Clinical and economic impact of 2nd line initiation of empagliflozin after metformin, as compared to 2nd line initiation of sulfonylurea after metformin in patients with type 2 diabetes and cardiovascular disease

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Burden
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  JARDIANCE
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Short description of the study population:
  Type 2 Diabetes (T2D) patients with Cardiovascular Disease (CVD).; ; Inclusion criteria:; • Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of a sulfonylurea; • ≥18 years of age at index date during study observation; • ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date; • ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date ; • ≥2 months post-index date; • ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms); • ≥12 months of continuous enrollment prior to index date; Exclusion criteria:; • Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date; • Diagnosis of severe comorbidities including malignancy, end‐stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date; • Admission to nursing home in the 12 months prior to index date
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  265

Study design details

• Main study objective:
  Evaluate clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with T2D and CVD.
• Outcomes:
  First hospitalization for heart failure (HHF) (we will first analyze this by looking at diagnosis code in any position, we will then run the analysis considering diagnosis coding in either the principal or secondary position). Healthcare utilization outcomes: hospitalizations, emergency department (ED) visits, length of stay, number of filled drugs, outpatient visits All cause cost outcomes: Total cost of care, divided by medical (inpatient costs, outpatient costs, emergency costs) and pharmacy costs (all reported in Per Patient Per Month (PPPM) costs)
• Data analysis plan:
  This study will be a non-interventional study using existing data from January 1, 2014 to the date of the latest available data from IQVIA (detailed below). Data available after March 31, 2020 will not be used due to the potential confounding events of coronavirus. The study will analyze the clinical and economic effect of empagliflozin in T2D patients with CVD. Empagliflozin initiators as an add-on therapy to metformin, comprise the treatment population. Patients initiating sulfonylureas as add-on to metformin comprise the control population.