AustralieFrV1, PascalFrancis, Corpus, bibRecord, 002E86

Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study

Identifieur interne : 002E86 ( PascalFrancis/Corpus ); précédent : 002E85; suivant : 002E87

Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study

Auteurs : Annamaria Colao ; Paolo Cappabianca ; Philippe Caron ; Ernesto De Menis ; Andrew J. Farrall ; Monica R. Gadelha ; Abdel Hmissi ; Aled Rees ; Martin Reincke ; Mitra Safari ; Guy T'Sjoen ; Hakim Bouterfa ; Ross C. Cuneo

Source :

Clinical endocrinology : (Oxford. Print)) [ 0300-0664 ] ; 2009.

RBID : Pascal:09-0164227

Descripteurs français

Pascal (Inist)
- Octréotide, Etude comparative, Stade précoce, Chirurgie, Homme, Malade, Acromégalie, Randomisation, Essai clinique, Médicament, Etude multicentrique, Endocrinologie, Traitement, Essai thérapeutique, Essai ouvert.

English descriptors

KwdEn :
- Acromegaly, Clinical trial, Comparative study, Drug, Early stage, Endocrinology, Human, Multicenter study, Octreotide, Patient, Randomization, Surgery, Treatment.

Abstract

Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A14	`01`			`@1 Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples @2 Naples @3 ITA @Z 1 aut.`
A14	`02`			`@1 Department of Neurological Sciences, Section of Neurosurgery, Federico II University of Naples @2 Naples @3 ITA @Z 2 aut.`
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C01	`01`		`ENG`	@0 Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.
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C03	`08`	`X`	`FRE`	`@0 Randomisation @5 08`
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Format Inist (serveur)

NO :	PASCAL 09-0164227 INIST
ET :	Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study
AU :	COLAO (Annamaria); CAPPABIANCA (Paolo); CARON (Philippe); DE MENIS (Ernesto); FARRALL (Andrew J.); GADELHA (Monica R.); HMISSI (Abdel); REES (Aled); REINCKE (Martin); SAFARI (Mitra); T'SJOEN (Guy); BOUTERFA (Hakim); CUNEO (Ross C.)
AF :	Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples/Naples/Italie (1 aut.); Department of Neurological Sciences, Section of Neurosurgery, Federico II University of Naples/Naples/Italie (2 aut.); CHU de Rangueil-Larrey/Toulouse/France (3 aut.); Ospedale Generale Ca'Foncello/Treviso/Italie (4 aut.); University of Edinburgh/Edinburgh/Royaume-Uni (5 aut.); Hospital Universitdrio Clementino Fraga Filho (UFRJ)/Rio de Janeiro/Brésil (6 aut.); Novartis Pharma AG/Basel/Suisse (7 aut., 10 aut., 12 aut.); Centre for Endocrine and Diabetes Sciences, Cardiff University/Cardiff/Royaume-Uni (8 aut.); Klinikum der Universität München/Munich/Allemagne (9 aut.); University Hospital/Gent/Belgique (11 aut.); Metabolic Research Unit, Princess Alexandra Hospital, University of Queensland/Brisbane/Australie (13 aut.)
DT :	Publication en série; Niveau analytique
SO :	Clinical endocrinology : (Oxford. Print)); ISSN 0300-0664; Coden CLECAP; Royaume-Uni; Da. 2009; Vol. 70; No. 5; Pp. 757-768; Bibl. 36 ref.
LA :	Anglais
EA :	Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.
CC :	002A28; 002B21A01
FD :	Octréotide; Etude comparative; Stade précoce; Chirurgie; Homme; Malade; Acromégalie; Randomisation; Essai clinique; Médicament; Etude multicentrique; Endocrinologie; Traitement; Essai thérapeutique; Essai ouvert
FG :	Analogue; Somatostatine; Endocrinopathie; Pathologie de l'hypophyse; Pathologie du système ostéoarticulaire; Hormone peptide; Neuropeptide
ED :	Octreotide; Comparative study; Early stage; Surgery; Human; Patient; Acromegaly; Randomization; Clinical trial; Drug; Multicenter study; Endocrinology; Treatment
EG :	Analog; Somatostatin; Endocrinopathy; Pituitary diseases; Diseases of the osteoarticular system; Peptide hormone; Neuropeptide
SD :	Octreotida; Estudio comparativo; Estadio precoz; Cirugía; Hombre; Enfermo; Acromegalia; Aleatorización; Ensayo clínico; Medicamento; Estudio multicéntrico; Endocrinología; Tratamiento
LO :	INIST-15568.354000187432460150
ID :	09-0164227

