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Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency.

Nilsson, Anna G; Marelli, Claudio; Fitts, David; Bergthorsdottir, Ragnhildur; Burman, Pia LU ; Dahlqvist, Per; Ekman, Bertil; Edén Engström, Britt; Olsson, Tommy and Ragnarsson, Oskar, et al. (2014) In European Journal of Endocrinology 171(3). p.369-377
Abstract
Objective: The objective was to assess the long-term safety profile of dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency. Design: Randomized, 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... (More)
Objective: The objective was to assess the long-term safety profile of dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency. Design: Randomized, 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 has demonstrated that such treatment is well tolerated during 24 consecutive months of therapy. (Less)
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publication status
published
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European Journal of Endocrinology
volume
171
issue
3
pages
369 - 377
publisher
Society of the European Journal of Endocrinology
external identifiers
  • pmid:24944332
  • wos:000343670900015
  • scopus:84907206929
ISSN
1479-683X
DOI
10.1530/EJE-14-0327
language
English
LU publication?
yes
id
484e1d36-1feb-4f43-926f-34c80ad931b6 (old id 4527976)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/24944332?dopt=Abstract
date added to LUP
2014-07-06 19:07:21
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2017-10-29 03:08:49
@article{484e1d36-1feb-4f43-926f-34c80ad931b6,
  abstract     = {Objective: The objective was to assess the long-term safety profile of dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency. Design: Randomized, 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 has demonstrated that such treatment is well tolerated during 24 consecutive months of therapy.},
  author       = {Nilsson, Anna G and Marelli, Claudio and Fitts, David and Bergthorsdottir, Ragnhildur and Burman, Pia and Dahlqvist, Per and Ekman, Bertil and Edén Engström, Britt and Olsson, Tommy and Ragnarsson, Oskar and Ryberg, Mats and Wahlberg, Jeanette and Lennernas, Hans and Skrtic, Stanko and Johannsson, Gudmundur},
  issn         = {1479-683X},
  language     = {eng},
  number       = {3},
  pages        = {369--377},
  publisher    = {Society of the European Journal of Endocrinology},
  series       = {European Journal of Endocrinology},
  title        = {Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency.},
  url          = {http://dx.doi.org/10.1530/EJE-14-0327},
  volume       = {171},
  year         = {2014},
}