Endocrine Abstracts (2013) 32 P907 | DOI: 10.1530/endoabs.32.P907

Characteristics and outcomes of the Italian subpopulation enrolled in the observational, multicenter hypopituitary control and complications study (HypoCCS)

Gianluca Aimaretti1, Diego Ferone2, Maria Rosaria Ambrosio3, Paolo Beck-Peccoz4, Salvatore Cannavò5, Anna Maria Colao6, Marco Losa7, Beverly Festin Martinez8, Paolo Marchi9 & Alessandra Vottero9

1Department of Translational Medicine, University of the Eastern Piedmont, Novara, Italy; 2Endocrinology Unit, Department of Internal Medicine and Medical Specialties and Center of Excelence for Biomedical Research, IRCCS AOU San Martino-IST, Genoa, Italy; 3Department of Medical sciences, University of Ferrara, Ferrara, Italy; 4Department of MedicalSciences, Fondazione Policlinico IRCCS, Milan, Italy; 5Department of Clinical and Experimental Medicine – Endocrinology, University of Messina, Messina, Italy; 6University Federico II of Naples, Naples, Italy; 7Department of Neurosurgery, IRCCS San Raffaele, Università Vita-Salute, Milan, Italy; 8Eli Lilly & Co, Indianapolis, USA; 9Medical department, Eli Lilly Italy S.p.A, Sesto Fiorentino, Italy.

Aim: To describe characteristics and outcomes of Italian patients with hypopituitarism participating in HypoCCS.

Methods: Study population was stratified by max GH peak (mGHp) and BMI. Baseline variables included demographic characteristics, type of deficit, smoking habits; variables analyzed over time included weight, Framingham cardiovascular disease (CVD) risk, lipids, GH dose.

Results: Italian subpopulation included 342 patients with mGHp ≤33 (group A); 345 with 33<mGHp≤66 (group B); and 337 with mGHpk >66 percentile (group C) with mean age (years (S.D.)) of 44.2 (16.2), 44. 6 (16.0), 42.6 (15.1), respectively, and adult onset GHD ((%): 75.8, 77.1 and 78.4% respectively). GHD was diagnosed mainly with GHRH+Arginine test (roughly 66% of diagnoses) and percentage of multiple pituitary hormone deficits was higher (P<0.001) in subgroup A (92.7) than in B (85.2) or C (69.5). Patients were equally distributed across normal-, under- and over-weight with average BMI of 28. No differences were detected in smoking habits or in Framingham CVD risk at baseline. More patients in group A than in B or C had hyperlipidemia (n (%): 92 (35.1), 86 (31.1), 69 (24.7) respectively; P=0.029). Mean GH dose at baseline was significantly lower in group A than in B and C (dose/kg (S.D.): 311.0 (162.5), 356.3 (217.9), 391.7 (323.1); P=0.0009) and with a longer treatment duration (years (S.D.): 7.2 (9.2), 5.5 (8.2), 5.0 (7.6); P=0.0014). Analyses over time showed group differences only at certain single time-points. Overall, no significant differences in treatment emergent adverse events (TEAEs) were detected across subgroups, while among the serious TEAEs, only ‘infections and infestations’ were significantly different (n (%): 6 (1.8), 5 (1.5), 0 (0.00); P=0.0406).

Conclusions: Italian patients with mGHp <33 percentile had the worst lipid profile and were given the lower GH treatment dose. The highest percentage of multiple deficits in this group suggests the more severe GHD.