Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Department of Medicare Administration, Backseok Arts University, Seoul, Korea.
J Diabetes Investig. 2018 Sep;9(5):1144-1152. doi: 10.1111/jdi.12801. Epub 2018 Feb 9.
AIMS/INTRODUCTION: We investigated the failure of monotherapy in patients with type 2 diabetes mellitus in real practice settings.
The Korean National Diabetes Program was a prospective, multicenter observational cohort study of type 2 diabetes mellitus patients in Korea. Of the 3,950 patients enrolled in the study, we studied 998 who were continuously maintained on monotherapy for at least 90 days at six participating centers. To balance the baseline characteristics of patients in each group, we used propensity matching at a 1:1 ratio (metformin vs sulfonylureas) and 4:1 ratio (metformin vs meglitinides and metformin vs alpha-glucosidase inhibitors [aGIs]). The hazard ratios (HRs) of treatments (compared with metformin) were determined by Cox's proportional hazards regression modeling.
The median follow-up time was 56 months, and monotherapy failed in 45% of all patients. The annual incidences of failure were 15.6%, 21.3%, 27% and 9.6% in the metformin, sulfonylurea, meglitinide and aGI groups. Compared with metformin, sulfonylureas and meglitinides were associated with higher risks of monotherapy failure (HR 1.39, 95% confidence interval [CI] 1.08-1.80; HR 1.92, 95% CI 1.13-3.27), and aGIs with risks similar to that of metformin (HR 0.80, 95% CI 0.44-1.45). When analyzed by failure type, sulfonylureas, meglitinides and aGIs were associated with a higher risk of a switch to other agents (HR 4.43, 95% CI 2.14-9.17; HR 18.80, 95% CI 6.21-56.93; HR 4.25, 95% CI 1.49-12.13), and aGIs with a lower risk of prescription of add-on second agents (HR 0.16, 95% CI 0.04-0.64).
Metformin was associated with a lower failure risk than were sulfonylureas and meglitinides, but a comparable aGI failure rate.
目的/引言：我们在真实实践环境中研究了 2 型糖尿病患者单药治疗失败的情况。
韩国国家糖尿病计划是一项针对韩国 2 型糖尿病患者的前瞻性、多中心观察性队列研究。在纳入研究的 3950 名患者中，我们研究了在六个参与中心至少连续接受 90 天单药治疗的 998 名患者。为了平衡每组患者的基线特征，我们使用倾向评分匹配（1:1 比例[二甲双胍与磺酰脲类]和 4:1 比例[二甲双胍与格列奈类和二甲双胍与 α-葡萄糖苷酶抑制剂[aGIs]）。通过 Cox 比例风险回归模型确定治疗的风险比（与二甲双胍相比）。
中位随访时间为 56 个月，所有患者中单药治疗失败的比例为 45%。在二甲双胍、磺酰脲类、格列奈类和 aGI 组中，每年的失败发生率分别为 15.6%、21.3%、27%和 9.6%。与二甲双胍相比，磺酰脲类和格列奈类与更高的单药治疗失败风险相关（风险比 1.39，95%置信区间[CI] 1.08-1.80；风险比 1.92，95% CI 1.13-3.27），而 aGIs 的风险与二甲双胍相似（风险比 0.80，95% CI 0.44-1.45）。按失败类型分析时，磺酰脲类、格列奈类和 aGIs 与转为其他药物的风险较高相关（风险比 4.43，95% CI 2.14-9.17；风险比 18.80，95% CI 6.21-56.93；风险比 4.25，95% CI 1.49-12.13），而 aGIs 与添加二线药物的处方风险较低相关（风险比 0.16，95% CI 0.04-0.64）。
与磺酰脲类和格列奈类相比，二甲双胍与较低的失败风险相关，但 aGI 的失败率相当。
