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生物类似物后续胰岛素在糖尿病管理中的有效性、安全性及治疗依从性

Effectiveness, safety and treatment adherence of biosimilar follow-on insulin in diabetes management.

作者信息

Pham Timothy T, Chen Xiaoxue, Barron John, Hart Richard, Abarca Jacob, DeVries Andrea

机构信息

Enterprise Health Services Research, Anthem, Inc., Indianapolis, Indiana.

HealthCore, Inc., Wilmington, Delaware.

出版信息

Diabetes Obes Metab. 2022 Oct;24(10):1989-1997. doi: 10.1111/dom.14786. Epub 2022 Jun 28.

Abstract

AIM

To assess the change in HbA1c after initiation of biosimilar follow-on insulin (Basaglar) or reference insulin (Lantus) among patients with type 2 diabetes. We also compared treatment adherence, safety events and costs at 1 year after initiation of insulin.

MATERIALS AND METHODS

Using claims data from a large US health plan during 2016-2020, we identified adults with type 2 diabetes who initiated either Basaglar or Lantus. Generalized linear regression modelling assessed the differences in outcomes between the two groups. A 0.4% margin was used to determine non-inferiority for HbA1c.

RESULTS

The study included 1136 Basaglar users and 6304 Lantus users. Both Lantus and Basaglar groups showed more than 1% reduction in HbA1c over 6 months and over 12 months. Reduction in HbA1c with Basaglar was similar (non-inferior) to that with Lantus, with an adjusted difference of Basaglar to Lantus of 0.14% (95% CI -0.02 to 0.30) over 6 months and 0.17% (95% CI 0.02 to 0.32) over 12 months. Rates of adverse events were similar for both hypoglycaemia and vascular events. The Basaglar group showed higher adherence in terms of proportion of days covered (adjusted difference 0.06, 95% CI 0.04 to 0.08). Medical costs were similar, but the cost of Basaglar was lower (adjusted mean cost difference -$462, 95% CI -$556 to -$363) after adjustment.

CONCLUSIONS

In patients with type 2 diabetes, Basaglar provided similar glycaemic control compared with Lantus, had a similar safety profile and lower drug costs, and showed more favourable adherence.

摘要

目的

评估2型糖尿病患者起始使用生物类似物后续胰岛素(Basaglar)或参比胰岛素(来得时)后糖化血红蛋白(HbA1c)的变化。我们还比较了起始胰岛素治疗1年后的治疗依从性、安全事件和成本。

材料与方法

利用2016 - 2020年美国一项大型健康计划的理赔数据,我们确定了起始使用Basaglar或来得时的2型糖尿病成年患者。广义线性回归模型评估了两组间结局的差异。采用0.4%的界值来确定HbA1c的非劣效性。

结果

该研究纳入了1136名Basaglar使用者和6304名来得时使用者。来得时组和Basaglar组在6个月和12个月内HbA1c均降低超过1%。Basaglar降低HbA1c的效果与来得时相似(非劣效),6个月时Basaglar与来得时的校正差异为0.14%(95%置信区间 -0.02至0.30),12个月时为0.17%(95%置信区间0.02至0.32)。低血糖和血管事件的不良事件发生率在两组中相似。Basaglar组在覆盖天数比例方面显示出更高的依从性(校正差异0.06,95%置信区间0.04至0.08)。医疗成本相似,但校正后Basaglar的成本更低(校正平均成本差异 -462美元,95%置信区间 -556至 -363美元)。

结论

在2型糖尿病患者中,与来得时相比,Basaglar提供了相似的血糖控制,具有相似的安全性和更低的药物成本,且显示出更有利的依从性。

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