Hypertension and Cardiovascular Risk Factors Research Center, Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, Bologna, Italy; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Nutr Metab Cardiovasc Dis. 2021 Nov 29;31(12):3305-3313. doi: 10.1016/j.numecd.2021.09.011. Epub 2021 Sep 20.
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.
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.
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.
我们调查了在测试血清尿酸（SUA）降低药物的临床试验中性别和种族不平等现象，并分析了预先指定的人口统计学群体参与的时间趋势。数据来自测试 SUA 降低药物的临床试验出版物。线性回归分析用于评估药物批准年份与纳入临床试验的女性和少数族裔比例之间的关系。
临床试验中女性的平均入组比例随着时间的推移明显下降（r=-0.43，P 值=0.02）。此外，不同 SUA 降低药物试验中女性的平均入组比例存在统计学差异，其中 rasburicase 的代表性最高（71.1%），dotinurad 的女性代表性最低（0.8%）。随着时间的推移，少数族裔的平均入组比例也有所下降，在 10 年内从 8.7%下降到 2.2%。女性在无症状高尿酸血症人群中的比例与总体相比（参与率与患病率之比（PPR）=0.34），在黄嘌呤氧化酶抑制剂（PPR=0.38）和尿酸排泄剂（PPR=0.29）的试验中以及在 febuxostat、allopurinol、pegloticase、halofenate/arhalofenate、verinurad、lesinurad 和 dotinurad 的试验中，均不成比例地代表性不足。女性在痛风人群中的比例与总体相比（PPR=0.69）以及在 XOIs（PPR=0.69）、尿酸排泄剂（PPR=0.68）的试验中以及除 rasburicase、pegloticase 和 topiroxostat 以外的所有 SUA 降低药物的试验中，均不成比例地代表性不足。
我们的分析表明，女性和少数族裔在测试 SUA 降低药物的对照临床试验中代表性不足，且在不同药物类别中存在类似模式。
