Cardiovascular-Renal-Metabolism comorbidity epidemiology and healthcare utilisation – Observational studies across Europe – French part of the study program (CaReMe Europe)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Healthcare resource cost study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

  Cardiac failure

  Chronic kidney disease

  Myocardial infarction

  Cerebrovascular accident

  Peripheral arterial occlusive disease

Population studied

• 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)
• Estimated number of subjects:
  3346431

Study design details

• Main study objective:
  The main objective is to estimate the incidence rate of the first specific cardiorenal event (HF, CKD, cardiorenal diseases HF or CKD, PAD, MI, or stroke) in T2D patients free from cardiovascular and renal diseases.
• Outcomes:
  Outcomes and comorbidities (main analysis): main, linked, or associated diagnoses of hospitalisation associated with cardiorenal diseases (HF or CKD), HF, CKD, PAD, MI, stroke, and all-cause death. Outcomes (sensitivity analysis): main diagnosis of hospitalisation associated with cardiorenal diseases (HF or CKD), HF, CKD, PAD, MI, stroke, and all-cause death.
• Data analysis plan:
  -Incidence estimate of HF, CKD, cardiorenal diseases (HF or CKD), PAD, MI, stroke, (first event) in cardiovascular and renal disease-free T2D population, using incidence rate and Cumulative Incidence Function (CIF), to take death into account as a competing risk -Incidence estimate of PAD, MI, stroke, or all-cause death in comorbid T2D population, using incidence rate and Kaplan-Meier estimator (for all-cause death) or CIF (for other outcomes) -Incidence comparison of each outcome between disease-free and comorbid populations performed using a multivariable Cox proportional hazards regression model (disease-free patients as the reference category). Sensitivity analyses performed using multivariable Fine and Gray regression models for all outcomes except death -Description of healthcare resources use and cost (all payer perspective) of HF, CKD, cardiorenal diseases (HF or CKD), PAD, MI, or stroke (first event) for 5 years in T2D patients free from cardiovascular and renal diseases.