Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study
Identifieur interne : 001490 ( Istex/Corpus ); précédent : 001489; suivant : 001491Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study
Auteurs : Björn Holmberg ; Jan-Ove Johansson ; Werner Poewe ; Gregor Wenning ; Niall P. Quinn ; Chris Mathias ; Eduardo Tolosa ; Adriana Cardozo ; Nil Dizdar ; Olivier Rascol ; Tarik SlaouiSource :
- Movement Disorders [ 0885-3185 ] ; 2007-06-15.
English descriptors
Abstract
The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21501
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ISTEX:42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title><author><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name><affiliation><mods:affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</mods:affiliation></affiliation><affiliation><mods:affiliation>Sahlgrenska University Hospital, Göteborg University, SE 41345 Göteborg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Johansson, Jan Ve" sort="Johansson, Jan Ve" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name><affiliation><mods:affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name><affiliation><mods:affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</mods:affiliation></affiliation></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name><affiliation><mods:affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</mods:affiliation></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation><mods:affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name><affiliation><mods:affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><affiliation><mods:affiliation>Department of Neurology, Linköping University Hospital, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><mods:affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><affiliation><mods:affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2</idno><date when="2007" year="2007">2007</date><idno type="doi">10.1002/mds.21501</idno><idno type="url">https://api.istex.fr/document/42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001490</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001490</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title><author><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name><affiliation><mods:affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</mods:affiliation></affiliation><affiliation><mods:affiliation>Sahlgrenska University Hospital, Göteborg University, SE 41345 Göteborg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Johansson, Jan Ve" sort="Johansson, Jan Ve" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name><affiliation><mods:affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name><affiliation><mods:affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</mods:affiliation></affiliation></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name><affiliation><mods:affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</mods:affiliation></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation><mods:affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name><affiliation><mods:affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><affiliation><mods:affiliation>Department of Neurology, Linköping University Hospital, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><mods:affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><affiliation><mods:affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-06-15">2007-06-15</date><biblScope unit="volume">22</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="1138">1138</biblScope><biblScope unit="page" to="1144">1144</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2</idno><idno type="DOI">10.1002/mds.21501</idno><idno type="ArticleID">MDS21501</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>UMSARS</term><term>UPDRS</term><term>autonomic testing</term><term>growth hormone treatment</term><term>multiple system atrophy</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Björn Holmberg MD</name><affiliations><json:string>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</json:string><json:string>Sahlgrenska University Hospital, Göteborg University, SE 41345 Göteborg, Sweden</json:string></affiliations></json:item><json:item><name>Jan‐Ove Johansson MD</name><affiliations><json:string>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</json:string></affiliations></json:item><json:item><name>Werner Poewe MD</name><affiliations><json:string>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</json:string></affiliations></json:item><json:item><name>Gregor Wenning MD</name><affiliations><json:string>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</json:string></affiliations></json:item><json:item><name>Niall P. Quinn MD</name><affiliations><json:string>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</json:string></affiliations></json:item><json:item><name>Chris Mathias MD</name><affiliations><json:string>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</json:string></affiliations></json:item><json:item><name>Eduardo Tolosa MD</name><affiliations><json:string>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</json:string></affiliations></json:item><json:item><name>Adriana Cardozo MD</name><affiliations><json:string>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</json:string></affiliations></json:item><json:item><name>Nil Dizdar MD</name><affiliations><json:string>Department of Neurology, Linköping University Hospital, Sweden</json:string></affiliations></json:item><json:item><name>Olivier Rascol MD</name><affiliations><json:string>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</json:string><json:string>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</json:string></affiliations></json:item><json:item><name>Tarik Slaoui MD</name><affiliations><json:string>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</json:string><json:string>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>multiple