Are participants in gout medication registration clinical trials representative of people with gout in the general population?
Authors' conclusion
FDA approved gout medication trials since 2009 have not enrolled a study population that is representative of the US general population with gout, particularly regarding age, ethnicity, and cardiometabolic comorbidities.
Study context
- Population
- Participants in phase 3 clinical trials of Food and Drug Administration (FDA) approved gout medications, 2009–202312 phase 3 trials
- Comparison
- Phase 3 trial participants of FDA-approved gout medications vs US general population with gout (National Health and Nutrition Examination Survey (NHANES))
- Outcome
- Representativeness of trial participants vs US general population with gout: demographics (sex, age, ethnicity) and comorbidities (hypertension, MI, HF, nephrolithiasis, CKD, BMI ≥30 kg/m², diabetes)
Methodological detailsrandom effects model, comparison with NHANES 2007-2008 and 2015-2016
- Random effects model
- Comparison with NHANES 2007-2008 and 2015-2016
Pooled result
As reported in the abstract
Representation vs NHANES gout population
- Clinical trials over-represented men, younger individuals, and White ethnicity participants
- Under-representation of participants with hypertension, prior MI, nephrolithiasis, and diabetes
- Participants with BMI ≥30 kg/m² over-represented
Original publication
Are participants in gout medication registration clinical trials representative of people with gout in the general population? Semin Arthritis Rheum. Published 29 January 2025. doi:10.
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