Pasireotide LAR and octreotide LAR maintain inhibition of GH and IGF1 in patients with acromegaly: 12-month extension phase of a randomized, double-blind, multicenter, phase III study

Michael Sheppard; Marcello Bronstein; Pamela Freda; Omar Serri; Marinis Laura De; Luciana Naves; Liudmila Rozhinskaya; Resendiz Karina Hermosillo; Matthieu Ruffin; Kobby Asubonteng; Annamaria Colao

doi:10.1530/endoabs.32.P845

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Endocrine Abstracts (2013) 32 P845 | DOI: 10.1530/endoabs.32.P845

ECE2013 Poster Presentations Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) (127 abstracts)

Pasireotide LAR and octreotide LAR maintain inhibition of GH and IGF1 in patients with acromegaly: 12-month extension phase of a randomized, double-blind, multicenter, phase III study

Michael Sheppard ¹ , Marcello Bronstein ² , Pamela Freda ³ , Omar Serri ⁴ , Laura De Marinis ⁵ , Luciana Naves ⁶ , Liudmila Rozhinskaya ⁷ , Karina Hermosillo Reséndiz ⁸ , Matthieu Ruffin ⁹ , Kobby Asubonteng ⁸ & Annamaria Colao ¹⁰

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¹University of Birmingham, Edgbaston, Birmingham, UK; ²University of São Paulo Medical School, São Paulo, Brazil; ³Columbia University College of Physicians and Surgeons, New York, New York, USA; ⁴University of Montreal, Montreal, Canada; ⁵Università Cattolica del Sacro Cuore, Rome, Italy; ⁶University of Brasília, Brasília, Brazil; ⁷National Research Center for Endocrinology of the Russian Academy of Medical Science, Moscow, Russia; ⁸Novartis Pharmaceuticals Corporation, Florham Park, New Jersey, USA; ⁹Novartis Pharma AG, Basel, Switzerland; ¹⁰Università Federico II di Napoli, Naples, Italy.

Introduction: Pasireotide LAR was significantly superior to octreotide LAR at providing biochemical control in a 12-month trial in 358 medically naïve patients with acromegaly. Patients with clinical benefit or GH <2.5 μg/l and IGF1≤ULN could continue therapy in the extension study.

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 60 mg/28 days or octreotide LAR 30 mg/28 days (if GH ≥2.5 μg/l and/or IGF1>ULN) or to pasireotide LAR 20 mg/28 days or octreotide LAR 10 mg/28 days (for tolerability) was permitted throughout core and extension.

Results: Mean duration of exposure was 465 days (pasireotide LAR) and 412 days (octreotide LAR). 51 pasireotide LAR and 36 octreotide LAR patients completed month 26. Suppression of GH and IGF1 was maintained throughout the extension in both arms. Median GH (μg/l) and IGF1 (×ULN) in pasireotide LAR vs octreotide LAR patients were: at baseline, 8.8 vs 10.1 and 2.9 vs 2.9; at month 12, 1.9 vs 2.0 and 0.9 vs 1.3; and at month 25, 1.0 vs 1.0 and 0.6 vs 0.9. Median percentage change in GH and IGF1 at month 25 was −83% and −71% with pasireotide LAR and −86% and −64% with octreotide LAR. Mean percentage change in tumor volume from core baseline to month 25 was −51.8% (n=54) for pasireotide LAR and −55.0% (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, and 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 IGF1 in patients with acromegaly.