Introduction: Glucocorticoid (GC) replacement therapy is administered to patients with adrenal insufficiency (AI) in multiple daily doses; however, there are no consensus guidelines on the optimal regimen.
Methods: The European Adrenal Insufficiency Registry (EU-AIR) is a multinational, multicentre, observational study sponsored by Shire, initiated to monitor the long-term safety of GC replacement in patients with chronic AI. We analysed baseline data to gain insight into the current clinical management of primary (PAI) and secondary AI (SAI). Patients receiving modified-release hydrocortisone and those with congenital adrenal hyperplasia were excluded from this analysis.
Results: As of 13 May 2015, 1166 patients (364 (31.2%) with PAI, 801 (68.7%) with SAI, 1 (0.1%) with unknown aetiology) were enrolled in EU-AIR. Overall, 87.4% of patients were receiving hydrocortisone (HC), 5.1% prednisolone and 4.0% cortisone acetate. For patients receiving HC, daily doses ranged from 5>45 mg. Most patients (42.2%) were receiving 20<25 mg/day; 22.9% of patients were receiving 15< 20 mg/day, and 27.8% were receiving ≧25 mg/day. Patients with PAI and SAI were receiving average HC doses of 23.4 and 19.6 mg/day, respectively. Most patients with PAI were receiving HC three times daily (BID, 38.8%; TID, 53.7%) whereas most patients with SAI were receiving HC twice daily (BID, 52.9%; TID, 39.2%). Overall, HC was taken QD, BID, TID and QID by 5.5, 48.7, 43.6% and 2.1% of patients, respectively. There were 25 different regimens used to deliver a daily dose of 20 mg HC.
Conclusions: There is significant heterogeneity in the clinical management of AI. This likely reflects individualization of therapy in the absence of consensus guidelines.