Vanderpoel Daniel R, Hussein Mohamed A, Watson-Heidari Teresa, Perry Andrew
Outcomes Research Center, Humana Inc., 500 West Main Street, 16th Floor, Louisville, KY 40202, USA.
Clin Ther. 2004 Dec;26(12):2066-75. doi: 10.1016/j.clinthera.2004.12.018.
In 2002, fixed-dose combination therapy (FDCT) with rosiglitazone maleate plus metformin hydrochloride became available for the treatment of type 2 diabetes mellitus (DM-2) in subjects whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione. FDCT allows a reduced pill burden and a less complex medication regimen.
The objective of this study was to assess changes in medication adherence rates associated with oral hypoglycemic agents in subjects switching from either monotherapy or dual therapy with metformin and/or rosiglitazone to rosiglitazone-metformin FDCT.
In this retrospective database analysis, data were obtained from the pharmacy claims database of a large health benefits company. Prescription claims for subjects aged > or =18 years with DM-2 whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione were analyzed over a 12-month study period (a 6-month preindex period and a 6-month postindex period). Some subjects were receiving monotherapy with either metformin or rosiglitazone during the preindex period and remained on monotherapy throughout the postindex period (Mono/Mono cohort), switched to dual therapy with both agents (Mono/Dual cohort), or switched to FDCT (Mono/FDCT cohort). Some subjects were receiving dual therapy with metformin and rosiglitazone during the preindex period and remained on dual therapy throughout the postindex period (Dual/Dual cohort) or switched to FDCT (Dual/FDCT cohort). A medication possession ratio (MPR)-a proxy measurement of medication adherence-was calculated for each subject for each period. Changes in medication adherence were compared using a general linear model.
Overall, data from the records of 16,928 subjects (8499 men, 8429 women; mean [SD] age, 58.12 [11.97] years) were included in this study. There was significantly less reduction in the MPR change for the Mono/FDCT cohort compared with the Mono/Dual cohort (-4.6% vs -12.4%; P < 0.001). There was significant improvement in the mean MPR change for the Dual/FDCT cohort compared with the Dual/Dual cohort (3.5% vs -1.3%; P < 0.005).
The results of this retrospective database analysis suggest that rosiglitazone-metformin FDCT yielded significant improvements in medication adherence rates compared with dual therapy regimens.
2002年，马来酸罗格列酮与盐酸二甲双胍的固定剂量联合疗法（FDCT）开始用于治疗2型糖尿病（DM - 2），适用于单药使用二甲双胍或噻唑烷二酮治疗效果不佳的患者。FDCT可减少服药量并简化用药方案。
本研究旨在评估从二甲双胍和/或罗格列酮单药治疗或联合治疗转换为罗格列酮 - 二甲双胍FDCT的患者口服降糖药用药依从率的变化。
在这项回顾性数据库分析中，数据来自一家大型健康福利公司的药房理赔数据库。对年龄≥18岁、DM - 2且单药使用二甲双胍或噻唑烷二酮治疗效果不佳的患者的处方理赔数据进行了为期12个月的研究分析（6个月的索引前期和6个月的索引后期）。一些患者在索引前期接受二甲双胍或罗格列酮单药治疗，并在索引后期一直保持单药治疗（单药/单药队列），转换为两种药物的联合治疗（单药/联合队列），或转换为FDCT（单药/FDCT队列）。一些患者在索引前期接受二甲双胍和罗格列酮联合治疗，并在索引后期一直保持联合治疗（联合/联合队列）或转换为FDCT（联合/FDCT队列）。计算每个患者在每个时期的药物持有率（MPR）——一种用药依从性的替代测量指标。使用一般线性模型比较用药依从性的变化。
总体而言，本研究纳入了16928名患者的记录数据（8499名男性，8429名女性；平均[标准差]年龄为58.12[11.97]岁）。与单药/联合队列相比，单药/FDCT队列的MPR变化减少幅度明显更小（-4.6%对-12.4%；P<0.001）。与联合/联合队列相比，联合/FDCT队列的平均MPR变化有显著改善（3.5%对-1.3%；P<0.005）。
这项回顾性数据库分析结果表明，与联合治疗方案相比，罗格列酮 - 二甲双胍FDCT在用药依从率方面有显著提高。
