Switching patients with acromegaly from octreotide to pasireotide improves biochemical control

Crossover extension to a randomized, double-blind, Phase III study

Pasireotide C2305 Study Group

Research output: Contribution to journalArticle

29 Citations (Scopus)

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

Original languageEnglish (US)
Article number16
JournalBMC Endocrine Disorders
Volume16
Issue number1
DOIs
StatePublished - 2016

Fingerprint

Acromegaly
Octreotide
Somatostatin
Insulin-Like Growth Factor I
Safety
pasireotide
Therapeutics

Keywords

  • Acromegaly
  • Crossover
  • Extension
  • Octreotide
  • Pasireotide

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

@article{8ba9337f28b14364adb9ffa71901696a,
title = "Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: Crossover extension to a randomized, double-blind, Phase III study",
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",
keywords = "Acromegaly, Crossover, Extension, Octreotide, Pasireotide",
author = "{Pasireotide C2305 Study Group} and Bronstein, {Marcello D.} and Maria Fleseriu and Sebastian Neggers and Annamaria Colao and Michael Sheppard and Feng Gu and Shen, {Chiung Chyi} and M{\^o}nica Gadelha and Farrall, {Andrew J.} and Res{\'e}ndiz, {Karina Hermosillo} and Matthieu Ruffin and Chen, {Yin Miao} and Pamela Freda",
year = "2016",
doi = "10.1186/s12902-016-0096-8",
language = "English (US)",
volume = "16",
journal = "BMC Endocrine Disorders",
issn = "1472-6823",
publisher = "BioMed Central",
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T1 - Switching patients with acromegaly from octreotide to pasireotide improves biochemical control

T2 - Crossover extension to a randomized, double-blind, Phase III study

AU - Pasireotide C2305 Study Group

AU - Bronstein, Marcello D.

AU - Fleseriu, Maria

AU - Neggers, Sebastian

AU - Colao, Annamaria

AU - Sheppard, Michael

AU - Gu, Feng

AU - Shen, Chiung Chyi

AU - Gadelha, Mônica

AU - Farrall, Andrew J.

AU - Reséndiz, Karina Hermosillo

AU - Ruffin, Matthieu

AU - Chen, Yin Miao

AU - Freda, Pamela

PY - 2016

Y1 - 2016

N2 - 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

AB - 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

KW - Acromegaly

KW - Crossover

KW - Extension

KW - Octreotide

KW - Pasireotide

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