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

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, pro...

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Autores principales: Nilsson, A G, Marelli, C, Fitts, D, Bergthorsdottir, R, Burman, P, Dahlqvist, P, Ekman, B, Edén Engström, B, Olsson, T, Ragnarsson, O, Ryberg, M, Wahlberg, J, Lennernäs, H, Skrtic, S, Johannsson, G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Bioscientifica Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106399/
https://www.ncbi.nlm.nih.gov/pubmed/24944332
http://dx.doi.org/10.1530/EJE-14-0327
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author Nilsson, A G
Marelli, C
Fitts, D
Bergthorsdottir, R
Burman, P
Dahlqvist, P
Ekman, B
Edén Engström, B
Olsson, T
Ragnarsson, O
Ryberg, M
Wahlberg, J
Lennernäs, H
Skrtic, S
Johannsson, G
author_facet Nilsson, A G
Marelli, C
Fitts, D
Bergthorsdottir, R
Burman, P
Dahlqvist, P
Ekman, B
Edén Engström, B
Olsson, T
Ragnarsson, O
Ryberg, M
Wahlberg, J
Lennernäs, H
Skrtic, S
Johannsson, G
author_sort Nilsson, A G
collection PubMed
description 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.
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spelling pubmed-41063992014-09-01 Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency Nilsson, A G Marelli, C Fitts, D Bergthorsdottir, R Burman, P Dahlqvist, P Ekman, B Edén Engström, B Olsson, T Ragnarsson, O Ryberg, M Wahlberg, J Lennernäs, H Skrtic, S Johannsson, G Eur J Endocrinol Clinical Study 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. Bioscientifica Ltd 2014-09 /pmc/articles/PMC4106399/ /pubmed/24944332 http://dx.doi.org/10.1530/EJE-14-0327 Text en © 2014 The authors http://creativecommons.org/licenses/by/3.0/deed.en_GB This work is licensed under a Creative Commons Attribution 3.0 Unported License (http://creativecommons.org/licenses/by/3.0/deed.en_GB)
spellingShingle Clinical Study
Nilsson, A G
Marelli, C
Fitts, D
Bergthorsdottir, R
Burman, P
Dahlqvist, P
Ekman, B
Edén Engström, B
Olsson, T
Ragnarsson, O
Ryberg, M
Wahlberg, J
Lennernäs, H
Skrtic, S
Johannsson, G
Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title_full Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title_fullStr Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title_full_unstemmed Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title_short Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
title_sort prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106399/
https://www.ncbi.nlm.nih.gov/pubmed/24944332
http://dx.doi.org/10.1530/EJE-14-0327
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