ECE2017 Guided Posters Pituitary (12 abstracts)
Octreotide subcutaneous (s.c.) depot, a novel ready-to-use formulation, provides higher exposure and maintains response in patients with acromegaly and functioning neuroendocrine tumours (NETs) previously treated with long-acting octreotide: Results from a phase 2, open-label, multicentre, randomized study
Diego Ferone 1 , Françoise Borson-Chazot 2 , Anne Cailleux 3 , Dieter Hörsch 4 , Harald lahner 5 , Rosario Pivonello 6 , Libuse Tauchmanova 7 , Christelle Darstein 7 , Håkan Olsson 8 , Fredrik Tiberg 8, & Marianne Pavel 10
1Endocrinology, DiMI, IRCCS AOU San Martino-IST, University of Genoa, Genoa, Italy; 2Fédération d’Endocrinologie, Hospices Civils de Lyon and University Lyon1, Lyon, France; 3CHU ouen, Hôpital Charles Nicolle, 1 rue de Germont, 76031 Rouen cedex, Rouen, France; 4Department of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors Bad Berka – ENETS Center of Excellence, Zentralklinik Bad Berka GmbH, Bad Berka, Germany; 5Universitaetsklinikum Essen, Zentrum f. Innere Medizin, Essen, Germany; 6Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Naples, Italy; 7Novartis Pharma AG, Basel, Switzerland; 8Camurus AB, Lund, Sweden; 9Physical Chemistry, Lund University, Lund, Sweden; 10Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany.
Background: Octreotide s.c. depot is a novel, ready-to-use formulation administered via a thin needle, which may allow self-administration. In a phase 1 study in healthy volunteers, octreotide s.c. depot provided greater bioavailability with faster onset and greater IGF1 suppression than long-acting octreotide. Here, we present data from a phase 2 study evaluating pharmacokinetics (PK), efficacy, safety, and tolerability of octreotide s.c. depot in patients with acromegaly and neuroendocrine tumours (NETs).
Methods: Adult patients with acromegaly or functioning, well-differentiated NETs treated with long-acting octreotide 10 mg/20 mg/30 mg every 4 weeks (q4w) for ≥2 months received the last dose of long-acting octreotide in period 0 (P0). Patients were randomized 28 days later to receive octreotide s.c. depot 10 mg q2w or 20 mg q4w for 3 months (period 1 [P1]).
Results: Twelve patients were randomized to receive octreotide s.c. depot 10 mg q2w (acromegaly, n=3; NET, n=1) or 20 mg q4w (acromegaly, n=4; NET, n=4). Acromegaly: steady state (SS) PK (for octreotide s.c. depot 10 mg, 20 mg vs long-acting octreotide 10 mg, 30 mg, respectively) – AUC0-28d(day*ng/l): 95.6, 78.5 vs 6.23, 24.1; Cmax(ng/ml): 10.6, 11.3 vs 0.35, 1.41. NETs: SS PK (for octreotide s.c. depot 10 mg, 20 mg vs long-acting octreotide 20 mg, 30 mg, respectively) – AUC0-28d(day*ng/l): 83.3, 135.0 vs 27.8, 39.9; Cmax(ng/ml): 5.61, 15.7 vs 1.68, 2.48. In acromegaly, control of IGF-1 and GH levels was maintained or improved in P1 vs P0. In NETs, symptoms of carcinoid syndrome were similar or improved in P1 vs P0; symptoms disappeared in two patients in 20 mg group. Adverse events (all grade 1-2) were reported in six and eight patients during P0 and P1, respectively; most common in P1 were GI disorders.
Conclusions: Octreotide s.c. depot provided higher exposure than long-acting octreotide, maintained biochemical control in patients with acromegaly and symptom control in patients with functioning NETs, and was well tolerated with a safety profile consistent with long-acting octreotide.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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