system atrophy</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>growth hormone treatment</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>UPDRS</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>UMSARS</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>autonomic testing</value></json:item></subject><articleId><json:string>MDS21501</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society</abstract><qualityIndicators><score>6.966</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1331</abstractCharCount><pdfWordCount>4482</pdfWordCount><pdfCharCount>28248</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>207</abstractWordCount></qualityIndicators><title>Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title><corporate><json:item><name>Growth‐Hormone MSA Study Group</name></json:item><json:item><name>European MSA Study Group (EMSA‐SG)</name></json:item></corporate><refBibs><json:item><author><json:item><name>GK Wenning</name></json:item><json:item><name>F Tison</name></json:item><json:item><name>Y Ben Shlomo</name></json:item><json:item><name>SE Daniel</name></json:item><json:item><name>NP 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neurosurgery</json:string></scienceMetrix></categories><publicationDate>2007</publicationDate><copyrightDate>2007</copyrightDate><doi><json:string>10.1002/mds.21501</json:string></doi><id>42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2</id><score>0.118519485</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Copyright © 2007 Movement Disorder Society</p></availability><date>2007</date></publicationStmt><notesStmt><note>Serono International S.A.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title><author><orgName>Growth‐Hormone MSA Study Group</orgName></author><author><orgName>European MSA Study Group (EMSA‐SG)</orgName></author><author xml:id="author-1"><persName><forename type="first">Björn</forename><surname>Holmberg</surname></persName><roleName type="degree">MD</roleName><affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</affiliation><affiliation>Sahlgrenska University Hospital, Göteborg University, SE 41345 Göteborg, Sweden</affiliation></author><author xml:id="author-2"><persName><forename type="first">Jan‐Ove</forename><surname>Johansson</surname></persName><roleName type="degree">MD</roleName><affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</affiliation></author><author xml:id="author-3"><persName><forename type="first">Werner</forename><surname>Poewe</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</affiliation></author><author xml:id="author-4"><persName><forename type="first">Gregor</forename><surname>Wenning</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</affiliation></author><author xml:id="author-5"><persName><forename type="first">Niall P.</forename><surname>Quinn</surname></persName><roleName type="degree">MD</roleName><affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</affiliation></author><author xml:id="author-6"><persName><forename type="first">Chris</forename><surname>Mathias</surname></persName><roleName type="degree">MD</roleName><affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</affiliation></author><author xml:id="author-7"><persName><forename type="first">Eduardo</forename><surname>Tolosa</surname></persName><roleName type="degree">MD</roleName><affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</affiliation></author><author xml:id="author-8"><persName><forename type="first">Adriana</forename><surname>Cardozo</surname></persName><roleName type="degree">MD</roleName><affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</affiliation></author><author xml:id="author-9"><persName><forename type="first">Nil</forename><surname>Dizdar</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Linköping University Hospital, Sweden</affiliation></author><author xml:id="author-10"><persName><forename type="first">Olivier</forename><surname>Rascol</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation></author><author xml:id="author-11"><persName><forename type="first">Tarik</forename><surname>Slaoui</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-06-15"></date><biblScope unit="volume">22</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="1138">1138</biblScope><biblScope unit="page" to="1144">1144</biblScope></imprint></monogr><idno type="istex">42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2</idno><idno type="DOI">10.1002/mds.21501</idno><idno type="ArticleID">MDS21501</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2007</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>keywords</head><item><term>multiple system atrophy</term></item><item><term>growth hormone treatment</term></item><item><term>UPDRS</term></item><item><term>UMSARS</term></item><item><term>autonomic testing</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2006-12-01">Received</change><change when="2007-03-08">Registration</change><change when="2007-06-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. 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elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS21501.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="23"></count><count type="wordTotal" number="5124"></count></countGroup><titleGroup><title type="main" xml:lang="en">Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title><title type="short" xml:lang="en">Effects of Growth Hormone in Patients</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Björn</givenNames><familyName>Holmberg</familyName><degrees>MD</degrees></personName><contactDetails><email>bjorn.holmberg@neuro.gu.se</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Jan‐Ove</givenNames><familyName>Johansson</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Werner</givenNames><familyName>Poewe</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Gregor</givenNames><familyName>Wenning</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Niall P.