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利拉鲁肽在 2 型糖尿病的西班牙裔和非西班牙裔白种人患者中的疗效和安全性。

EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.

出版信息

Endocr Pract. 2019 Nov;25(11):1091-1100. doi: 10.4158/EP-2018-0615. Epub 2019 Jun 26.

DOI:10.4158/EP-2018-0615
PMID:31241362
Abstract

Type 2 diabetes (T2D) is more common in Hispanic than non-Hispanic white (NHW) populations worldwide, and ethnicity, among other factors, may affect response to therapy. The efficacy and safety of insulin glargine 100 units/mL (iGlar) and the fixed-ratio combination of iGlar and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) was assessed in Hispanic and NHW patients with T2D from 25 countries. In this post hoc analysis, data from two 30-week randomized controlled trials comparing iGlar and iGlarLixi in patients with T2D uncontrolled on basal insulin ± oral antidiabetes drugs (OADs; LixiLan-L: NCT02058160) or uncontrolled on metformin ± OADs (LixiLan-O: NCT02058147) were evaluated. Of the 1,512 patients included across trials, 301 were Hispanic and 1,211 NHW. Compared with iGlar, iGlarLixi resulted in greater reductions in glycated hemoglobin (A1C) and 2-hour postprandial glucose and a higher proportion of patients at target A1C <7.0% (<53 mmol/mol), regardless of ethnicity. Among NHWs from the LixiLan-L trial, documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL) rates were higher with iGlar compared with iGlarLixi ( = .06), whereas this trend was reversed among Hispanics ( = .07). Nevertheless, in both trials, a greater proportion of patients taking iGlarLixi than iGlar reached the composite efficacy endpoints of target A1C without hypoglycemia and target A1C without weight gain, regardless of ethnicity. These results indicate that iGlarLixi is a viable therapeutic option for both Hispanic and NHW patients with T2D, as it is efficacious without a significant increase in hypoglycemia, irrespective of ethnicity. = glycated hemoglobin; = body mass index; = fasting plasma glucose; = fixed-ratio combination; = glucagon-like peptide 1 receptor agonist; = high-density-lipoprotein cholesterol; = insulin glargine; = insulin glargine + lixisenatide; = low-density-lipoprotein cholesterol; = non-Hispanic white; = oral antidiabetes drug; = postprandial glucose; = type 2 diabetes.

摘要

2 型糖尿病(T2D)在西班牙裔人群中的发病率高于非西班牙裔白人(NHW)人群,且种族等因素可能会影响治疗反应。本研究评估了胰岛素甘精 100U/ml(iGlar)与 iGlar 和胰高血糖素样肽 1 受体激动剂利西那肽固定比例复方制剂(iGlarLixi)在来自 25 个国家的 T2D 西班牙裔和 NHW 患者中的疗效和安全性。在这项事后分析中,比较了 iGlar 和 iGlarLixi 在基础胰岛素±口服降糖药(OAD;LixiLan-L:NCT02058160)治疗血糖控制不佳或二甲双胍±OAD 治疗血糖控制不佳(LixiLan-O:NCT02058147)的两项 30 周随机对照试验的数据。在这两项试验中,共纳入 1512 例患者,其中 301 例为西班牙裔,1211 例为 NHW。与 iGlar 相比,iGlarLixi 可使糖化血红蛋白(A1C)和餐后 2 小时血糖显著降低,且更多患者达到目标 A1C<7.0%(<53mmol/mol),无论种族如何。在 LixiLan-L 试验中,NHW 患者中,记录到的有症状低血糖(血浆葡萄糖≤70mg/dL)发生率,iGlar 组高于 iGlarLixi 组( =.06),而西班牙裔患者中,这种趋势则相反( =.07)。然而,在两项试验中,与 iGlar 相比,更多的 iGlarLixi 治疗患者达到了无低血糖和无体重增加的复合疗效终点,无论种族如何。这些结果表明,iGlarLixi 是 T2D 西班牙裔和 NHW 患者的一种可行的治疗选择,因为它在不增加低血糖的情况下具有疗效,与种族无关。

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