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

Open access
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., on behalf of the Pasireotide C2305 Study Group·2014·The Journal of Clinical Endocrinology & Metabolism

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.

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Metadata

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., & on behalf of the Pasireotide C2305 Study Group
Venue
The Journal of Clinical Endocrinology & Metabolism
Published
2014-03-01
Volume
99
Issue
3
Pages
791-799
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
OpenAlex
W1996943463
Cited by
400
References
24
FWCI
33.51
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study. https://app.cochat.ai/papers/10.1210/jc.2013-2480
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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., & on behalf of the Pasireotide C2305 Study Group. (2014). Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study. The Journal of Clinical Endocrinology & Metabolism. https://doi.org/10.1210/jc.2013-2480

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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