An oral multiparticulate, modified-release, hydrocortisone replacement therapy that provides physiological cortisol exposure

Clinical Endocrinology

Volumn 80, Issue 4, 2014, Pages 554-561

  Whitaker, Martin J ^a   Debono, Miguel ^b   Huatan, Hiep ^a   Merke, Deborah P ^c   Arlt, Wiebke ^d   Ross, Richard J ^b  

^a Diurnal Limited   (United Kingdom)

^b UNIVERSITY OF SHEFFIELD   (United Kingdom)

^c EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^d UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CHRONOCORT; DEXAMETHASONE; DIURF 003; DIURF 006; DIURF OOO; HYDROCORTISONE; UNCLASSIFIED DRUG; DELAYED RELEASE FORMULATION;

ADULT; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DELAYED RELEASE FORMULATION; DISSOLUTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; EXPERIMENTAL DOG; HUMAN; HUMAN EXPERIMENT; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE RELEASE; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; NONHUMAN; NORMAL HUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SUBSTITUTION THERAPY; SUSTAINED DRUG RELEASE; TIME TO MAXIMUM PLASMA CONCENTRATION; YOUNG ADULT; ADOLESCENT; ADRENAL INSUFFICIENCY; ANIMAL; BIOAVAILABILITY; CIRCADIAN RHYTHM; DOG; MEDICINAL CHEMISTRY; PHYSIOLOGY; SOLUBILITY;

ADOLESCENT; ADRENAL INSUFFICIENCY; ADULT; ANIMALS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CIRCADIAN RHYTHM; DELAYED-ACTION PREPARATIONS; DEXAMETHASONE; DOGS; HUMANS; HYDROCORTISONE; MALE; MIDDLE AGED; SOLUBILITY;

EID: 84895922678     PISSN: 03000664     EISSN: 13652265     Source Type: Journal    
DOI: 10.1111/cen.12316     Document Type: Article

References (25)

