Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Department of Pharmacy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Br J Clin Pharmacol. 2018 Feb;84(2):379-391. doi: 10.1111/bcp.13461. Epub 2017 Nov 28.
We compared the effects of two types of basal insulin: long-acting insulin analogues vs. intermediate/long-acting human insulin, on diabetes-related complications in type 1 diabetes.
A total of 1188 patients with type 1 diabetes who had recently started on long-acting insulin analogues or intermediate/long-acting human insulin were identified in 2004-2008 and followed until death or the end of 2013. Clinical outcomes included acute (i.e. hyperglycaemia, hypoglycaemia) and chronic (i.e. nephropathy, retinopathy, neuropathy, cardiovascular diseases) complications. Diabetes-related complications were measured as a composite outcome which included acute and chronic complications. Cox proportional hazards models were used to assess the time to event hazard ratio. Three propensity score (PS) methods were applied to adjust for baseline imbalances between basal insulin groups, including the PS-matching approach (as the main analysis), standardized mortality ratio weighting (SMRW) and inverse probability of treatment weighting (IPTW).
Long-acting insulin analogues vs. intermediate/long-acting human insulin had a lower risk for a composite of diabetes-related complications {adjusted hazards ratios [aHRs] [95% confidence interval (CI)] 0.782 [0.639, 0.956], 0.743 [0.598, 0.924] and 0.699 [0.577, 0.846] according to the PS-matching approach, SMRW and IPTW, respectively}. Compared with intermediate/long-acting human insulin, using long-acting insulin analogues had a lower hypoglycaemia risk: aHRs (95% CI) 0.681 (0.498, 0.930), 0.662 (0.466, 0.943) and 0.639 (0.471, 0.867) from the PS-matching approach, SMRW and IPTW, respectively. No statistical differences were found between two types of insulin on individual chronic complications.
A trend of lower diabetes-related complications associated with long-acting insulin analogues vs. intermediate/long-acting human insulin was observed. A reduced hypoglycaemia risk with long-acting insulin analogues was confirmed in this 'real-world' study.
我们比较了两种基础胰岛素：长效胰岛素类似物与中效/长效人胰岛素，对 1 型糖尿病患者糖尿病相关并发症的影响。
2004-2008 年共纳入 1188 例近期开始使用长效胰岛素类似物或中效/长效人胰岛素的 1 型糖尿病患者，并随访至死亡或 2013 年底。临床结局包括急性（即高血糖、低血糖）和慢性（即肾病、视网膜病变、神经病变、心血管疾病）并发症。糖尿病相关并发症作为包括急性和慢性并发症在内的复合结局进行测量。采用 Cox 比例风险模型评估事件时间风险比。应用 3 种倾向评分（PS）方法调整基础胰岛素组间的基线不平衡，包括 PS 匹配法（主要分析）、标准化死亡率比加权法（SMRW）和逆概率治疗加权法（IPTW）。
与中效/长效人胰岛素相比，长效胰岛素类似物发生糖尿病相关并发症复合结局的风险较低[校正后风险比（aHR）[95%置信区间（CI）]分别为 0.782[0.639，0.956]、0.743[0.598，0.924]和 0.699[0.577，0.846]，根据 PS 匹配法、SMRW 和 IPTW]。与中效/长效人胰岛素相比，使用长效胰岛素类似物发生低血糖的风险较低：PS 匹配法、SMRW 和 IPTW 得出的 aHR（95%CI）分别为 0.681（0.498，0.930）、0.662（0.466，0.943）和 0.639（0.471，0.867）。两种胰岛素在各慢性并发症方面未见统计学差异。
长效胰岛素类似物与中效/长效人胰岛素相比，与糖尿病相关并发症相关的趋势较低。本“真实世界”研究证实，长效胰岛素类似物可降低低血糖风险。
