None listed
Conditions
Brief summary
Gout is particularly prevalent in Aotearoa/NZ, with 13.8% of Maori men, 22.5% of Pacific men, and 6.9% of NZ European men affected. Effective management requires lowering the blood urate level to a treatment target, usually with a medication called allopurinol. There are important inequities based on ethnicity in allopurinol prescribing in Aotearoa. The current best practice treatment strategy is time consuming and difficult to implement. An easier way to use allopurinol is required, especially since gout disproportionately affects middle-age men who are frequently working and are not able to take time off work or afford the costs involved with the current strategy. The aim of this Programme is to determine whether a protocol-driven allopurinol dose escalation strategy based on the dose predicted to achieve target urate is as effective as the current best practice intensive treat-to-target strategy.
Interventions
Allopurinol dose escalation to a maximum of 900mg will be based on a monthly serum urate and phone contact with the study coordinator. The dose will be increased until serum urate has been <0.36mmol/l for three, monthly consecutive visits. Starting dose of allopurinol will be 50mg daily in those with eGFR<60mls/min and 100mg daily in those with eGFR great than or equal 60mls/min. For all participants allopurinol dose will be increased monthly by 50 or 100mg per day as determined by eGFR. Adhere
Allopurinol dose escalation to a maximum of 900mg will be based on a monthly serum urate and phone contact with the study coordinator. The dose will be increased until serum urate has been <0.36mmol/l for three, monthly consecutive visits. Starting dose of allopurinol will be 50mg daily in those with eGFR<60mls/min and 100mg daily in those with eGFR great than or equal 60mls/min. For all participants allopurinol dose will be increased monthly by 50 or 100mg per day as determined by eGFR. Adherence will be assessed by pill count. Participants will continue allopurinol for the entire 36 months. Allopurinol will be in the form of an oral tablet.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years 2. Gout according to the 2015 ACR/EULAR criteria 3. Serum urate greater than or equal to 0.36mmol/l (6mg/dl) AND - not taking allopurinol, but starting urate-lowering therapy strongly recommended in the 2020 ACR gout management guidelines (i.e. any of the following: greater than or equal to 2 gout flares/year, greater than or equal to 1 subcutaneous tophi, radiographic damage due to gout) OR - already taking allopurinol for gout at lower than predicted dose OR - already taking allopurinol but not regularly 4. Agreeable to starting or continuing allopurinol 5. Ability to give informed consent 6. Ability to communicate via telephone
Exclusion criteria
1. Severe kidney disease with estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2 2. Contra-indication or previous intolerance to allopurinol 3. Concomitant azathioprine, due to interactions with allopurinol 4. HLA-B*5801 positive in high allele frequency populations (South East Asian and African), due to high risk of allopurinol hypersensitivity syndrome 5. Female of childbearing age not on contraception 5. Unstable co-morbid health conditions (e.g. NYHA stage 4 heart failure, recent myocardial infarction, advanced cancer) 6. Dementia
Outcome results
None listed