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| |  Overnight Administration of Hydrocortisone Mimics Natural Adrenal Function: Presented at ACCP By Crystal Phend WASHINGTON, D.C. -- September 16, 2005 -- Overnight administration of hydrocortisone in patients with adrenal insufficiency mimics the circadian rhythm and improves adrenocorticotropic hormone (ACTH) control, researchers reported here on September 12th at the annual meeting of the American College of Clinical Pharmacology (ACCP). Their study found that programmed hydrocortisone IV infusions were superior to conventional oral tablets for patients whose adrenal system cannot produce cortisol. "The full circadian profile of cortisol secretion, particularly the overnight maximum plasma concentration, is not considered in [traditional] regimens because of practical difficulties in administering tablets after midnight," said lead author Zayd Merza, MD, Specialist Registrar, Academic Units of Diabetes and Endocrinology and Clinical Pharmacology, University of Sheffield, United Kingdom. In the small proof of concept crossover study, 6 participants treated with conventional hydrocortisone tablets had serum cortisol, ACTH and 17-hydroxyprogesterone (17-OHP) levels measured at regular intervals for up to 24 hours. Four of the patients had adrenal insufficiency (2 Addison's disease, 2 congenital adrenal hyperplasia) and two were healthy volunteers whose cortisol function was suppressed with oral dexamethasone. These cortisol levels were compared to those obtained after the participants received programmed IV infusions of hydrocortisone. The researchers also compared ACTH and 17-OHP levels in the patients on conventional and infusion hydrocortisone. When cortisol levels were graphed by time, the area under the curve (AUC) for normal, healthy cortisol production and for the infusion treatment were similar. Although the AUC of patients with adrenal insufficiency was similar with the two treatments; infusion treatment raised morning and daytime cortisol levels to mimic the circadian rhythm of cortisol production. In the traditional treatment group, cortisol levels were very low in the morning, which makes patients feel tired in the mornings and makes it difficult to wake up, Dr. Merza said. ACTH and 17-OHP levels were also improved by infusion treatment compared to conventional therapy. Dr. Merza said that the pattern of hydrocortisone injection doses could be duplicated by a delayed onset, slow release tablet administered before bedtime and have similar benefits. One company is already developing such a pill and will start clinical studies soon, he said.
[Presentation title: Overnight Administration of Hydrocortisone (HC) to Mimic Circadian Rhythm in Plasma Cortisol Improves ACTH Control in Adrenally Insufficient Patients. Abstract 114]
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