Cardiac profile of patients using rosiglitazone-containing anti-diabetes medicines: a study using the THIN database

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Off-label prescribing
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ROSIGLITAZONE

Population studied

• Short description of the study population:
  Patients received at least one prescription of rosiglitazone-containing products in a clinical practice during a time window of 20 months from (April 1, 2008 through November 30, 2009).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Discover how many patients receive rosiglitazone despite having cardiac contra-indications
• Outcomes:
  Proportion of patients with cardiac contra-indications, Proportion of patients with history of heart failure
• Data analysis plan:
  Data and main analysisWe performed the study using The Health Improvement Network (THIN) database, patient receiving rosiglitazone were identified and then their medical history checked for events associated with either heart failure or acute coronary syndrome. Simple proportions were presented with confidence intervals.