Abstract
BackgroundMany patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension.MethodsPatients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.ResultsTwelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.ConclusionsPasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR.Trial registrationclinicaltrials.gov, NCT00600886. Registered 14 January 2008Electronic supplementary materialThe online version of this article (doi:10.1186/s12902-016-0096-8) contains supplementary material, which is available to authorized users.
Highlights
Many patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues
Some patients who crossed over had control of either insulin-like growth factor 1 (IGF-1) or growth hormone (GH) at the end of the core study
These results suggest that pasireotide long-acting release (LAR) may be a promising therapeutic alternative in patients uncontrolled with octreotide LAR
Summary
Many patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension. Somatostatin analogues are the mainstay of medical therapy for patients with acromegaly who have not achieved biochemical control after transsphenoidal surgery. They can be used as first-line treatment when the chance of surgical cure is low (invasive macroadenomas), when surgery is contraindicated, or for patients who refuse surgery [6]. In those patients who do not fully respond to somatostatin analogue monotherapy, recent clinical practice guidelines have advocated the addition of a dopamine agonist (cabergoline) or a GH receptor antagonist (pegvisomant) to somatostatin analogue treatment [13]
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