Session: SUN 88-129-Acromegaly & Prolactinoma
Poster Board SUN-95
Methods: Eligible patients were switched to either pasireotide LAR 40mg/28d (n=81) or octreotide LAR 20mg/28d (n=38). One dose escalation to pasireotide LAR 60mg/28d or octreotide LAR 30mg/28d was permitted, but not mandatory, after crossover. Dose decrease to pasireotide LAR 20 mg/28d or octreotide LAR 10 mg/28d was permitted at any time in the event of tolerability issues. Main outcome measures included GH<2.5μg/L and normal IGF-1 12 months after switching medical therapy.
Results: 31 (38%) pasireotide LAR and 13 (34%) octreotide LAR patients discontinued within 12 months after crossover. Response rates (95% CI) 12 months after crossover to pasireotide LAR [n=81] and octreotide LAR [n=38], respectively, were as follows: GH<2.5μg/L and normal IGF-1, 17.3% (9.8–27.3) and 0%; GH<2.5µg/L, 44.4% (33.4–55.9) and 23.7% (11.4–40.2); normal IGF-1, 27.2% (17.9–38.2) and 5.3% (0.6–17.7). Median percentage change in tumor volume from extension baseline was –22.1% (n=46) with pasireotide LAR and –11.8% (n=26) with octreotide LAR. A significant (≥20%) tumor volume reduction from extension baseline was seen in 54.3% (25/46) of pasireotide LAR and 42.3% (11/26) of octreotide LAR patients. The safety profile of both the agents following crossover was consistent with that seen in the core trial: hyperglycemia-related AEs, while mostly mild or moderate, were more frequent with pasireotide LAR (64.2%) than octreotide LAR (21.1%). Fasting plasma glucose and HbA1c levels decreased to near normal levels within 3 months after switching from pasireotide LAR to octreotide LAR.
Conclusions: Pasireotide LAR holds promise as a treatment option for acromegaly patients inadequately controlled with octreotide LAR. Hyperglycemia associated with pasireotide LAR appeared to be reversible upon discontinuation of pasireotide.
Disclosure: PUF: Medical Advisory Board Member, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals. MF: Consultant, Ipsen, Investigator, Novartis Pharmaceuticals, Investigator, Ipsen, Consultant, Novartis Pharmaceuticals. AC: Committee Member, Novartis Pharmaceuticals. MCS: Consultant, Novartis Pharmaceuticals, Speaker, Novartis Pharmaceuticals. MG: Speaker, Novartis Pharmaceuticals, Speaker, Ipsen, Speaker, Pfizer, Inc., Investigator, Pfizer, Inc., Investigator, Novartis Pharmaceuticals, Medical Advisory Board Member, Novartis Pharmaceuticals. AJF: Consultant, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals. KHR: Employee, Novartis Pharmaceuticals. MR: Employee, Novartis Pharmaceuticals, Employee, Novartis Pharmaceuticals. YC: Employee, Novartis Pharmaceuticals. MDB: Speaker, Ipsen, Speaker, Novartis Pharmaceuticals, , Ipsen, Committee Member, Novartis Pharmaceuticals, Committee Member, Chiasma, Investigator, Novartis Pharmaceuticals. Nothing to Disclose: AJV, FG, CCS
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