None listed
Conditions
Brief summary
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.
Interventions
Comparison of two different tapering regimens for withdrawal of glucocorticoids in patients where the clinician is aiming to cease the medication.
12 week Intervention:
Hydrocortisone 20 mg once daily for 4 weeks, followed by 10 mg once daily for 8 weeks
Oral tablet
Adherence monitored with tablet count at week 4 and week 12 visits
Sponsors
A/Prof W Inder - Investigator initiated
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or over • Able to give written informed consent • Medical condition which has required supraphysiological glucocorticoid therapy: o Prednisolone dose (or equivalent) greater than or equal to 5 mg daily for 6 or more weeks o Dexamethasone greater than or equal to 0.5 mg daily for 6 or more weeks • Pre-dose morning cortisol <200 nmol/L • Managing clinician has clinical intent to cease glucocorticoids completely
Exclusion criteria
• Condition requiring lifelong chronic glucocorticoid use • Known pathological pituitary or adrenal dysfunction • Active malignancy • Pregnancy
Outcome results
None listed