EMA study on prescribing of ibuprofen in the French primary care setting

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M01A) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

  ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

Population studied

• Short description of the study population:
  Patients recorded in the France IMS database as having received a prescription of ibuprofen from 1st January 1997 to 30th June 2014.
• Age groups:
  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)
• Estimated number of subjects:
  3889629

Study design details

• Main study objective:
  The primary objective of the present analysis is to provide drug utilisation data on the exposure of high-dose ibuprofen prescribing (2,400 mg or above per day) in France in adults.Furthermore, the duration of the prescription will be calculated to estimate the percentage of patients prescribed high-dose ibuprofen for long periods.
• Outcomes:
  The primary objective of the present analysis is to provide drug utilisation data on the exposure of high-dose ibuprofen prescribing (2,400 mg or above per day) in France in adults. The duration of the prescription will be calculated to estimate the percentage of patients prescribed high-dose ibuprofen for long periods.
• Data analysis plan:
  This study is a descriptive analysis of EHR data from IMS Health. No sample size or statistical precision calculation is performed.