Improvement of anthropometric and metabolic parameters, and quality of life following treatment with dual-release hydrocortisone in patients with Addison’s disease

• DOI: 10.1007/s12020-015-0681-z
• Publication Date: 2015-07-16T14:24:04Z
• Authors: Roberta Giordano; Federica Guaraldi; Elisa Marinazzo; Federica Fumarola; Alessia Rampino; Rita Berardelli; Ioannis Karamouzis; Manuela Lucchiari; Tilde Manetta; Giulio Mengozzi; Emanuela Arvat; Ezio Ghigo
• Keywords: Adult; Male; Hydrocortisone; Hormone Replacement Therapy; Blood Pressure; Middle Aged; Lipids; Body Mass Index; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Addison Disease; Delayed-Action Preparations; Quality of Life; Humans; Female; Waist Circumference; Glucocorticoids; Aged

In patients with Addison's disease (AD), a dual-release preparation of hydrocortisone (Plenadren, PLEN) has been demonstrated to maintain cortisol levels in a more physiological range than conventional glucocorticoid therapy, and to exert positive effects. This study aimed to assess variations of anthropometric, metabolic, and hormonal parameters in patients with AD after switching from conventional hydrocortisone (HC) treatment to PLEN. In nineteen AD patients (15 F and 4 M, age 27-65 years) treated with HC 20 mg/day thrice daily, body weight, BMI, waist circumference, fasting glucose, HbA1c, serum lipids, plasma renin activity, electrolytes, and blood pressure were evaluated at baseline, and 1, 3, 6, and 12 months after switching from HC to PLEN. At baseline, and after 1 and 12 months of PLEN, blood ACTH and cortisol (at 0800 h at fasting, and 30, 60, 90, 120, and 240 min after drug ingestion), and health-related quality of life (HRQoL), using 30-AddiQoL questionnaire, were evaluated. During PLEN, waist and serum lipid progressively decreased. After 12 months of PLEN, a significant difference was observed in waist circumference (P = 0.007), HbA1c (P = 0.002), total and LDL-cholesterol levels (P < 0.05). ACTH levels at 240 min and the area under the curve (AUC) were lower (P < 0.05) during PLEN than HC, while cortisol peaks and AUC were similar. 30-AddiQoL total score also improved (P = 0.04) during PLEN. In AD patients, PLEN reduces central adiposity, and improves glucose and metabolism parameters and HRQoL.