Prescribing of digoxin for long-term use in atrial fibrillation in France, Germany and the UK during 2000-2014

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DIGOXIN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Atrial fibrillation patients receiving a prescription of digoxin for oral use, excluding products that contain digoxin in combination with another active substance, recorded in the IMS Disease Analyser in France and Germany.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • 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

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  19000

Study design details

• Main study objective:
  To study prescribing of digoxin in patients with atrial fibrillation
• Data analysis plan:
  The yearly prevalence of prescribing of digoxin will be estimated from the number of patients with a prescription and the total number of patients with a consultation during the time period.