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Comparative Effectiveness Study of Febuxostat versus Allopurinol in Gout

(Seng Chan You) #1

Dear all,

The new network study is launched to evaluate the efficacy and safety febuxostat in gout compared to allopurinol.

Comparative Effectiveness Study of Febuxostat versus Allopurinol in Gout

Objective: The goal of this protocols is conducting comparative effectiveness research to establish evidences for benefits and harms of febuxostat and allopurinol. The primary endpoint is the risk of sudden cardiac death. The secondary endpoints include acute myocardial infarction, stroke, heart failure, gout flare and drug hypersensitivity (TEN, SJS, and DRESS)

Rationale: Febuxostat is widely used urate-lowering agent because it is more effective than allopurinol to lower serum urate in patients with gout. Furthermore, febuxostat can be used without dosage adjustment in chronic kidney disease. The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) group was a prospective multicenter, double-blind randomized clinical trial, which assessed the cardiovascular risk of febuxostat compared with allopurinol in patients with gout and a history of CVD. This study concluded that febuxostat was associated with significantly higher overall and cardiovascular mortality compared to allopurinol, mostly driven by sudden cardiac death. Still, there is scarce evidence for risk of sudden cardiac death between febuxostat and allopurinol in real-world practice.

The whole protocol is released at github

We are searching for collaborators to join this network study. Please let me know if you’re interested in joining this study! And please provide any comments or suggestions.


I’d add another RCT of Febuxostat vs. Allopurinol on cardiovascular outcomes: Febuxostat vs Allopurinol Streamlined Trial (FAST). It’s a UK trial, completed last year, not published yet.

(Seng Chan You) #3

I thought it’s ongoing. Thank you for the helpful comment! @BridgetWang .

(Seng Chan You) #4

I moved the primary repo for the study from OHDSI studyprotocolsandbox to my git repo

Please use the link above for this study.