Long-term pasireotide therapy in acromegaly: extensive real-life experience of a referral center.

ABSTRACT

PURPOSE: Pasireotide is a novel therapeutic option for patients with acromegaly resistant to first-generation somatostatin receptor ligands. To date, real-life data are still scant, therefore, the aim of the current study is to evaluate the impact of long-term pasireotide therapy on disease control, pituitary tumor size, gluco-insulinemic and lipid profile in a real-life setting. METHODS: Retrospective study of data prospectively collected, evaluating hormonal, tumoral, and metabolic data of 28 patients with acromegaly administered with pasireotide in a pituitary tertiary referral center. RESULTS: Within the first 12 months of treatment, 70.4% of patients achieved normal IGF-I levels, which was maintained at 36-month evaluation in these responders patients. Patients who started with pasireotide 60 mg monthly exhibited significantly lower IGF-I levels after 36 months (p = 0.05) as compared to patients administered first with pasireotide 20 or 40 mg monthly. The maximal tumoral diameter was significantly decreased after 12 months of pasireotide (p < 0.001) and a further reduction was registered throughout the following months, with 41.2% of patients achieving a significant reduction (> 25% of baseline measurement) after 36 months of treatment. Fasting glucose significantly increased during the first 6 months (p < 0.001) with a gradual rise in diabetes prevalence during the following months, resulting diabetes prevalence after 36 months of pasireotide significantly increased compared to baseline (p = 0.003), although with glycated hemoglobin levels within the normal range. Diabetes was managed using oral glucose-lowering drugs or glucagon-like peptide 1 agonists, with no patient requiring insulin therapy. Pasireotide improved lipid profile, mainly during the first 12 months of treatment, by increasing HDL and decreasing triglycerides levels. CONCLUSION: Pasireotide is effective and safe in the long-term. Hyperglycemia is a common event and is manageable even without insulin treatment.