Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study
Identifieur interne : 002B91 ( Main/Exploration ); précédent : 002B90; suivant : 002B92Safety and tolerability of growth hormone therapy in multiple system atrophy: A double‐blind, placebo‐controlled study
Auteurs : Björn Holmberg [Suède] ; Jan-Ove Johansson [Suède] ; Werner Poewe [Autriche] ; Gregor Wenning [Autriche] ; Niall P. Quinn [Royaume-Uni] ; Chris Mathias [Royaume-Uni] ; Eduardo Tolosa [Espagne] ; Adriana Cardozo [Espagne] ; Nil Dizdar [Suède] ; Olivier Rascol [France] ; Tarik Slaoui [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-06-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Body Mass Index, Constipation (chemically induced), Constipation (epidemiology), Double blind study, 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), Multiple system atrophy, Nervous system diseases, Placebo, Safety, Somatotropin hormone, Treatment, UMSARS, UPDRS, autonomic testing, growth hormone treatment, multiple system atrophy.
- 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. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21501
Affiliations:
- Autriche, Espagne, France, Royaume-Uni, Suède
- Angleterre, Catalogne, Grand Londres, Götaland, Midi-Pyrénées, Suède occidentale, Tyrol (Land)
- Barcelone, Göteborg, Innsbruck, Londres, Toulouse
- Université Toulouse III - Paul Sabatier, Université de Göteborg, Université de Toulouse, Université de médecine d'Innsbruck
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Le document en format XML
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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="4"><country xml:lang="fr">Suède</country><wicri:regionArea>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</wicri:regionArea><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></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 wicri:level="4"><country xml:lang="fr">Suède</country><wicri:regionArea>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</wicri:regionArea><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, University Hospital Innsbruck, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion><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><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, University Hospital Innsbruck, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion></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 wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="3"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name><affiliation wicri:level="3"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Clinic de Barcelona, Servicio de Neurologia, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Neurology, Linköping University Hospital</wicri:regionArea><wicri:noRegion>Linköping University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Pharmacology, Clinical Investigation Center, Hôpital Purpan, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></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="vol">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>Body Mass Index</term><term>Constipation (chemically induced)</term><term>Constipation (epidemiology)</term><term>Double blind study</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><term>Multiple system atrophy</term><term>Nervous system diseases</term><term>Placebo</term><term>Safety</term><term>Somatotropin hormone</term><term>Treatment</term><term>UMSARS</term><term>UPDRS</term><term>autonomic testing</term><term>growth hormone treatment</term><term>multiple system atrophy</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><keywords scheme="Pascal" xml:lang="fr"><term>Atrophie multisystématisée</term><term>Etude double insu</term><term>Placebo</term><term>STH</term><term>Système nerveux pathologie</term><term>Sécurité</term><term>Traitement</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><affiliations><list><country><li>Autriche</li><li>Espagne</li><li>France</li><li>Royaume-Uni</li><li>Suède</li></country><region><li>Angleterre</li><li>Catalogne</li><li>Grand Londres</li><li>Götaland</li><li>Midi-Pyrénées</li><li>Suède occidentale</li><li>Tyrol (Land)</li></region><settlement><li>Barcelone</li><li>Göteborg</li><li>Innsbruck</li><li>Londres</li><li>Toulouse</li></settlement><orgName><li>Université Toulouse III - Paul Sabatier</li><li>Université de Göteborg</li><li>Université de Toulouse</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Suède"><region name="Götaland"><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name></region><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><name sortKey="Johansson, Jan Ve" sort="Johansson, Jan Ve" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></region><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name></region><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></region><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name></country><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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