Pasireotide versus octreotide in acromegaly: a head-to-head superiority study.
Ontology highlight
ABSTRACT: 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.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 ?g/L or GH nadir ?1 ?g/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 ?2.5?g/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 ?g/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 ?g/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.
SUBMITTER: Colao A
PROVIDER: S-EPMC3965714 | biostudies-literature | 2014 Mar
REPOSITORIES: biostudies-literature
ACCESS DATA