Abstract
ABSTRACT Objective: Pasireotide long-acting release (LAR), a next-generation, multireceptor-targeted somatostatin analogue with high binding affinity to somatostatin receptor type 5, has been shown to be superior to octreotide LAR in inducing biochemical control in a multicenter, phase III clinical trial of medically naive patients with acromegaly (C2305 study: NCT00600886). However, hyperglycemia-related adverse events were observed more frequently with pasireotide LAR. This case study highlights the efficacy and glycemic control in a patient treated with pasireotide LAR and discusses the current recommendations regarding optimal management of pasireotide-induced hyperglycemia. Methods: This study reports the 12-month outcomes of a 48-year-old treatment-naive male who was enrolled in the C2305 study and treated with pasireotide LAR 40-mg intramuscular depot injection every 28 days. Biochemical parameters, tumor volume, and safety profiles were evaluated. Results: Levels of insulin-like growth factor 1 (IGF-1) were reduced from 411 ng/mL (reference range, 94 to 252 ng/mL) at baseline to 127 ng/mL at 4 months, and levels of growth hormone (GH) declined from 5.4 ng/mL to 0.1 ng/mL; these levels remained controlled throughout the study. Tumor volume was reduced from baseline by 60% after 1 month and by 77% after 7 months. Fasting plasma glucose and glycated hemoglobin levels remained below diabetic thresholds throughout the study. Conclusion: Pasireotide LAR induced and maintained biochemical control of GH and IGF-1 levels and tumor volume reduction without worsening of glycemia after 12 months of treatment. Longer-term studies with a greater number of subjects are needed to monitor for future glycemic changes. Abbreviations: FPG = fasting plasma glucose GH = growth hormone IGF-1 = insulin-like growth factor 1 LAR = long-acting release MRI = magnetic resonance imaging SSA = somatostatin analogue SSTRs = somatostatin receptor subtypes
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