Meckley L M, Miyasato G, Kokkotos F, Bumbaugh J, Bailey R A
a a Trinity Partners LLC , Waltham , MA , USA.
Curr Med Res Opin. 2015 Aug;31(8):1479-86. doi: 10.1185/03007995.2015.1047748. Epub 2015 Jun 24.
To evaluate changes in glycemic control following the initial canagliflozin pharmacy claim in a real-world population.
A retrospective cohort analysis of adult patients with type 2 diabetes mellitus (T2DM) was conducted using 2013 medical, pharmacy and laboratory claims from the Inovalon MORE 2 Registry. Patients with T2DM aged ≥18 years with ≥60 days of canagliflozin supply and HbA1c test results within 120 days before and ≥60 days after initial canagliflozin claim (defined as index date) were included. The differences between HbA1c levels pre- and post-index were assessed. Changes pre- and post-index in Healthcare Effectiveness Data and Information Set (HEDIS) glycemic control criteria of HbA1c <7% and <8% and poor control of HbA1c >9% were evaluated. Subgroup analyses of patients with HbA1c >7% at baseline and patients aged ≥65 were also conducted.
Among the 268 patients meeting the study criteria, mean HbA1c pre-index was 8.3% and post-index was 7.6%; the mean reduction in HbA1c pre-post index was 0.7% (95% CI: 0.6%, 0.9%). The proportions of patients meeting the HEDIS glycemic control measures (HbA1c <7%, <8% and poor control of >9%) improved and was significantly different pre- and post-index (all p < 0.001). Of the patients with an HbA1c >7% prior to index (81% of the cohort; mean pre-index HbA1c = 8.8%), HbA1c was reduced by 0.9% (95% CI: 0.8%, 1.1%). The aged ≥65 subgroup consisted of 15% of the cohort, with a pre-index HbA1c of 8.3%. The mean reduction in HbA1c test results pre- and post-canagliflozin index was 0.6% (95% CI: 0.4%, 0.9%). This analysis did not adjust for changes in antihyperglycemic agents during the study period.
Patients with T2DM were observed to have improved glycemic control following initial canagliflozin pharmacy claim as measured by HbA1c change and attainment of specific glycemic control criteria.
评估在真实世界人群中首次开具卡格列净处方后血糖控制的变化情况。
使用来自Inovalon MORE 2注册中心2013年的医疗、药房和实验室数据，对成年2型糖尿病（T2DM）患者进行回顾性队列分析。纳入年龄≥18岁、卡格列净供应时间≥60天且在首次开具卡格列净处方（定义为索引日期）前120天内及之后≥60天有糖化血红蛋白（HbA1c）检测结果的T2DM患者。评估索引前后HbA1c水平的差异。评估索引前后医疗保健有效性数据和信息集（HEDIS）中糖化血红蛋白控制标准（HbA1c<7%和<8%）以及HbA1c>9%的控制不佳情况的变化。还对基线时HbA1c>7%的患者和年龄≥65岁的患者进行了亚组分析。
在符合研究标准的268例患者中，索引前平均HbA1c为8.3%，索引后为7.6%；索引前后HbA1c的平均降低值为0.7%（95%CI：0.6%，0.9%）。达到HEDIS血糖控制指标（HbA1c<7%、<8%以及控制不佳>9%）的患者比例有所改善，且索引前后存在显著差异（所有p<0.001）。在索引前HbA1c>7%的患者中（占队列的81%；索引前平均HbA1c = 8.8%），HbA1c降低了0.9%（95%CI：0.8%，1.1%）。年龄≥65岁的亚组占队列的15%，索引前HbA1c为8.3%。卡格列净索引前后HbA1c检测结果的平均降低值为0.6%（95%CI：0.4%，0.9%）。该分析未对研究期间降糖药物的变化进行调整。
观察到T2DM患者在首次开具卡格列净处方后，通过HbA1c变化和达到特定血糖控制标准，血糖控制得到改善。
