Department of Epidemiology, University of North Carolina, Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
Inflamm Bowel Dis. 2011 Mar;17(3):787-94. doi: 10.1002/ibd.21348.
Recent animal studies and clinical trials suggest that thiazolidinediones, a class of oral antidiabetic agents, are efficacious in reducing inflammation, yet no studies have evaluated their effectiveness in preventing flares. We examined the association between thiazolidinedione use and ulcerative colitis (UC)-related flares.
We conducted a retrospective cohort study using administrative data from 87 health plans across 33 states. Individuals with both UC and diabetes were identified using administrative definitions. Exposure to thiazolidinediones or other oral antidiabetic agents was ascertained through outpatient pharmacy claims. The primary outcome was occurrence of a UC flare defined by: 1) a new prescription for oral steroids, infliximab, or oral/rectal salicylates, or 2) a claim for colectomy. Secondary analyses analyzed outcomes separately. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Cox proportional hazards regression after matching each thiazolidinedione user to a comparable oral antidiabetic user on propensity score.
This study included 142 thiazolidinedione and 468 other oral antidiabetic users with a mean follow-up of 7.3 and 6.2 months, respectively. Thiazolidinedione use was not associated with UC-related flares as measured by the composite outcome (HR = 1.05, 95% CI: 0.66, 1.68). However, thiazolidinedione use was associated with a nonsignificant reduction in risk of oral steroid use when analyzed as a separate outcome (HR = 0.53, 95% CI: 0.20, 1.44).
Thiazolidinediones do not provide any benefit over other oral antidiabetics in preventing UC-related flares as measured by our primary composite outcome. However, thiazolidinedione use may reduce the risk of more significant disease flares requiring oral steroid treatment.
最近的动物研究和临床试验表明,噻唑烷二酮类,一类口服抗糖尿病药物,在减轻炎症方面是有效的,但没有研究评估它们在预防发作方面的有效性。我们研究了噻唑烷二酮类药物的使用与溃疡性结肠炎(UC)相关发作之间的关联。
我们使用来自 33 个州的 87 个健康计划的行政数据进行了回顾性队列研究。使用行政定义确定同时患有 UC 和糖尿病的个体。通过门诊药房理赔确定噻唑烷二酮类或其他口服抗糖尿病药物的暴露情况。主要结局是通过以下方式发生 UC 发作:1)新处方口服类固醇、英夫利昔单抗或口服/直肠柳氮磺胺吡啶,或 2)结肠切除术理赔。二次分析分别分析了结果。我们使用 Cox 比例风险回归估计了风险比(HR)和 95%置信区间(CI),在匹配每个噻唑烷二酮类使用者和可比的口服抗糖尿病使用者的倾向评分后。
这项研究包括 142 名噻唑烷二酮类使用者和 468 名其他口服抗糖尿病使用者,平均随访时间分别为 7.3 个月和 6.2 个月。噻唑烷二酮类药物的使用与复合结局的 UC 相关发作无关(HR = 1.05,95%CI:0.66,1.68)。然而,当作为单独的结局进行分析时,噻唑烷二酮类药物的使用与口服类固醇使用风险的降低无关(HR = 0.53,95%CI:0.20,1.44)。
在我们的主要复合结局中,噻唑烷二酮类药物在预防 UC 相关发作方面并没有比其他口服抗糖尿病药物提供任何益处。然而,噻唑烷二酮类药物的使用可能会降低需要口服类固醇治疗的更严重疾病发作的风险。