Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule
Aim The adequate dosing of topiramate in neonates undergoing therapeutic hypothermia has not been established. The aim of this study was to design a dosing schedule capable of providing topiramate serum concentrations within the accepted therapeutic range. Methods Neonates (n = 52) with hypoxic isch...
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| Veröffentlicht in: | ACTA PAEDIATRICA 2020-02, Vol.109 (2), p.300-308 |
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| creator | Marques, María Remedios Garcia‐Robles, Ana Usach, Iris Vento, Maximo Poveda, José Luis Peris, José Esteban Mangas‐Sanjuan, Victor |
| description | Aim
The adequate dosing of topiramate in neonates undergoing therapeutic hypothermia has not been established. The aim of this study was to design a dosing schedule capable of providing topiramate serum concentrations within the accepted therapeutic range.
Methods
Neonates (n = 52) with hypoxic ischaemic encephalopathy and subjected to therapeutic hypothermia were dosed with topiramate, 5 mg/kg on day one and 3 mg/kg on days two to five, to decrease seizure events. A total of 451 topiramate serum concentrations obtained in the patients were used to develop a population pharmacokinetic model using a non‐linear mixed‐effects modelling approach.
Results
A one‐compartment model with first‐order absorption and two different clearance terms, one for the cooling period and another for the post‐warming period, were used to describe the concentration‐time topiramate data. The probability of no‐seizure events could not be related to topiramate concentrations, which was attributed to excessively low topiramate concentrations. A modified dosage schedule was designed with the aim of obtaining more than 90% of patients with topiramate concentrations within the therapeutic range after the first dose.
Conclusion
The dosage schedule of topiramate in these patients should be modified with the aim of decreasing the frequency of seizure events. |
| doi_str_mv | 10.1111/apa.14944 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1111_apa_14944</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2336248594</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3534-9ab9de2142ec1449b3a16e349a63a5a7f969448854d03c04879b6d9b49e338853</originalsourceid><addsrcrecordid>eNqNkE9v3CAQxVHVqtmkPeQLREg9VZET_tlrjqtVmlSK1B7SszWGcZZkDQRsRfvty3a3uVUqFxj4vZnHI-Scsyte1jVEuOJKK_WOLHhT80oIsXxPFqxlsqpFLU_Iac5PjAmpVfORnEguZaMYX5DXhxBdghEmpHEDaQQTnp3HyZlMnacegy9vmc7eYnoMzj_SaYMJIs6FoZtdDPt6dEDBWxpTiCHDloah1DTEyY0uo6U25L02mw3aeYufyIcBthk_H_cz8uvbzcP6rrr_cft9vbqvjKylqjT02qLgSqDhSuleAm9QKg2NhBqWg27Kt9u2VpZJw1S71H1jda80Slmu5Rn5cuhbjL3MmKfuKczJl5GdKBkI1dZaFerrgTIp5Jxw6GJyI6Rdx1m3j7grEXd_Ii7sxbHj3I9o38i_mRagPQCv2IchG4fe4BvGWHEpOVNNOTG-dhNMLvh1mP1UpJf_Ly309ZF2W9z923K3-rk6eP8NdO2nXg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2336248594</pqid></control><display><type>article</type><title>Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><source>Web of Science - Science Citation Index Expanded - 2020<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><source>Alma/SFX Local Collection</source><creator>Marques, María Remedios ; Garcia‐Robles, Ana ; Usach, Iris ; Vento, Maximo ; Poveda, José Luis ; Peris, José Esteban ; Mangas‐Sanjuan, Victor</creator><creatorcontrib>Marques, María Remedios ; Garcia‐Robles, Ana ; Usach, Iris ; Vento, Maximo ; Poveda, José Luis ; Peris, José Esteban ; Mangas‐Sanjuan, Victor</creatorcontrib><description>Aim
The adequate dosing of topiramate in neonates undergoing therapeutic hypothermia has not been established. The aim of this study was to design a dosing schedule capable of providing topiramate serum concentrations within the accepted therapeutic range.
Methods
Neonates (n = 52) with hypoxic ischaemic encephalopathy and subjected to therapeutic hypothermia were dosed with topiramate, 5 mg/kg on day one and 3 mg/kg on days two to five, to decrease seizure events. A total of 451 topiramate serum concentrations obtained in the patients were used to develop a population pharmacokinetic model using a non‐linear mixed‐effects modelling approach.
Results
A one‐compartment model with first‐order absorption and two different clearance terms, one for the cooling period and another for the post‐warming period, were used to describe the concentration‐time topiramate data. The probability of no‐seizure events could not be related to topiramate concentrations, which was attributed to excessively low topiramate concentrations. A modified dosage schedule was designed with the aim of obtaining more than 90% of patients with topiramate concentrations within the therapeutic range after the first dose.
