Produção Nacional
Revisado por pares
Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study
2014; Oxford University Press; Volume: 99; Issue: 3 Linguagem: Inglês
10.1210/jc.2013-2480
ISSN1945-7197
AutoresAnnamaria Colao, Marcello D. Bronstein, Pamela U. Freda, Feng Gu, Chiung‐Chyi Shen, Mônica R. Gadelha, Maria Fleseriu, A. J. van der Lely, Andrew J. Farrall, Karina Hermosillo Reséndiz, Matthieu Ruffin, Yixin Chen, Mary N. Sheppard,
Tópico(s)Adrenal and Paraganglionic Tumors
ResumoBiochemical 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.Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly.We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries.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.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.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.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%).Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.
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