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

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          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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          Most cited references18

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          Adrenal insufficiency.

          W Oelkers (1996)
          Article 0 comments Cited 133 times – based on 0 reviews     Review now
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            Clinical, immunological, and genetic features of autoimmune primary adrenal insufficiency: observations from a Norwegian registry.

            Martina M. Erichsen, Kristian Løvås, Beate Skinningsrud … (2009)
            Primary adrenal insufficiency [Addison's disease (AD)] is rare, and systematic studies are few, mostly conducted on small patient samples. We aimed to determine the clinical, immunological, and genetic features of a national registry-based cohort. Patients with AD identified through a nationwide search of diagnosis registries were invited to participate in a survey of clinical features, health-related quality of life (HRQoL), autoantibody assays, and human leukocyte antigen (HLA) class II typing. Of 664 registered patients, 64% participated in the study. The prevalence of autoimmune or idiopathic AD in Norway was 144 per million, and the incidence was 0.44 per 100,000 per year (1993-2007). Familial disease was reported by 10% and autoimmune comorbidity by 66%. Thyroid disease was most common (47%), followed by type 1 diabetes (12%), vitiligo (11%), vitamin B12 deficiency (10%), and premature ovarian insufficiency (6.6% of women). The mean daily treatment for AD was 40.5 mg cortisone acetate and 0.1 mg fludrocortisone. The mean Short Form 36 vitality scores were significantly diminished from the norm (51 vs. 60), especially among those with diabetes. Concomitant thyroid autoimmunity did not lower scores. Anti-21-hydroxylase antibodies were found in 86%. Particularly strong susceptibility for AD was found for the DR3-DQ2/ DRB1*0404-DQ8 genotype (odds ratio, 32; P = 4 x 10(-17)), which predicted early onset. AD is almost exclusively autoimmune, with high autoimmune comorbidity. Both anti-21-hydroxylase antibodies and HLA class II can be clinically relevant predictors of AD. HRQoL is reduced, especially among diabetes patients, whereas thyroid disease did not have an impact on HRQoL. Treatment modalities that improve HRQoL are needed.
            Article 0 comments Cited 122 times – based on 0 reviews     Review now
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              Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies.

              Manfred Ventz, Danijela Milovanovic, Martin Fassnacht … (2010)
              Adrenal crisis (AC) is a life-threatening complication of adrenal insufficiency (AI). Here, we evaluated frequency, causes and risk factors of AC in patients with chronic AI. In a cross-sectional study, 883 patients with AI were contacted by mail. Five-hundred and twenty-six patients agreed to participate and received a disease-specific questionnaire. Four-hundred and forty-four datasets were available for analysis (primary AI (PAI), n=254; secondary AI (SAI), n=190). Forty-two percent (PAI 47% and SAI 35%) reported at least one crisis. Three hundred and eighty-four AC in 6092 patient years were documented (frequency of 6.3 crises/100 patient years). Precipitating causes were mainly gastrointestinal infection and fever (45%) but also other stressful events (e.g. major pain, surgery, psychic distress, heat and pregnancy). Sudden onset of apparently unexplained AC was also reported (PAI 6.6% and SAI 12.7%). Patients with PAI reported more frequent emergency glucocorticoid administration (42.5 vs 28.4%, P=0.003). Crisis incidence was not influenced by educational status, body mass index, glucocorticoid dose, DHEA treatment, age at diagnosis, hypogonadism, hypothyroidism or GH deficiency. In PAI, patients with concomitant non-endocrine disease were at higher risk of crisis (odds ratio (OR)=2.02, 95% confidence interval (CI) 1.05-3.89, P=0.036). In SAI, female sex (OR=2.18, 95% CI 1.06-4.5, P=0.035) and diabetes insipidus (OR=2.71, 95% CI 1.22-5.99, P=0.014) were associated with higher crisis incidence. AC occurs in a substantial proportion of patients with chronic AI, mainly triggered by infectious disease. Only a limited number of risk factors suitable for targeting prevention of AC were identified. These findings indicate the need for new concepts of crisis prevention in patients with AI.
              Article 0 comments Cited 121 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Eur J Endocrinol
                Journal ID (iso-abbrev): Eur. J. Endocrinol
                Journal ID (publisher-id): EJE
                Title: European Journal of Endocrinology
                Publisher: Bioscientifica Ltd (Bristol )
                ISSN (Print): 0804-4643
                ISSN (Electronic): 1479-683X
                Publication date (Print): September 2014
                Publication date (Electronic preprint): 16 June 2014
                Volume: 171
                Issue: 3
                Pages: 369-377
                Affiliations
                [1]Department of Endocrinology, Sahlgrenska Academy, University of Gothenburg , Sahlgrenska University Hospital, Gröna Stråket 8SE-413 45, Gothenburg, Sweden
                [1 ]Medical Affairs, ViroPharma SPRL , Maidenhead, UK
                [2 ]Biostatistics ViroPharma Incorporated, Skånes University Hospital , SE-205 02, Malmö, Sweden
                [3 ]Department of Endocrinology, Skånes University Hospital , SE-205 02, Malmö, Sweden
                [4 ]Department of Public Health and Clinical Medicine, Umeå University , SE-90187, Umeå, Sweden
                [5 ]Section of Endocrinology, Department of Medical and Health Sciences, Faculty of Health Sciences, Linköping University , SE-581 83, Linköping, Sweden
                [6 ]Department of Endocrinology, Diabetes, and Metabolism, University Hospital, Uppsala University , SE-751 85, Uppsala, Sweden
                [7 ]Department of Pharmacy, Uppsala University , SE-751 85, Uppsala, Sweden
                [8 ]Department of Clinical Pharmacology, Sahlgrenska Academy, University of Gothenburg , SE-413 45, Gothenburg, Sweden
                [9 ]AstraZeneca R&D , Mölndal, Sweden
                Author notes
                Correspondence should be addressed to G Johannsson Email: gudmundur.johannsson@ 123456gu.se
                Article
                Publisher ID: EJE140327
                DOI: 10.1530/EJE-14-0327
                PMC ID: 4106399
                PubMed ID: 24944332
                SO-VID: 01940c28-db1b-44a6-b38e-e725fec7b03c
                Copyright © © 2014 The authors
                License:

                This work is licensed under a Creative Commons Attribution 3.0 Unported License

                History
                Date received : 22 April 2014
                Date accepted : 18 June 2014
                Categories
                Subject: Clinical Study

                ScienceOpen disciplines: Endocrinology & Diabetes
                Data availability:
                ScienceOpen disciplines: Endocrinology & Diabetes

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