| アブストラクト | AIMS: Randomized controlled trials (RCTs) have high internal validity but often have limited generalizability. To our knowledge, there have been no previous studies emulating RCTs using real-world data to evaluate the risk of major adverse cardiovascular events (MACE) among patients with type 2 diabetes mellitus (T2DM) treated with long-acting insulin analogues. METHODS: We emulated the DEVOTE trial of insulin degludec vs. glargine among patients with T2DM using data from the United Kingdom's Clinical Practice Research Datalink. DEVOTE eligible and ineligible subpopulations were created. Cox proportional hazards models with inverse probability of treatment weighting were used to estimate hazard ratios (HRs) and corresponding confidence intervals (CIs) for MACE comparing new users of insulin degludec to new users of insulin glargine overall and in the eligible/ineligible subpopulations. RESULTS: There were 10 430 patients in the overall population, 5280 in the DEVOTE eligible population, and 5150 in the DEVOTE ineligible population. The overall (HR: 1.36, 95% CI: 0.83, 1.86) and DEVOTE eligible populations (HR: 1.07, 95% CI: 0.63, 1.58) were compatible with findings from the DEVOTE trial (HR: 0.91, 95% CI: 0.78, 1.06) for the risk of MACE. Due to a low number of events, the DEVOTE ineligible population had deviations in point estimates and wider CIs (HR: 2.19, 95% CI: 0.30, 3.83). CONCLUSION: The risk of MACE among patients with T2DM newly prescribed insulin degludec compared to insulin glargine was consistent between the overall population and the DEVOTE eligible subpopulation, while the DEVOTE ineligible population had discrepant point estimates. |
|---|
| ジャーナル名 | Pharmacoepidemiology and drug safety |
|---|
| Pubmed追加日 | 2026/1/6 |
|---|
| 投稿者 | Wang, Wanning; Reynier, Pauline; Webster-Clark, Michael; Yu, Oriana H Y; Brunetti, Vanessa; Filion, Kristian B |
|---|
| 組織名 | Department of Epidemiology, Biostatistics and Occupational Health, McGill;University, Montreal, Quebec, Canada.;Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital,;Montreal, Quebec, Canada.;Department of Medicine, McGill University, Montreal, Quebec, Canada.;Division of Endocrinology and Metabolism, Jewish General Hospital/, McGill;Center for Observational Research, Amgen Ltd, Uxbridge, UK. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41490717/ |
|---|
