MovDisordV3, PascalFrancis, Curation, bibRecord, 001679

Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study

Identifieur interne : 001679 ( PascalFrancis/Curation ); précédent : 001678; suivant : 001680

Safety 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.

RBID : Pascal:07-0349117

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Atrophie multisystématisée, Sécurité, STH, Traitement, Etude double insu, Placebo.

English descriptors

KwdEn :
- Double blind study, Multiple system atrophy, Nervous system diseases, Placebo, Safety, Somatotropin hormone, Treatment.

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), I 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% Cl 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.

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A11	`01`	`1`		`@1 HOLMBERG (Björn)`
A11	`02`	`1`		`@1 JOHANSSON (Jan-Ove)`
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A14	`01`			`@1 Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University @3 SWE @Z 1 aut. @Z 2 aut.`
A14	`02`			`@1 Department of Neurology, University Hospital Innsbruck @2 Innsbruck @3 AUT @Z 3 aut. @Z 4 aut.`
A14	`03`			`@1 Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology @2 London @3 GBR @Z 5 aut. @Z 6 aut.`
A14	`04`			`@1 Hospital Clinic de Barcelona, Servicio de Neurologia @2 Barcelona @3 ESP @Z 7 aut. @Z 8 aut.`
A14	`05`			`@1 Department of Neurology, Linköping University Hospital @3 SWE @Z 9 aut.`
A14	`06`			`@1 Department of Pharmacology, Clinical Investigation Center, Hopital Purpan @2 Toulouse @3 FRA @Z 10 aut. @Z 11 aut.`
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A17	`01`	`1`		`@1 Behalf of the Growth-Hormone MSA Study Group, and of the European MSA Study Group (EMSA-SG) @3 INC`
A20				`@1 1138-1144`
A21				`@1 2007`
A23	`01`			`@0 ENG`
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A44				`@0 0000 @1 © 2007 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 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), I 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% Cl 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.
C02	`01`	`X`		`@0 002B17`
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C03	`01`	`X`	`FRE`	`@0 Système nerveux pathologie @5 01`
C03	`01`	`X`	`ENG`	`@0 Nervous system diseases @5 01`
C03	`01`	`X`	`SPA`	`@0 Sistema nervioso patología @5 01`
C03	`02`	`X`	`FRE`	`@0 Atrophie multisystématisée @2 NM @5 02`
C03	`02`	`X`	`ENG`	`@0 Multiple system atrophy @2 NM @5 02`
C03	`02`	`X`	`SPA`	`@0 Atrofia multisistematizada @2 NM @5 02`
C03	`03`	`X`	`FRE`	`@0 Sécurité @5 09`
C03	`03`	`X`	`ENG`	`@0 Safety @5 09`
C03	`03`	`X`	`SPA`	`@0 Seguridad @5 09`
C03	`04`	`X`	`FRE`	`@0 STH @5 10`
C03	`04`	`X`	`ENG`	`@0 Somatotropin hormone @5 10`
C03	`04`	`X`	`SPA`	`@0 STH @5 10`
C03	`05`	`X`	`FRE`	`@0 Traitement @5 11`
C03	`05`	`X`	`ENG`	`@0 Treatment @5 11`
C03	`05`	`X`	`SPA`	`@0 Tratamiento @5 11`
C03	`06`	`X`	`FRE`	`@0 Etude double insu @5 12`
C03	`06`	`X`	`ENG`	`@0 Double blind study @5 12`
C03	`06`	`X`	`SPA`	`@0 Estudio doble ciego @5 12`
C03	`07`	`X`	`FRE`	`@0 Placebo @5 13`
C03	`07`	`X`	`ENG`	`@0 Placebo @5 13`
C03	`07`	`X`	`SPA`	`@0 Placebo @5 13`
C07	`01`	`X`	`FRE`	`@0 Hormone adénohypophysaire @5 37`
C07	`01`	`X`	`ENG`	`@0 Adenohypophyseal hormone @5 37`
C07	`01`	`X`	`SPA`	`@0 Hormona adenohipofisaria @5 37`
N21				`@1 225`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study</title>
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<author><name sortKey="Johansson, Jan Ove" sort="Johansson, Jan Ove" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name>
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<author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
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<author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name>
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<author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name>
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<author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
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<author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name>
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<author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name>
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<s3>SWE</s3>
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<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
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<author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1>
<s2>Toulouse</s2>
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<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
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</analytic>
<series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint><date when="2007">2007</date>
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<seriesStmt><title level="j" type="main">Movement disorders</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Double blind study</term>
<term>Multiple system atrophy</term>
<term>Nervous system diseases</term>
<term>Placebo</term>
<term>Safety</term>
<term>Somatotropin hormone</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
<term>Atrophie multisystématisée</term>
<term>Sécurité</term>
<term>STH</term>
<term>Traitement</term>
<term>Etude double insu</term>
<term>Placebo</term>
</keywords>
</textClass>
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</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), I 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% Cl 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>
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<fA03 i2="1"><s0>Mov. disord.</s0>
</fA03>
<fA05><s2>22</s2>
</fA05>
<fA06><s2>8</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>HOLMBERG (Björn)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>JOHANSSON (Jan-Ove)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>POEWE (Werner)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>WENNING (Gregor)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>QUINN (Niall P.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>MATHIAS (Chris)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>TOLOSA (Eduardo)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>CARDOZO (Adriana)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>DIZDAR (Nil)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>RASCOL (Olivier)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>SLAOUI (Tarik)</s1>
</fA11>
<fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1>
<s3>SWE</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Neurology, Linköping University Hospital</s1>
<s3>SWE</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>Behalf of the Growth-Hormone MSA Study Group, and of the European MSA Study Group (EMSA-SG)</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>1138-1144</s1>
</fA20>
<fA21><s1>2007</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000159429990120</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2007 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>23 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>07-0349117</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Movement disorders</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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), I 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% Cl 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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17F</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002B02Q</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Atrophie multisystématisée</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Multiple system atrophy</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Atrofia multisistematizada</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Sécurité</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Safety</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Seguridad</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>STH</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Somatotropin hormone</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>STH</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Etude double insu</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Double blind study</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Estudio doble ciego</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Placebo</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Placebo</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Placebo</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Hormone adénohypophysaire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Adenohypophyseal hormone</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Hormona adenohipofisaria</s0>
<s5>37</s5>
</fC07>
<fN21><s1>225</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study

Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study

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