School of Public Health, University of Alberta, Edmonton, Alberta, Canada; ACHORD, 2-040 Li Ka Shing Center, University of Alberta, Edmonton, Alberta, Canada.
Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
JACC Heart Fail. 2014 Dec;2(6):573-82. doi: 10.1016/j.jchf.2014.04.005. Epub 2014 Jul 2.
The study objective was to evaluate the effects of sitagliptin in patients with type 2 diabetes (T2D) and heart failure (HF).
There is uncertainty in the literature about whether dipeptidyl peptidase (DPP)-4 inhibitors cause harm in patients with HF and T2D.
We analyzed data from a national commercially insured U.S. claims database. Patients with incident HF were identified from individuals with T2D initially treated with metformin or sulfonylurea and followed over time. Subjects subsequently using sitagliptin were compared with those not using sitagliptin in the 90 days before our primary outcome of all-cause hospital admission or death using a nested case-control analysis after adjustment for demographics and clinical and laboratory data. HF-specific hospital admission or death also was assessed.
A total of 7,620 patients with diabetes and incident HF met our inclusion criteria. Mean (SD) age was 54 years (9), and 58% (3,180) were male. Overall, 887 patients (12%) were exposed to sitagliptin therapy (521 patient years of exposure) after incident HF. Our primary composite endpoint occurred in 4,137 patients (54%). After adjustment, sitagliptin users were not at an increased risk for the primary endpoint (7.1% vs. 9.2%, adjusted odds ratio [aOR]: 0.84, 95% confidence interval [CI]: 0.69 to 1.03) or each component (hospital admission 7.5% vs. 9.2%, aOR: 0.93, 95% CI: 0.76 to 1.14; death 6.9% vs. 9.3%, aOR: 1.16, 95% CI: 0.68 to 1.97). However, sitagliptin use was associated with an increased risk of HF hospitalizations (12.5% vs. 9.0%, aOR: 1.84, 95% CI: 1.16 to 2.92).
Sitagliptin use was not associated with an increased risk of all-cause hospitalizations or death, but was associated with an increased risk of HF-related hospitalizations among patients with T2D with pre-existing HF.
本研究旨在评估二肽基肽酶-4(DPP-4)抑制剂西他列汀在 2 型糖尿病(T2D)合并心力衰竭(HF)患者中的作用。
关于 DPP-4 抑制剂是否会对 HF 和 T2D 患者造成危害,文献中仍存在不确定性。
我们分析了美国全国商业保险索赔数据库的数据。从最初接受二甲双胍或磺酰脲类药物治疗的 T2D 患者中确定发生 HF 的患者,并随时间进行随访。通过嵌套病例对照分析,比较在主要结局(全因住院或死亡)发生前 90 天内使用西他列汀的患者与未使用西他列汀的患者,同时调整了人口统计学、临床和实验室数据。还评估了 HF 特异性住院或死亡情况。
共纳入 7620 例患有糖尿病且发生 HF 的患者,符合纳入标准。平均(SD)年龄为 54 岁(9),其中 58%(3180 人)为男性。总体而言,887 例(12%)患者在发生 HF 后接受西他列汀治疗(521 人年暴露)。我们的主要复合终点在 4137 例患者(54%)中发生。调整后,西他列汀使用者发生主要终点的风险并未增加(7.1%比 9.2%,调整后比值比[aOR]:0.84,95%置信区间[CI]:0.69 至 1.03)或各组成部分(住院治疗 7.5%比 9.2%,aOR:0.93,95%CI:0.76 至 1.14;死亡 6.9%比 9.3%,aOR:1.16,95%CI:0.68 至 1.97)。然而,西他列汀的使用与 HF 住院风险增加相关(12.5%比 9.0%,aOR:1.84,95%CI:1.16 至 2.92)。
西他列汀的使用与全因住院或死亡风险的增加无关,但与 T2D 合并 HF 的患者 HF 相关住院风险的增加相关。