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Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
University of Gothenburg, Sweden.
ViroPharma SPRL, England.
ViroPharma Inc, Sweden.
University of Gothenburg, Sweden.
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2014 (English)In: European Journal of Endocrinology, ISSN 0804-4643, E-ISSN 1479-683X, Vol. 171, no 3, 369-377 p.Article in journal (Refereed) Published
Abstract [en]

Objective: The objective was to assess the long-term safety profile of dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency (AI). Design: Randomised, open-label, crossover trial of DR-HC or thrice-daily hydrocortisone for 3 months each (stage 1) followed by two consecutive, prospective, open-label studies of DR-HC for 6 months (stage 2) and 18 months (stage 3) at five university clinics in Sweden. Methods: Sixty-four adults with primary AI started stage 1, and an additional 16 entered stage 3. Patients received DR-HC 20-40 mg once daily and hydrocortisone 20-40 mg divided into three daily doses (stage 1 only). Main outcome measures were adverse events (AEs) and intercurrent illness (self-reported hydrocortisone use during illness). Results: In stage 1, patients had a median 1.5 (range, 1-9) intercurrent illness events with DR-HC and 1.0 (1-8) with thrice-daily hydrocortisone. AEs during stage 1 were not related to the cortisol exposure-time profile. The percentage of patients with one or more AEs during stage 1 (73.4% with DR-HC; 65.6% with thrice-daily hydrocortisone) decreased during stage 2, when all patients received DR-HC (51% in the first 3 months; 54% in the second 3 months). In stages 1-3 combined, 19 patients experienced 27 serious AEs, equating to 18.6 serious AEs/100 patient-years of DR-HC exposure. Conclusions: This long-term prospective trial is the first to document the safety of DR-HC in patients with primary AI and demonstrates that such treatment is well tolerated during 24 consecutive months of therapy.

Place, publisher, year, edition, pages
BioScientifica , 2014. Vol. 171, no 3, 369-377 p.
National Category
Clinical Medicine
URN: urn:nbn:se:liu:diva-112489DOI: 10.1530/EJE-14-0327ISI: 000343670900015PubMedID: 24944332OAI: diva2:766714

Funding Agencies|ViroPharma SPRL, Maidenhead, UK

Available from: 2014-11-28 Created: 2014-11-28 Last updated: 2014-12-02

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Ekman, BertilWahlberg Topp, Jeanette
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Division of Cardiovascular MedicineFaculty of Health SciencesDepartment of Endocrinology
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