Clinical Outcomes Associated With Switching From Combustible Cigarettes to Electronic Cigarettes Among Adults With Newly Diagnosed Type 2 Diabetes: A Nationwide Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133,320
- 试验地点
- 1
- 主要终点
- Rates of MACE
研究概览
简要总结
Individuals with T2DM who smoke have higher risks of cardiovascular disease and other complications. Many people consider e-cigarette as a "harm-reduction" alternatives to combustible cigarettes, but it is not clear whether switching to e-cigarettes improves health outcomes in patients with diabetes.
详细描述
Use of electronic cigarettes has increased, partly driven by the perception that they may serve as a "harm-reduction" alternative to combustible cigarettes. Evidence cited in prior work includes higher cessation rates versus nicotine replacement therapy in a randomized trial and reductions in biomarkers of potential harm after switching from combustible cigarettes to e-cigarettes; observational data in high-risk PCI populations have also suggested lower MACCE risk after switching. However, constituents such as nicotine and heavy metals may adversely affect diabetes management, and most prior studies have emphasized potential harms of e-cigarette use itself. As a result, whether switching from combustible cigarettes to e-cigarettes confers a harm-reduction benefit in patients with diabetes remains uncertain. In this regards, the current study evaluated clinical outcomes associated with switching from combustible cigarettes to e-cigarettes in patients with diabetes and to assess whether the degree of switching (partial vs full transition) modifies the risk of adverse clinical events.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with diabetes who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis.
排除标准
- •age <40 years or ≥75 years
- •Pre-existing AMI before diabetes diagnosis
- •Pre-existing Revascularization before diabetes diagnosis
- •Pre-existing diabetes complications before diabetes diagnosis
- •Pre-existing cancer before diabetes diagnosis
- •Death within 6 months of the first health examination after diabetes diagnosis
- •Cancer within 6 months of the first health examination after diabetes diagnosis
研究组 & 干预措施
Continued combustible cigarette use
Continued combustible cigarette users after diagnosed DM
Partial Switching to E-cigarette
partial switching to E-cigarette users after diagnosed DM
干预措施: Switching to E-cigarette (Behavioral)
Full switching to E-cigarette
fully switching to E-cigarette users after diagnosed DM
干预措施: Switching to E-cigarette (Behavioral)
结局指标
主要结局
Rates of MACE
时间窗: Up to 5 years
MACE was defined as the composite of all-cause death, MI, and repeat revascularization. The diagnosis of MI was made if patients were hospitalized with primary diagnostic codes related to MI (ICD-10 I21, I22) during follow-up period. In a previous validation study, the accuracy of diagnosis of MI in NHIS data was 93%.16 Unplanned revascularization was defined as presence of procedure codes for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index date.
次要结局
- Rates of Diabetic complications(Up to 5 years)
- Rates of All-cause death(Up to 5 years)
- Rates of Myocardial infarction(Up to 5 years)
- Rates of Unplanned Revascularization(Up to 5 years)
- Rates of Ischemic stroke(Up to 5 years)
- Rates of Hemorrhage stroke(Up to 5 years)
- Rates of Mild pulmonary disease(Up to 5 years)
- Rates of Severe exacerbation of Pulmonary disease(Up to 5 years)
- Rates of Cancer(Up to 5 years)
研究者
Ki Hong Choi
Associate Professor
Samsung Medical Center