Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics
To determine the safety and pharmacokinetics of erythropoietin (Epo) given in conjunction with hypothermia for hypoxic-ischemic encephalopathy (HIE). We hypothesized that high dose Epo would produce plasma concentrations that are neuroprotective in animal studies (ie, maximum concentration = 6000-10...
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| Veröffentlicht in: | Pediatrics (Evanston) 2012-10, Vol.130 (4), p.683-691 |
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| creator | WU, Yvonne W BAUER, Larry A GONZALEZ, Fernando F GLASS, Hannah C JUUL, Sandra E BALLARD, Roberta A FERRIERO, Donna M GLIDDEN, David V MAYOCK, Dennis E CHANG, Taeun DURAND, David J DONGLI SONG BONIFACIO, Sonia L |
| description | To determine the safety and pharmacokinetics of erythropoietin (Epo) given in conjunction with hypothermia for hypoxic-ischemic encephalopathy (HIE). We hypothesized that high dose Epo would produce plasma concentrations that are neuroprotective in animal studies (ie, maximum concentration = 6000-10000 U/L; area under the curve = 117000-140000 U*h/L).
In this multicenter, open-label, dose-escalation, phase I study, we enrolled 24 newborns undergoing hypothermia for HIE. All patients had decreased consciousness and acidosis (pH < 7.00 or base deficit ≥ 12), 10-minute Apgar score ≤ 5, or ongoing resuscitation at 10 minutes. Patients received 1 of 4 Epo doses intravenously: 250 (N = 3), 500 (N = 6), 1000 (N = 7), or 2500 U/kg per dose (N = 8). We gave up to 6 doses every 48 hours starting at |
| doi_str_mv | 10.1542/peds.2012-0498 |
| format | Article |
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In this multicenter, open-label, dose-escalation, phase I study, we enrolled 24 newborns undergoing hypothermia for HIE. All patients had decreased consciousness and acidosis (pH < 7.00 or base deficit ≥ 12), 10-minute Apgar score ≤ 5, or ongoing resuscitation at 10 minutes. Patients received 1 of 4 Epo doses intravenously: 250 (N = 3), 500 (N = 6), 1000 (N = 7), or 2500 U/kg per dose (N = 8). We gave up to 6 doses every 48 hours starting at <24 hours of age and performed pharmacokinetic and safety analyses.
Patients received mean 4.8 ± 1.2 Epo doses. Although Epo followed nonlinear pharmacokinetics, excessive accumulation did not occur during multiple dosing. At 500, 1000, and 2500 U/kg Epo, half-life was 7.2, 15.0, and 18.7 hours; maximum concentration was 7046, 13780, and 33316 U/L, and total Epo exposure (area under the curve) was 50306, 131054, and 328002 U*h/L, respectively. Drug clearance at a given dose was slower than reported in uncooled preterm infants. No deaths or serious adverse effects were seen.
Epo 1000 U/kg per dose intravenously given in conjunction with hypothermia is well tolerated and produces plasma concentrations that are neuroprotective in animals. A large efficacy trial is needed to determine whether Epo add-on therapy further improves outcome in infants undergoing hypothermia for HIE.