Observational studyJournal of endocrinological investigation2025
Mineralocorticoid effects of fludrocortisone and hydrocortisone in primary adrenal insufficiency: EU-AIR patient data.
Observational study in Journal of endocrinological investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01661387 (A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
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7 authors.
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Abstract
purposePatients with primary adrenal insufficiency (PAI) require mineralocorticoid replacement therapy in addition to glucocorticoids. These therapies should be considered in combination because most glucocorticoids also possess mineralocorticoid activity. We aimed to investigate the relationship between fludrocortisone and hydrocortisone-equivalent dosing in patients with PAI.
methodsData were obtained from the European Adrenal Insufficiency Registry (EU-AIR), a multinational, multicenter, observational study conducted between August 7, 2012, and October 31, 2020, in endocrinology centers in Germany, Italy, the Netherlands, Sweden, and the UK. Patients with PAI (excluding congenital adrenal hyperplasia or known hypertension) and treated with immediate-release hydrocortisone (IRHC), modified-release hydrocortisone (MRHC), or cortisone acetate were included. The relationship between hydrocortisone-equivalent and fludrocortisone doses and mineralocorticoid potency corrected for body surface area (BSA) was examined.
resultsOverall, 670 (mean age: 46.2 years; 453 [67.6%] women) of 924 patients with PAI in EU-AIR were analyzed. Of those who received at least one dose of fludrocortisone (n = 350), 45 patients (12.9%) were receiving hydrocortisone-equivalent doses/BSA of ≤ 10 mg/day/m
conclusionsFludrocortisone prescription in PAI appears to be independent of glucocorticoid replacement therapy. IRHC and MRHC might differ in mineralocorticoid effect owing to different pharmacokinetic profiles. CLINICAL
trial registrationNCT01661387.
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