Feasibility of conducting a randomized, placebo-controlled study assessing whether omega-3 fatty acids prevent gout flares when starting urate-lowering treatment

Abhishek, Abhishek; Fuller, Amy; Nakafero, Georgina; Zhang, Weiya; Dumbleton, Jennifer; Hawkey, Christopher; Coupland, Carol; Terkeltaub, Robert; Doherty, Michael

Abstract

Objective: The aim was to test the feasibility of a randomized controlled trial exploring whether omega-3 fatty acid supplementation limits gout flares during treat-to-target urate-lowering treatment (T2T-ULT). Methods: Adults with at least one gout flare in the past 12 months and serum urate (SU) ≥360 μmol/l were recruited from general practices (primary method) and randomly assigned 1:1 to receive omega-3 fatty acid supplementation (4 g/day) or placebo for 28 weeks. At week 5, participants began T2T-ULT. The primary outcome was drop-out rate. Secondary outcomes were recruitment rate, outcome data completeness, the number, severity and duration of gout flares between weeks 5 and 28, and study drug compliance. Results: Ninety-five per cent of randomized participants (n = 60) completed all study visits. The primary method recruitment rate was 2.2%. Fifty and 42 participants achieved SU < 360 and 300 μmol/l (6 and 5 mg/dl), respectively. The number of gout flares [median (interquartile range): active 1 (0-2) and placebo 1 (0-2)], flare duration [mean (s.d.): active 7.00 (4.52) days and placebo 7.06 (8.14) days] and time to first flare [hazard ratio (95% CI) 0.97 (0.50, 1.86)] were comparable between both arms. Study drug compliance was high and comparable in both arms [median (interquartile range) returned capsule count: active 57 (26-100) and placebo 58 (27-154)]; red blood cell omega-3 fatty acid index increased twofold in the active arm and remained unchanged in the control arm. Conclusion: The study demonstrated feasibility and provided useful metrics for conducting a community-based gout flare prophylaxis trial.

Citation

Abhishek, A., Fuller, A., Nakafero, G., Zhang, W., Dumbleton, J., Hawkey, C., …Doherty, M. (2022). Feasibility of conducting a randomized, placebo-controlled study assessing whether omega-3 fatty acids prevent gout flares when starting urate-lowering treatment. Rheumatology Advances in Practice, 6(3), Article rkac086. https://doi.org/10.1093/rap/rkac086

• Journal Article Type: Article
• Acceptance Date: Sep 28, 2022
• Online Publication Date: Oct 25, 2022
• Publication Date: Jan 1, 2022
• Deposit Date: Sep 30, 2022
• Publicly Available Date: Sep 30, 2022
• Journal: Rheumatology Advances in Practice
• Electronic ISSN: 2514-1775
• Publisher: Oxford University Press
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Issue: 3
• Article Number: rkac086
• DOI: https://doi.org/10.1093/rap/rkac086
• Keywords: Rheumatology
• Public URL: https://nottingham-repository.worktribe.com/output/11755308
• Publisher URL: https://academic.oup.com/rheumap/advance-article/doi/10.1093/rap/rkac086/6772537?searchresult=1