MEDLINE/PubMed Journal Browser Search

Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

Title: [The efficacy and safety of linagliptin in elderly patients with type 2 diabetes: a pooled analysis of eight placebo-controlled clinical trials].
Author: Guo XH, Feng ZK, Xu LH.
Journal: Zhonghua Nei Ke Za Zhi; 2017 Aug 01; 56(8):588-594. PubMed ID: 28789492.
Abstract:
Objective: To evaluate the efficacy and safety of dipeptidyl peptidase-4 inhibitor, linagliptin, in subjects aged 60 years or older with type 2 diabetes mellitus (T2DM). Methods: Data from eight 24-week, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies were analyzed. Patients aged 60 years or older with T2DM were received oral linagliptin (5 mg/d) or placebo in combination with metformin, or metformin plus sulfonylurea. Efficacy was assessed by the changes in glycosylated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment. Safety endpoint included the frequency and intensity of adverse events. Results: A total of 1 421 patients (placebo 429, linagliptin 992) were included in the full analysis set (FAS). Mean ages of the subjects were (67.4±5.6) years in the linagliptin group and (66.7±5.6) years in the placebo group. Baseline HbA1c was (8.0±0.8) % in the linagliptin group and (8.1±0.9) % in the placebo group. At the end of 24-week, placebo-adjusted reduction in HbA1c in subjects with linagliptin was (0.7±0.1)% (95%CI 0.6-0.8, P<0.000 1), and placebo-adjusted reduction in FPG in subjects with linagliptin was (0.88±0.12) mmol/L(95%CI 0.65-1.11, P<0.000 1). Overall safety and tolerability in the two groups were similar. Adverse events occurred in 57.1% of patients in the placebo group and 61.1% of patients in the linagliptin group, and the incidence of adverse events leading to discontinuation was 3.2% in the placebo group and 3.8% in the linagliptin group. Serious adverse events occurred in 1.6% of patients in the placebo group and 2.8% of patients in the linagliptin group. Investigator-defined hypoglycaemia occurred in 7.3% of patients in the placebo group and 11.9% of patients in the linagliptin group. Among them, most were mild or moderate hypoglycaemia, and severe hypoglycaemia only occurred in 0.2% of patients in the placebo and 0.5% in the linagliptin groups. Overall incidence of hypoglycaemia in linagliptin group was slightly higher than that in placebo group, which might be due to the fact that more patients were taking sulfonylureas in linagliptin group than in placebo group (26.8% linagliptin; 18.4% placebo). No difference could be viewed in hypoglycaemia between the two groups in patients without sulfonylureas (1.2% linagliptin, 1.1% placebo). Moreover, no severe hypoglycaemia was reported in subjects without sulfonylureas. The incidences of other adverse events were similar in both groups. Conclusion: Linagliptin was efficacious in lowering glucose with a safety profile similar to placebo in type 2 diabetic patients aged 60 years or older. 目的： 评价利格列汀在老年2型糖尿病患者的疗效及安全性。 方法： 汇总分析8项全球多中心随机双盲安慰剂对照临床试验中≥60岁的2型糖尿病患者使用利格列汀5 mg 1次/d治疗24周的研究数据，包括利格列汀单药治疗、利格列汀联合二甲双胍治疗以及利格列汀联合二甲双胍、磺脲类三药治疗。有效性评估指标为24周后糖化血红蛋白(HbA1c)和空腹血糖(FPG)较基线的变化值。运用不良事件的发生率和发生强度作为安全性的评价指标。 结果： 共1 421例患者(安慰剂组429例，利格列汀组992例)纳入全分析集(FAS)进行分析。患者的平均年龄安慰剂组为(66.7±5.6)岁，利格列汀组为(67.4±5.6)岁，安慰剂组和利格列汀组基线HbA1c分别为(8.1±0.9)%和(8.0±0.8)%。治疗24周时，经安慰剂校正后利格列汀组HbA1c下降(0.7±0.1)%(95%CI 0.6～0.8, P<0.000 1)，FPG下降(0.88±0.12)mmol/L(95%CI 0.65～1.11，P<0.000 1)。安全性方面两组类似，任何不良事件的发生率安慰剂组和利格列汀组分别为57.1%和61.1%，导致停药的不良事件两组发生率都较低，分别为3.2%和3.8%，严重不良事件的发生率分别为1.6%和2.8%。低血糖事件发生率安慰剂组和利格列汀组分别为7.3%和11.9%，但其中大部分为轻中度低血糖事件，严重低血糖事件两组发生率均较低，分别为0.2%和0.5%。总体上利格列汀组低血糖事件发生率稍高于安慰剂组，这主要是由于在磺脲类药物治疗背景的人群中低血糖发生率利格列汀组(26.8%)高于安慰剂组(18.4%)，而在无磺脲类药物治疗背景的人群中低血糖发生率两组均非常低，利格列汀组为1.2%，安慰剂组为1.1%，且全部为轻中度低血糖事件，无严重低血糖发生。其他不良事件两组发生率均类似。 结论： 利格列汀不论单药、联合二甲双胍以及联合二甲双胍和磺脲治疗年龄≥60岁2型糖尿病患者均能有效控制血糖，且安全性较好。.

[Abstract] [Full Text] [Related] [New Search]