Pasireotide versus octreotide in acromegaly: a head-to-head superiority study

Pasireotide C2305 Study Group, A Colao, M D Bronstein, P Freda, F Gu, C-C Shen, M Gadelha, M Fleseriu, A J van der Lely, A J Farrall, K Hermosillo Reséndiz, M Ruffin, Y Chen, M Sheppard

Research output: Contribution to journalArticlepeer-review

Abstract

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 <2.5 μg/L and normal IGF-1) at month 12.

RESULTS: Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 μg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%).

CONCLUSIONS: Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.

Original languageEnglish
Pages (from-to)791-9
Number of pages9
JournalJournal of Clinical Endocrinology & Metabolism
Volume99
Issue number3
DOIs
Publication statusPublished - Mar 2014

Keywords

  • Acromegaly
  • Adenoma
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents, Hormonal
  • Female
  • Growth Hormone-Secreting Pituitary Adenoma
  • Humans
  • Male
  • Middle Aged
  • Octreotide
  • Somatostatin
  • Therapeutic Equivalency
  • Young Adult

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