PHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical Centre, Amsterdam, the Netherlands.
Diabetes Obes Metab. 2018 Sep;20(9):2093-2102. doi: 10.1111/dom.13335. Epub 2018 May 29.
To compare real-world antidiabetic treatment outcomes over 12 months in obese people with type 2 diabetes mellitus (T2DM) who previously received oral antidiabetic therapy and then initiated a first injectable therapy with liraglutide or basal insulin.
This was a retrospective, propensity score-matched, longitudinal cohort study using real-world data (January 2010 to December 2015) from the Dutch PHARMO Database Network. Adult obese (body mass index [BMI] ≥35 kg/m ) patients with T2DM with ≥2 dispensing dates for liraglutide or basal insulin supported oral therapy (BOT) were selected. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline during 12 months of follow-up. The secondary endpoints were the changes in weight, BMI and cardiovascular risk factors from baseline. Clinical data were analysed using descriptive statistics and compared using mixed models for repeated measures.
Obese patients with T2DM (N = 1157) in each treatment group were matched (liraglutide cohort, n = 544; BOT cohort, n = 613). From 3 months onwards, glycaemic control improved in both cohorts but improved significantly more with liraglutide than with BOT (12 months: -12.2 mmol/mol vs -8.8 mmol/mol; P = .0053). In addition, weight and BMI were significantly lower for treatments with liraglutide vs BOT (12 months: -6.0 kg vs -1.6 kg and - 2.1 kg/m vs -0.5 kg/m , respectively; P < .0001 for both). No significant differences were seen in changes in cardiovascular risk factors.
The results of this real-world study in matched obese patients with T2DM showed that liraglutide was more effective than BOT for HbA1c control and weight/BMI reductions. Patients were more likely to maintain glycaemic control over time after initiating liraglutide than after initiating BOT.
比较肥胖 2 型糖尿病(T2DM)患者在接受口服降糖药治疗后,起始使用利拉鲁肽或基础胰岛素的首个注射治疗 12 个月的真实世界降糖治疗结局。
这是一项回顾性、倾向评分匹配、纵向队列研究,使用荷兰 PHARMO 数据库网络的真实世界数据(2010 年 1 月至 2015 年 12 月)。选择肥胖(BMI≥35kg/m2)、接受过≥2 次利拉鲁肽或基础胰岛素支持的口服降糖药(BOT)治疗的 T2DM 成年患者。主要终点是随访 12 个月时糖化血红蛋白(HbA1c)从基线的变化。次要终点是从基线开始体重、BMI 和心血管危险因素的变化。临床数据采用描述性统计进行分析,并采用重复测量混合模型进行比较。
每个治疗组的肥胖 T2DM 患者(N=1157)均进行了匹配(利拉鲁肽组,n=544;BOT 组,n=613)。从 3 个月开始,两个队列的血糖控制均得到改善,但利拉鲁肽组的改善明显优于 BOT 组(12 个月:-12.2mmol/mol 比-8.8mmol/mol;P=0.0053)。此外,与 BOT 相比,利拉鲁肽治疗的体重和 BMI 显著降低(12 个月:-6.0kg 比-1.6kg 和-2.1kg/m2 比-0.5kg/m2,均 P<0.0001)。心血管危险因素的变化无显著差异。
这项针对匹配肥胖 T2DM 患者的真实世界研究结果表明,利拉鲁肽在 HbA1c 控制和体重/BMI 降低方面优于 BOT。与起始 BOT 相比,起始利拉鲁肽后患者更有可能在更长时间内维持血糖控制。