Clinical Outcomes, Diabete Type 2, E Cigarette Use
Conditions
Keywords
Diabetes mellitus, E-cigarette, Smoking
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSwitching to E-cigarette
Switching to E-cigarette
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with diabetes who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of MACE | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Diabetic complications | Up to 5 years | Diabetic complications were defined as presence of diabetic neuropathy (ICD-10: E10.4, E11.4, E12.4, E13.4, E14.4, G59.0, G63.2, and G99.0), diabetic foot without amputation (ICD-10: E10.5, E10.7, E11.5, E11.7, E12.5, E12.7, E13.5, E13.7, E14.5, and E14.7), diabetic foot with amputation (ICD-10: E10.5, E10.7, E11.5, E11.7, E12.5, E12.7, E13.5, E13.7, E14.5, and E14.7; procedure codes: N0572-0575), and diabetic retinopathy, including non-proliferative (ICD-10: H360) and proliferative (ICD-10: H360; procedure codes: S5160 and S516) forms. |
| Rates of All-cause death | Up to 5 years | the individual components of MACE |
| Rates of Myocardial infarction | Up to 5 years | the individual components of MACE. 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. |
| Rates of Unplanned Revascularization | Up to 5 years | Unplanned revascularization was defined as presence of procedure codes for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index date. |
| Rates of Ischemic stroke | Up to 5 years | Stroke was defined based on ICD codes for ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes for hospitalization. |
| Rates of Hemorrhage stroke | Up to 5 years | Hemorrhage stroke was defined based on ICD codes for intracranial hemorrhage (ICD-10 I60-62), combined with the codes for hospitalization. |
| Rates of Mild pulmonary disease | Up to 5 years | Mild pulmonary disease were identified using validated ICD-10 codes. |
| Rates of Severe exacerbation of Pulmonary disease | Up to 5 years | Hospitalization for exacerbation in patients with a documented pulmonary disease code. |
| Rates of Cancer | Up to 5 years | Cancer was defined as the presence of cancer-specific insurance claim code (V193 code) with a C code which was an ICD-10 code for cancer. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORKi Hong Choi, MD, PhD
Samsung Medical Center
Outcome results
None listed