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Prospective evaluat...
Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency
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Nilsson, A G (författare)
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Marelli, C (författare)
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Fitts, D (författare)
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visa fler...
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Bergthorsdottir, R (författare)
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Burman, P (författare)
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Dahlqvist, Per (författare)
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Ekman, B (författare)
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Engström, B Edén (författare)
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Olsson, Tommy (författare)
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Ragnarsson, O (författare)
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Ryberg, Mats (författare)
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Wahlberg, J (författare)
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Lennernäs, H (författare)
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Skrtic, S (författare)
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Johannsson, G (författare)
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visa färre...
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(utgivare)
- 2014
- 2014
- Engelska.
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Ingår i: European Journal of Endocrinology. - 0804-4643. ; 171:3, 369-377
Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- Medical and Health Sciences (hsv)
- Clinical Medicine (hsv)
- Endocrinology and Diabetes (hsv)
- Medicin och hälsovetenskap (hsv)
- Klinisk medicin (hsv)
- Endokrinologi och diabetes (hsv)
Nyckelord
- Fructose
- Endocannabinoid
- fructose
- endocannabinoid
- CB1 receptors
- [S-35]GTP gamma S autoradiography
- leptin
- adiponectin
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Till lärosätets databas
- Av författaren/redakt...
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Nilsson, A G
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Marelli, C
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Fitts, D
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Bergthorsdottir, ...
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Burman, P
-
Dahlqvist, Per
-
visa fler...
-
Ekman, B
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Engström, B Edén
-
Olsson, Tommy
-
Ragnarsson, O
-
Ryberg, Mats
-
Wahlberg, J
-
Lennernäs, H
-
Skrtic, S
-
Johannsson, G
-
visa färre...
- Av lärosätet
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