Comparison of two tapering regimens in the management of glucocorticoid withdrawal - the PRED-STOP trial

Background: Glucocorticoids such as prednisolone are commonly prescribed for inflammatory and autoimmune conditions, with estimated long-term use in 1-3% of adults in the general population. Long-term glucocorticoid therapy is associated with significant adverse effects such as weight gain, osteoporosis, diabetes, hypertension and cardiovascular disease. Chronic high doses suppress the function of the pituitary-adrenal system and impair endogenous cortisol production, which may lead to adrenal insufficiency. An estimated 48-63% of patients receiving long-term glucocorticoids develop adrenal insufficiency. Recovery can occur approximately four weeks after stopping glucocorticoids, but may take up to one year or more. Few studies have described specific tapering regimens and associated outcomes and there is no standardised method to withdraw glucocorticoids. Whether continuing prednisolone in smaller doses or converting to hydrocortisone is superior in outcome is unknown. Hypothesis: That a glucocorticoid tapering regimen using the short-acting glucocorticoid hydrocortisone is superior to a standard gradual dose reduction in prednisolone.