Pasireotide LAR and Octreotide LAR Efficacy Compared for GH/IGF-1 Normalization in Active Acromegaly

Acromegaly is a chronic endocrine disorder characterized by excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1) secretion, often due to a pituitary adenoma. This leads to significant morbidity and mortality if untreated. A key therapeutic goal is to normalize serum IGF-1 levels, which has become more challenging with updated, lower normative data. Current standard-of-care often involves somatostatin analogs like Octreotide LAR, but some patients show inadequate response, necessitating alternative or more potent options.

This Phase 2, randomized clinical trial aimed to compare the safety and efficacy of Pasireotide LAR against Octreotide LAR in patients with active acromegaly. Participants had active disease despite stable prior treatment with Octreotide-LAR and/or cabergoline for at least one year, and elevated IGF-1 levels. Patients were randomized to receive either Pasireotide LAR or Octreotide LAR for one year. The primary endpoints were the proportion of patients achieving a mean GH level <2.5 µg/L and normalization of age- and sex-related IGF-1 levels at 12 months. Non-responders could switch treatments in an extension phase.

This study was officially WITHDRAWN (NCT00517491) and no results were published. Therefore, no data regarding the comparative efficacy or safety of Pasireotide LAR versus Octreotide LAR in achieving GH or IGF-1 normalization in patients with active acromegaly are available from this trial. The study's status indicates that it did not proceed to completion or publication of findings.