</givenNames><familyName>Quinn</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Chris</givenNames><familyName>Mathias</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" 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Group</groupName></creator><creator xml:id="au13" creatorRole="author" noteRef="#fn1"><groupName>European MSA Study Group (EMSA‐SG)</groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="SE" type="organization"><unparsedAffiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="AT" type="organization"><unparsedAffiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="GB" type="organization"><unparsedAffiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="ES" type="organization"><unparsedAffiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="SE" type="organization"><unparsedAffiliation>Department of Neurology, Linköping University Hospital, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="FR" type="organization"><unparsedAffiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="FR" type="organization"><unparsedAffiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">multiple system atrophy</keyword><keyword xml:id="kwd2">growth hormone treatment</keyword><keyword xml:id="kwd3">UPDRS</keyword><keyword xml:id="kwd4">UMSARS</keyword><keyword xml:id="kwd5">autonomic testing</keyword></keywordGroup><fundingInfo><fundingAgency>Serono International S.A.</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Members of the Growth‐Hormone MSA Study Group and the European MSA Study Group are listed as an <link href="#app1">Appendix</link></p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Effects of Growth Hormone in Patients</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study</title></titleInfo><name type="personal"><namePart type="given">Björn</namePart><namePart type="family">Holmberg</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</affiliation><affiliation>Sahlgrenska University Hospital, Göteborg University, SE 41345 Göteborg, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jan‐Ove</namePart><namePart type="family">Johansson</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Werner</namePart><namePart type="family">Poewe</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gregor</namePart><namePart type="family">Wenning</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Hospital Innsbruck, Innsbruck, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Niall P.</namePart><namePart type="family">Quinn</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Chris</namePart><namePart type="family">Mathias</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eduardo</namePart><namePart type="family">Tolosa</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Adriana</namePart><namePart type="family">Cardozo</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nil</namePart><namePart type="family">Dizdar</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Linköping University Hospital, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tarik</namePart><namePart type="family">Slaoui</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><affiliation>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>Growth‐Hormone MSA Study Group</namePart><description>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, SwedenDepartment of Neurology, University Hospital Innsbruck, Innsbruck, AustriaSobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UKHospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, SpainDepartment of Neurology, Linköping University Hospital, SwedenDepartment of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, FranceDepartment of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</description></name><name type="corporate"><namePart>European MSA Study Group (EMSA‐SG)</namePart><description>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, SwedenDepartment of Neurology, University Hospital Innsbruck, Innsbruck, AustriaSobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London, UKHospital Clinic de Barcelona, Servicio de Neurologia, Barcelona, SpainDepartment of Neurology, Linköping University Hospital, SwedenDepartment of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse, FranceDepartment of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse, France</description></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-06-15</dateIssued><dateCaptured encoding="w3cdtf">2006-12-01</dateCaptured><dateValid encoding="w3cdtf">2007-03-08</dateValid><copyrightDate encoding="w3cdtf">2007</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">4</extent><extent unit="references">23</extent><extent unit="words">5124</extent></physicalDescription><abstract lang="en">The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double‐blind pilot study, MSA patients were randomized to recombinant human growth hormone (r‐hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between‐group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r‐hGH‐treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r‐hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r‐hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r‐hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients. © 2007 Movement Disorder Society</abstract><note type="funding">Serono International S.A.</note><subject lang="en"><genre>keywords</genre><topic>multiple system atrophy</topic><topic>growth hormone treatment</topic><topic>UPDRS</topic><topic>UMSARS</topic><topic>autonomic testing</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>8</number></detail><extent unit="pages"><start>1138</start><end>1144</end><total>7</total></extent></part></relatedItem><identifier type="istex">42A6C3E12B4F24D2ED689E59DB9B5A6693D388C2</identifier><identifier type="DOI">10.1002/mds.21501</identifier><identifier type="ArticleID">MDS21501</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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