Department of Medicine , Sahlgrenska Academy, University of Gothenburg , Göteborg , Sweden.
Centre of Registers in Region Västra Götaland , Göteborg , Sweden.
BMJ Open Diabetes Res Care. 2015 Mar 19;3(1):e000059. doi: 10.1136/bmjdrc-2014-000059. eCollection 2015.
To analyze the durability of monotherapy with different classes of oral hypoglycemic agents (OHAs) in drug naïve patients with type 2 diabetes mellitus (T2DM) in real life.
Men and women with T2DM, who were new users of OHA monotherapy and registered in the Swedish National Diabetes Register July 2005-December 2011, were available (n=17 309) and followed for up to 5.5 years. Time to monotherapy failure, defined as discontinuation of continuous use with the initial agent, switch to a new agent, or add-on treatment of a second agent, was analyzed as a measure of durability. Baseline characteristics were balanced by propensity score matching 1:5 between groups of sulfonylurea (SU) versus metformin (n=4303) and meglitinide versus metformin (n=1308). HRs with 95% CIs were calculated using Cox regression models.
SU and meglitinide, as compared with metformin, were associated with increased risk of monotherapy failure (HR 1.74; 95% CI 1.56 to 1.94 and 1.66; 1.37 to 2.00 for SU and meglitinide, respectively). When broken down by type of monotherapy failure, SU and meglitinide were associated with an increased risk of add-on treatment of a second agent (HR 3.14; 95% CI 2.66 to 3.69 and 2.52; 1.89 to 3.37 for SU and meglitinide, respectively) and of switch to a new agent (HR 2.81; 95% CI 2.01 to 3.92 and 3.78; 2.25 to 6.32 for SU and meglitinide, respectively). The risk of discontinuation did not differ significantly between the groups.
In this nationwide observational study reflecting clinical practice, SU and meglitinide showed substantially increased risk of switch to a new agent or add on of a second agent compared with metformin. These results indicate superior glycemic durability with metformin compared with SU and also meglitinide in real life.
分析在真实世界中，新诊断 2 型糖尿病（T2DM）患者使用不同类别的口服降糖药（OHA）单药治疗的持久性。
纳入 2005 年 7 月至 2011 年 12 月期间在瑞典国家糖尿病登记处登记的新开始 OHA 单药治疗且为药物初治的 T2DM 男性和女性患者（n=17309），并随访 5.5 年。以单药治疗失败为终点，定义为连续使用初始药物的治疗中断、换用新药物或加用第二种药物，以此评估药物的持久性。通过倾向评分匹配，将磺酰脲类（SU）与二甲双胍组（n=4303）和格列奈类与二甲双胍组（n=1308）进行 1:5 配对，以平衡基线特征。采用 Cox 回归模型计算 HRs 及其 95%置信区间。
与二甲双胍相比，SU 和格列奈类药物与单药治疗失败风险增加相关（SU：HR 1.74；95%CI 1.56 至 1.94；格列奈类：HR 1.66；95%CI 1.37 至 2.00）。按单药治疗失败类型进行细分，SU 和格列奈类药物与加用第二种药物（SU：HR 3.14；95%CI 2.66 至 3.69；格列奈类：HR 2.52；95%CI 1.89 至 3.37）和换用新药物（SU：HR 2.81；95%CI 2.01 至 3.92；格列奈类：HR 3.78；95%CI 2.25 至 6.32）的风险增加相关。两组停药风险无显著差异。
在这项反映临床实践的全国性观察性研究中，SU 和格列奈类药物与换用新药物或加用第二种药物的风险显著高于二甲双胍。这些结果表明，在真实世界中，与 SU 相比，二甲双胍具有更好的血糖持久性，与格列奈类药物相比也是如此。
