Chow Wing, Miyasato Gavin, Kokkotos Fotios K, Bailey Robert A, Buysman Erin K, Henk Henry J
Health Economics & Outcomes Research, Janssen Scientific Affairs, LLC, Raritan, New Jersey.
Trinity Partners, LLC, Waltham, Massachusetts.
Clin Ther. 2016 Sep;38(9):2071-82. doi: 10.1016/j.clinthera.2016.07.168. Epub 2016 Sep 3.
Randomized controlled trials have found that treatment of type 2 diabetes mellitus with canagliflozin, a sodium glucose co-transporter 2 inhibitor, is associated with significant reductions in glycosylated hemoglobin (HbA1c) levels. However, very few studies have evaluated the effectiveness of sodium glucose co-transporter 2 inhibitors in a real-world context. This data synthesis aims to examine the demographic characteristics and glycemic control among patients treated with canagliflozin in clinical practice, using results obtained from 2 US-specific retrospective administrative claims databases.
Data included in the synthesis were derived from 2 large claims databases (the Optum Research Database and the Inovalon MORE(2) Registry, Research Edition) and were obtained from 3 recently published retrospective observational studies of adult patients with type 2 diabetes mellitus who were treated with canagliflozin. Two of the studies used the Optum database (3-month and 6-month follow-up) and 1 study used the Inovalon database (mean follow-up of 4 months). Patient demographic characteristics, clinical characteristics, treatment utilization, and achievement of glycemic goals at baseline and after canagliflozin treatment were evaluated across the 3 studies. Results were assessed using univariate descriptive statistics.
Baseline demographic characteristics were generally similar between the Optum and Inovalon cohorts. Mean baseline HbA1c was 8.7% in the Optum and 8.3% in the Inovalon cohort. Seventy-five percent of the Optum (3-month study) cohort and 74% of the Inovalon cohort used 2 or more antihyperglycemic agents. During follow-up, in both cohorts, the proportion of patients who achieved tight glycemic control (HbA1c <7.0%) more than doubled, while the proportion who had poor control (HbA1c ≥9.0%) decreased by approximately 50%. Among patients who had baseline HbA1c ≥7.0%, 21% of the Optum cohort and 24% of the Inovalon cohort achieved tight glycemic control (HbA1c <7.0%), and the proportion of patients achieving HbA1c <8.0% more than doubled in both cohorts (from 30% to 61% in the Optum cohort, and from 33% to 69% in the Inovalon cohort).
This synthesis of real-world data from 2 large patient databases suggests that treatment of type 2 diabetes mellitus with canagliflozin is associated with significant and consistent improvements in glycemic control. Patients with varying HbA1c control and multiple antihyperglycemic agent use were able to lower their HbA1c levels with canagliflozin treatment. Additional studies with longer follow-up would be beneficial to evaluate the durability of the real-world effectiveness of canagliflozin.
随机对照试验发现，使用钠-葡萄糖协同转运蛋白2抑制剂卡格列净治疗2型糖尿病与糖化血红蛋白（HbA1c）水平显著降低相关。然而，极少有研究在实际应用环境中评估钠-葡萄糖协同转运蛋白2抑制剂的有效性。本数据综合分析旨在利用来自2个美国特定回顾性管理索赔数据库的结果，研究临床实践中接受卡格列净治疗的患者的人口统计学特征和血糖控制情况。
综合分析中纳入的数据来自2个大型索赔数据库（Optum研究数据库和Inovalon MORE(2)注册研究版），取自最近发表的3项关于接受卡格列净治疗的2型糖尿病成年患者的回顾性观察研究。其中2项研究使用Optum数据库（3个月和6个月随访），1项研究使用Inovalon数据库（平均随访4个月）。在这3项研究中评估了患者的人口统计学特征、临床特征、治疗使用情况以及基线和卡格列净治疗后的血糖目标达成情况。结果采用单变量描述性统计进行评估。
Optum队列和Inovalon队列的基线人口统计学特征总体相似。Optum队列的平均基线HbA1c为8.7%，Inovalon队列的为8.3%。Optum队列（3个月研究）中75%的患者和Inovalon队列中74%的患者使用了2种或更多种降糖药物。在随访期间，两个队列中实现严格血糖控制（HbA1c<7.0%）的患者比例均增加了一倍多，而控制不佳（HbA1c≥9.0%）的患者比例下降了约50%。在基线HbA1c≥7.0%的患者中，Optum队列中有21%的患者和Inovalon队列中有24%的患者实现了严格血糖控制（HbA1c<7.0%），并且两个队列中HbA1c<8.0%的患者比例均增加了一倍多（Optum队列从30%增至61%，Inovalon队列从33%增至69%）。
对来自2个大型患者数据库的实际数据进行的综合分析表明，使用卡格列净治疗2型糖尿病与血糖控制的显著且持续改善相关。糖化血红蛋白控制情况各异且使用多种降糖药物的患者能够通过卡格列净治疗降低其HbA1c水平。进行更长随访时间的进一步研究将有助于评估卡格列净在实际应用中的有效性的持久性。
