertension ; Female ; Follow-Up Studies ; Heart ; Heart attacks ; Heart rate ; Hemodynamics - drug effects ; Hemodynamics - physiology ; Humans ; Hypertension ; Hypertension, Pulmonary - drug therapy ; Hypertension, Pulmonary - physiopathology ; Infusions, Intravenous ; Male ; Middle Aged ; Patient Satisfaction ; Prospective Studies ; Pulmonary arteries ; Quality of life ; Single-Blind Method ; Surveys and Questionnaires ; Treatment Outcome ; Veins & arteries ; Young Adult</subject><ispartof>The American heart journal, 2014-02, Vol.167 (2), p.210-217</ispartof><rights>The Authors</rights><rights>2014 The Authors</rights><rights>2014.</rights><rights>Copyright Elsevier Limited Feb 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-359c6e00c8c70abdc632f5523a238e4e05b1519653d374f5979a0f2bcd6bc40d3</citedby><cites>FETCH-LOGICAL-c479t-359c6e00c8c70abdc632f5523a238e4e05b1519653d374f5979a0f2bcd6bc40d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870313005310$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24439982$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sitbon, Olivier, MD</creatorcontrib><creatorcontrib>Delcroix, Marion, MD</creatorcontrib><creatorcontrib>Bergot, Emmanuel, MD</creatorcontrib><creatorcontrib>Boonstra, Anco B., MD</creatorcontrib><creatorcontrib>Granton, John, MD</creatorcontrib><creatorcontrib>Langleben, David, MD</creatorcontrib><creatorcontrib>Subías, Pilar Escribano, MD</creatorcontrib><creatorcontrib>Galiè, Nazzareno, MD</creatorcontrib><creatorcontrib>Pfister, Thomas, PhD</creatorcontrib><creatorcontrib>Lemarié, Jean-Christophe, MSc</creatorcontrib><creatorcontrib>Simonneau, Gérald, MD</creatorcontrib><title>EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. Methods The EPITOME-2 trial was an open-label, prospective, multicenter, single-arm, phase IIIb study. Patients with pulmonary arterial hypertension on long-term, stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients (Flolan; GlaxoSmithKline, Durham, NC) to epoprostenol with arginine and sucrose excipients (Veletri; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland). Patients were followed up for 3 months, and dose adjustments were recorded. Efficacy measures included the 6-minute walk distance, hemodynamics assessed by right heart catheterization, and New York Heart Association functional class. Safety and tolerability of the transition were also evaluated. Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication. Results Forty-two patients enrolled in the study, and 1 patient withdrew consent before treatment; thus, 41 patients received treatment and completed the study. Six patients required dose adjustments. There were no clinically relevant changes from baseline to month 3 in any of the efficacy end points. Adverse events were those previously described with intravenous prostacyclin therapy. Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month 3 in the domain of treatment convenience. Conclusions Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy, raised no new safety or tolerability concerns, and provided patients with an increased sense of treatment convenience.</description><subject>Adult</subject><subject>Aged</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Aqueous solutions</subject><subject>Blood pressure</subject><subject>Cardiac Catheterization</subject><subject>Cardiovascular</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug therapy</subject><subject>Epoprostenol - administration & dosage</subject><subject>Exercise Tolerance - drug effects</subject><subject>Familial Primary Pulmonary Hypertension</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart rate</subject><subject>Hemodynamics - drug effects</subject><subject>Hemodynamics - physiology</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypertension, Pulmonary - drug therapy</subject><subject>Hypertension, Pulmonary - physiopathology</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patient Satisfaction</subject><subject>Prospective Studies</subject><subject>Pulmonary arteries</subject><subject>Quality of life</subject><subject>Single-Blind Method</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>Veins & arteries</subject><subject>Young Adult</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kt1qFDEUxwdR7Fp9AG8k4I03M54k8xUFoZRVC5UK1uuQyZxxs2aTMcm07KP4tmbdqtALr5KT_M7n_xTFcwoVBdq-3lZqs60YUF5BXwF0D4oVBdGVbVfXD4sVALCy74CfFE9i3GazZX37uDhhdc2F6Nmq-Ln-fHF99WldsjfkzBE_oyutGtCSmJZxT1SMGKNx30jaIElBuWiS8Y4kTxRxeEsmH3aLVb8f_USMy9ANOr9EgrOfg48pWzZ_kDlT6FIktyZtyLzYnXcq5CQhYTDKks1-xnzPObx7WjyalI347O48Lb6-X1-ffywvrz5cnJ9dlrruRCp5I3SLALrXHahh1C1nU9MwrhjvsUZoBtpQ0TZ85F09NaITCiY26LEddA0jPy1eHePmUn8sGJPcmajRWuUwNyFpLaAXoqMioy_voVu_BJerk7SBuuU9gzZT9Ejp3HsMOMk5mF3uU1KQB93kVmbd5EE3Cb3MumWfF3eRl2GH41-PP0Jl4O0RwDyKG4NBRp1nqXE0AXWSozf_Df_unre2xhmt7HfcY_zXhYxMgvxyWJzD3lAO0HAK_BczQb9I</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Sitbon, Olivier, MD</creator><creator>Delcroix, Marion, MD</creator><creator>Bergot, Emmanuel, MD</creator><creator>Boonstra, Anco B., MD</creator><creator>Granton, John, MD</creator><creator>Langleben, David, MD</creator><creator>Subías, Pilar Escribano, MD</creator><creator>Galiè, Nazzareno, MD</creator><creator>Pfister, Thomas, PhD</creator><creator>Lemarié, Jean-Christophe, MSc</creator><creator>Simonneau, Gérald, MD</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</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>20140201</creationdate><title>EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension</title><author>Sitbon, Olivier, MD ; Delcroix, Marion, MD ; Bergot, Emmanuel, MD ; Boonstra, Anco B., MD ; Granton, John, MD ; Langleben, David, MD ; Subías, Pilar Escribano, MD ; Galiè, Nazzareno, MD ; Pfister, Thomas, PhD ; Lemarié, Jean-Christophe, MSc ; Simonneau, Gérald, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-359c6e00c8c70abdc632f5523a238e4e05b1519653d374f5979a0f2bcd6bc40d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Aqueous solutions</topic><topic>Blood pressure</topic><topic>Cardiac Catheterization</topic><topic>Cardiovascular</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug therapy</topic><topic>Epoprostenol - administration & dosage</topic><topic>Exercise Tolerance - drug effects</topic><topic>Familial Primary Pulmonary Hypertension</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Heart rate</topic><topic>Hemodynamics - drug effects</topic><topic>Hemodynamics - physiology</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hypertension, Pulmonary - drug therapy</topic><topic>Hypertension, Pulmonary - physiopathology</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patient Satisfaction</topic><topic>Prospective Studies</topic><topic>Pulmonary arteries</topic><topic>Quality of life</topic><topic>Single-Blind Method</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><topic>Veins & arteries</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sitbon, Olivier, MD</creatorcontrib><creatorcontrib>Delcroix, Marion, MD</creatorcontrib><creatorcontrib>Bergot, Emmanuel, MD</creatorcontrib><creatorcontrib>Boonstra, Anco B., MD</creatorcontrib><creatorcontrib>Granton, John, MD</creatorcontrib><creatorcontrib>Langleben, David, MD</creatorcontrib><creatorcontrib>Subías, Pilar Escribano, MD</creatorcontrib><creatorcontrib>Galiè, Nazzareno, MD</creatorcontrib><creatorcontrib>Pfister, Thomas, PhD</creatorcontrib><creatorcontrib>Lemarié, Jean-Christophe, MSc</creatorcontrib><creatorcontrib>Simonneau, Gérald, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>Proquest Nursing & Allied Health Source</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 Edition)</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 Korea</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>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>Sitbon, Olivier, MD</au><au>Delcroix, Marion, MD</au><au>Bergot, Emmanuel, MD</au><au>Boonstra, Anco B., MD</au><au>Granton, John, MD</au><au>Langleben, David, MD</au><au>Subías, Pilar Escribano, MD</au><au>Galiè, Nazzareno, MD</au><au>Pfister, Thomas, PhD</au><au>Lemarié, Jean-Christophe, MSc</au><au>Simonneau, Gérald, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>167</volume><issue>2</issue><spage>210</spage><epage>217</epage><pages>210-217</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. Methods The EPITOME-2 trial was an open-label, prospective, multicenter, single-arm, phase IIIb study. Patients with pulmonary arterial hypertension on long-term, stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients (Flolan; GlaxoSmithKline, Durham, NC) to epoprostenol with arginine and sucrose excipients (Veletri; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland). Patients were followed up for 3 months, and dose adjustments were recorded. Efficacy measures included the 6-minute walk distance, hemodynamics assessed by right heart catheterization, and New York Heart Association functional class. Safety and tolerability of the transition were also evaluated. Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication. Results Forty-two patients enrolled in the study, and 1 patient withdrew consent before treatment; thus, 41 patients received treatment and completed the study. Six patients required dose adjustments. There were no clinically relevant changes from baseline to month 3 in any of the efficacy end points. Adverse events were those previously described with intravenous prostacyclin therapy. Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month 3 in the domain of treatment convenience. Conclusions Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy, raised no new safety or tolerability concerns, and provided patients with an increased sense of treatment convenience.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>24439982</pmid><doi>10.1016/j.ahj.2013.08.007</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The American heart journal, 2014-02, Vol.167 (2), p.210-217 |
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| subjects | Adult Aged Antihypertensive Agents - administration & dosage Aqueous solutions Blood pressure Cardiac Catheterization Cardiovascular Dose-Response Relationship, Drug Drug therapy Epoprostenol - administration & dosage Exercise Tolerance - drug effects Familial Primary Pulmonary Hypertension Female Follow-Up Studies Heart Heart attacks Heart rate Hemodynamics - drug effects Hemodynamics - physiology Humans Hypertension Hypertension, Pulmonary - drug therapy Hypertension, Pulmonary - physiopathology Infusions, Intravenous Male Middle Aged Patient Satisfaction Prospective Studies Pulmonary arteries Quality of life Single-Blind Method Surveys and Questionnaires Treatment Outcome Veins & arteries Young Adult |
| title | EPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension |
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