DARWIN EU® - Assessing the potential association between venlafaxine and heart failure in adults

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AX16) venlafaxine

  venlafaxine
• Additional medical condition(s):
  heart failure

Population studied

• Short description of the study population:
  The study population will include all individuals with a recorded first prescription for venlafaxine or mirtazapine within the study period from 01/01/2010 up to the end of data availability who meet the eligibility criteria at study entry.
• 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)

Study design details

• Study design:
  New user cohort studies will be conducted using routinely collected health data from 6 data sources from 5 countries across Europe and in 4 European Union (EU) member states.
• Main study objective:
  1) To assess the risk of incident heart failure and incident cardiomyopathy between new users of venlafaxine vs. new users of mirtazapine.; 2) To assess the risk of heart failure exacerbation between new users of venlafaxine vs. new users of mirtazapine who have been diagnosed with heart failure before treatment initiation. ; 3) To characterise both new venlafaxine and new mirtazapine users at the time of treatment start (in terms of demographics, pre-defined comorbidities/comedication/conditions of interest, and drug utilisation) for contextualisation of Objectives 1+2.;