Predictors of outcomes in patients with type 2 diabetes in the lixisenatide GetGoal clinical trials.
Predictors of outcomes in patients with type 2 diabetes in the lixisenatide GetGoal clinical trials.
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DOI：
10.1111/dom.12815
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发表时间：
2017-02
期刊：
影响因子：
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通讯作者：
Goldenberg RM
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文献类型：
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作者：
Blonde L;Chava P;Dex T;Lin J;Nikonova EV;Goldenberg RM
旨在探讨参加 lixisenatide (LIXI) GetGoal 试验的成年 2 型糖尿病 (T2D) 患者的治疗结果，以及基线特征对结果的预测作用。本研究对 LIXI GetGoal 研究中的患者水平数据进行了汇总分析，比较了 LIXI 和安慰剂。患者被分为基线治疗组：基线时接受口服抗糖尿病药物 (OAD) 的患者 (n = 2760) 或基线时接受基础胰岛素的患者 (n = 1198)。与安慰剂相比，LIXI 治疗导致糖化血红蛋白 (HbA1c) 显着更大程度地降低，并且在 OAD 组（34% vs 18%；P < .0001）或基础胰岛素组（19% vs 10%；P < .0001）中更显着地实现 HbA1c <7.0% (53 mmol/mol) 的复合终点，且无症状性低血糖且体重没有增加。 .0001）。与安慰剂组相比，在 OAD 组（5% vs 3%；P = 0.0098）和基础胰岛素组（27% vs 17%；P < 0.0001）中，LIXI 治疗与出现症状性低血糖事件的患者比例较高相关。在评估作为治疗结果预测因素的基线因素时，只有基线 HbA1c 和 LIXI 治疗是 OAD 组和基础胰岛素组结果的强有力预测因素。没有其他基线特征对治疗结果具有如此大或一致的临床相关预测效果。这项研究的结果表明，无论基线特征如何，LIXI 治疗作为 OAD 或基础胰岛素治疗的补充，可有效降低 HbA1c 并实现复合终点。
To explore the treatment outcomes in adult patients with type 2 diabetes (T2D) enrolled in the GetGoal trials of lixisenatide (LIXI), and the predictive effects of baseline characteristics on outcomes. This study was a pooled analysis of patient‐level data from the LIXI GetGoal studies comparing LIXI and placebo. Patients were divided into baseline therapy groups: those receiving oral antidiabetes drugs (OADs) at baseline (n = 2760) or those receiving basal insulin at baseline (n = 1198). Compared with placebo, LIXI treatment led to significantly greater reductions in glycated haemoglobin (HbA1c), and greater achievement of the composite endpoint of HbA1c <7.0% (53 mmol/mol) with no symptomatic hypoglycaemia and no weight gain in either the OAD (34% vs 18%; P < .0001) or the basal insulin groups (19% vs 10%; P < .0001). Treatment with LIXI was associated with a greater percentage of patients experiencing a symptomatic hypoglycaemic event compared with placebo in both the OAD (5% vs 3%; P = .0098) and basal insulin groups (27% vs 17%; P < .0001). In assessing baseline factors that were predictors of treatment outcomes, only baseline HbA1c and LIXI treatment were strong predictors of outcomes in both the OAD and basal insulin groups. No other baseline characteristic had such a large or consistent clinically relevant predictive effect across treatment outcomes. The results from this study show that irrespective of baseline characteristics, LIXI treatment, as an add‐on to OAD or basal insulin therapy, is effective in reducing HbA1c and achieving composite endpoints.