Effect of once-daily, modified-release hydrocortisone versus standard glucocorticoid therapy on metabolism and innate immunity in patients with adrenal insufficiency (DREAM): a single-blind, randomised controlled trial

Publication date: Available online 8 December 2017 Source:The Lancet Diabetes & Endocrinology Author(s): Andrea M Isidori, Mary Anna Venneri, Chiara Graziadio, Chiara Simeoli, Daniela Fiore, Valeria Hasenmajer, Emilia Sbardella, Daniele Gianfrilli, Carlotta Pozza, Patrizio Pasqualetti, Stefania Morrone, Angela Santoni, Fabio Naro, Annamaria Colao, Rosario Pivonello, Andrea Lenzi Background Conventional treatment of patients with adrenal insufficiency involves administration of glucocorticoids multiple times a day and has been associated with weight gain and metabolic impairment. The optimal glucocorticoid replacement therapy for these patients is highly debated because of the scarcity of evidence from randomised trials. We aimed to establish whether the timing and pharmacokinetics of glucocorticoid replacement therapy affect the metabolism and immune system of patients with adrenal insufficiency. Methods We did a single-blind randomised controlled trial at two reference university hospitals in Italy. Eligible patients (aged 18–80 years) with adrenal insufficiency were on conventional glucocorticoid therapy and had been stable for at least 3 months before enrolment. Patients were randomly assigned (1:1) with a computer-generated random sequence stratified by type of adrenal insufficiency and BMI to continue conventional glucocorticoid therapy (standard treatment group) or to switch to an equivalent dose of once-daily, modified-release oral hydrocor...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research