Lora-Escobar Santiago José, Rodríguez-de Francisco Lupe, López-Feijoo Manuel, Santos-Ramos Bernardo, Bellido Virginia, Casado-Mejía Rosa, Acosta-García Héctor
Pharmacy Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
Endocrinology and Nutrition Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
J Diabetes Res. 2025 Apr 22;2025:3733178. doi: 10.1155/jdr/3733178. eCollection 2025.
The study is aimed at assessing gender bias in Phase III clinical trials (CTs) of sodium-glucose cotransporter type 2 (iSGLT2) inhibitors in adults with Type 2 diabetes mellitus (T2DM). We searched PubMed and EMBASE databases until June 2023. To estimate sex bias in recruitment, the difference between F-Particip (fraction of women recruited) and F-Prev (prevalence fraction of women with T2DM) was calculated. A significant sex bias in recruitment was considered to exist when the difference between F-Particip and F-Prev was greater than 0.05, 0.1, and 0.2. The analysis was considered to have a sex bias when the efficacy variables were not analyzed by sex. Gender of the first, last, and corresponding author was also assessed. In total, 70 articles met all inclusion criteria. Sex bias in recruitment showed variable results depending on the reference value. No significant sex bias in recruitment was found in the total number of included patients. Examining each CT individually, using values of significant sex bias in recruitment of ±0.05, ±0.1, or ±0.2, we found that 41.4%, 20%, and 5.7% of the trials, respectively, showed this bias. In 34.3% of the articles, women were the first, last, or corresponding authors. Sex-based analysis of the results was performed in five studies. Although the proportion of women included in iSGLT2 CTs seems acceptable, gender bias persists in the analysis of variables and in the study authors. However, the lack of gender focus may be explained by the characteristics of the patients included in the CTs.
本研究旨在评估钠-葡萄糖协同转运蛋白2（iSGLT2）抑制剂在2型糖尿病（T2DM）成年患者的III期临床试验（CT）中的性别偏见。我们检索了截至2023年6月的PubMed和EMBASE数据库。为了估计招募中的性别偏见，计算了女性招募比例（F-Particip）与T2DM女性患病率（F-Prev）之间的差异。当F-Particip与F-Prev之间的差异大于0.05、0.1和0.2时，则认为存在显著的招募性别偏见。当疗效变量未按性别进行分析时，该分析被认为存在性别偏见。还评估了第一作者、最后作者和通讯作者的性别。总共有70篇文章符合所有纳入标准。招募中的性别偏见结果因参考值而异。在纳入患者总数中未发现显著的招募性别偏见。单独检查每个CT，使用招募中显著性别偏见值±0.05、±0.1或±0.2，我们发现分别有41.4%、20%和5.7%的试验存在这种偏见。在34.3%的文章中，女性是第一作者、最后作者或通讯作者。五项研究对结果进行了基于性别的分析。虽然iSGLT2 CT中纳入的女性比例似乎可以接受，但在变量分析和研究作者方面性别偏见仍然存在。然而，缺乏性别关注可能由CT中纳入患者的特征来解释。
