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Cortisol profile improved with once-daily vs. thrice-daily hydrocortisone dose in adrenal insufficiency
Johannsson G. J Clin Endocrinol Metab. 2011;doi:10.1210/jc.2011-1926.
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Once-daily dual-release hydrocortisone was associated with a more circadian-based serum cortisol profile compared with the thrice-daily dose tablets in patients with adrenal insufficiency.
Researchers compared the pharmacokinetics and metabolic outcome of once-daily and thrice-daily hydrocortisone tablets in an open, randomized, two-period, 12-week crossover, multicenter study conducted at five university hospitals. The trial included a 24-week extension.
Sixty-four adults with primary adrenal insufficiency were included in the study; 11 had concomitant diabetes and the mean age was 47 years.
Dual-release tablets (20 mg and 5 mg) were administered orally once daily in the morning during fasting. The reference drug was 10 mg hydrocortisone thrice daily.
The once-daily dose provided sustained serum cortisol profile zero to 4 hours after morning intake and reduced late afternoon and 24-hour cortisol exposure vs. the thrice-daily dose, the researchers wrote. Additionally, at 12 weeks, the once-daily tablets were associated with decreases in mean weight (P=.005), systolic blood pressure (P=.0001) and diastolic BP (P=.03), as well as glycated hemoglobin (P=.0006), compared with the thrice-daily dose.
Patients with concomitant diabetes experienced a 0.6% reduction in glycated hemoglobin after the once-daily dose vs. thrice daily (P=.004).
Quality-of-life questionnaires assessed fatigue effect and psychological general well-being, as well as treatment preference. According to the results, scores favored the once-daily dose for psychosocial functioning (P=.004), cognitive functioning (P=.054) and total score (P=.08) vs. the thrice-daily dose. At 12 weeks, 85% of patients assessed the preference of once-daily dosing vs. thrice-daily dosing as large or very large (P<.0001), and 59 of 64 patients chose to continue into the extension phase of the trial, the researchers said.
“The once-daily dosing achieved a high and reliable bioavailability and consistent exposure [serum] cortisol profile more resembling normal physiology, avoiding the last two peaks during thrice-daily, all of which may be of importance for improving outcome in adrenal insufficient patients,” they wrote.
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