Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study
Background Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pu...
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| Veröffentlicht in: | The American heart journal 2014-02, Vol.167 (2), p.218-225.e1 |
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| creator | Chin, Kelly M., MD Badesch, David B., MD Robbins, Ivan M., MD Tapson, Victor F., MD Palevsky, Harold I., MD Kim, Nick H., MD Kawut, Steven M., MD Frost, Adaani, MD Benton, Wade W., PharmD Lemarie, Jean-Christophe, MSc Bodin, Frederic, MD Rubin, Lewis J., MD McLaughlin, Vallerie, MD |
| description | Background Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. Methods In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM. The study period was 28 days, followed by a 30-day safety follow-up. Study aims were to descriptively compare the safety, tolerability, drug metabolite levels, and treatment effects of epoprostenol AM and epoprostenol GM in PAH. Statistical analysis was descriptive only because of the exploratory nature of the study. Results Thirty patients with PAH (18-70 years, 24 women, 20 idiopathic PAH) were randomized to epoprostenol AM (n = 20) or epoprostenol GM (n = 10). Most frequently reported adverse events included jaw pain, headache, nausea, and flushing. Two deaths occurred during the study period, and 1 death occurred during the 30-day safety follow-up period, all in patients receiving epoprostenol AM. All deaths were classified by the treating physician as unrelated to epoprostenol AM. The median (range) change from baseline to day 28 in 6-minute walk distance was 36 m (−127 to 210 m) and 49 m (−44 to 110 m) for the epoprostenol AM and epoprostenol GM groups, respectively. Conclusions In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated. |
| doi_str_mv | 10.1016/j.ahj.2013.08.008 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1490899738</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0002870313005322</els_id><sourcerecordid>1490899738</sourcerecordid><originalsourceid>FETCH-LOGICAL-c545t-c978a885d931cb69dedb9222dfd123c09bb947006204910be9b9be92f2ecac523</originalsourceid><addsrcrecordid>eNqFkl2L1DAUhoso7jj6A7yRgDcrTMd8tJ1kBUGWUQdWVnD0NqTJKZPaJjVplfFX-pNMmVVxL_QmH_Ce5-S8b7LsMcFrgkn1vF2rQ7ummLA15muM-Z1sQbDY5NWmKO5mC4wxzfkGs7PsQYxtulaUV_ezM1oUTAjOFtmP_TePGh_6qVOj9S4i3yAY_BB8HMH5DkVv7NQj69B4ADQGUGMPbpx1w9T13qlwRCqMEKzq0OE4QDq7mFgXaPt-t79-t80JOv-LmRomYAt6bjmj_0N6tkIKDQcVAe0-rZAfwOWdqqFboaCc8b39DgbFcTLHh9m9RnURHt3sy-zj6-3-8m1-df1md_nqKtdlUY65FhuuOC-NYETXlTBgakEpNY0hlGks6loUm9kwXAiCaxC1SAttKGilS8qW2fmJm6b6MkEcZW-jhq5TDvwUJSkE5kJsGE_Sp7ekrZ-CS6-TpMRFxfgc4TIjJ5VONsUAjRyC7ZMlkmA5xy1bmeKWs1ZiLlPcqebJDXmqezC_K37lmwQvTgJIVny1EGTUFpwGY0NyXxpv_4l_eatad9ZZrbrPcIT4ZwoZqcTyw_zf5u9GGMYlo5T9BKei09o</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1504638201</pqid></control><display><type>article</type><title>Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Chin, Kelly M., MD ; Badesch, David B., MD ; Robbins, Ivan M., MD ; Tapson, Victor F., MD ; Palevsky, Harold I., MD ; Kim, Nick H., MD ; Kawut, Steven M., MD ; Frost, Adaani, MD ; Benton, Wade W., PharmD ; Lemarie, Jean-Christophe, MSc ; Bodin, Frederic, MD ; Rubin, Lewis J., MD ; McLaughlin, Vallerie, MD</creator><creatorcontrib>Chin, Kelly M., MD ; Badesch, David B., MD ; Robbins, Ivan M., MD ; Tapson, Victor F., MD ; Palevsky, Harold I., MD ; Kim, Nick H., MD ; Kawut, Steven M., MD ; Frost, Adaani, MD ; Benton, Wade W., PharmD ; Lemarie, Jean-Christophe, MSc ; Bodin, Frederic, MD ; Rubin, Lewis J., MD ; McLaughlin, Vallerie, MD</creatorcontrib><description>Background Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. Methods In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM. The study period was 28 days, followed by a 30-day safety follow-up. Study aims were to descriptively compare the safety, tolerability, drug metabolite levels, and treatment effects of epoprostenol AM and epoprostenol GM in PAH. Statistical analysis was descriptive only because