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Endocrine Abstracts (2016) 41 EP901 | DOI: 10.1530/endoabs.41.EP901

ECE2016 Eposter Presentations Pituitary - Clinical (83 abstracts)

High burden of illness at baseline in patients with uncontrolled acromegaly participating in the PAOLA study

Ilan Shimon 1, , Gerald Raverot 3 , Mihail Coculescu 4 , Marek Bolanowski 5 , Annamaria Colao 6 , Albert Kandra 7 , Karina Hermosillo Reséndiz 8 , Alberto M Pedroncelli 7 & Mônica Gadelha 9


1Institute of Endocrinology and Metabolism, Rabin Medical Center, Petah Tiqva, Israel; 2Sackler School of Medicine, Tel-Aviv University, Petah Tiqva, Israel; 3Fédération d’Endocrinologie, Groupement Hospitalier Est, Hospices Civils de Lyon, Lyon, France; 4Academy of Medical Sciences of Romania, University of Medicine and Pharmacy ‘Carol Davila’, National Institute of Endocrinology ‘CI Parhon’, Bucharest, Romania; 5Wroclaw Medical University, Wroclaw, Poland; 6Università Federico II di Napoli, Naples, Italy; 7Novartis Pharma AG, Basel, Switzerland; 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 9Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.

Background: The Phase III PAOLA study assessed the efficacy and safety of pasireotide LAR versus continued treatment with octreotide LAR or lanreotide Autogel in patients with uncontrolled acromegaly. The current analysis investigated overall baseline characteristics and response rates to pasireotide according to co-morbidities.

Methods: Patients were classified into five groups of co-morbidities related to acromegaly: glucose- (n=104), endocrine- (n=127), lipid-related (n=56), vascular disorders (n=80), and all other acromegaly-related disorders not included in these previous groups (n=111). A sixth group consisted of patients without any acromegaly-related co-morbidity (n=17). Baseline characteristics and efficacy were based on the total population (N=198) and patients receiving pasireotide (N=130), respectively.

Results: of patients had ≥1 co-morbidity, while 70%, 49%, and 24% had ≥2, ≥3, and ≥4 co-morbidities, respectively. The most common co-morbidities were endocrine related (64%; eg goitre and hypothyroidism), all other acromegaly related (56%; eg sleep apnoea and headache), and glucose related (53%, eg diabetes mellitus and impaired glucose tolerance), followed by vascular (40%, eg hypertension), lipid-related (28%, eg dyslipidaemia and hypercholesterolaemia), and without any acromegaly-related co-morbidity (9%). Across the five groups of comorbidities related to acromegaly, mean age (45.8–52.3 years), baseline insulin-like growth factor 1 (IGF-1; 2.2–3.1× upper limit of normal), and baseline growth hormone (GH) levels (9.0–12.4 μg/L) were similar. Across these same groups, pasireotide treatment reduced mean GH and IGF-1 levels from baseline to week 24 by 26.5–47.5% and 33.2–46.2%, respectively. Response rates to pasireotide (defined as GH <2.5 μg/L and IGF-1 normalization at week 24) were similar (18.2–20.6%).

Conclusions: Most patients in the PAOLA study had multiple acromegaly-related co-morbidities at baseline. GH/IGF-1 response to pasireotide treatment was similar between groups of patients regardless of co-morbidity at baseline. Qualitative analysis of the effect of each co-morbidity on treatment outcome is ongoing.

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