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.2012-0498</identifier><identifier>PMID: 23008465</identifier><identifier>CODEN: PEDIAU</identifier><language>eng</language><publisher>Elk Grove Village, IL: American Academy of Pediatrics</publisher><subject>Analysis of Variance ; Biological and medical sciences ; Brain diseases ; Care and treatment ; Combined Modality Therapy ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug dosages ; Encephalopathy ; Erythropoietin ; Erythropoietin - adverse effects ; Erythropoietin - blood ; Erythropoietin - pharmacokinetics ; Erythropoietin - therapeutic use ; Female ; General aspects ; Glycoproteins ; Half-Life ; Health aspects ; Humans ; Hypothermia, Induced ; Hypoxia-Ischemia, Brain - drug therapy ; Hypoxia-Ischemia, Brain - therapy ; Infant, Newborn ; Infusions, Intravenous ; Male ; Medical sciences ; Metabolic Clearance Rate ; Neurology ; Neuroprotective Agents - adverse effects ; Neuroprotective Agents - blood ; Neuroprotective Agents - pharmacokinetics ; Neuroprotective Agents - therapeutic use ; Pediatric neurology ; Pediatrics ; Pharmacology ; Treatment outcome</subject><ispartof>Pediatrics (Evanston), 2012-10, Vol.130 (4), p.683-691</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright American Academy of Pediatrics Oct 2012</rights><rights>Copyright © 2012 by the American Academy of Pediatrics 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c597t-7125d3335c49647a0232e7f3bddfb1abf49a0afd177b68efc358f23ee3f43e393</citedby><cites>FETCH-LOGICAL-c597t-7125d3335c49647a0232e7f3bddfb1abf49a0afd177b68efc358f23ee3f43e393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26384896$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23008465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>WU, Yvonne W</creatorcontrib><creatorcontrib>BAUER, Larry A</creatorcontrib><creatorcontrib>GONZALEZ, Fernando F</creatorcontrib><creatorcontrib>GLASS, Hannah C</creatorcontrib><creatorcontrib>JUUL, Sandra E</creatorcontrib><creatorcontrib>BALLARD, Roberta A</creatorcontrib><creatorcontrib>FERRIERO, Donna M</creatorcontrib><creatorcontrib>GLIDDEN, David V</creatorcontrib><creatorcontrib>MAYOCK, Dennis E</creatorcontrib><creatorcontrib>CHANG, Taeun</creatorcontrib><creatorcontrib>DURAND, David J</creatorcontrib><creatorcontrib>DONGLI SONG</creatorcontrib><creatorcontrib>BONIFACIO, Sonia L</creatorcontrib><title>Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics</title><title>Pediatrics (Evanston)</title><addtitle>Pediatrics</addtitle><description>To determine the safety and pharmacokinetics of erythropoietin (Epo) given in conjunction with hypothermia for hypoxic-ischemic encephalopathy (HIE). We hypothesized that high dose Epo would produce plasma concentrations that are neuroprotective in animal studies (ie, maximum concentration = 6000-10000 U/L; area under the curve = 117000-140000 U*h/L).
In this multicenter, open-label, dose-escalation, phase I study, we enrolled 24 newborns undergoing hypothermia for HIE. All patients had decreased consciousness and acidosis (pH < 7.00 or base deficit ≥ 12), 10-minute Apgar score ≤ 5, or ongoing resuscitation at 10 minutes. Patients received 1 of 4 Epo doses intravenously: 250 (N = 3), 500 (N = 6), 1000 (N = 7), or 2500 U/kg per dose (N = 8). We gave up to 6 doses every 48 hours starting at <24 hours of age and performed pharmacokinetic and safety analyses.
Patients received mean 4.8 ± 1.2 Epo doses. Although Epo followed nonlinear pharmacokinetics, excessive accumulation did not occur during multiple dosing. At 500, 1000, and 2500 U/kg Epo, half-life was 7.2, 15.0, and 18.7 hours; maximum concentration was 7046, 13780, and 33316 U/L, and total Epo exposure (area under the curve) was 50306, 131054, and 328002 U*h/L, respectively. Drug clearance at a given dose was slower than reported in uncooled preterm infants. No deaths or serious adverse effects were seen.
