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Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly: a randomized, open-label, multicentre study |
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| Authors: | Annamaria Colao,Paolo Cappabianca&dagger ,Philippe Caron&Dagger ,Ernesto De Menis§ ,rew J. Farrall¶ ,Monica R. Gadelha,Abdel Hmissi&dagger &dagger ,Aled Rees&Dagger &Dagger ,Martin Reincke§ § ,Mitra Safari&dagger &dagger ,Guy T'Sjoen¶ ¶ ,Hakim Bouterfa&dagger &dagger , Ross C. Cuneo |
| Affiliation: | Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology;;Department of Neurological Sciences, Section of Neurosurgery, Federico II University of Naples, Naples, Italy;;CHU de Rangueil-Larrey, Toulouse, France;;Ospedale Generale Ca' Foncello, Treviso, Italy;;University of Edinburgh, Edinburgh, UK;;Hospital Universitário Clementino Fraga Filho (UFRJ), Rio de Janeiro, Brazil;;Novartis Pharma AG, Basel, Switzerland;;Centre for Endocrine and Diabetes Sciences, Cardiff University, Cardiff, UK;;Klinikum der Universität München, Munich, Germany;;University Hospital, Gent, Belgium;;and Metabolic Research Unit, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia |
| 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. |
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