Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study

Context: Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control. Objective: Our objective was to demonstrate th...

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Published in:The journal of clinical endocrinology and metabolism 2014-03, Vol.99 (3), p.791-799
Main Authors: Colao, A, Bronstein, M. D, Freda, P, Gu, F, Shen, C.-C, Gadelha, M, Fleseriu, M, van der Lely, A. J, Farrall, A. J, Hermosillo Reséndiz, K, Ruffin, M, Chen, Y, Sheppard, M
Format: Article
Language:English
Subjects:
Acromegaly - drug therapy
Acromegaly - etiology
Adenoma - complications
Adenoma - drug therapy
Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Hormonal - therapeutic use
Biological and medical sciences
Endocrine Care
Endocrinopathies
Feeding. Feeding behavior
Female
Fundamental and applied biological sciences. Psychology
Growth Hormone-Secreting Pituitary Adenoma - complications
Growth Hormone-Secreting Pituitary Adenoma - drug therapy
Humans
Hypothalamus. Hypophysis. Epiphysis (diseases)
Male
Medical sciences
Middle Aged
Non tumoral diseases. Target tissue resistance. Benign neoplasms
Octreotide - therapeutic use
Somatostatin - analogs & derivatives
Somatostatin - therapeutic use
Therapeutic Equivalency
Vertebrates: anatomy and physiology, studies on body, several organs or systems
Vertebrates: endocrinology
Young Adult
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Summary:Context: Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control. Objective: Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly. Design and Setting: We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries. Patients: A total of 358 patients with medically naive acromegaly (GH >5 μg/L or GH nadir ≥1 μg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging. Interventions: Patients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5μg/L and/or IGF-1 was above the upper limit of normal. Main Outcome Measure: The main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH
ISSN:0021-972X
1945-7197
DOI:10.1210/jc.2013-2480