Document Detail

Improved Cortisol Exposure-Time Profile and Outcome in Patients with Adrenal Insufficiency: A Prospective Randomized Trial of a Novel Hydrocortisone Dual-Release Formulation.
MedLine Citation:
PMID:  22112807     Owner:  NLM     Status:  Publisher    
Context:Patients with treated adrenal insufficiency (AI) have increased morbidity and mortality rate. Our goal was to improve outcome by developing a once-daily (OD) oral hydrocortisone dual-release tablet with a more physiological exposure-time cortisol profile.Objective:The aim was to compare pharmacokinetics and metabolic outcome between OD and the same daily dose of thrice-daily (TID) dose of conventional hydrocortisone tablets.Design and Setting:We conducted an open, randomized, two-period, 12-wk crossover multicenter trial with a 24-wk extension at five university hospital centers.Patients:The trial enrolled 64 adults with primary AI; 11 had concomitant diabetes mellitus (DM).Intervention:The same daily dose of hydrocortisone was administered as OD dual-release or TID.Main Outcome Measure:We evaluated cortisol pharmacokinetics.Results:Compared with conventional TID, OD provided a sustained serum cortisol profile 0-4 h after the morning intake and reduced the late afternoon and the 24-h cortisol exposure. The mean weight (difference = -0.7 kg, P = 0.005), systolic blood pressure (difference = -5.5 mm Hg, P = 0.0001) and diastolic blood pressure (difference: -2.3 mm Hg; P = 0.03), and glycated hemoglobin (absolute difference = -0.1%, P = 0.0006) were all reduced after OD compared with TID at 12 wk. Compared with TID, a reduction in glycated hemoglobin by 0.6% was observed in patients with concomitant DM during OD (P = 0.004).Conclusion:The OD dual-release tablet provided a more circadian-based serum cortisol profile. Reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during OD treatment. In particular, glucose metabolism improved in patients with concomitant DM.
G Johannsson; A G Nilsson; R Bergthorsdottir; P Burman; P Dahlqvist; B Ekman; B E Engström; T Olsson; O Ragnarsson; M Ryberg; J Wahlberg; B M K Biller; J P Monson; P M Stewart; H Lennernäs; S Skrtic
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-23
Journal Detail:
Title:  The Journal of clinical endocrinology and metabolism     Volume:  -     ISSN:  1945-7197     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375362     Medline TA:  J Clin Endocrinol Metab     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Departments of Endocrinology (G.J., A.G.N., R.B., O.R.) and Clinical Pharmacology (S.S.), Sahlgrenska Academy, University of Gothenburg, SE-413 45 Gothenburg, Sweden; Department of Endocrinology (P.B.), Skånes University Hospital Malmö, SE-205 02 Malmö, Sweden; Department of Public Health and Clinical Medicine (P.D., T.O., M.R.), Umeå University, SE-901 87 Umeå, Sweden; Division of Cardiovascular Medicine (B.E., J.W.), Department of Medical and Health Sciences Faculty of Health Sciences, Linköping University, SE-581 83 Linköping, Sweden; Department of Endocrinology, Diabetes, and Metabolism (B.E.E.), University Hospital, and Department of Pharmacy (H.L.), Uppsala University, SE-751 85 Uppsala, Sweden; Neuroendocrine Clinical Center (B.M.K.B.), Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114; Centre for Clinical Endocrinology (J.P.M.), St. Bartholomew's Hospital, Queen Mary University of London, London EC1A 7BE, United Kingdom; and College of Medical and Dental Sciences (P.M.S.), University of Birmingham, Birmingham B15 2TT, United Kingdom.
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