Adrenal Insufficiency
Conditions
Keywords
glucocorticoids, prednisolone, hydrocortisone
Brief summary
This study is designed to collect data on individuals with adrenal insufficiency who are changing treatments from hydrocortisone to prednisolone, or vice versa. It will compare anthropometric, biochemical and subjective health outcomes between both treatments.
Detailed description
In the UK, oral immediate release hydrocortisone divided in three doses daily has been the traditional treatment. The most common regimen in clinical practice uses doses of 10 mg on waking, 5 mg at lunch time and 5 mg in the afternoon. Once daily prednisolone is another regimen in clinical use and now prescribed at less than 5mg daily. It has a longer duration of action and a smoother pharmacokinetic profile compared to hydrocortisone. Moreover, prednisolone is much more cost-effective than hydrocortisone with 5mg tablets. Prednisolone is less commonly used due to perceived concerns regarding loss of bone mineral density leading to osteoporosis, increased insulin resistance leading to steroid induced diabetes, and rises in blood pressure and weight leading to increased cardiovascular risk. This belief is perhaps driven by the fact that most clinicians encounter prednisolone in the context of the treatment of asthma, rheumatoid arthritis etc. where far higher doses are employed. Where effects on bone health have been noted, they have been in association with higher doses of prednisolone (7.5mg) than those employed today (2-5mg). Although conventionally prednisolone 5 mg is assumed to be bioequivalent to HC 20 mg (ratio 1:4), newer studies suggest that the ratio may be nearer 1:6-8 i.e. lower doses can be used.
Interventions
OTHERThere is no specific intervention other than an individual changing their treatment as part of their usual care
There is no specific intervention other than an individual changing their treatment as part of their usual care
Sponsors
Imperial College London
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
* Aged 18 - 85 years * Male or female * Diagnosed with adrenal insufficiency (AI) for over 6 months according to standard diagnostic criteria * Established on stable hydrocortisone or prednisolone replacement, dose not altered for at least 4 months * Individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months; * Individuals who are able and willing to give written informed consent to participate in the study
Exclusion criteria
* Individuals who are unable to give informed consent * Pregnancy (determined by patients self-reporting pregnancy status) * Patients using the combined oral contraceptive pill
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P1NP | Minimum 4 months of stable treatment | measurement of bone turnover markers: P1NP, |
| NTX | Minimum 4 months of stable treatment | measurement of bone turnover markers: NTX |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist-hip circumference | Minimum 4 months of stable treatment | recording observations- waist-hip circumference ratios |
| Lipid profile (Total cholesterol, HDL, LDL and triglycerides) | Minimum 4 months of stable treatment | measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides |
| High sensitivity CRP | Minimum 4 months of stable treatment | measuring biochemical indicators of cardiovascular risk: high sensitivity CRP |
| Heart rate | Minimum 4 months of stable treatment | recording observations- heart rate |
| HbA1c | Minimum 4 months of stable treatment | assessed by measuring HBA1c |
| Frequency and severity of steroid replacement related symptoms | Minimum 4 months of stable treatment | assessed by reporting of symptoms of steroid deficiency, their frequency and severity stratified by the patient's current replacement regimen. Symptoms include nausea, lethargy, muscle pain, headaches etc.) |
| Efficacy of replacement and wellbeing | Minimum 4 months of stable treatment | assessed using subjective health questionnaire |
| Glucose | Minimum 4 months of stable treatment | assessed by measuring glucose |
| Blood pressure | Minimum 4 months of stable treatment | recording observations- blood pressure |
Countries
United Kingdom
Contacts
Primary ContactSirazum Choudhury, MBBS MRCP
Outcome results
None listed