ECE2016 Eposter Presentations Neuroendocrinology (43 abstracts)
The medical treatment with pasireotide in Cushing’s disease: an Italian multicenter experience based on “Real Word Evidence”
Rosario Pivonello 1 , Giorgio Arnaldi 2 , Carla Maria Scaroni 3 , Carla Giordano 4 , Salvatore Cannavo 5 , Davide Iacuaniello 1 , Laura Trementino 2 , Marialuisa Zilio 3 , Valentina Guarnotta 4 , Adriana Albani 5 , Alessia Cozzolino 1 , Grazia Michetti 2 , Marco Boscaro 3 & Annamaria Colao 1
1Università Federico II, Naples, Italy; 2Ospedali Riuniti di Ancona, Ancona, Italy; 3Università di Padova, Padua, Italy; 4A.O.U.P. Paolo Giaccone, Palermo, Italy; 5Università di Messina, Messina, Italy.
A recent phase III clinical trial has demonstrated that the treatment with the somatostatin analogue pasireotide normalizes cortisol secretion in 15–28% of patients with Cushing’s disease (CD). The aim of the current study was to evaluate the effectiveness of 6-months pasireotide treatment on clinical and hormonal profiles in a group of CD patients with mild to moderate disease according with the real-word evidence. Thirty-two patients with CD unsuccessfully treated by surgery and with persistently increased urinary free cortisol (UFC) levels started pasireotide treatment at the dose of 600 mg bid. UFC, plasma ACTH and serum cortisol levels were measured every three months together with clinical and metabolic parameters. Five patients discontinued treatment during the first 6 months for adverse events, mainly gastrointestinal disturbances; among the remaining 27 patients, 14 with very mild, 6 with mild, 6 with moderate and 1 with very severe UFC increase reached 6-months follow-up; the study focused on the 26 patients with very mild to moderate disease. After 6-months pasireotide treatment, UFC levels were normalized (ULN<1) or nearly normalized (ULN between 1 and 1.1) in 22 out of 32 (68.7%) patients. A significant decrease of UFC (P=0.004), serum cortisol (P=0.011) and ACTH levels (P=0.002) were demonstrated in the entire cohort of CD patients. The decrease of UFC levels was accompanied by a significant decrease in weight (P=0.000), body mass index (P=0.000), waist circumference (P=0.01) as well as serum total cholesterol (0.023) and LDL cholesterol levels (P=0.011). Fasting plasma glucose (P=0.003) and glycosylated haemoglobin (P=0.000) levels increased significantly. Hyperglycaemia or deterioration of diabetes was documented in 67% whereas gastrointestinal disturbances, mainly diarrhoea, were documented in 31% of patients. Among the 18 patients with available pituitary MRI at baseline and at 6 months of follow-up, tumour remained stable in 13 patients and decreased in 4 patients; in particular, 1 macroadenoma became a microadenoma, 2 microadenoma became invisible. A slight enlargement was found in one macroadenoma. In conclusion, pasireotide treatment induces normalization of UFC in nearly 70% of patients with very mild to moderate CD during clinical practice, with consequent improvement in the clinical picture, but with occurrence or deterioration of diabetes or gastrointestinal disturbances in 31–67% of cases. These results confirmed the usefulness of pasireotide in controlling CD especially in patients with non severe disease.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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