Conclusion
The dosage schedule of topiramate in these patients should be modified with the aim of decreasing the frequency of seizure events.</description><identifier>ISSN: 0803-5253</identifier><identifier>EISSN: 1651-2227</identifier><identifier>DOI: 10.1111/apa.14944</identifier><identifier>PMID: 31336401</identifier><language>eng</language><publisher>HOBOKEN: Wiley</publisher><subject>Dosage ; Encephalopathy ; Humans ; Hypothermia ; Hypothermia, Induced ; Hypoxia ; Hypoxia-Ischemia, Brain - therapy ; hypoxic ischaemic encephalopathy ; Infant, Newborn ; Life Sciences & Biomedicine ; Neonates ; Pediatrics ; Pharmacokinetics ; population pharmacokinetics ; Schedules ; Science & Technology ; Seizures ; therapeutic hypothermia ; Topiramate ; topiramate dosing</subject><ispartof>ACTA PAEDIATRICA, 2020-02, Vol.109 (2), p.300-308</ispartof><rights>2019 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd</rights><rights>2019 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.</rights><rights>2020 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>8</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000483104600001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c3534-9ab9de2142ec1449b3a16e349a63a5a7f969448854d03c04879b6d9b49e338853</citedby><cites>FETCH-LOGICAL-c3534-9ab9de2142ec1449b3a16e349a63a5a7f969448854d03c04879b6d9b49e338853</cites><orcidid>0000-0002-4811-239X ; 0000-0003-0061-4742 ; 0000-0002-2503-3373 ; 0000-0002-5786-5668</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapa.14944$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapa.14944$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,782,786,1419,27931,27932,28255,45581,45582</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31336401$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marques, María Remedios</creatorcontrib><creatorcontrib>Garcia‐Robles, Ana</creatorcontrib><creatorcontrib>Usach, Iris</creatorcontrib><creatorcontrib>Vento, Maximo</creatorcontrib><creatorcontrib>Poveda, José Luis</creatorcontrib><creatorcontrib>Peris, José Esteban</creatorcontrib><creatorcontrib>Mangas‐Sanjuan, Victor</creatorcontrib><title>Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule</title><title>ACTA PAEDIATRICA</title><addtitle>ACTA PAEDIATR</addtitle><addtitle>Acta Paediatr</addtitle><description>Aim
The adequate dosing of topiramate in neonates undergoing therapeutic hypothermia has not been established. The aim of this study was to design a dosing schedule capable of providing topiramate serum concentrations within the accepted therapeutic range.
Methods
Neonates (n = 52) with hypoxic ischaemic encephalopathy and subjected to therapeutic hypothermia were dosed with topiramate, 5 mg/kg on day one and 3 mg/kg on days two to five, to decrease seizure events. A total of 451 topiramate serum concentrations obtained in the patients were used to develop a population pharmacokinetic model using a non‐linear mixed‐effects modelling approach.
Results
A one‐compartment model with first‐order absorption and two different clearance terms, one for the cooling period and another for the post‐warming period, were used to describe the concentration‐time topiramate data. The probability of no‐seizure events could not be related to topiramate concentrations, which was attributed to excessively low topiramate concentrations. A modified dosage schedule was designed with the aim of obtaining more than 90% of patients with topiramate concentrations within the therapeutic range after the first dose.
Conclusion
The dosage schedule of topiramate in these patients should be modified with the aim of decreasing the frequency of seizure events.</description><subject>Dosage</subject><subject>Encephalopathy</subject><subject>Humans</subject><subject>Hypothermia</subject><subject>Hypothermia, Induced</subject><subject>Hypoxia</subject><subject>Hypoxia-Ischemia, Brain - therapy</subject><subject>hypoxic ischaemic encephalopathy</subject><subject>Infant, Newborn</subject><subject>Life Sciences & Biomedicine</subject><subject>Neonates</subject><subject>Pediatrics</subject><subject>Pharmacokinetics</subject><subject>population pharmacokinetics</subject><subject>Schedules</subject><subject>Science & Technology</subject><subject>Seizures</subject><subject>therapeutic hypothermia</subject><subject>Topiramate</subject><subject>topiramate dosing</subject><issn>0803-5253</issn><issn>1651-2227</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>EIF</sourceid><recordid>eNqNkE9v3CAQxVHVqtmkPeQLREg9VZET_tlrjqtVmlSK1B7SszWGcZZkDQRsRfvty3a3uVUqFxj4vZnHI-Scsyte1jVEuOJKK_WOLHhT80oIsXxPFqxlsqpFLU_Iac5PjAmpVfORnEguZaMYX5DXhxBdghEmpHEDaQQTnp3HyZlMnacegy9vmc7eYnoMzj_SaYMJIs6FoZtdDPt6dEDBWxpTiCHDloah1DTEyY0uo6U25L02mw3aeYufyIcBthk_H_cz8uvbzcP6rrr_cft9vbqvjKylqjT02qLgSqDhSuleAm9QKg2NhBqWg27Kt9u2VpZJw1S71H1jda80Slmu5Rn5cuhbjL3MmKfuKczJl5GdKBkI1dZaFerrgTIp5Jxw6GJyI6Rdx1m3j7grEXd_Ii7sxbHj3I9o38i_mRagPQCv2IchG4fe4BvGWHEpOVNNOTG-dhNMLvh1mP1UpJf_Ly309ZF2W9z923K3-rk6eP8NdO2nXg</recordid><startdate>202002</startdate><enddate>202002</enddate><creator>Marques, María