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Easing the way to achieving target serum urate in people with gout: protocol for a non-inferiority randomised strategy trial using an allopurinol dosing model in Aotearoa/New Zealand (the Easy-Allo Study). | LitMetric

AI Article Synopsis

  • Gout is a common arthritis condition affecting a significant percentage of Māori and Pacific men in New Zealand, requiring effective long-term treatment through lowering serum urate levels.
  • A clinical trial will compare two methods of allopurinol dosage adjustments to see which is more effective at achieving target urate levels in people with gout.
  • The study has received ethical approval and aims to publish results in peer-reviewed journals, enhancing care and treatment strategies for gout patients.

Article Abstract

Introduction: Gout is one of the most common forms of arthritis worldwide. Gout is particularly prevalent in Aotearoa/New Zealand and is estimated to affect 13.1% of Māori men, 22.9% of Pacific men and 7.4% of New Zealand European men. Effective long-term treatment requires lowering serum urate to <0.36 mmol/L. Allopurinol is the most commonly used urate-lowering medication worldwide. Despite its efficacy and safety, the allopurinol dose escalation treat-to-target serum urate strategy is difficult to implement and there are important inequities in allopurinol prescribing in Aotearoa. The escalation strategy is labour intensive, time consuming and costly for people with gout and the healthcare system. An easy and effective way to dose-escalate allopurinol is required, especially as gout disproportionately affects working-age Māori men and Pacific men, who frequently do not receive optimal care.

Methods And Analysis: A 12-month non-inferiority randomised controlled trial in people with gout who have a serum urate ≥ 0.36 mmol/l will be undertaken. 380 participants recruited from primary and secondary care will be randomised to one of the two allopurinol dosing strategies: intensive nurse-led treat-to-target serum urate dosing (intensive treat-to-target) or protocol-driven dose escalation based on dose predicted by an allopurinol dosing model (Easy-Allo). The primary endpoint will be the proportion of participants who achieve target serum urate (<0.36 mmol/L) at 12 months.

Ethics And Dissemination: The New Zealand Northern B Health and Disability Ethics Committee approved the study (2022 FULL 13478). Results will be disseminated in peer-reviewed journals and to participants.

Trial Registration Number: ACTRN12622001279718p.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298718PMC
http://dx.doi.org/10.1136/bmjopen-2024-084665DOI Listing

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