> Details

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

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

Reference
management

Bookmarks

Remove from
bookmarks

Share this on Whatsapp

Close

Bookmarks



You can manage bookmarks using lists, please log in to your user account for this.
  • Media type: E-Article
  • Title: Feasibility of conducting a randomized, placebo-controlled study assessing whether omega-3 fatty acids prevent gout flares when starting urate-lowering treatment
  • Contributor: Abhishek, Abhishek; Fuller, Amy; Nakafero, Georgina; Zhang, Weiya; Dumbleton, Jennifer; Hawkey, Christopher; Coupland, Carol; Terkeltaub, Robert; Doherty, Michael
  • Published: Oxford University Press (OUP), 2022
  • Published in: Rheumatology Advances in Practice, 6 (2022) 3
  • Language: English
  • DOI: 10.1093/rap/rkac086
  • ISSN: 2514-1775
  • Keywords: Rheumatology
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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 &amp;lt; 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The study demonstrated feasibility and provided useful metrics for conducting a community-based gout flare prophylaxis trial.</jats:p></jats:sec><jats:sec><jats:title>Study registration</jats:title><jats:p>ISRCTN; https://www.isrctn.com/; ISRCTN79392964.</jats:p></jats:sec>
  • Access State: Open Access