Introduction: A once-daily modified-release formulation of hydrocortisone (Plenadren®) has been developed to better mimic physiological cortisol secretion in the treatment of patients with adrenal insufficiency (AI). Here, we describe EU-AIR, an ongoing post-authorization observational study (registry) designed to collect information on AI management and to assess the long-term safety of Plenadren® compared with traditional glucocorticoid replacement therapies in routine clinical practice.
Design: Patients with AI (primary or secondary), not participating in an interventional clinical study, are eligible for inclusion. The registry focuses on intercurrent illness, adrenal crisis, and serious adverse events. Other data collected include mortality, adverse drug reactions, dose changes, metabolic parameters, bone mineral density/content, and concomitant therapies. At enrolment, comprehensive demographic and baseline data, aetiology of AI and details of glucocorticoid replacement therapy, are collected electronically. Safety data and treatment information will be collected at subsequent clinic visits. The overall dataset will be analysed and, additionally, stratified according to patient subgroups (e.g. patients with hypertension, diabetes and/or other hormone deficiencies). All medical care decisions, including whether to treat with Plenadren® or conventional glucocorticoids, are made by the registry physician and patient.
Results: Approximately 20 centres in Germany, The Netherlands, Sweden, and the UK have been selected to participate in the study. Recruitment began in August 2012. As of 9 January 2013, the study had been initiated in eight centres and the total number of patients enrolled was 155. Primary analysis will be performed when 1800 patient-years of exposure have been achieved for each patient group (Plenadren® vs other replacement therapies). Reports will be provided to the European Medicines Agency every 6 months.
Conclusion: EU-AIR provides an opportunity to document evidence that will inform future clinical practice in the treatment of patients with AI.
27 Apr - 01 May 2013
European Society of Endocrinology