Epo 1000 U/kg per dose intravenously given in conjunction with hypothermia is well tolerated and produces plasma concentrations that are neuroprotective in animals. A large efficacy trial is needed to determine whether Epo add-on therapy further improves outcome in infants undergoing hypothermia for HIE.</description><subject>Analysis of Variance</subject><subject>Biological and medical sciences</subject><subject>Brain diseases</subject><subject>Care and treatment</subject><subject>Combined Modality Therapy</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Encephalopathy</subject><subject>Erythropoietin</subject><subject>Erythropoietin - adverse effects</subject><subject>Erythropoietin - blood</subject><subject>Erythropoietin - pharmacokinetics</subject><subject>Erythropoietin - therapeutic use</subject><subject>Female</subject><subject>General aspects</subject><subject>Glycoproteins</subject><subject>Half-Life</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Hypothermia, Induced</subject><subject>Hypoxia-Ischemia, Brain - drug therapy</subject><subject>Hypoxia-Ischemia, Brain - therapy</subject><subject>Infant, Newborn</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic Clearance Rate</subject><subject>Neurology</subject><subject>Neuroprotective Agents - adverse effects</subject><subject>Neuroprotective Agents - blood</subject><subject>Neuroprotective Agents - pharmacokinetics</subject><subject>Neuroprotective Agents - therapeutic use</subject><subject>Pediatric neurology</subject><subject>Pediatrics</subject><subject>Pharmacology</subject><subject>Treatment outcome</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkV2LEzEUhoMobl299VIGxMupJ1-TGS-EpdQPWHYF9cabkMmctLNOkzFJxf57U1pXvQqcPHl5Tx5CnlNYUinY6xmHtGRAWQ2iax-QBYWurQVT8iFZAHBaCwB5QZ6kdAcAQir2mFwwDtCKRi7It3U85G0Mcxgxj75yIVY3uC-DGDLaPAZflfENBm-ymaq1tzhvzRRmk7eHN9Vn4zAfKuOH6tPWxJ2x4fvoS5RNT8kjZ6aEz87nJfn6bv1l9aG-vn3_cXV1XVvZqVwryuTAOZdWdI1QBhhnqBzvh8H11PROdAaMG6hSfdOis1y2jnFE7gRH3vFL8vaUO-_7HQ4WfY5m0nMcdyYedDCj_v_Gj1u9CT81L7_RMFYCXp4DYvixx5T1XdhHXzprCm2po1qQhapP1MZMqEdvg8_4K9swTbhBXVZa3eorDp3iTVFR-OWJtzGkFNHdN6Kgj-700Z0-utNwevDi3z3u8T-yCvDqDJhkzeSi8XZMf7mGt6LtGv4b_nCkBg</recordid><startdate>20121001</startdate><enddate>20121001</enddate><creator>WU, Yvonne W</creator><creator>BAUER, Larry A</creator><creator>GONZALEZ, Fernando F</creator><creator>GLASS, Hannah C</creator><creator>JUUL, Sandra E</creator><creator>BALLARD, Roberta A</creator><creator>FERRIERO, Donna M</creator><creator>GLIDDEN, David V</creator><creator>MAYOCK, Dennis E</creator><creator>CHANG, Taeun</creator><creator>DURAND, David J</creator><creator>DONGLI SONG</creator><creator>BONIFACIO, Sonia L</creator><general>American Academy of Pediatrics</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>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>5PM</scope></search><sort><creationdate>20121001</creationdate><title>Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics</title><author>WU, Yvonne W ; BAUER, Larry A ; GONZALEZ, Fernando F ; GLASS, Hannah C ; JUUL, Sandra E ; BALLARD, Roberta A ; FERRIERO, Donna M ; GLIDDEN, David V ; MAYOCK, Dennis E ; CHANG, Taeun ; DURAND, David J ; DONGLI SONG ; BONIFACIO, Sonia L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c597t-7125d3335c49647a0232e7f3bddfb1abf49a0afd177b68efc358f23ee3f43e393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Analysis of Variance</topic><topic>Biological and medical sciences</topic><topic>Brain diseases</topic><topic>Care and treatment</topic><topic>Combined Modality Therapy</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Encephalopathy</topic><topic>Erythropoietin</topic><topic>Erythropoietin - adverse effects</topic><topic>Erythropoietin - blood</topic><topic>Erythropoietin - pharmacokinetics</topic><topic>Erythropoietin - therapeutic use</topic><topic>Female</topic><topic>General aspects</topic><topic>Glycoproteins</topic><topic>Half-Life</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Hypothermia, Induced</topic><topic>Hypoxia-Ischemia, Brain - drug therapy</topic><topic>Hypoxia-Ischemia, Brain - therapy</topic><topic>Infant, Newborn</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic Clearance Rate</topic><topic>Neurology</topic><topic>Neuroprotective Agents - adverse effects</topic><topic>Neuroprotective Agents - blood</topic><topic>Neuroprotective Agents - pharmacokinetics</topic><topic>Neuroprotective Agents - therapeutic