MHRA 和 EMA:达格列净不应再用于 1 型糖尿病治疗
钠-葡萄糖协同转运蛋白 2(sodium-glucose co-transporter 2, SGLT-2)抑制剂在英国和整个欧洲不再获批用于 1 型糖尿病治疗。
制造商自愿撤除该适应症,并非出于任何新发安全问题,欧洲药品管理局(European Medicines Agency, EMA)和英国药品和医疗产品监管署(Medicines and Healthcare products Regulatory Agency, MHRA)先后于 2021 年 11 月和 2021 年 12 月宣布该决定。达格列净的其他适应症保持不变。
达格列净之前曾被英国国家卫生与临床优化研究所(National Institute for Health and Care Excellence, NICE)推荐为某些 1 型糖尿病患者的胰岛素辅助用药。如果您的患者已开始服用达格列净,MHRA 和 EMA 建议:
应尽快由专科医生进行分析和停药处理,或与专科医生进行协商
停用达格列净后,加强血糖监测
考虑谨慎增加胰岛素剂量,尽量减少低血糖或高血糖风险。
小结
定义
病史和体格检查
诊断性检查
治疗流程
撰稿人
作者 展开全部内容
Consultant Endocrinologist
Portsmouth Hospitals University NHS Trust
UK
利益声明
EN has received honoraria for educational activities/advisory boards from NovoNordisk, Eli Lilly and Boehringer Ingelheim.Honorary Associate Professor
University of Liverpool
Consultant Paediatrician and Paediatric Endocrinologist
Southport and Ormskirk NHS Trust
UK
利益声明
SMN declares that she has no competing interests.Consultant Endocrinologist
Portsmouth Hospitals University NHS Trust
National Specialty Advisor, Diabetes, NHS England
UK
利益声明
PK has sat on advisory boards and attended events reimbursed by Novo Nordisk, Eli Lilly and Sanofi.Dr Eveleigh Nicholson, Dr Sze May Ng, and Professor Partha Kar would like to gratefully acknowledge Dr Rajesh K. Garg and Dr Varsha Vimalananda, the previous contributors to this topic.
利益声明
RKG is an author of a number of references cited in this topic. VV declares that she has no competing interests.同行评议者 展开全部内容
Consultant Physician in Diabetes
Senior Lecturer in Medical Education
King's College Hospital NHS Foundation Trust
King’s College London
London
UK
利益声明
OM has received honoraria for educational activities/lectures from NovoNordisk, Eli Lilly, Sanofi, and Boehringer Ingelheim.Consultant Diabetologist & Honorary Senior Lecturer
Manchester University Hospitals NHS Foundation Trust
University of Manchester
Manchester
UK
利益声明
HT has received research support from Dexcom, Inc., and speaker fees from Eli Lilly.
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