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Long-term safety of...
Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency : a phase 3b, open-label, extension study
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- Nilsson, Anna G. (author)
- Department of Endocrinology, Sahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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- Bergthorsdottir, Ragnhildur (author)
- Department of Endocrinology, Sahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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- Burman, Pia (author)
- Department of Endocrinology, Skåne University Hospital Malmö, University of Lund, Lund, Sweden
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- Dahlqvist, Per (author)
- Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden
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- Ekman, Bertil (author)
- Departments of Endocrinology and Medical and Health Sciences, Linköping University, Linköping, Sweden
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- Engström, Britt Edén (author)
- Department of Medical Sciences, Endocrinology and Metabolism, University Hospital, Uppsala, Sweden
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- Ragnarsson, Oskar (author)
- Department of Endocrinology, Sahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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- Skrtic, Stanko (author)
- Department of Endocrinology, Sahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; AstraZeneca R&D, Mölndal, Sweden
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- Wahlberg, Jeanette, 1969- (author)
- Departments of Endocrinology and Medical and Health Sciences, Linköping University, Linköping, Sweden
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- Achenbach, Heinrich (author)
- Shire International GmbHZug, Switzerland
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- Uddin, Sharif (author)
- ShireLexington, Massachusetts, USA
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- Marelli, Claudio (author)
- Shire International GmbHZug, Switzerland
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- Johannsson, Gudmundur (author)
- Department of Endocrinology, Sahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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(creator_code:org_t)
- Bioscientifica, 2017
- 2017
- English.
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In: European Journal of Endocrinology. - : Bioscientifica. - 0804-4643 .- 1479-683X. ; 176:6, s. 715-725
- Related links:
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https://doi.org/10.1...
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https://eje.bioscien...
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Abstract
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- Objective: To investigate the long-term safety and tolerability of a once-daily, dual-release hydrocortisone (DR-HC) tablet as oral glucocorticoid replacement therapy in patients with primary adrenal insufficiency (AI).Design: Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden.Methods: Seventy-one adult patients diagnosed with primary AI who were receiving stable glucocorticoid replacement therapy were recruited. Safety and tolerability outcomes included adverse events (AEs), intercurrent illness episodes, laboratory parameters and vital signs. Quality of life (QoL) was evaluated using generic questionnaires.Results: Total DR-HC exposure was 328 patient-treatment years. Seventy patients reported 1060 AEs (323 per 100 patient-years); 85% were considered unrelated to DR-HC by the investigator. The most common AEs were nasopharyngitis (70%), fatigue (52%) and gastroenteritis (48%). Of 65 serious AEs reported by 32 patients (20 per 100 patient-years), four were considered to be possibly related to DR-HC: acute AI (n = 2), gastritis (n = 1) and syncope (n = 1). Two deaths were reported (fall from height and subarachnoid hemorrhage), both considered to be unrelated to DR-HC. From baseline to 5 years, intercurrent illness episodes remained relatively stable (mean 2.6-5.4 episodes per patient per year), fasting plasma glucose (0.7 mmol/L; P < 0.0001) and HDL cholesterol (0.2 mmol/L; P < 0.0001) increased and patient-/investigator-assessed tolerability improved. QoL total scores were unchanged but worsening physical functioning was recorded (P = 0.008).Conclusions: In the first prospective study evaluating the long-term safety of glucocorticoid replacement therapy in patients with primary AI, DR-HC was well tolerated with no safety concerns observed during 5-year treatment.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
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Nilsson, Anna G.
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Bergthorsdottir, ...
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Burman, Pia
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Dahlqvist, Per
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Ekman, Bertil
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Engström, Britt ...
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Ragnarsson, Oska ...
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Skrtic, Stanko
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Wahlberg, Jeanet ...
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Achenbach, Heinr ...
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Uddin, Sharif
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Marelli, Claudio
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Johannsson, Gudm ...
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Örebro University