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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<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>
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<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>
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<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>
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<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>
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<titleInfo type="abbreviated" lang="en"><title>Effects of Growth Hormone in Patients</title>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<dateIssued encoding="w3cdtf">2007-06-15</dateIssued>
<dateCaptured encoding="w3cdtf">2006-12-01</dateCaptured>
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<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>
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<relatedItem type="host"><titleInfo><title>Movement Disorders</title>
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<titleInfo type="abbreviated"><title>Mov. Disord.</title>
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<topic>Research Article</topic>
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<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>
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<detail type="issue"><caption>no.</caption>
<number>8</number>
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<extent unit="pages"><start>1138</start>
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<identifier type="DOI">10.1002/mds.21501</identifier>
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<accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Movement Disorder Society</accessCondition>
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