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Endocrine Abstracts (2015) 37 GP19.09 | DOI: 10.1530/endoabs.37.GP.19.09

ECE2015 Guided Posters Pituitary–Acromegaly (10 abstracts)

Management of pasireotide-induced hyperglycaemia with proactive monitoring and early intervention: key learnings from the phase III, 24-week PAOLA study

Monica R Gadelha 1 , Thierry Brue 2 , Maria Fleseriu 3 , Ilan Shimon 4 , Karina Hermosillo Reséndiz 5 , Albert Kandra 6 , Alberto M Pedroncelli 6 & AnnaMaria Colao 7


1Division of Endocrinology, Medical School and Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 2Hôpital de la Timone, Aix-Marseille University, Centre National de la Recherche Scientifique, and Assistance Publique-Hôpitaux de Marseille, Marseille, France; 3Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA; 4Rabin Medical Center, and Sackler School of Medicine, Tel-Aviv University, Petah-Tiqva, Israel; 5Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA; 6Novartis Pharma AG, Basel, Switzerland; 7Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Naples, Italy.

Introduction: In PAOLA study, pasireotide showed superior efficacy over continued treatment with octreotide/lanreotide in patients with inadequately-controlled acromegaly; 64% of patients receiving pasireotide long-acting release (LAR) reported hyperglycaemia-related adverse events. Pasireotide has been shown to inhibit insulin secretion. The aim of this exploratory analysis was to investigate the effect of timing of antidiabetic medication (ADM) intervention on the fasting plasma glucose (FPG) outcome during pasireotide LAR treatment.

Methods: Patients randomised to pasireotide LAR, who received ≥1 dose of pasireotide and had a valid post-baseline safety assessment (safety population for pasireotide; n=125), were included and categorised by baseline diabetic status: non-diabetic; pre-diabetic (FPG 100–<126 mg/dl or HbA1c 5.7–<6.5% or 2 h post-OGTT glucose 140–<200 mg/dl); diabetic (current/prior ADM use or FPG ≥126 mg/dl or HbA1c ≥6.5% or 2 h post-OGTT glucose ≥200 mg/dl).

Results: Hyperglycaemia (first occurrence of FPG ≥126 mg/dl or HbA1c ≥6.5% in non-diabetic/pre-diabetic; or first occurrence of FPG or HbA1c increase ≥20% from baseline in diabetic) was experienced by 5/19 non-diabetic, 9/24 pre-diabetic and 68/82 diabetic patients. Due to fewer non-diabetic/pre-diabetic patients, the analysis is focused on 68 diabetic patients. ADM was initiated/adjusted in 36/68 diabetic patients after 0–<15 (n=7), 15–<30 (n=8) or ≥30 (n=21) days; mean FPG change ±S.D. at week 20 (maximum follow-up) was –110.0±96.3 mg/dl (from 255.9±89.8 mg/dl during occurrence of hyperglycaemia), –7.3±91.1 (from 186.9±92.2) and 2.1±78.9 (from 178.7±38.0), respectively. Mean FPG change was –10.7±91.5 mg/dl (from 152.4±44.0) in patients who did not receive ADM (n=32). Significant (P<0.01) factors predicting hyperglycaemia were BMI ≥25 kg/m2 (OR=2.3), per unit increase in HbA1c (OR=4.3) and diabetes at baseline (OR=4.8); and history of dyslipidaemia (OR=3.6).

Conclusions: Pasireotide-induced hyperglycaemia can be managed with proactive monitoring and early intervention (e.g., within 2 week if FPG >250 mg/dl). These data suggest that in patients receiving pasireotide, early intervention can improve hyperglycaemia control.

Disclosure: This work was supported by Novartis.

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