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Pascal:09-0164227

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study</title>
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</author>
<author><name sortKey="De Menis, Ernesto" sort="De Menis, Ernesto" uniqKey="De Menis E" first="Ernesto" last="De Menis">Ernesto De Menis</name>
<affiliation><inist:fA14 i1="04"><s1>Ospedale Generale Ca'Foncello</s1>
<s2>Treviso</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Farrall, Andrew J" sort="Farrall, Andrew J" uniqKey="Farrall A" first="Andrew J." last="Farrall">Andrew J. Farrall</name>
<affiliation><inist:fA14 i1="05"><s1>University of Edinburgh</s1>
<s2>Edinburgh</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Gadelha, Monica R" sort="Gadelha, Monica R" uniqKey="Gadelha M" first="Monica R." last="Gadelha">Monica R. Gadelha</name>
<affiliation><inist:fA14 i1="06"><s1>Hospital Universitdrio Clementino Fraga Filho (UFRJ)</s1>
<s2>Rio de Janeiro</s2>
<s3>BRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hmissi, Abdel" sort="Hmissi, Abdel" uniqKey="Hmissi A" first="Abdel" last="Hmissi">Abdel Hmissi</name>
<affiliation><inist:fA14 i1="07"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rees, Aled" sort="Rees, Aled" uniqKey="Rees A" first="Aled" last="Rees">Aled Rees</name>
<affiliation><inist:fA14 i1="08"><s1>Centre for Endocrine and Diabetes Sciences, Cardiff University</s1>
<s2>Cardiff</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Reincke, Martin" sort="Reincke, Martin" uniqKey="Reincke M" first="Martin" last="Reincke">Martin Reincke</name>
<affiliation><inist:fA14 i1="09"><s1>Klinikum der Universität München</s1>
<s2>Munich</s2>
<s3>DEU</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Safari, Mitra" sort="Safari, Mitra" uniqKey="Safari M" first="Mitra" last="Safari">Mitra Safari</name>
<affiliation><inist:fA14 i1="07"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="T Sjoen, Guy" sort="T Sjoen, Guy" uniqKey="T Sjoen G" first="Guy" last="T'Sjoen">Guy T'Sjoen</name>
<affiliation><inist:fA14 i1="10"><s1>University Hospital</s1>
<s2>Gent</s2>
<s3>BEL</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bouterfa, Hakim" sort="Bouterfa, Hakim" uniqKey="Bouterfa H" first="Hakim" last="Bouterfa">Hakim Bouterfa</name>
<affiliation><inist:fA14 i1="07"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Cuneo, Ross C" sort="Cuneo, Ross C" uniqKey="Cuneo R" first="Ross C." last="Cuneo">Ross C. Cuneo</name>
<affiliation><inist:fA14 i1="11"><s1>Metabolic Research Unit, Princess Alexandra Hospital, University of Queensland</s1>
<s2>Brisbane</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
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<series><title level="j" type="main">Clinical endocrinology : (Oxford. Print))</title>
<title level="j" type="abbreviated">Clin. endocrinol. : (Oxf., Print)</title>
<idno type="ISSN">0300-0664</idno>
<imprint><date when="2009">2009</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Clinical endocrinology : (Oxford. Print))</title>
<title level="j" type="abbreviated">Clin. endocrinol. : (Oxf., Print)</title>
<idno type="ISSN">0300-0664</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acromegaly</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Drug</term>
<term>Early stage</term>
<term>Endocrinology</term>
<term>Human</term>
<term>Multicenter study</term>
<term>Octreotide</term>
<term>Patient</term>
<term>Randomization</term>
<term>Surgery</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Octréotide</term>
<term>Etude comparative</term>
<term>Stade précoce</term>
<term>Chirurgie</term>
<term>Homme</term>
<term>Malade</term>
<term>Acromégalie</term>
<term>Randomisation</term>
<term>Essai clinique</term>
<term>Médicament</term>
<term>Etude multicentrique</term>
<term>Endocrinologie</term>
<term>Traitement</term>
<term>Essai thérapeutique</term>
<term>Essai ouvert</term>
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<front><div type="abstract" xml:lang="en">Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study</s1>
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<fA11 i1="01" i2="1"><s1>COLAO (Annamaria)</s1>
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<fA11 i1="03" i2="1"><s1>CARON (Philippe)</s1>
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<fA11 i1="04" i2="1"><s1>DE MENIS (Ernesto)</s1>
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<fA11 i1="05" i2="1"><s1>FARRALL (Andrew J.)</s1>
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<fA11 i1="06" i2="1"><s1>GADELHA (Monica R.)</s1>
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<fA11 i1="07" i2="1"><s1>HMISSI (Abdel)</s1>
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<fA11 i1="08" i2="1"><s1>REES (Aled)</s1>
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<fA11 i1="09" i2="1"><s1>REINCKE (Martin)</s1>
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<fA11 i1="10" i2="1"><s1>SAFARI (Mitra)</s1>
