Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance

We investigated the long-term safety and effectiveness of linagliptin in Japanese type 2 diabetes (T2D) patients starting linagliptin add-on therapy in routine clinical practice. This 3-year prospective, observational, post-marketing surveillance (PMS) was conducted in Japanese patients starting linagliptin add-on therapy. The primary outcome was the incidence of adverse drug reactions (ADRs). The secondary outcome was the change from baseline in HbA1c. The safety analysis set comprised of 3,372 patients. Mean ± standard deviation (SD) age was 66.5 ± 12.4 years. Most patients (63.2%) received linagliptin in combination with another antidiabetic drug, most commonly a sulfonylurea (38.6%). The incidence of ADRs was 11.39%; the most common ADRs according to MedDRA preferred terms were diabetes mellitus (1.25%), hypertension (0.83%), and hypoglycemia (0.80%). In the effectiveness analysis set (n = 3,029), mean ± SD HbA1c was 7.76 ± 1.37% at baseline and 7.26 ± 1.19% at last observation; mean change from baseline to last observation was – 0.49 ± 1.33%; sustained reductions in HbA1c were observed. These results were consistent across patient subgroups. In this PMS, linagliptin add-on therapy for Japanese T2D patients had a safety profile consistent with its known profile and HbA1c reductions over 3 years were observed. NCT01904383

本研究针对日本2型糖尿病（T2D）患者在常规临床实践中起始利格列汀（linagliptin）附加治疗的长期安全性与有效性展开了调查。本项研究为为期3年的前瞻性观察性上市后监测（PMS），纳入起始利格列汀附加治疗的日本患者。研究的主要终点为药品不良反应（ADRs）的发生率，次要终点为糖化血红蛋白（HbA1c）较基线的变化值。安全性分析集共纳入3372例患者，患者平均年龄为66.5±12.4岁（均值±标准差（SD））。多数患者（63.2%）联合使用利格列汀与另一种抗糖尿病药物，其中最常见的联合用药为磺脲类药物（38.6%）。药品不良反应发生率为11.39%；依据医学术语规范辞典（MedDRA）首选术语分类，最常见的药品不良反应为糖尿病（1.25%）、高血压（0.83%）与低血糖（0.80%）。在有效性分析集（n=3029）中，患者基线糖化血红蛋白（HbA1c）水平为7.76±1.37%，末次随访时为7.26±1.19%；从基线至末次随访的平均变化值为-0.49±1.33%，且观察到糖化血红蛋白水平持续降低。上述结果在各患者亚组中均保持一致。本项上市后监测结果显示，针对日本2型糖尿病（T2D）患者的利格列汀附加治疗，其安全性特征与已知的安全性特征相符，且在3年随访期间观察到糖化血红蛋白水平降低。临床试验注册号：NCT01904383