of the exploratory nature of the study. Results Thirty patients with PAH (18-70 years, 24 women, 20 idiopathic PAH) were randomized to epoprostenol AM (n = 20) or epoprostenol GM (n = 10). Most frequently reported adverse events included jaw pain, headache, nausea, and flushing. Two deaths occurred during the study period, and 1 death occurred during the 30-day safety follow-up period, all in patients receiving epoprostenol AM. All deaths were classified by the treating physician as unrelated to epoprostenol AM. The median (range) change from baseline to day 28 in 6-minute walk distance was 36 m (−127 to 210 m) and 49 m (−44 to 110 m) for the epoprostenol AM and epoprostenol GM groups, respectively. Conclusions In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2013.08.008</identifier><identifier>PMID: 24439983</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Antibiotics ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - pharmacokinetics ; Blood ; Cardiovascular ; Cardiovascular disease ; Dose-Response Relationship, Drug ; Drug dosages ; Drug therapy ; Epoprostenol - administration & dosage ; Epoprostenol - pharmacokinetics ; Exercise Tolerance - drug effects ; Familial Primary Pulmonary Hypertension ; Female ; Follow-Up Studies ; Gallbladder diseases ; Heart attacks ; Heart failure ; Heart rate ; Hemodynamics - drug effects ; Hospitalization ; Humans ; Hypertension ; Hypertension, Pulmonary - drug therapy ; Hypertension, Pulmonary - metabolism ; Hypertension, Pulmonary - physiopathology ; Injections, Intravenous ; Intensive care ; Male ; Middle Aged ; Prospective Studies ; Sodium ; Treatment Outcome ; Young Adult</subject><ispartof>The American heart journal, 2014-02, Vol.167 (2), p.218-225.e1</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-c545t-c978a885d931cb69dedb9222dfd123c09bb947006204910be9b9be92f2ecac523</citedby><cites>FETCH-LOGICAL-c545t-c978a885d931cb69dedb9222dfd123c09bb947006204910be9b9be92f2ecac523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870313005322$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24439983$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chin, Kelly M., MD</creatorcontrib><creatorcontrib>Badesch, David B., MD</creatorcontrib><creatorcontrib>Robbins, Ivan M., MD</creatorcontrib><creatorcontrib>Tapson, Victor F., MD</creatorcontrib><creatorcontrib>Palevsky, Harold I., MD</creatorcontrib><creatorcontrib>Kim, Nick H., MD</creatorcontrib><creatorcontrib>Kawut, Steven M., MD</creatorcontrib><creatorcontrib>Frost, Adaani, MD</creatorcontrib><creatorcontrib>Benton, Wade W., PharmD</creatorcontrib><creatorcontrib>Lemarie, Jean-Christophe, MSc</creatorcontrib><creatorcontrib>Bodin, Frederic, MD</creatorcontrib><creatorcontrib>Rubin, Lewis J., MD</creatorcontrib><creatorcontrib>McLaughlin, Vallerie, MD</creatorcontrib><title>Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. Methods In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM. The study period was 28 days, followed by a 30-day safety follow-up. Study aims were to descriptively compare the safety, tolerability, drug metabolite levels, and treatment effects of epoprostenol AM and epoprostenol GM in PAH. Statistical analysis was descriptive only because of the exploratory nature of the study. Results Thirty patients with PAH (18-70 years, 24 women, 20 idiopathic PAH) were randomized to epoprostenol AM (n = 20) or epoprostenol GM (n = 10). Most frequently reported adverse events included jaw pain, headache, nausea, and flushing. Two deaths occurred during the study period, and 1 death occurred during the 30-day safety follow-up period, all in patients receiving epoprostenol AM. All deaths were classified by the treating physician as unrelated to epoprostenol AM. The median (range) change from baseline to day 28 in 6-minute walk distance was 36 m (−127 to 210 m) and 49 m (−44 to 110 m) for the epoprostenol AM and epoprostenol GM groups, respectively. Conclusions In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Antihypertensive Agents - pharmacokinetics</subject><subject>Blood</subject><subject>Cardiovascular</subject><subject>Cardiovascular disease</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Epoprostenol - administration & dosage</subject><subject>Epoprostenol - pharmacokinetics</subject><subject>Exercise Tolerance - drug effects</subject><subject>Familial Primary Pulmonary Hypertension</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gallbladder diseases</subject><subject>Heart attacks</subject><subject>Heart failure</subject><subject>Heart rate</subject><subject>Hemodynamics - drug effects</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypertension, Pulmonary - drug therapy</subject><subject>Hypertension, Pulmonary - metabolism</subject><subject>Hypertension, Pulmonary - physiopathology</subject><subject>Injections, Intravenous</subject><subject>Intensive care</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Sodium</subject><subject>Treatment Outcome</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>eNqFkl2L1DAUhoso7jj6A7yRgDcrTMd8tJ1kBUGWUQdWVnD0NqTJKZPaJjVplfFX-pNMmVVxL_QmH_Ce5-S8b7LsMcFrgkn1vF2rQ7ummLA15muM-Z1sQbDY5NWmKO5mC4wxzfkGs7PsQYxtulaUV_ezM1oUTAjOFtmP_TePGh_6qVOj9S4i3yAY_BB8HMH5DkVv7NQj69B4ADQGUGMPbpx1w9T13qlwRCqMEKzq0OE4QDq7mFgXaPt-t79-t80JOv-LmRomYAt6bjmj_0N6tkIKDQcVAe0-rZAfwOWdqqFboaCc8b39DgbFcTLHh9m9RnURHt3sy-zj6-3-8m1-df1md_nqKtdlUY65FhuuOC-NYETXlTBgakEpNY0hlGks6loUm9kwXAiCaxC1SAttKGilS8qW2fmJm6b6MkEcZW-jhq5TDvwUJSkE5kJsGE_Sp7ekrZ-CS6-TpMRFxfgc4TIjJ5VONsUAjRyC7ZMlkmA5xy1bmeKWs1ZiLlPcqebJDXmqezC_K37lmwQvTgJIVny1EGTUFpwGY0NyXxpv_4l_eatad9ZZrbrPcIT4ZwoZqcTyw_zf5u9GGMYlo5T9BKei09o</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Chin, Kelly M., MD</creator><creator>Badesch, David B., MD</creator><creator>Robbins, Ivan M., MD</creator><creator>Tapson, Victor F., MD</creator><creator>Palevsky, Harold I., MD</creator><creator>Kim, Nick H., MD</creator><creator>Kawut, Steven M., MD</creator><creator>Frost, Adaani, MD</creator><creator>Benton, Wade W., PharmD</creator><creator>Lemarie, Jean-Christophe, MSc</creator><creator>Bodin, Frederic, MD</creator><creator>Rubin, Lewis J., MD</creator><creator>McLaughlin, Vallerie, 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>Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study</title><author>Chin, Kelly M., MD ; Badesch, David B., MD ; Robbins, Ivan M., MD ; Tapson, Victor F., MD ; Palevsky, Harold I., MD ; Kim, Nick H., MD ; Kawut, Steven M., MD ; Frost, Adaani, MD ; Benton, Wade W., PharmD ; Lemarie, Jean-Christophe, MSc ; Bodin, Frederic, MD ; Rubin, Lewis J., MD ; McLaughlin, Vallerie, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c545t-c978a885d931cb69dedb9222dfd123c09bb947006204910be9b9be92f2ecac523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Antihypertensive Agents - pharmacokinetics</topic><topic>Blood</topic><topic>Cardiovascular</topic><topic>Cardiovascular disease</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Epoprostenol - administration & dosage</topic><topic>Epoprostenol - pharmacokinetics</topic><topic>Exercise Tolerance - drug effects</topic><topic>Familial Primary Pulmonary Hypertension</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gallbladder diseases</topic><topic>Heart attacks</topic><topic>Heart failure</topic><topic>Heart rate</topic><topic>Hemodynamics - drug effects</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hypertension, Pulmonary - drug therapy</topic><topic>Hypertension, Pulmonary - metabolism</topic><topic>Hypertension, Pulmonary - physiopathology</topic><topic>Injections, Intravenous</topic><topic>Intensive care</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Sodium</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chin, Kelly M., MD</creatorcontrib><creatorcontrib>Badesch, David B., MD</creatorcontrib><creatorcontrib>Robbins, Ivan M., MD</creatorcontrib><creatorcontrib>Tapson, Victor F., MD</creatorcontrib><creatorcontrib>Palevsky, Harold I., MD</creatorcontrib><creatorcontrib>Kim, Nick H., MD</creatorcontrib><creatorcontrib>Kawut, Steven