| Outcome Measures: |
Primary: Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition, 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., 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), Broad Definition, 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)., 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), Specific Definition, 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., 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 all-cause mortality (ACM)., 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 hospitalization for heart failure (HHF) and all cause mortality (ACM)., 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 composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM)., 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 myocardial infarction (MI)., 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, Number of participants with stroke., 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. | Secondary: Number of Participants With Cardiovascular Mortality (CM), 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, 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, 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, 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), 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, 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, 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, Number of participants with composite outcome including Estimated glomerular filtration rate (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, Number of participants with bone fracture. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i., From index date until end of follow-up, up to 67 months.|Number of Participants With Diabetic Ketoacidosis, Number of participants with diabetic ketoacidosis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i, From index date until end of follow-up, up to 67 months.|Number of Participants With Severe Hypoglycemia, Number of participants with severe hypoglycemia. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i., From index date until end of follow-up, up to 67 months.|Number of Participants With Lower-limb Amputation, Number of participants with lower-limb amputation. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i., From index date until end of follow-up, up to 67 months.|Number of Participants With Acute Kidney Injury Requiring Dialysis, Number of participants with acute kidney injury requiring dialysis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i., From index date until end of follow-up, up to 67 months.|Healthcare Resource Utilization (HCRU): Number of Any Medical Visit, HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include emergency room visits, first inpatient stay, all-cause hospital admissions and outpatient healthcare visits. HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan. For arms with 0 patients analyzed, no data was collected for the specific outcome in this country., From index date until end of follow-up, up to 67 months.|Healthcare Resource Utilization (HCRU): Number of Any Prescription, HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan. For arms with 0 patients analyzed, no data was collected for the specific outcome in this country., From index date until end of follow-up, up to 67 months.|Total Healthcare Costs - Finland, Norway, Sweden, Total healthcare cost include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare costs for Finland, Norway and Sweden are reported in Euro per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan., From index date until end of follow-up, up to 67 months.|Total Healthcare Cost - Japan, Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare cost for Japan are reported in Japanese Yen (JPY) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan., From index date until end of follow-up, up to 67 months.|Total Healthcare Cost - South Korea, Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare costs for South Korea are reported in 1000 Korean Won (KRW) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan., From index date until end of follow-up, up to 67 months.|Total Healthcare Cost - Taiwan, Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare cost for Taiwan are reported in United States Dollar (USD) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan., From index date until end of follow-up, up to 67 months.
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| Locations: |
Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology, Gentofte, 2820, Denmark|Helsinki University Hospital, Helsinki, 00029, Finland|University of Ulm, Institute for Epidemiology and medical biometry, Ulm, 89081, Germany|Maccabi Healthcare Services, Tel Aviv, 6812509, Israel|Gifu University, Gifu, 501-1193, Japan|Ajou University Hospital, Suwon, 16499, Korea, Republic of|Oslo University Hospital, Department of Clinical Lipidology, Oslo, 0424, Norway|Oslo University Hospital, Department of Cardiology, Oslo, 0450, Norway|Instituto de Investigación Sanitaria INCLIVA, Valencia, 46010, Spain|TFS Trial Form Support International AB, Lund, 223 63, Sweden|Quantify Research AB, Stockholm, 112 21, Sweden|Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR), Taipei City, 100, Taiwan|Leicester Real World Evidence Unit, Leicester general Hospital, Leicester, LE5 4PW, United Kingdom
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