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甘精胰岛素联合艾塞那肽治疗 2 型糖尿病的真实世界结局。

Combination therapy with insulin glargine and exenatide: real-world outcomes in patients with type 2 diabetes.

机构信息

MODEL Clinical Research, Baltimore, MD 21204, USA.

出版信息

Curr Med Res Opin. 2012 Mar;28(3):439-46. doi: 10.1185/03007995.2012.654850. Epub 2012 Jan 23.

Abstract

OBJECTIVE

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.

METHODS

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).

RESULTS

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).

CONCLUSIONS

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.

摘要

目的

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。

方法

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。

结果

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)。

结论

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。

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