Quinzler Renate, Ude Miriam, Franzmann Alexandra, Feldt Sandra, Schüssel Katrin, Leuner Kristina, Müller Walter E, Dippel Franz-Werner, Schulz Martin
DAPI-German Institute for Drug Use Evaluation, Eschborn, Germany.
Int J Clin Pharmacol Ther. 2012 Jan;50(1):24-32. doi: 10.5414/cp201572.
To compare the persistence (treatment duration) of basal insulin supported oral therapy (BOT) using insulin glargine (GLA) or NPH insulin (NPH) in Type-2 diabetic patients.
This retrospective cohort study reports results from an analysis of claims data from prescriptions for ambulatory patients within the German Statutory Health Insurance scheme. The study is based on claims data from more than 80% of German community pharmacies. Treatment duration until switching to a basal bolus treatment regimen (intensified conventional insulin therapy: ICT) was determined in insulin-naïve patients who began treatment with BOT using GLA or NPH between 01/2003 and 12/2006.
A total of 97,998 patients (61,070 GLA and 36,928 NPH) were included. Within the observation period, 23.5% of GLA patients and 28.0% of NPH patients switched from BOT to ICT. The upper quartile of probability of continuation of therapy (the 75th percentile) was reached after 769 days in GLA patients and after 517 days in NPH patients. Therefore, the risk of switching to ICT was significantly higher with NPH compared to GLA: hazard ratios were 1.34 (99% CI: 1.29-1.38; unadjusted) and 1.22 (99% CI: 1.18-1.27) after adjustment for predefined covariates. Various sensitivity analyses using modified inclusion criteria and endpoint definitions were applied and these confirmed the initial results.
Type-2 diabetic patients under BOT with GLA stayed significantly longer on the initial therapy before switching to ICT than patients on BOT using NPH.
比较使用甘精胰岛素(GLA)或中性胰岛素(NPH)的基础胰岛素支持口服治疗(BOT)在2型糖尿病患者中的持续时间(治疗时长)。
这项回顾性队列研究报告了对德国法定健康保险计划中门诊患者处方索赔数据的分析结果。该研究基于德国80%以上社区药房的索赔数据。在2003年1月至2006年12月期间开始使用GLA或NPH进行BOT治疗的初治患者中,确定了直到转换为基础-餐时治疗方案(强化常规胰岛素治疗:ICT)的治疗持续时间。
共纳入97,998例患者(61,070例使用GLA,36,928例使用NPH)。在观察期内,23.5%的GLA患者和28.0%的NPH患者从BOT转换为ICT。GLA患者在769天后达到治疗持续概率的上四分位数(第75百分位数),NPH患者在517天后达到。因此,与GLA相比,NPH转换为ICT的风险显著更高:在对预定义协变量进行调整后,风险比分别为1.34(99%CI:1.29 - 1.38;未调整)和1.22(99%CI:1.18 - 1.27)。应用了使用修改后的纳入标准和终点定义的各种敏感性分析,这些分析证实了初始结果。
与使用NPH进行BOT的患者相比,使用GLA进行BOT的2型糖尿病患者在转换为ICT之前在初始治疗上停留的时间显著更长。