MODEL Clinical Research, Baltimore, MD 21204, USA.
Curr Med Res Opin. 2012 Mar;28(3):439-46. doi: 10.1185/03007995.2012.654850. Epub 2012 Jan 23.
To investigate the real-world use of combination insulin glargine/exenatide therapy for type 2 diabetes mellitus (T2DM) and associated treatment persistence and glycemic control.
In this retrospective study, data were extracted from a national US insurance claims database for patients with T2DM for whom insulin glargine and exenatide were co-prescribed in differing order: insulin glargine added after exenatide (EXE+); exenatide added after insulin glargine (GLA+); glargine and exenatide initiated together (GLA + EXE). Patients had continuous health plan coverage for 6 months pre- (baseline) and 1-year post-index (follow-up).
A total of 453 patients were eligible for analysis: 141 patients were included in the EXE+ cohort, 281 in the GLA+ cohort, and 31 in the GLA + EXE cohort. There were significant differences between the groups at baseline, including a significantly lower A1C in the GLA+ versus the EXE+ cohort (p = 0.0023). Around one third of patients stayed on both drugs up until the end of the follow-up period (GLA+: 30.2%; EXE+: 29.0%; GLA + EXE: 29.0%). However, more patients stayed on insulin glargine than on exenatide in each cohort. Significant A1C reductions were observed in each of the cohorts at follow-up: GLA+: -0.4%; EXE+: -0.9%; GLA + EXE: -1.2%; p < 0.01, and were significantly higher in the GLA + EXE and EXE+ cohorts than in the GLA+ cohort (p = 0.03 and p = 0.002, respectively). The mean number of hypoglycemic events increased slightly from baseline but remained low in each of the cohorts (GLA+: 0.12 to 1.42; EXE+: 0.09 to 1.04; GLA + EXE: 0.23 to 1.87 per patient, all p > 0.1).
Combined therapy with insulin glargine and exenatide resulted in A1C reductions in T2DM patients with poor glycemic control without a significantly increased risk of hypoglycemia irrespective of treatment order. Limitations of this study are the between-cohort differences at baseline, lack of a comparator group, and small n number, particularly in the GLA + EXE cohort.
研究甘精胰岛素和艾塞那肽联合治疗 2 型糖尿病（T2DM）的真实世界应用及相关治疗的持久性和血糖控制情况。
在这项回顾性研究中，从美国全国性医疗保险索赔数据库中提取了数据，这些数据来自于甘精胰岛素和艾塞那肽联合处方的 T2DM 患者：艾塞那肽加用甘精胰岛素（EXE+）；甘精胰岛素加用艾塞那肽（GLA+）；甘精胰岛素和艾塞那肽同时起始（GLA+EXE）。患者在指数（随访）前（基线）和指数后 1 年有连续的健康计划覆盖。
共有 453 名患者符合分析条件：141 名患者纳入 EXE+ 队列，281 名患者纳入 GLA+ 队列，31 名患者纳入 GLA+EXE 队列。各组在基线时存在显著差异，包括 GLA+ 队列的 A1C 显著低于 EXE+ 队列（p=0.0023）。大约三分之一的患者在随访结束时仍同时使用两种药物（GLA+：30.2%；EXE+：29.0%；GLA+EXE：29.0%）。然而，每个队列中使用甘精胰岛素的患者多于使用艾塞那肽的患者。在每个队列中，随访时均观察到 A1C 显著降低：GLA+：-0.4%；EXE+：-0.9%；GLA+EXE：-1.2%；p<0.01，且 GLA+EXE 和 EXE+ 队列的降幅均显著高于 GLA+ 队列（p=0.03 和 p=0.002）。低血糖事件的平均发生次数从基线略有增加，但在每个队列中仍保持较低水平（GLA+：0.12 至 1.42；EXE+：0.09 至 1.04；GLA+EXE：0.23 至 1.87 次/患者，均 p>0.1）。
在血糖控制不佳的 T2DM 患者中，无论治疗顺序如何，联合使用甘精胰岛素和艾塞那肽均可降低 A1C，且低血糖风险无显著增加。本研究的局限性在于基线时存在队列间差异、缺乏对照组和样本量小，尤其是在 GLA+EXE 队列中。
