Introduction. Randomized clinical trials have not shown an additional clinical benefit of sitagliptin treatment over conventional treatment alone. However, studies of sitagliptin treatment have not examined the relationship between anemia and treatment group outcomes. Methods. The PROLOGUE study is a prospective clinical trial of 442 participants with type 2 diabetes mellitus (T2DM) randomized to sitagliptin treatment or conventional treatment which showed no treatment differences [Estimated mean (± standard error) common carotid intima-media thickness (CIMT) was and , respectively, with a mean difference of -0.009 mm (97.2% CI −0.028 to 0.011, ) at 24 mo of follow-up]. This is a post hoc subanalysis using data obtained from the PROLOGUE study; the study population was divided into anemic groups () and nonanemic group () based on hemoglobin level. And we analyzed for the changes in each CIMT parameter from baseline to 24 months in subgroups. Results. The treatment group difference in baseline-adjusted mean common carotid artery- (CCA-) IMT at 24 months was −0.003 mm (95% CI −0.022 to 0.015, ) in the nonanemic subgroup and −0.007 mm (95% CI −0.043 to 0.030, ) in the anemic subgroup. Although there were no significant differences in the other CIMT parameters between the treatment groups in the anemic subgroup, the changes in mean and max ICA-IMT at 24 months in the nonanemic subgroup were significantly lower in the sitagliptin group than the conventional group [−0.104 mm (95% CI −0.182 to −0.026), and −0.142 mm (−0.252 to −0.033), , respectively]. Conclusion. These data suggest that nonanemia may indicate a potentially large subgroup of those with T2DM patients that sitagliptin therapy has a better antiatherosclerotic effect than conventional therapy. Further research is needed to confirm these preliminary observations.

中文翻译：

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西格列汀对 2 型糖尿病患者和贫血患者颈动脉内膜中层厚度的影响：PROLOGUE 研究的亚组分析。

简介。随机临床试验未显示西格列汀治疗比单独的常规治疗有额外的临床益处。然而，西格列汀治疗的研究并未检验贫血与治疗组结局之间的关系。方法。PROLOGUE 研究是一项前瞻性临床试验，共有 442 名 2 型糖尿病 (T2DM) 参与者随机接受西格列汀治疗或常规治疗，未显示治疗差异 [估计平均 (± 标准误差) 颈总动脉内膜中层厚度 (CIMT) 为和,平均差为 -0.009 mm (97.2% CI -0.028 to 0.011,)在 24 个月的随访]。这是使用从 PROLOGUE 研究中获得的数据进行的事后子分析；研究人群分为贫血组（)和非贫血组 ()基于血红蛋白水平。我们分析了亚组中每个 CIMT 参数从基线到 24 个月的变化。结果。治疗组在 24 个月时基线校正的平均颈总动脉 (CCA-) IMT 差异为 -0.003 mm（95% CI -0.022 至 0.015，)在非贫血亚组和 -0.007 mm (95% CI -0.043 to 0.030,)在贫血亚组中。尽管贫血亚组治疗组之间的其他 CIMT 参数没有显着差异，但非贫血亚组在 24 个月时平均和最大 ICA-IMT 的变化在西格列汀组显着低于常规组 [-0.104毫米（95% CI -0.182 至 -0.026），和 -0.142 毫米（-0.252 至 -0.033），，分别]。结论。这些数据表明，非贫血可能表明西格列汀治疗比传统治疗具有更好的抗动脉粥样硬化作用的 2 型糖尿病患者可能有很大的亚组。需要进一步的研究来证实这些初步观察。