Dataset Information

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

ABSTRACT: 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?

SUBMITTER: Nilsson AG

PROVIDER: S-EPMC5425941 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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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.

Nilsson Anna G AG Bergthorsdottir Ragnhildur R Burman Pia P Dahlqvist Per P Ekman Bertil B Engström Britt Edén BE Ragnarsson Oskar O Skrtic Stanko S Wahlberg Jeanette J Achenbach Heinrich H Uddin Sharif S Marelli Claudio C Johannsson Gudmundur G

European journal of endocrinology 20170314 6

<h4>Objective</h4>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).<h4>Design</h4>Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden.<h4>Methods</h4>Seventy-one adult patients diagnosed with primary AI who were receiving stable glucocorticoid replacement therapy were recruit ...[more]

PMID: 28292927

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Dataset Information

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

Publications

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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