Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171,808
- 试验地点
- 13
- 主要终点
- Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition
研究概览
简要总结
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
- •No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
- •Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data
排除标准
- •Aged <18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
- •Type 1 diabetes mellitus
- •Secondary diabetes
- •Gestational diabetes
- •Having a diagnosis of ESRD during the 12 months before the index date
- •<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
- •Missing or ambiguous data on age or sex
研究组 & 干预措施
New users of SGLT-2i
Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.
干预措施: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor (Drug)
New users of DPP-4i
Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).
干预措施: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor (Drug)
结局指标
主要结局
Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Number of participants with Hospitalization for Heart Failure (HHF), using broad + specific HHF definition. HHF - broad defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics). HHF - specific defined as a primary diagnosis associated with hospital admission. For HHF - broad + specific, HHF-specific definition was used unless only broad definition were available. However, for Japan South Korea and Taiwan, both definitions were available, but broad definition was used.
Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Reported is the number of participants with hospitalization for heart failure (HHF), using broad definition of HHF. HHF - broad is defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics).
Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Reported is the number of participants with hospitalization for heart failure, using specific definition for HHF. HHF - specific defined as a primary diagnosis associated with hospital admission.
Number of Participants With All-cause Mortality (ACM)
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of participants with all-cause mortality (ACM).
Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM)
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of participants with composite outcome, including hospitalization for heart failure (HHF) and all cause mortality (ACM).
Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM)
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of participants with composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM).
Number of Participants With Myocardial Infarction (MI)
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of participants with myocardial infarction (MI).
Number of Participants With Stroke
时间窗: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of participants with stroke.
次要结局
- Healthcare Resource Utilization (HCRU): Number of Any Prescription(From index date until end of follow-up, up to 67 months.)
- Total Healthcare Costs - Finland, Norway, Sweden(From index date until end of follow-up, up to 67 months.)
- Total Healthcare Cost - Japan(From index date until end of follow-up, up to 67 months.)
- Total Healthcare Cost - South Korea(From index date until end of follow-up, up to 67 months.)
- Total Healthcare Cost - Taiwan(From index date until end of follow-up, up to 67 months.)
- Number of Participants With Cardiovascular Mortality (CM)(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With 3-point Major Adverse Cardiovascular (CV) Events (MACE), Defined as a Composite Outcome Including Myocardial Infarction (MI), Stroke and Cardiovascular (CV) Mortality(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Coronary Revascularization Procedure(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With End-stage Renal Disease (ESRD)(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Estimated Glomerular Filtration Rate (eGFR) Decline(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Progression From Normoalbuminuria to Micro- or Macroalbuminuria(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Composite Outcome Including eGFR Decline and Progression to Micro- or Macroalbuminuria(From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.)
- Number of Participants With Bone Fracture(From index date until end of follow-up, up to 67 months.)
- Number of Participants With Diabetic Ketoacidosis(From index date until end of follow-up, up to 67 months.)
- Number of Participants With Severe Hypoglycemia(From index date until end of follow-up, up to 67 months.)
- Number of Participants With Lower-limb Amputation(From index date until end of follow-up, up to 67 months.)
- Number of Participants With Acute Kidney Injury Requiring Dialysis(From index date until end of follow-up, up to 67 months.)
- Healthcare Resource Utilization (HCRU): Number of Any Medical Visit(From index date until end of follow-up, up to 67 months.)