Yabe Daisuke, Hamamoto Yoshiyuki, Seino Yusuke, Kuwata Hitoshi, Kurose Takeshi, Seino Yutaka
a Yutaka Seino Distinguished Center for Diabetes Research , Kansai Electric Power Medical Research Institute , Kobe , Japan.
b Center for Diabetes, Endocrinology and Metabolism , Kansai Electric Power Hospital , Osaka , Japan.
Expert Opin Drug Saf. 2017 Oct;16(10):1211-1218. doi: 10.1080/14740338.2017.1359252. Epub 2017 Aug 18.
Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co., Ltd. and was approved as an oral anti-diabetic drug for T2D in Japan Areas covered: The overall safety and efficacy of SGLT2 inhibitor luseogliflozin are summarized on the basis of a literature review, with a focus on reported adverse drug reactions in preapproval clinical trials and a post-marketing surveillance. Expert opinion: SGLT2 inhibitor luseogliflozin is well tolerated, significantly improves hyperglycemia in preapproval clinical trials, and has a favorable safety profile in both preapproval clinical trials and post-marketing surveillance in elderly patients. While long-term safety and efficacy remain to be seen, luseogliflozin can benefit T2D patients worldwide. However, healthcare professionals must perform appropriate patient education that includes temporary withdrawal of luseogliflozin during patient a 'sick day' and avoidance of strict carbohydrate restriction during luseogliflozin treatment.
钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂作为一类新型抗糖尿病药物，近年来已被研发出来，并在2型糖尿病（T2D）的治疗中得到广泛应用。由于这类药物的降糖机制与其他抗糖尿病药物有很大不同，因此需要根据批准前临床试验以及真实世界研究的数据来讨论该类药物的安全使用问题。SGLT2抑制剂鲁格列净由大正制药株式会社研发，并在日本被批准为用于治疗T2D的口服抗糖尿病药物。涵盖领域：基于文献综述总结了SGLT2抑制剂鲁格列净的总体安全性和有效性，重点关注批准前临床试验及上市后监测中报告的药物不良反应。专家意见：SGLT2抑制剂鲁格列净耐受性良好，在批准前临床试验中能显著改善高血糖，且在老年患者的批准前临床试验和上市后监测中均具有良好的安全性。虽然长期安全性和有效性仍有待观察，但鲁格列净可为全球的T2D患者带来益处。然而，医疗保健专业人员必须对患者进行适当的教育，包括在患者“患病日”暂时停用鲁格列净，以及在鲁格列净治疗期间避免严格限制碳水化合物摄入。
