A pharmacoepidemiological study of rivaroxaban use and potential adverse outcomes in routine clinical practice in Sweden

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Xarelto
• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  100000093931

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Acute coronary syndrome

  Venous thrombosis

  Pulmonary embolism

  Atrial fibrillation

Population studied

• Short description of the study population:
  All patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor in any pharmacy in Sweden.
• Age groups:
  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:
  Renal impaired
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  To assess patterns of drug utilization and to quantify outcomes related to safety and effectiveness in new users of rivaroxaban compared with new users of standard of care in routine clinical practice in Sweden.
• Outcomes:
  1) Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time 2) Occurrence of hospitalization for a) intracranial haemorrhage, (b) gastrointestinal bleeding, (c) urogenital bleeding among users of rivaroxaban, 1) Occurrence of hospitalization for bleeding events not specified as primary safety outcomes 2) Occurrence of non-infective liver disease 3) Outcomes related to effectiveness (ischaemic stroke or myocardial infarction) 4) All-cause mortality as well as cause-specific mortality
• Data analysis plan:
  The diagnosis associated with the prescribing of the index drug will be grouped by indication. The patient populations will be described according to demographics, previous and current disease and concomitant medication at baseline both overall and stratified by indication. For descriptive purposes, annualized crude incidence rates of the specified outcome events will be calculated, accompanied by 95% confidence intervals. For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.

Documents

Study results

EUPAS9895-43209

Study report

EUPAS9895-43210

Sweden EUPAS9895 - Summary Interim Report

Sweden EUPAS9895_ Progress report

Study, other information

Sweden EUPAS9895_ Progress report.pdf

Sweden EUPAS9895 - Summary Interim Report.pdf