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Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study.

Artikel i vetenskaplig tidskrift
Författare Anna G Nilsson
Ragnhildur Bergthorsdottir
Pia Burman
Per Dahlqvist
Bertil Ekman
Britt Edén Engström
Oskar Ragnarsson
Stanko Skrtic
Jeanette Wahlberg
Heinrich Achenbach
Sharif Uddin
Claudio Marelli
Gudmundur Johannsson
Publicerad i European journal of endocrinology
Volym 176
Nummer/häfte 6
Sidor 715-725
ISSN 1479-683X
Publiceringsår 2017
Publicerad vid Institutionen för medicin
Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition
Sidor 715-725
Språk en
Länkar dx.doi.org/10.1530/EJE-17-0067
www.ncbi.nlm.nih.gov/entrez/query.f...
https://gup.ub.gu.se/file/207002
Ämnesord Addison Disease, drug therapy, Adult, Aged, Delayed-Action Preparations, Fatigue, chemically induced, Female, Gastroenteritis, chemically induced, Glucocorticoids, therapeutic use, Hormone Replacement Therapy, adverse effects, methods, Humans, Hydrocortisone, therapeutic use, Longitudinal Studies, Male, Middle Aged, Nasopharyngitis, chemically induced, Quality of Life, Sweden, Treatment Outcome
Ämneskategorier Endokrinologi och diabetes

Sammanfattning

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).Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden.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.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).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.

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