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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; Engström, B Edén; Olsson, T; Ragnarsson, O; Ryberg, M; Wahlberg, J; Lennernäs, H; Skrtic, S; Johannsson, G.
Affiliation
  • Nilsson AG; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Marelli C; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Fitts D; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Bergthorsdottir R; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Burman P; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Dahlqvist P; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Ekman B; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Engström BE; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Olsson T; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Ragnarsson O; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Ryberg M; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Wahlberg J; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Lennernäs H; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Skrtic S; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
  • Johannsson G; Department of EndocrinologySahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gröna Stråket 8, SE-413 45 Gothenburg, SwedenMedical AffairsViroPharma SPRL, Maidenhead, UKBiostatisticsViroPharma IncorporatedDepartment of EndocrinologySkånes University Hospital, SE-205 02 M
Eur J Endocrinol ; 171(3): 369-77, 2014 Sep.
Article in En | MEDLINE | ID: mdl-24944332
ABSTRACT

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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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hydrocortisone / Adrenal Insufficiency Type of study: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: Eur J Endocrinol Journal subject: ENDOCRINOLOGIA Year: 2014 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hydrocortisone / Adrenal Insufficiency Type of study: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: Eur J Endocrinol Journal subject: ENDOCRINOLOGIA Year: 2014 Document type: Article