1. Krieger, D.T., Allen, W., Rizzo, F., et al,. (1971) Characterization of the normal temporal pattern of plasma corticosteroid levels. Journal of Clinical Endocrinology & Metabolism, 32, 266-284.
2. Plat, L., Leproult, R., L'Hermite-Baleriaux, M., et al,. (1999) Metabolic effects of short-term elevations of plasma cortisol are more pronounced in the evening than in the morning. Journal of Clinical Endocrinology and Metabolism, 84, 3082-3092.
3. Spiegel, K., Leproult, R., &, Van Cauter, E., (1999) Impact of sleep debt on metabolic and endocrine function. Lancet, 354, 1435-1439.
4. Mah, P.M., Jenkins, R.C., Rostami-Hodjegan, A., et al,. (2004) Weight-related dosing, timing and monitoring hydrocortisone replacement therapy in patients with adrenal insufficiency. Clinical Endocrinology, 61, 367-375.
5. Simon, N., Castinetti, F., Ouliac, F., et al,. (2010) Pharmacokinetic evidence for suboptimal treatment of adrenal insufficiency with currently available hydrocortisone tablets. Clinical Pharmacokinetics, 49, 455-463.
6. Moeller, H., (1985) Chronopharmacology of hydrocortisone and 9 alpha-fluorhydrocortisone in the treatment for congenital adrenal hyperplasia. European Journal of Pediatrics, 144, 370-373.
7. Bergthorsdottir, R., Leonsson-Zachrisson, M., Oden, A., et al,. (2006) Premature mortality in patients with Addison's disease: a population-based study. Journal of Clinical Endocrinology and Metabolism, 91, 4849-4853.
8. Tomlinson, J.W., Holden, N., Hills, R.K., et al,. (2001) Association between premature mortality and hypopituitarism. West Midlands Prospective Hypopituitary Study Group. Lancet, 357, 425-431.
9. Bensing, S., Brandt, L., Tabaroj, F., et al,. (2008) Increased death risk and altered cancer incidence pattern in patients with isolated or combined autoimmune primary adrenocortical insufficiency. Clinical Endocrinology, 69, 697-704.
10. Lovas, K., Loge, J.H., &, Husebye, E.S., (2002) Subjective health status in Norwegian patients with Addison's disease. [see comment]. Clinical Endocrinology, 56, 581-588.
11. Arlt, W., Willis, D.S., Wild, S.H., et al,. (2010) Health status of adults with congenital adrenal hyperplasia: a cohort study of 203 patients. The Journal of Clinical Endocrinology and Metabolism, 95, 5110-5121.
12. Finkielstain, G.P., Kim, M.S., Sinaii, N., et al,. (2012) Clinical characteristics of a cohort of 244 patients with congenital adrenal hyperplasia. The Journal of Clinical Endocrinology and Metabolism, 97, 4429-4438.
13. Merza, Z., Rostami-Hodjegan, A., Memmott, A., et al,. (2006) Circadian hydrocortisone infusions in patients with adrenal insufficiency and congenital adrenal hyperplasia. Clinical Endocrinology, 65, 45-50.
14. Bryan, S.M., Honour, J.W., &, Hindmarsh, P.C., (2009) Management of altered hydrocortisone pharmacokinetics in a boy with congenital adrenal hyperplasia using a continuous subcutaneous hydrocortisone infusion. The Journal of Clinical Endocrinology and Metabolism, 94, 3477-3480.
15. Lovas, K., &, Husebye, E.S., (2007) Continuous subcutaneous hydrocortisone infusion in Addison's disease. European Journal of Endocrinology, 157, 109-112.
16. Johannsson, G., Nilsson, A.G., Bergthorsdottir, R., et al,. (2012) Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. The Journal of Clinical Endocrinology and Metabolism, 97, 473-481.
17. Duocort (2011) Plenadren. European public assessment reports (EPAR) EMEA/H/C/2185.
18. Newell-Price, J., Whiteman, M., Rostami-Hodjegan, A., et al,. (2008) Modified-release hydrocortisone for circadian therapy: a proof-of-principle study in dexamethasone-suppressed normal volunteers. Clinical Endocrinology, 68, 130-135.
19. Debono, M., Ghobadi, C., Rostami-Hodjegan, A., et al,. (2009) Modified-release hydrocortisone to provide circadian cortisol profiles. The Journal of Clinical Endocrinology and Metabolism, 94, 1548-1554.
20. Verma, S., Vanryzin, C., Sinaii, N., et al,. (2010) A pharmacokinetic and pharmacodynamic study of delayed- and extended-release hydrocortisone (Chronocort) vs. conventional hydrocortisone (Cortef) in the treatment of congenital adrenal hyperplasia. Clinical Endocrinology, 72, 441-447.
21. Lennernas, H., Skrtic, S., &, Johannsson, G., (2008) Replacement therapy of oral hydrocortisone in adrenal insufficiency: the influence of gastrointestinal factors. Expert Opinion on Drug Metabolism & Toxicology, 4, 749-758.
22. Clark, P.M., Neylon, I., Raggatt, P.R., et al,. (1998) Defining the normal cortisol response to the short Synacthen test: implications for the investigation of hypothalamic-pituitary disorders. Clinical Endocrinology, 49, 287-292.
23. Roberts, R.F., &, Roberts, W.L., (2004) Performance characteristics of five automated serum cortisol immunoassays. Clinical Biochemistry, 37, 489-493.
24. Kushnir, M.M., Neilson, R., Roberts, W.L., et al,. (2004) Cortisol and cortisone analysis in serum and plasma by atmospheric pressure photoionization tandem mass spectrometry. Clinical Biochemistry, 37, 357-362.
25. Tunn, S., Mollmann, H., Barth, J., et al,. (1992) Simultaneous measurement of cortisol in serum and saliva after different forms of cortisol administration. Clinical Chemistry, 38, 1491-1494.