Trial reportEuropean journal of endocrinology2017
Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study.
Trial report in European journal of endocrinology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Dual-release hydrocortisone for treatment of adrenal insufficiency: a systematic review.Endocrine · 2020Pooled it
- Cognitive Assessment in Adults With Adrenal Cortisol Insufficiency: Challenges and Opportunities.Endocrine reviews · 2026Review
- Impact of dual-release hydrocortisone on disease control and metabolism in congenital adrenal hyperplasia: a retrospective cohort study.Endocrine · 2025Article
- Extended-release Hydrocortisone Formulations-Is There a Clinically Meaningful Benefit?The Journal of clinical endocrinology and metabolism · 2025Review
- A Contemporary Approach to the Diagnosis and Management of Adrenal Insufficiency.Endocrinology and metabolism (Seoul, Korea) · 2024Review
- Adrenal crisis in infants and young children with adrenal insufficiency: Management and prevention.Frontiers in endocrinology · 2023Article
- Adrenal insufficiency.Nature reviews. Disease primers · 2021Review
- The use of prednisolone versus dual-release hydrocortisone in the treatment of hypoadrenalism.Endocrine connections · 2021Review
- The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments.Endocrine · 2021Article
- Hepatocyte ATF3 protects against atherosclerosis by regulating HDL and bile acid metabolism.Nature metabolism · 2021Article
- Article
- Case 1-2020: An 11-Year-Old Boy with Vomiting and Weight Loss.The New England journal of medicine · 2020Article
- Dual-release hydrocortisone vs conventional glucocorticoids in adrenal insufficiency.Endocrine connections · 2019Article
- Novel insights into glucocorticoid replacement therapy for pediatric and adult adrenal insufficiency.Therapeutic advances in endocrinology and metabolism · 2019Review
- Improved salivary cortisol rhythm with dual-release hydrocortisoneEndocrine connections · 2018Article
- Latest Insights on the Etiology and Management of Primary Adrenal Insufficiency in Children.Journal of clinical research in pediatric endocrinology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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).
designProspective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden.
methodsSeventy-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.
resultsTotal 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 (
conclusionsIn 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.