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<fA11 i1="11" i2="1"><s1>T'SJOEN (Guy)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>BOUTERFA (Hakim)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>CUNEO (Ross C.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Neurological Sciences, Section of Neurosurgery, Federico II University of Naples</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>CHU de Rangueil-Larrey</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Ospedale Generale Ca'Foncello</s1>
<s2>Treviso</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>University of Edinburgh</s1>
<s2>Edinburgh</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Hospital Universitdrio Clementino Fraga Filho (UFRJ)</s1>
<s2>Rio de Janeiro</s2>
<s3>BRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Centre for Endocrine and Diabetes Sciences, Cardiff University</s1>
<s2>Cardiff</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Klinikum der Universität München</s1>
<s2>Munich</s2>
<s3>DEU</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>University Hospital</s1>
<s2>Gent</s2>
<s3>BEL</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Metabolic Research Unit, Princess Alexandra Hospital, University of Queensland</s1>
<s2>Brisbane</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA20><s1>757-768</s1>
</fA20>
<fA21><s1>2009</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
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<fA43 i1="01"><s1>INIST</s1>
<s2>15568</s2>
<s5>354000187432460150</s5>
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<fA44><s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>36 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>09-0164227</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
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<fA64 i1="01" i2="1"><s0>Clinical endocrinology : (Oxford. Print))</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.</s0>
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<s5>03</s5>
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<s5>04</s5>
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<s5>05</s5>
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<s5>05</s5>
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<s5>06</s5>
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<s5>11</s5>
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<s5>41</s5>
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<ET>Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study</ET>
<AU>COLAO (Annamaria); CAPPABIANCA (Paolo); CARON (Philippe); DE MENIS (Ernesto); FARRALL (Andrew J.); GADELHA (Monica R.); HMISSI (Abdel); REES (Aled); REINCKE (Martin); SAFARI (Mitra); T'SJOEN (Guy); BOUTERFA (Hakim); CUNEO (Ross C.)</AU>
<AF>Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples/Naples/Italie (1 aut.); Department of Neurological Sciences, Section of Neurosurgery, Federico II University of Naples/Naples/Italie (2 aut.); CHU de Rangueil-Larrey/Toulouse/France (3 aut.); Ospedale Generale Ca'Foncello/Treviso/Italie (4 aut.); University of Edinburgh/Edinburgh/Royaume-Uni (5 aut.); Hospital Universitdrio Clementino Fraga Filho (UFRJ)/Rio de Janeiro/Brésil (6 aut.); Novartis Pharma AG/Basel/Suisse (7 aut., 10 aut., 12 aut.); Centre for Endocrine and Diabetes Sciences, Cardiff University/Cardiff/Royaume-Uni (8 aut.); Klinikum der Universität München/Munich/Allemagne (9 aut.); University Hospital/Gent/Belgique (11 aut.); Metabolic Research Unit, Princess Alexandra Hospital, University of Queensland/Brisbane/Australie (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Clinical endocrinology : (Oxford. Print)); ISSN 0300-0664; Coden CLECAP; Royaume-Uni; Da. 2009; Vol. 70; No. 5; Pp. 757-768; Bibl. 36 ref.</SO>
<LA>Anglais</LA>
<EA>Objective This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients. Methods Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled. Results Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0-047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71% vs. 27%), hepatobiliary (41% vs. 8%) and respiratory (5% vs. 28%). Conclusion This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.</EA>
<CC>002A28; 002B21A01</CC>
<FD>Octréotide; Etude comparative; Stade précoce; Chirurgie; Homme; Malade; Acromégalie; Randomisation; Essai clinique; Médicament; Etude multicentrique; Endocrinologie; Traitement; Essai thérapeutique; Essai ouvert</FD>
<FG>Analogue; Somatostatine; Endocrinopathie; Pathologie de l'hypophyse; Pathologie du système ostéoarticulaire; Hormone peptide; Neuropeptide</FG>
<ED>Octreotide; Comparative study; Early stage; Surgery; Human; Patient; Acromegaly; Randomization; Clinical trial; Drug; Multicenter study; Endocrinology; Treatment</ED>
<EG>Analog; Somatostatin; Endocrinopathy; Pituitary diseases; Diseases of the osteoarticular system; Peptide hormone; Neuropeptide</EG>
<SD>Octreotida; Estudio comparativo; Estadio precoz; Cirugía; Hombre; Enfermo; Acromegalia; Aleatorización; Ensayo clínico; Medicamento; Estudio multicéntrico; Endocrinología; Tratamiento</SD>
<LO>INIST-15568.354000187432460150</LO>
<ID>09-0164227</ID>
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Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study

Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly : a randomized, open-label, multicentre study

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