NDLI: Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study

Content Provider	Springer Nature : BioMed Central
Author	Bronstein, Marcello D. Fleseriu, Maria Neggers, Sebastian Colao, Annamaria Sheppard, Michael Gu, Feng Shen, Chiung-Chyi Gadelha, Mônica Farrall, Andrew J. Hermosillo Reséndiz, Karina Ruffin, Matthieu Chen, YinMiao Freda, Pamela
Abstract	Background Many patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension. Methods Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20. Results Twelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events. Conclusions Pasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR. Trial registration clinicaltrials.gov, NCT00600886 . Registered 14 January 2008
Related Links	https://bmcendocrdisord.biomedcentral.com/counter/pdf/10.1186/s12902-016-0096-8.pdf
Ending Page	10
Page Count	10
Starting Page	1
File Format	HTM / HTML
ISSN	14726823
DOI	10.1186/s12902-016-0096-8
Journal	BMC Endocrine Disorders
Issue Number	1
Volume Number	16
Language	English
Publisher	BioMed Central
Publisher Date	2016-04-02
Access Restriction	Open
Subject Keyword	Endocrinology Metabolic Diseases Diabetes Andrology Pasireotide Octreotide Acromegaly Extension Crossover
Content Type	Text
Resource Type	Article
Subject	Endocrinology, Diabetes and Metabolism
Journal Impact Factor	2.8/2023
5-Year Journal Impact Factor	3.1/2023

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Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study

Switching patients with acromegaly from octreotide LAR to pasireotide LAR improves biochemical control: crossover extension to a randomized, double-blind, multicenter, Phase III study

Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study

Erratum to: Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study

Pasireotide LAR and octreotide LAR maintain inhibition of GH and IGF1 in patients with acromegaly: 12-month extension phase of a randomized, double-blind, multicenter, phase III study

Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study

Erratum to: Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study

Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study.

Treatment with pasireotide LAR normalizes prolactin levels in patients with acromegaly and hyperprolactinemia: randomized, double-blind, 12-month, phase III study

Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study

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