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    Modified-release hydrocortisone for circadian therapy: a proof-of-principle study in dexamethasone-suppressed normal volunteers.

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    Authors
    Newell-Price, John
    Whiteman, M
    Rostami-Hodjegan, A
    Darzy, Ken H
    Shalet, Stephen M
    Tucker, G T
    Ross, R J M
    Affiliation
    Academic Unit of Diabetes, Endocrinology and Metabolism, The University of Sheffield, Sheffield, UK. j.newellprice@sheffield.ac.uk
    Issue Date
    2008-01
    
    Metadata
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    Abstract
    BACKGROUND: All existing long-term glucocorticoid replacement therapy is suboptimal as the normal nocturnal rise and waking morning peak of serum cortisol is not reproduced. AIM: To test whether it is possible to reproduce the normal overnight rise and morning peak in serum cortisol using an oral delayed and sustained release preparation of hydrocortisone (Cortisol(ds)). SUBJECTS AND METHODS: Six healthy normal male volunteers attended on two occasions, in a single-dose, open-label, nonrandomized study. Endogenous cortisol secretion was suppressed by administration of dexamethasone. Cortisol(ds) (formulation A or B) was administered at 2200 h on day 1. Blood samples for measurement of cortisol were taken from 2200 h every 30 min until 0700 h, then hourly until 2200 h on day 2. Fifteen body mass index (BMI)-matched control subjects had serum cortisol levels measured at 20-min intervals for 24 h. Serum cortisol profiles and pharmacokinetics after Cortisol(ds) were compared with those in controls. RESULTS: Formulations A and B were associated with delayed drug release (by 2 h and 4 h, respectively), with median peak cortisol concentrations at 4.5 h (0245 h) and 10 h (0800 h), respectively, thereby reproducing the normal early morning rise in serum cortisol. Total cortisol exposure was not different from controls. CONCLUSIONS: For the first time we have shown that it is possible to mimic the normal circadian rhythm of circulating cortisol with an oral modified-release formulation of hydrocortisone, providing the basis for development of physiological circadian replacement therapy in patients with adrenal insufficiency.
    Citation
    Modified-release hydrocortisone for circadian therapy: a proof-of-principle study in dexamethasone-suppressed normal volunteers. 2008, 68 (1):130-5 Clin. Endocrinol.
    Journal
    Clinical Endocrinology
    URI
    http://hdl.handle.net/10541/58679
    DOI
    10.1111/j.1365-2265.2007.03011.x
    PubMed ID
    17803699
    Type
    Article
    Language
    en
    ISSN
    1365-2265
    ae974a485f413a2113503eed53cd6c53
    10.1111/j.1365-2265.2007.03011.x
    Scopus Count
    Collections
    All Christie Publications
    Endocrinology

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