Remedios</creator><creator>Garcia‐Robles, Ana</creator><creator>Usach, Iris</creator><creator>Vento, Maximo</creator><creator>Poveda, José Luis</creator><creator>Peris, José Esteban</creator><creator>Mangas‐Sanjuan, Victor</creator><general>Wiley</general><general>Wiley Subscription Services, Inc</general><scope>AOWDO</scope><scope>BLEPL</scope><scope>DTL</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>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><orcidid>https://orcid.org/0000-0002-4811-239X</orcidid><orcidid>https://orcid.org/0000-0003-0061-4742</orcidid><orcidid>https://orcid.org/0000-0002-2503-3373</orcidid><orcidid>https://orcid.org/0000-0002-5786-5668</orcidid></search><sort><creationdate>202002</creationdate><title>Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule</title><author>Marques, María Remedios ; Garcia‐Robles, Ana ; Usach, Iris ; Vento, Maximo ; Poveda, José Luis ; Peris, José Esteban ; Mangas‐Sanjuan, Victor</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-9ab9de2142ec1449b3a16e349a63a5a7f969448854d03c04879b6d9b49e338853</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Dosage</topic><topic>Encephalopathy</topic><topic>Humans</topic><topic>Hypothermia</topic><topic>Hypothermia, Induced</topic><topic>Hypoxia</topic><topic>Hypoxia-Ischemia, Brain - therapy</topic><topic>hypoxic ischaemic encephalopathy</topic><topic>Infant, Newborn</topic><topic>Life Sciences & Biomedicine</topic><topic>Neonates</topic><topic>Pediatrics</topic><topic>Pharmacokinetics</topic><topic>population pharmacokinetics</topic><topic>Schedules</topic><topic>Science & Technology</topic><topic>Seizures</topic><topic>therapeutic hypothermia</topic><topic>Topiramate</topic><topic>topiramate dosing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marques, María Remedios</creatorcontrib><creatorcontrib>Garcia‐Robles, Ana</creatorcontrib><creatorcontrib>Usach, Iris</creatorcontrib><creatorcontrib>Vento, Maximo</creatorcontrib><creatorcontrib>Poveda, José Luis</creatorcontrib><creatorcontrib>Peris, José Esteban</creatorcontrib><creatorcontrib>Mangas‐Sanjuan, Victor</creatorcontrib><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</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><jtitle>ACTA PAEDIATRICA</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marques, María Remedios</au><au>Garcia‐Robles, Ana</au><au>Usach, Iris</au><au>Vento, Maximo</au><au>Poveda, José Luis</au><au>Peris, José Esteban</au><au>Mangas‐Sanjuan, Victor</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule</atitle><jtitle>ACTA PAEDIATRICA</jtitle><stitle>ACTA PAEDIATR</stitle><addtitle>Acta Paediatr</addtitle><date>2020-02</date><risdate>2020</risdate><volume>109</volume><issue>2</issue><spage>300</spage><epage>308</epage><pages>300-308</pages><issn>0803-5253</issn><eissn>1651-2227</eissn><abstract>Aim
The adequate dosing of topiramate in neonates undergoing therapeutic hypothermia has not been established. The aim of this study was to design a dosing schedule capable of providing topiramate serum concentrations within the accepted therapeutic range.
Methods
Neonates (n = 52) with hypoxic ischaemic encephalopathy and subjected to therapeutic hypothermia were dosed with topiramate, 5 mg/kg on day one and 3 mg/kg on days two to five, to decrease seizure events. A total of 451 topiramate serum concentrations obtained in the patients were used to develop a population pharmacokinetic model using a non‐linear mixed‐effects modelling approach.
Results
A one‐compartment model with first‐order absorption and two different clearance terms, one for the cooling period and another for the post‐warming period, were used to describe the concentration‐time topiramate data. The probability of no‐seizure events could not be related to topiramate concentrations, which was attributed to excessively low topiramate concentrations. A modified dosage schedule was designed with the aim of obtaining more than 90% of patients with topiramate concentrations within the therapeutic range after the first dose.
Conclusion
The dosage schedule of topiramate in these patients should be modified with the aim of decreasing the frequency of seizure events.</abstract><cop>HOBOKEN</cop><pub>Wiley</pub><pmid>31336401</pmid><doi>10.1111/apa.14944</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-4811-239X</orcidid><orcidid>https://orcid.org/0000-0003-0061-4742</orcidid><orcidid>https://orcid.org/0000-0002-2503-3373</orcidid><orcidid>https://orcid.org/0000-0002-5786-5668</orcidid></addata></record> |
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| subjects | Dosage Encephalopathy Humans Hypothermia Hypothermia, Induced Hypoxia Hypoxia-Ischemia, Brain - therapy hypoxic ischaemic encephalopathy Infant, Newborn Life Sciences & Biomedicine Neonates Pediatrics Pharmacokinetics population pharmacokinetics Schedules Science & Technology Seizures therapeutic hypothermia Topiramate topiramate dosing |
| title | Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule |
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