The University of Texas Southwestern Medical Center , Dallas, Texas , USA.
Diabetes America-PA President , Plano, Texas , USA.
BMJ Open Diabetes Res Care. 2014 Apr 16;2(1):e000020. doi: 10.1136/bmjdrc-2014-000020. eCollection 2014.
The number of individuals diagnosed with type 2 diabetes mellitus is expected to rise disproportionately in Hispanic/Latino populations. We therefore aimed to assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin specifically in Hispanic/Latino patients with type 2 diabetes mellitus.
Data from 745 patients who self-identified their ethnicity as Hispanic or Latino were pooled from six randomized, placebo-controlled phase 3 trials. Participants received linagliptin (5 mg/day) or placebo as monotherapy, or in combination with other oral antidiabetes drugs for 18 or 24 weeks.
The placebo-adjusted mean change (95% CI) in glycated hemoglobin from baseline (mean 8.2%) was -0.63% (-0.77 to -0.48; p<0.0001) at week 18, and -0.58% (-0.74 to -0.42; p<0.0001) at week 24. The placebo-adjusted mean change (95% CI) in fasting plasma glucose from baseline was -11.7 mg/dL (-19.3 to -4.0; p=0.0028) at week 18 and -14.1 mg/dL (-22.0 to -6.3; p=0.0004) at week 24. Hypoglycemia incidence was 17.4% with linagliptin and 21% with placebo. In patients not receiving concomitant sulfonylurea, the hypoglycemia incidence was 10.1% with linagliptin and 19.4% with placebo. The overall incidence of adverse events (AEs), drug-related AEs, and serious AEs with linagliptin was similar to placebo (AEs 67.6% vs 68.9%; drug-related AEs 15.1% vs 18.7%; serious AEs 3.6% vs 3.0%). The mean body weight remained unchanged in both groups.
In Hispanic/Latino patients with inadequately controlled type 2 diabetes mellitus, linagliptin provided clinically meaningful improvements in glycemic control without weight gain or increased risk of hypoglycemia.
预计 2 型糖尿病患者的数量在西班牙裔/拉丁裔人群中不成比例地增加。因此，我们旨在评估二肽基肽酶-4 抑制剂利拉利汀在 2 型糖尿病西班牙裔/拉丁裔患者中的疗效和安全性。
从六项随机、安慰剂对照的 3 期临床试验中汇总了 745 名自我报告为西班牙裔或拉丁裔的患者的数据。参与者接受利拉利汀（5mg/天）或安慰剂单药治疗，或与其他口服抗糖尿病药物联合治疗 18 或 24 周。
从基线（平均 8.2%）开始，糖化血红蛋白的安慰剂调整平均变化（95%CI）在第 18 周为-0.63%（-0.77 至-0.48；p<0.0001），在第 24 周为-0.58%（-0.74 至-0.42；p<0.0001）。从基线开始，空腹血浆葡萄糖的安慰剂调整平均变化（95%CI）在第 18 周为-11.7mg/dL（-19.3 至-4.0；p=0.0028），在第 24 周为-14.1mg/dL（-22.0 至-6.3；p=0.0004）。利拉利汀组低血糖发生率为 17.4%，安慰剂组为 21%。在未接受磺酰脲类药物联合治疗的患者中，利拉利汀组低血糖发生率为 10.1%，安慰剂组为 19.4%。利拉利汀组与安慰剂组的总体不良事件（AE）、药物相关 AE 和严重 AE 发生率相似（AE 67.6% vs 68.9%；药物相关 AE 15.1% vs 18.7%；严重 AE 3.6% vs 3.0%）。两组的平均体重均保持不变。
在血糖控制不佳的 2 型糖尿病西班牙裔/拉丁裔患者中，利拉利汀可显著改善血糖控制，且不增加体重或低血糖风险。
