ECE2015 Eposter Presentations Pituitary: clinical (121 abstracts)
Pasireotide long-acting release maintains biochemical control in patients with acromegaly: results from the extension of randomised, Phase III, PAOLA study
Anna Maria Colao 1 , Marcello D Bronstein 2 , Thierry Brue 3 , Mihail Coculescu 4 , Laura De Marinis 5 , Maria Fleseriu 6 , Mirtha A Guitelman 7 , Vyacheslav Pronin 8 , Gérald Raverot 9 , Ilan Shimon 10 , Juergen Fleck 11 , Albert Kandra 11 , Alberto M Pedroncelli 11 & Monica R Gadelha 12
1Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Naples, Italy; 2Neuroendocrine Unit, Division of Endocrinology and Metabolism, University of São Paulo Medical School, São Paulo, Brazil; 3Hôpital de la Timone, Centre National de la Recherche Scientifique, and Assistance Publique-Hôpitaux de Marseille, Aix-Marseille University, Marseille, France; 4Academy of Medical Sciences of Romania University of Medicine and Pharmacy ‘Carol Davila’, National Institute of Endocrinology ‘CI Parhon’, Bucharest, Romania; 5Università Cattolica del Sacro Cuore, Rome, Italy; 6Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA; 7Hospital Carlos G Durand, Buenos Aires, Argentina; 8IM Sechenov First Moscow State Medical University, Moscow, Russia; 9Groupement Hospitalier Est, Hospices Civils de Lyon, Lyon, France; 10Rabin Medical Center, and Sackler School of Medicine, Tel-Aviv University, Petah-Tiqva, Israel; 11Novartis Pharma AG, Basel, Switzerland; 12Division of Endocrinology, Medical School and Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Introduction: The PAOLA study in patients with inadequately-controlled acromegaly (n=198) demonstrated superior efficacy of pasireotide long-acting release (LAR; 40 mg/60 mg) in biochemical control (GH <2.5 μg/l and normalized IGF-1) vs continued treatment with octreotide LAR 30 mg/lanreotide Autogel 120 mg (15.4% and 20.0% vs 0%). Here we report preliminary data from the extension phase of PAOLA at wk28.
Methods: Pasireotide-LAR (40 mg/60 mg) patients who were biochemically controlled at wk24 (core phase) continued with the same double-blind pasireotide LAR dose whereas uncontrolled patients started open-label pasireotide LAR 60 mg. Uncontrolled patients in the active-control group (octreotide LAR/lanreotide Autogel) patients crossed over to open-label pasireotide LAR 40 mg. Key efficacy endpoints at extension wk28 were i) proportion of patients with biochemical control ii) proportion of patients with GH <2.5 μg/l or normal IGF-1 alone. Safety and tolerability were evaluated.
Results: A total of 173 patients entered the extension (pasireotide LAR 40 mg, n=57; pasireotide LAR 60mg, n=54 by randomised dose; crossover, n=62). The preliminary analysis at wk28 in all patients achieving that time point, including early discontinuation showed that the proportion of patients with i) biochemical control was 18.4% (9/49), 33.3% (15/45), and 20.0% (10/50) ii) GH <2.5 μg/l was 38.8% (19/49), 46.7% (21/45), and 42.0% (21/50); normal IGF-1 was 32.7% (16/49), 37.8% (17/45), and 24.0% (12/50), in the pasireotide LAR 40 mg-, pasireotide LAR 60 mg-, and crossover arm, respectively. Safety findings were consistent with the ones in the core phase; most common adverse events were hyperglycaemia, diabetes mellitus, cholelithiasis, and diarrhoea.
Conclusions: The preliminary data in patients achieving wk28 indicate that pasireotide LAR maintained biochemical control during the extension in patients with inadequately-controlled acromegaly; ~20% of the active-control patients achieved biochemical control after crossing over to pasireotide in the extension. No new safety signals were identified during the extension. These findings suggest that pasireotide LAR is a viable, long-term treatment option for patients with acromegaly.
Disclosure: This work was supported by Novartis.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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