Use of Low-dose Quetiapine and the Risk of Major Adverse Cardiovascular Events

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AH04) quetiapine

  (N05CF) Benzodiazepine related drugs
• Medical condition to be studied:
  Cardiac death

  Acute myocardial infarction

  Ischaemic stroke

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:
  850000

Study design details

• Main study objective:
  To investigate the association between the use of low-dose quetiapine and major adverse cardiovascular events.
• Outcomes:
  Primary outcome is major adverse cardiovascular events defined as a composite of: i) Death from cardiovascular causes, ii) non-fatal myocardial infarction, or iii) non-fatal stroke. Secondary outcomes are the individual items of the primary (composite) outcome: i) Death from cardiovascular causes, ii) non-fatal myocardial infarction iii) non-fatal stroke.
• Data analysis plan:
  Intention-to-treat-like and on-treatment-like analyses will be conducted on the full cohort using propensity-score weighting to adjust for baseline confounding. The main measure of risk is hazard ratios. Furthermore, we will calculate the number of cases attributable to use of low-dose quetiapine.