Zeng Zhengpei, Choi Dong Seop, Mohan Viswanathan, Emser Angela, Siddiqui Kamran, Gong Yan, Patel Sanjay, Woerle Hans-Juergen
Peking Union Medical College Hospital , Beijing , China.
Curr Med Res Opin. 2015 Jan;31(1):99-106. doi: 10.1185/03007995.2014.964856. Epub 2014 Oct 8.
To evaluate the efficacy and safety of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin in Asian patients with type 2 diabetes mellitus (T2DM), a rapidly increasing population.
Data were pooled for Asian patients receiving linagliptin orally once daily, as monotherapy or added to existing oral antidiabetes therapies, in multinational randomized placebo-controlled clinical trials. Efficacy data were taken from four pivotal trials with 24-week durations to allow for robust efficacy assessment. Safety data were pooled from a wider group of 10 trials with varying durations to capture the largest possible incidence of adverse events (AEs). The primary efficacy endpoint was change from baseline to week 24 in HbA1c. AEs were analyzed descriptively.
Mean baseline HbA1c (±SD) in this population was 8.2 ± 0.9%. Placebo-corrected mean change in HbA1c after 24 weeks was -0.79% (95% confidence interval [CI]: -0.92 to -0.67; p < 0.0001). Placebo-corrected mean change in fasting plasma glucose was -17.8 ± 2.4 mg/dL (95% CI: -22.6, -13.0; p < 0.0001). In a small subgroup, mean post-prandial glucose was reduced by a placebo-corrected -56.9 ± 14.0 mg/dL (95% CI: -85.2, -28.5). AEs occurred in 58.0% of linagliptin patients (serious AEs in 2.4%) and 58.2% of placebo patients (serious AEs in 3.0%).
This study was limited by the post hoc nature of the analysis, and because the pooling did not differentiate between geographically distant Asian regions. Nonetheless, this analysis provides evidence that linagliptin was efficacious and well tolerated as monotherapy or added to other oral antidiabetes therapies in Asian patients with T2DM.
评估二肽基肽酶（DPP）-4抑制剂利格列汀在亚洲2型糖尿病（T2DM）患者中的疗效和安全性，这一人群数量正在迅速增加。
在多国随机安慰剂对照临床试验中，汇总接受利格列汀每日一次口服治疗的亚洲患者的数据，该治疗作为单一疗法或添加到现有的口服抗糖尿病治疗方案中。疗效数据取自四项为期24周的关键试验，以进行有力的疗效评估。安全性数据汇总自10项持续时间不同的更广泛试验组，以获取最大可能的不良事件（AE）发生率。主要疗效终点是糖化血红蛋白（HbA1c）从基线到第24周的变化。对不良事件进行描述性分析。
该人群的平均基线HbA1c（±标准差）为8.2±0.9%。24周后，安慰剂校正后的HbA1c平均变化为-0.79%（95%置信区间[CI]：-0.92至-0.67；p<0.0001）。安慰剂校正后的空腹血糖平均变化为-17.8±2.4mg/dL（95%CI：-22.6，-13.0；p<0.0001）。在一个小亚组中，餐后血糖平均降低了安慰剂校正后的-56.9±14.0mg/dL（95%CI：-85.2，-28.5）。利格列汀组58.0%的患者发生不良事件（严重不良事件占2.4%），安慰剂组58.2%的患者发生不良事件（严重不良事件占3.0%）。
本研究受分析的事后性质限制，且由于汇总未区分地理位置较远的亚洲地区。尽管如此，该分析提供了证据表明，利格列汀作为单一疗法或添加到其他口服抗糖尿病治疗方案中，在亚洲T2DM患者中疗效显著且耐受性良好。
