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Cardiovascular Safety of Febuxostat in Patients With Gout or Hyperuricemia: A Systematic Review of Randomized
Roba Ghossan1, Ouidade Aitisha Tabesh2, Fouad Fayad2
1From the Rheumatology Department, Cochin University Hospital, Paris, France.
Insights
Febuxostat cardiovascular safety in gout patients is reassuring, despite study quality concerns. Further research is needed for those with severe cardiovascular disease.
Area of Science:
- Cardiology
- Pharmacology
- Gout Management
Background:
- The cardiovascular safety of febuxostat, a gout medication, remains debated due to challenges in comparing heterogeneous trial outcomes.
- Previous studies have yielded conflicting results regarding a potential causal link between febuxostat and cardiovascular events.
Approach:
- Conducted a systematic review of 20 RCTs identified through a comprehensive database search.
- Assessed the quality and risk of bias of included trials, analyzing definitions of major adverse cardiovascular events and other outcomes.
Key Points:
- The analysis included 20 RCTs with a mean follow-up of 69.7 weeks; 65% of studies raised quality concerns.
- Cardiovascular outcome reporting was highly heterogeneous across trials, with only 35% defining major adverse cardiovascular events consistently.
- Overall cardiovascular safety data for febuxostat appeared reassuring.
Conclusions:
- The systematic review identified significant concerns regarding the quality of evidence and heterogeneity of cardiovascular outcomes across studies.
- Febuxostat demonstrated reassuring cardiovascular outcomes compared to allopurinol in White males with gout.
- Additional research is necessary to establish definitive conclusions for patients with severe cardiovascular disease.
Introduction:
To this date, a causal relationship between febuxostat and cardiovascular disease remains controversial as comparison between trials can be challenging and may lead to misleading conclusions, especially when facing heterogeneous cardiovascular outcomes. We aimed to compare the cardiovascular outcomes in the most pertinent trials of febuxostat compared with controls.
Methods:
We searched electronic databases using a PICOS-style approach search strategy of randomized controlled trials (RCTs) on cardiovascular outcomes of febuxostat in patients with gout or hyperuricemia. We conducted a quality and risk of bias assessment of the included clinical trials. The definition of major adverse cardiovascular event as well as all reported cardiovascular outcomes were retrieved from every involved trial.
Results:
Of the 1173 records identified from all sources, 20 RCTs were included in the analysis. The mean duration of follow-up was 69.7 ± 81.5 weeks, and febuxostat dose ranged from 10 to 240 mg with 80 mg being the most commonly used dosage. Overall, the quality of evidence deriving from all RCTs showed concerns in most studies (65%). Major adverse cardiovascular event was defined in 7 of the 20 RCTs (35%), and cardiovascular outcome reporting was very heterogeneous. Overall, the data of cardiovascular safety of febuxostat were reassuring.
Conclusions:
Our systematic review showed high level of concerns in quality assessment domains as well heterogeneous cardiovascular outcomes across included studies. Cardiovascular outcomes in the majority of White males with gout treated with febuxostat were reassuring when compared with allopurinol. Further studies are needed to draw conclusions in patients with severe cardiovascular disease.
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