Safety and tolerability of growth hormone therapy in multiple system atrophy: a double-blind, placebo-controlled study.
Identifieur interne : 001B84 ( Ncbi/Curation ); précédent : 001B83; suivant : 001B85Safety and tolerability of growth hormone therapy in multiple system atrophy: a double-blind, placebo-controlled study.
Auteurs : Björn Holmberg [Suède] ; Jan-Ove Johansson ; Werner Poewe [Autriche] ; Gregor Wenning ; Niall P. Quinn ; Chris Mathias ; Eduardo Tolosa ; Adriana Cardozo ; Nil Dizdar ; Olivier Rascol ; Tarik SlaouiSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Body Mass Index, Constipation (chemically induced), Constipation (epidemiology), Double-Blind Method, Drug Tolerance, Female, Heart Rate (drug effects), Human Growth Hormone (adverse effects), Human Growth Hormone (therapeutic use), Humans, Male, Middle Aged, Multiple System Atrophy (drug therapy), Multiple System Atrophy (pathology).
- MESH :
- chemical , adverse effects : Human Growth Hormone.
- chemically induced : Constipation.
- drug effects : Heart Rate.
- drug therapy : Multiple System Atrophy.
- epidemiology : Constipation.
- pathology : Multiple System Atrophy.
- chemical , therapeutic use : Human Growth Hormone.
- Body Mass Index, Double-Blind Method, Drug Tolerance, Female, Humans, Male, Middle Aged.
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.
DOI: 10.1002/mds.21501
PubMed: 17469198
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Quinn</name></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21501</idno><idno type="RBID">pubmed:17469198</idno><idno type="pmid">17469198</idno><idno type="wicri:Area/PubMed/Corpus">002755</idno><idno type="wicri:Area/PubMed/Curation">002755</idno><idno type="wicri:Area/PubMed/Checkpoint">002572</idno><idno type="wicri:Area/Ncbi/Merge">001B84</idno><idno type="wicri:Area/Ncbi/Curation">001B84</idno></publicationStmt><sourceDesc><biblStruct><analytic><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 wicri:level="1"><nlm:affiliation>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Göteborg, Sweden. bjorn.holmberg@neuro.gu.se</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University, Göteborg</wicri:regionArea><wicri:noRegion>Göteborg</wicri:noRegion></affiliation></author><author><name sortKey="Johansson, Jan Ove" sort="Johansson, Jan Ove" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><country>Autriche</country><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name></author><author><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P" last="Quinn">Niall P. Quinn</name></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Body Mass Index</term><term>Constipation (chemically induced)</term><term>Constipation (epidemiology)</term><term>Double-Blind Method</term><term>Drug Tolerance</term><term>Female</term><term>Heart Rate (drug effects)</term><term>Human Growth Hormone (adverse effects)</term><term>Human Growth Hormone (therapeutic use)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Multiple System Atrophy (drug therapy)</term><term>Multiple System Atrophy (pathology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Human Growth Hormone</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Constipation</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Heart Rate</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Multiple System Atrophy</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Constipation</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Multiple System Atrophy</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Human Growth Hormone</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Body Mass Index</term><term>Double-Blind Method</term><term>Drug Tolerance</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></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.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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