M., MD</creatorcontrib><creatorcontrib>Frost, Adaani, MD</creatorcontrib><creatorcontrib>Benton, Wade W., PharmD</creatorcontrib><creatorcontrib>Lemarie, Jean-Christophe, MSc</creatorcontrib><creatorcontrib>Bodin, Frederic, MD</creatorcontrib><creatorcontrib>Rubin, Lewis J., MD</creatorcontrib><creatorcontrib>McLaughlin, Vallerie, 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>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 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>Chin, Kelly M., MD</au><au>Badesch, David B., MD</au><au>Robbins, Ivan M., MD</au><au>Tapson, Victor F., MD</au><au>Palevsky, Harold I., MD</au><au>Kim, Nick H., MD</au><au>Kawut, Steven M., MD</au><au>Frost, Adaani, MD</au><au>Benton, Wade W., PharmD</au><au>Lemarie, Jean-Christophe, MSc</au><au>Bodin, Frederic, MD</au><au>Rubin, Lewis J., MD</au><au>McLaughlin, Vallerie, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study</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>218</spage><epage>225.e1</epage><pages>218-225.e1</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. Methods In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM. The study period was 28 days, followed by a 30-day safety follow-up. Study aims were to descriptively compare the safety, tolerability, drug metabolite levels, and treatment effects of epoprostenol AM and epoprostenol GM in PAH. Statistical analysis was descriptive only because of the exploratory nature of the study. Results Thirty patients with PAH (18-70 years, 24 women, 20 idiopathic PAH) were randomized to epoprostenol AM (n = 20) or epoprostenol GM (n = 10). Most frequently reported adverse events included jaw pain, headache, nausea, and flushing. Two deaths occurred during the study period, and 1 death occurred during the 30-day safety follow-up period, all in patients receiving epoprostenol AM. All deaths were classified by the treating physician as unrelated to epoprostenol AM. The median (range) change from baseline to day 28 in 6-minute walk distance was 36 m (−127 to 210 m) and 49 m (−44 to 110 m) for the epoprostenol AM and epoprostenol GM groups, respectively. Conclusions In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>24439983</pmid><doi>10.1016/j.ahj.2013.08.008</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2014-02, Vol.167 (2), p.218-225.e1 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1490899738 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Aged Antibiotics Antihypertensive Agents - administration & dosage Antihypertensive Agents - pharmacokinetics Blood Cardiovascular Cardiovascular disease Dose-Response Relationship, Drug Drug dosages Drug therapy Epoprostenol - administration & dosage Epoprostenol - pharmacokinetics Exercise Tolerance - drug effects Familial Primary Pulmonary Hypertension Female Follow-Up Studies Gallbladder diseases Heart attacks Heart failure Heart rate Hemodynamics - drug effects Hospitalization Humans Hypertension Hypertension, Pulmonary - drug therapy Hypertension, Pulmonary - metabolism Hypertension, Pulmonary - physiopathology Injections, Intravenous Intensive care Male Middle Aged Prospective Studies Sodium Treatment Outcome Young Adult |
| title | Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-05T10%3A54%3A28IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Two%20formulations%20of%20epoprostenol%20sodium%20in%20the%20treatment%20of%20pulmonary%20arterial%20hypertension:%20EPITOME-1%20(epoprostenol%20for%20injection%20in%20pulmonary%20arterial%20hypertension),%20a%20phase%20IV,%20open-label,%20randomized%20study&rft.jtitle=The%20American%20heart%20journal&rft.au=Chin,%20Kelly%20M.,%20MD&rft.date=2014-02-01&rft.volume=167&rft.issue=2&rft.spage=218&rft.epage=225.e1&rft.pages=218-225.e1&rft.issn=0002-8703&rft.eissn=1097-6744&rft.coden=AHJOA2&rft_id=info:doi/10.1016/j.ahj.2013.08.008&rft_dat=%3Cproquest_cross%3E1490899738%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1504638201&rft_id=info:pmid/24439983&rft_els_id=S0002870313005322&rfr_iscdi=true |