A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new users of ticagrelor,clopidogrel and prasugrel in national Swedish registries.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  PRASUGREL

  CLOPIDOGREL
• Medical condition to be studied:
  Intracranial haematoma

  Gastrointestinal haemorrhage

  Bradyarrhythmia

  Cardiac pacemaker insertion

  Cardiac arrest

  Cardiac failure

  Acute kidney injury

  Liver injury

  Dyspnoea

  Syncope

Population studied

• Short description of the study population:
  All patients aged 20 to 84 years before their first study drug dispensing were included in the study.
• 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:
  Hepatic impaired

  Other

  Renal impaired
• Special population of interest, other:
  Patients with haemorrhages and cardiac issues
• Estimated number of subjects:
  75000

Study design details

• Main study objective:
  To provide a detailed description of patients who are prescribed ticagrelor for the first time
• Outcomes:
  The selected outcomes include hospitalizations for:intracranial bleeding, gastrointestinal bleeding, other bleeding, bradyarrhythmias,pacemaker insertion, cardiac arrest /CHD death outside hospital, heart failure, acute renalfailure and acute liver injury.Selected outcomes not requiring hospitalizations include: dyspnoea, syncope and gout.
• Data analysis plan:
  The patient populations and basic utilization measures will be described. This analysis will in-clude a description of the various subgroups: “naïve”, “non naïve”, “switchers” and “past thienopyridine users”. We will describe duration of treatment over the one year follow-up period in the three study cohorts. First time users of ticagrelor, clopidogrel and prasugrel, respectively will be described with regard to age- and sex distribution, and the prevalence of concomitant treatments and recorded comorbidities. Crude incidence rates and 95% confidence intervals will be estimated as the ratio of the number of cases of the outcome of interest divided by the number of person-years among current users of the study drugs. If numbers permit, event rates in different categories of treatment duration among current users as well as among discontinuers and past users will be reported.