Blonde Lawrence, Chava Pavan, Dex Terry, Lin Jay, Nikonova Elena V, Goldenberg Ronald M
Ochsner Diabetes Clinical Research Unit, Department of Endocrinology, Frank Riddick Diabetes Institute, Ochsner Medical Center, New Orleans, Louisiana.
Sanofi US, Inc., Bridgewater, New Jersey.
Diabetes Obes Metab. 2017 Feb;19(2):275-283. doi: 10.1111/dom.12815. Epub 2016 Nov 29.
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.
探讨纳入利司那肽（LIXI）GetGoal试验的成年2型糖尿病（T2D）患者的治疗效果，以及基线特征对治疗效果的预测作用。
本研究是一项对LIXI GetGoal研究中患者水平数据的汇总分析，比较了利司那肽和安慰剂。患者被分为基线治疗组：基线时接受口服抗糖尿病药物（OADs）的患者（n = 2760）或基线时接受基础胰岛素治疗的患者（n = 1198）。
与安慰剂相比，利司那肽治疗使糖化血红蛋白（HbA1c）显著降低，且在OAD组（34% 对18%；P <.0001）或基础胰岛素组（19% 对10%；P <.0001）中更能实现HbA1c <7.0%（53 mmol/mol）、无有症状低血糖且无体重增加的复合终点。与安慰剂相比，利司那肽治疗在OAD组（5% 对3%；P =.0098）和基础胰岛素组（27% 对17%；P <.0001）中导致有症状低血糖事件的患者比例更高。在评估作为治疗效果预测指标的基线因素时，仅基线HbA1c和利司那肽治疗是OAD组和基础胰岛素组治疗效果的强预测指标。没有其他基线特征在所有治疗效果方面具有如此大或一致的临床相关预测作用。
本研究结果表明，无论基线特征如何，利司那肽作为OAD或基础胰岛素治疗的附加治疗，在降低HbA1c和实现复合终点方面是有效的。
