失望但不意外——ORIGIN试验结果解读

甘精胰岛素初始干预改善临床结局试验(ORIGIN)是国际多中心随机对照临床研究,验证了与标准治疗相比,对伴有糖代谢异常的心血管疾病高危人群进行早期基础胰岛素治疗是否有额外的心血管获益。结果显示,与标准治疗相比,早期基础胰岛素治疗未能减少糖尿病前期和糖尿病患者心血管疾病的发生风险;两组的全因死亡率、微血管病变发生率以及总的肿瘤发生风险相似;早期基础胰岛素治疗与糖尿病前期患者发生糖尿病的风险下降相关,但因该试验的设计是开放标签研究且基础胰岛素治疗组的血糖管理强度明显高于标准治疗组,基础胰岛素治疗组糖尿病前期发生糖尿病的风险降低很难归因为胰岛素的治疗效果。早期基础胰岛素治疗者低血糖风险增加,体重增加。ORIGIN试验不能影响目前糖尿病的临床实践和指南,对于血糖控制不达标的T2DM,在口服药物治疗的基础上加用基础胰岛素治疗仍然是糖尿病患者血糖控制的标准模式,而包括降糖、降压、他汀药物和抗血小板治疗在内的综合控制措施是T2DM的标准药物治疗策略。

Disappointing but not unexpected-An appraisal of ORIGIN study

Outcome Reduction with an Initial Glargine Intervention(ORIGIN) is an international multicenter randomized controlled trial.It examined whether early basal insulin therapy can reduce the cardiovascular(CV) events as compared with standard glycemic approaches in people with diabetes or prediabetes and high CV risk.The results showed that as compared with standard-care group,basal insulin therapy did not reduce the risk of CV events in people with diabetes or prediabetes.Rates of all-cause mortality,microvascular events and any cancer were similar in the basal insulin and standard-care groups.Initiol basal insulin therapy was associated with a reduction of incident diabetes in people with prediabetes.However,the reduction of diabetes risk can hardly be attributed to insulin itself due to the open label design and more intensive management in insulin treatment group.Rate of hypoglycemia as well as body weight increased in basal insulin group.The findings of the ORIGIN trial will not change the current standard care of diabetic therapy.In patients with T2DM,the standard therapy of glycemic management is adding basal insulin to oral hypoglycemic agents when higher glucose levels can not be properly managed by oral hypoglycemic agents.Comprehensive medical treatment of diabetes should include management of hyperglycemia,hypertension,dyslipidemia and antiplatelet treatment.