Inequalities in enrollment of women and racial minorities in trials testing uric acid lowering drugs

Nutr Metab Cardiovasc Dis. 2021 Nov 29;31(12):3305-3313. doi: 10.1016/j.numecd.2021.09.011. Epub 2021 Sep 20.

Abstract

Aims: We investigated sex and racial inequalities in clinical trials testing serum uric acid (SUA) lowering drugs and analyzed the temporal trends of participation among the pre-specified demographic groups. Data were collected from publications of clinical trials testing SUA-lowering drugs. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled in clinical studies.

Data synthesis: The mean percentage enrollment of women in clinical trials significantly decreased over the time (r = -0.43, P-value = 0.02). Moreover, there was a statistically significant difference in mean percentage enrollment of women among trials testing different SUA-lowering drugs, with the highest representation in rasburicase (71.1%) and the lowest representation of women in dotinurad (0.8%). Over the time, also the mean percentage enrollment of racial minorities decreased, passing from 8.7% to 2.2% in a 10-year period. Women were proportionally underrepresented compared with their share of the population with asymptomatic hyperuricemia, overall (participation-to-prevalence ratio (PPR) = 0.34), in trials testing xanthine oxiase inhibitors (PPR = 0.38) and uricosurics (PPR = 0.29), and in trials with febuxostat, allopurinol, pegloticase, halofenate/arhalofenate, verinurad, lesinurad and dotinurad. Women were proportionally underreppresented also compared with their share of the population with gout, overall (PPR = 0.69) and in trials testing XOIs (PPR = 0.69), uricosurics (PPR = 0.68), and all SUA-lowering drugs excepted for rasburicase, pegloticase and topiroxostat.

Conclusions: Our analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes.

Keywords: Clinical trials; Minorities; Sex; Uric acid lowering drugs.

MeSH terms

  • Clinical Trials as Topic*
  • Ethnic and Racial Minorities / statistics & numerical data
  • Female
  • Gout Suppressants / therapeutic use
  • Healthcare Disparities* / ethnology
  • Healthcare Disparities* / trends
  • Humans
  • Hyperuricemia* / drug therapy
  • Hyperuricemia* / ethnology
  • Sex Factors

Substances

  • Gout Suppressants