Lung Cancer Incidence in Patients With Type 2 Diabetes and COPD: A Real-World Retrospective Cohort Study Comparing SGLT2 Inhibitors and Sulfonylureas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,692
- 主要终点
- Lung cancer
研究概览
简要总结
The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD).
The main question it aims to answer is:
- Does taking medicines called SGLT2 inhibitors lower the chance of getting lung cancer compared to medicines called sulfonylureas?
Researchers will compare the medical records of people taking SGLT2 inhibitors to those taking sulfonylureas to see if the SGLT2 group has fewer cases of lung cancer.
Participants will not need to visit a doctor or take new medicines for this study. Researchers will use information from existing medical records to answer the research question.
详细描述
Study Design: This is a comparative effectiveness research study utilizing large-scale, population-based Real-World Data (RWD). By analyzing longitudinal data from existing medical records, researchers will emulate a target trial to minimize bias and provide robust estimates of the treatment effect.
Statistical Analysis Plan: The study employs a rigorous analytic framework consisting of a primary analysis and multiple sensitivity analyses to ensure the validity of the findings:
Primary Analysis: A comparison of SGLT2 inhibitors versus sulfonylureas using an Intention-To-Treat (ITT) framework, with follow-up censored upon treatment switching to estimate the effect of the initial treatment choice.
Sensitivity Analysis 1 (Active Comparator): A comparison of DPP-4 inhibitors versus SGLT2 inhibitors using the same ITT framework (censoring on switching) to assess the consistency of the results against an alternative second-line antidiabetic class.
Sensitivity Analysis 2 (As-Treated): A comparison of SGLT2 inhibitors versus sulfonylureas using an As-Treated approach, defining continuous use with a permissible gap (grace period) of 60 days between prescriptions to account for adherence patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥40 years with prior COPD (from 2009) and newly diagnosed diabetes who initiated SU or SGLT2i between January 1, 2014 and December 31, 2023
排除标准
- •Pre-existing
- •Concurrent prescribing of the study drugs at the index date
- •Exposure to the drugs of interest during the year preceding the index date
- •Death or cancer incidence within a month
- •In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.
研究组 & 干预措施
Treatment group (S1)
Users of SGLT2 inhibitors (for ITT analysis)
干预措施: SGLT2 inhibitor (Drug)
Active control group (S1)
Users of DPP4 inhibitors (for ITT analysis)
干预措施: Sulfonylureas (SU) (Drug)
Treatment group (main)
Users of SGLT2 inhibitors (for ITT analysis)
干预措施: SGLT2 inhibitor (Drug)
Active control group (main)
Users of sulfonylureas for ITT analysis
干预措施: Sulfonylureas (SU) (Drug)
Treatment group (S2)
Users of SGLT2 inhibitors (for as-treated analysis)
干预措施: SGLT2 inhibitor (Drug)
Active control group (S2)
Users of sulfonylureas (for as-treated analysis)
干预措施: DPP4 inhibitors (Drug)
结局指标
主要结局
Lung cancer
时间窗: From index date + 30 days to the end of follow-up
ICD-10 code (C33 or C34) and code for special purposes (V193)
次要结局
- COPD exacerbation(From index date + 30 days to the end of follow-up)
- Any cancer(From index date + 30 days to the end of follow-up)
研究者
Danbee Kang
Associate Professor
Samsung Medical Center