Comparative Effectiveness and Safety of Immunosuppressive Drugs in Transplant patients (CESIT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Transplant

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  7000

Study design details

• Main study objective:
  1. To describe the prescriptive patterns of immunosuppressive drug regimens in different transplant settings (kidney, lung, liver, heart) used in maintenance phase and identify patient characteristics associated to these patterns in the four Italian regions 2. To compare the risk-benefit profile of different immunosuppressive therapeutic regimens in transplant patients
• Outcomes:
  Transplant rejection, organ survival, use of steroids or immunoglobulin or antibodies for acute rejection, overall mortality, infections, diabetes incidence, cancer incidence (including skin cancer and lymphoma), hypertension incidence,incident statin use, Use of health care services, adverse drug reactions, lymphoproliferative disease, hyperglycemia, magnesium metabolism disorders, recurrence of HCV
• Data analysis plan:
  Data will be organised and managed through a common data model. Analysis will be performed running the shared scripts at local level and pooling aggregated data at the end. Drug utilization will be defined on the basis of DDDs. CER will be performed through both a multivariate models and a propensity matched cohort design (head-to-head comparison between different drug groups/drugs). Patients in the compared exposure groups will be propensity matched. Intention-to-treat and As-treated analyses will be performed using Cox proportional Hazard models (HRs and 95%CIs).