RecruitingPhase 4ACTRN12622001279718

Allopurinol prescribing for gout management in Aotearoa New Zealand

Easing the way to achieving target serum urate in people with gout: a non-inferiority strategy trial using an allopurinol dosing model. (The Easy-Allo study)

Sponsor

University of Otago

Enrollment

380 participants

Start Date

Feb 20, 2023

Study Type

Interventional

Conditions

Gout

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria9

Age over 18 years
Gout according to the 2015 ACR/EULAR criteria
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
Agreeable to starting or continuing allopurinol
Ability to give informed consent
Ability to communicate via telephone

Exclusion Criteria7

Severe kidney disease with estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2
Contra-indication or previous intolerance to allopurinol
Concomitant azathioprine, due to interactions with allopurinol
HLA-B*5801 positive in high allele frequency populations (South East Asian and African), due to high risk of allopurinol hypersensitivity syndrome
Female of childbearing age not on contraception
Unstable co-morbid health conditions (e.g. NYHA stage 4 heart failure, recent myocardial infarction, advanced cancer)
Dementia

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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. 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.