use</topic><topic>Pediatric neurology</topic><topic>Pediatrics</topic><topic>Pharmacology</topic><topic>Treatment outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>WU, Yvonne W</creatorcontrib><creatorcontrib>BAUER, Larry A</creatorcontrib><creatorcontrib>GONZALEZ, Fernando F</creatorcontrib><creatorcontrib>GLASS, Hannah C</creatorcontrib><creatorcontrib>JUUL, Sandra E</creatorcontrib><creatorcontrib>BALLARD, Roberta A</creatorcontrib><creatorcontrib>FERRIERO, Donna M</creatorcontrib><creatorcontrib>GLIDDEN, David V</creatorcontrib><creatorcontrib>MAYOCK, Dennis E</creatorcontrib><creatorcontrib>CHANG, Taeun</creatorcontrib><creatorcontrib>DURAND, David J</creatorcontrib><creatorcontrib>DONGLI SONG</creatorcontrib><creatorcontrib>BONIFACIO, Sonia L</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>Physical Education Index</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pediatrics (Evanston)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>WU, Yvonne W</au><au>BAUER, Larry A</au><au>GONZALEZ, Fernando F</au><au>GLASS, Hannah C</au><au>JUUL, Sandra E</au><au>BALLARD, Roberta A</au><au>FERRIERO, Donna M</au><au>GLIDDEN, David V</au><au>MAYOCK, Dennis E</au><au>CHANG, Taeun</au><au>DURAND, David J</au><au>DONGLI SONG</au><au>BONIFACIO, Sonia L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>2012-10-01</date><risdate>2012</risdate><volume>130</volume><issue>4</issue><spage>683</spage><epage>691</epage><pages>683-691</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>To determine the safety and pharmacokinetics of erythropoietin (Epo) given in conjunction with hypothermia for hypoxic-ischemic encephalopathy (HIE). We hypothesized that high dose Epo would produce plasma concentrations that are neuroprotective in animal studies (ie, maximum concentration = 6000-10000 U/L; area under the curve = 117000-140000 U*h/L).
In this multicenter, open-label, dose-escalation, phase I study, we enrolled 24 newborns undergoing hypothermia for HIE. All patients had decreased consciousness and acidosis (pH < 7.00 or base deficit ≥ 12), 10-minute Apgar score ≤ 5, or ongoing resuscitation at 10 minutes. Patients received 1 of 4 Epo doses intravenously: 250 (N = 3), 500 (N = 6), 1000 (N = 7), or 2500 U/kg per dose (N = 8). We gave up to 6 doses every 48 hours starting at <24 hours of age and performed pharmacokinetic and safety analyses.
Patients received mean 4.8 ± 1.2 Epo doses. Although Epo followed nonlinear pharmacokinetics, excessive accumulation did not occur during multiple dosing. At 500, 1000, and 2500 U/kg Epo, half-life was 7.2, 15.0, and 18.7 hours; maximum concentration was 7046, 13780, and 33316 U/L, and total Epo exposure (area under the curve) was 50306, 131054, and 328002 U*h/L, respectively. Drug clearance at a given dose was slower than reported in uncooled preterm infants. No deaths or serious adverse effects were seen.
Epo 1000 U/kg per dose intravenously given in conjunction with hypothermia is well tolerated and produces plasma concentrations that are neuroprotective in animals. A large efficacy trial is needed to determine whether Epo add-on therapy further improves outcome in infants undergoing hypothermia for HIE.</abstract><cop>Elk Grove Village, IL</cop><pub>American Academy of Pediatrics</pub><pmid>23008465</pmid><doi>10.1542/peds.2012-0498</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Pediatrics (Evanston), 2012-10, Vol.130 (4), p.683-691 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Analysis of Variance Biological and medical sciences Brain diseases Care and treatment Combined Modality Therapy Dose-Response Relationship, Drug Drug Administration Schedule Drug dosages Encephalopathy Erythropoietin Erythropoietin - adverse effects Erythropoietin - blood Erythropoietin - pharmacokinetics Erythropoietin - therapeutic use Female General aspects Glycoproteins Half-Life Health aspects Humans Hypothermia, Induced Hypoxia-Ischemia, Brain - drug therapy Hypoxia-Ischemia, Brain - therapy Infant, Newborn Infusions, Intravenous Male Medical sciences Metabolic Clearance Rate Neurology Neuroprotective Agents - adverse effects Neuroprotective Agents - blood Neuroprotective Agents - pharmacokinetics Neuroprotective Agents - therapeutic use Pediatric neurology Pediatrics Pharmacology Treatment outcome |
| title | Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics |
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