High-Dose Sandostatin LAR or Combination Therapy Investigated for Acromegaly Control in Non-Responders

Acromegaly is a chronic endocrine disorder characterized by excessive secretion of Growth Hormone (GH) and subsequently Insulin-like Growth Factor I (IGF-I), primarily due to a pituitary adenoma. This leads to significant morbidity and mortality, including cardiovascular complications, diabetes, and musculoskeletal issues. Conventional Sandostatin LAR (octreotide LAR), a somatostatin analog, effectively controls GH and IGF-I in many patients by inhibiting GH secretion. However, a substantial subset of patients does not achieve biochemical normalization with standard regimens, necessitating exploration of intensified or combination therapies to improve disease management and patient outcomes.

This Phase 4 interventional study assessed the efficacy and safety of Sandostatin LAR High Dose monotherapy or in combination with either a GH-receptor antagonist or a dopamine agonist. The treatment duration was 8 months. The study population comprised acromegalic patients who had not achieved biochemical normalization with conventional Sandostatin LAR regimens. The primary endpoint was the assessment of biochemical parameters, specifically GH and IGF-I levels, to determine the proportion of responders achieving normal IGF-I. Secondary outcomes included evaluating cardiovascular risk markers, although the specific assays were not detailed in this record.