摘要
Abstract
Objective To assess the impact of dapagliflozin on bone metabolism and bone mineral density(BMD)in older adults with type 2 diabetes mellitus(T2DM),combining real-world and clinical evidence to clarify its skeletal safety.Methods The FDA Adverse Event Reporting System(FAERS)was queried for dapagliflozin-related adverse events from the first quarter to the fourth quarter of 2007.Reports of bone metabolism and fractures were extracted,with signal detection performed using PRR,ROR,BCPNN,and MGPS.Time-to-onset(TTO)analysis assessed event distribution after treatment initiation.Additionally,a clinical study enrolled T2DM patients aged 65-75 years treated with insulin alone and poor glycemic control at Anhui Provincial Military Region Hefei Second Retired Cadre Rehabilitation Center(January 2023-June 2024).Patients were randomized to insulin therapy(control)or insulin plus dapagliflozin 10 mg/d(observation)and followed for 24 weeks.Glycemic indices,body weight,bone markers,and BMD were compared.Results FAERS identified 11 661 dapagliflozin-related reports;47.4％were female and 23.7％aged≥65 years.Fractures of the radius,ulna,and femoral neck predominated.Overall signal strength was low,though higher in older adults and women.TTO showed fracture risk clustered in early treatment(β=0.55)and declined over time.In the clinical study,the dapagliflozin group had greater reductions in FBG,HbA1c,body weight,and insulin dose versus control(P＜0.05).No significant differences were observed in25(OH)D,osteocalcin,PINP,β-CTX,or BMD(LS-BMD,FN-BMD)(P＞0.05).Conclusions The overall risk of fractures with dapagliflozin is not high,but the risk is relatively increased in elderly women and individuals in the early stages of medication use.Clinical findings confirm no adverse effects on bone metabolism or BMD.Integrating both sources,dapagliflozin appears generally safe for skeletal health in older T2DM patients,but bone monitoring is advisable in high-risk groups.关键词
糖尿病,2型/骨密度/药物相关性副作用和不良反应/数据挖掘/老年人Key words
Diabetes mellitus,type 2/Bone density/Drug-related side effects and adverse reactions/Data mining/Aged
