Utilisation of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the united kingdom and the netherlands

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Medical condition to be studied:
  Arteriosclerosis

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:
  1300000

Study design details

• Main study objective:
  To compare the trends of the utilisation of low-dose rivaroxaban over the period 2015-2022, before and after guideline changes, in two European countries
• Outcomes:
  Incidence of the new (incident) use of low-dose rivaroxaban
• Data analysis plan:
  An ITS analysis will be used to determine whether the introduction of the Netherland’s National Health Care Institute (Zorginstituut Nederland, 29/01/2019) and UK’s National Institute for Health and Care Excellence (NICE, 17/10/2019) recommendations had an impact on utilisation. The primary analysis compared the periods pre- (from 01/01/2015 until the national guideline change “intervention”) and post-intervention (from intervention until the end of data collection) using a segmented Poisson regression analysis and per database. For the estimates of the effects of intervention, 95% confidence intervals (CI) and Wald p-values will be estimated. Chi-square and t-tests were used to evaluate differences in patient characteristics for the users versus non-users. Associations between the covariates and the probability of odds of low-dose rivaroxaban use were examined using a logistic regression model to estimate the odd ratio and corresponding 95% CI.