Session: FP27-Pituitary: Acromegaly and Prolactinoma
Room 135 (Moscone Center)
Poster Board SUN-88
Methods: Patients entering the extension (pasireotide LAR, n=74; octreotide LAR, n=46) were followed up to month 26 (core plus extension) for octreotide LAR, whereas pasireotide LAR patients could continue beyond month 26. Dose titration to pasireotide LAR 60mg/28d or octreotide LAR 30mg/28d (if GH≥2.5µg/L and/or IGF-1>ULN) or to pasireotide LAR 20mg/28d or octreotide LAR 10mg/28d (for tolerability issues) was permitted in the core and extension.
Results: Mean duration of exposure was 465 days in the pasireotide LAR arm and 412 days in the octreotide LAR arm. 51 pasireotide LAR and 36 octreotide LAR patients completed month 26. Suppression of GH and IGF-1 was maintained throughout the extension in both arms. Median GH (µg/L) and IGF-1 (x ULN) in pasireotide LAR vs octreotide LAR patients were: 8.8 vs 10.1 and 2.9 vs 2.9 at baseline; 1.9 vs 2.0 and 0.9 vs 1.3 at month 12; and 1.0 vs 1.0 and 0.6 vs 0.9 at month 25. Median percentage change in GH at month 25 was –83% with pasireotide LAR and –86% with octreotide LAR. Median percentage change in IGF-1 at month 25 was –71% with pasireotide LAR and –64% with octreotide LAR. Median percentage change in tumor volume from core baseline to month 25 was –54.1% (n=54) for pasireotide LAR and –57.3% (n=34) for octreotide LAR. Both treatments improved acromegaly symptom scores. Most common AEs during the core and extension in both treatment arms were diarrhea, cholelithiasis, hyperglycemia, headache, diabetes mellitus. Hyperglycemia-related AEs were more frequent with pasireotide LAR than octreotide LAR (62.9% [n=112/178] vs 25.0% [n=45/180]).
Conclusions: These results suggest that pasireotide LAR and octreotide LAR provide long-term inhibition of GH and IGF-1 in patients with acromegaly.
Disclosure: MCS: Consultant, Novartis Pharmaceuticals, Speaker, Novartis Pharmaceuticals. MDB: Investigator, Novartis Pharmaceuticals, , Ipsen, Committee Member, Chiasma, Committee Member, Novartis Pharmaceuticals, Speaker, Ipsen, Speaker, Novartis Pharmaceuticals. PUF: Medical Advisory Board Member, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals. LDM: Investigator, Novartis Pharmaceuticals. LR: Investigator, MSD, Speaker, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals, Speaker, MSD, Speaker, Amgen, Investigator, Amgen. KHR: Employee, Novartis Pharmaceuticals. MR: Employee, Novartis Pharmaceuticals, Employee, Novartis Pharmaceuticals. KA: Employee, Novartis Pharmaceuticals. AC: Committee Member, Novartis Pharmaceuticals. Nothing to Disclose: OS, LAN
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