Kolaczynski Wlodzimierz M, Hankins Matthew, Ong Siew H, Richter Hartmut, Clemens Andreas, Toussi Massoud
Novartis Pharma AG, Basel, Switzerland.
IMS Health, London, UK.
Diabetes Ther. 2016 Sep;7(3):483-96. doi: 10.1007/s13300-016-0177-8. Epub 2016 Jun 4.
Preliminary data suggest that dipeptidyl peptidase-4 (DPP-4) inhibitors may reduce microvascular events, but there is a little evidence to support this from adequate real-world studies. This study aimed to compare microvascular outcomes between patients-prescribed vildagliptin and those prescribed sulfonylurea (SU).
This retrospective cohort study was conducted on a large sample from the German electronic medical records database IMS Lifelink Disease Analyzer. We used propensity score-matched samples of patients prescribed either vildagliptin or SU. Exposure was defined as therapy (SU or vildagliptin); primary outcomes were a diagnosis of retinopathy, nephropathy, neuropathy, or diabetic foot ulcer over the observation period in patients with no previous record of these outcomes. Secondary outcome was a composite of any primary outcome occurring in the observation period.
In total, 16,321 patients prescribed SU and 4481 prescribed vildagliptin met the inclusion criteria. After propensity score matching, each sample comprised 3015 patients. Mean age was 63.7/64.6 years for SU/vildagliptin, respectively, with mean disease duration of 3.2/3.1 years, and mean treatment duration of 2.5/2.3 years. Treatment with vildagliptin was associated with a significant lower incidence of retinopathy [odds ratio (OR) = 0.55, P = 0.0004], neuropathy (OR 0.71, P = 0.0001), and composite outcome (OR 0.70, P < 0.0001). Incidences of nephropathy and diabetic foot ulcer were lower for vildagliptin, but not significantly so (OR 0.90, P = 0.3920; OR 0.76, P = 0.0742, respectively). There were no significant differences in incident rate ratios (all P > 0.05).
Treatment with vildagliptin was associated with a reduced incidence of microvascular complications, especially neuropathy and retinopathy, compared to treatment with SU in this clinical practice setting.
Novartis Pharma AG.
初步数据表明，二肽基肽酶 -4（DPP -4）抑制剂可能会减少微血管事件，但来自充分的真实世界研究的支持证据较少。本研究旨在比较接受维格列汀治疗的患者与接受磺脲类药物（SU）治疗的患者的微血管结局。
这项回顾性队列研究是基于德国电子病历数据库IMS Lifelink疾病分析仪中的大样本进行的。我们使用倾向得分匹配的方法，选取接受维格列汀或SU治疗的患者样本。暴露因素定义为治疗方式（SU或维格列汀）；主要结局是在观察期内，既往无这些结局记录的患者被诊断为视网膜病变、肾病、神经病变或糖尿病足溃疡。次要结局是观察期内出现的任何主要结局的综合情况。
共有16321例接受SU治疗的患者和4481例接受维格列汀治疗的患者符合纳入标准。经过倾向得分匹配后，每个样本包含3015例患者。SU/维格列汀组的平均年龄分别为63.7/64.6岁，平均病程为3.2/3.1年，平均治疗时长为2.5/2.3年。维格列汀治疗与视网膜病变（优势比[OR]=0.55，P = 0.0004）、神经病变（OR 0.71，P = 0.0001）及综合结局（OR 0.70，P < 0.0001）的发生率显著降低相关。维格列汀治疗的肾病和糖尿病足溃疡发生率较低，但差异无统计学意义（分别为OR 0.90，P = 0.3920；OR 0.76，P = 0.0742）。发生率比值无显著差异（所有P > 0.05）。
在本临床实践环境中，与SU治疗相比，维格列汀治疗与微血管并发症发生率降低相关，尤其是神经病变和视网膜病变。
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