Use of ondansetron in pregnant female patients in the IMS Disease Analyzer databases in France and Germany (Ondansetron use pregnancy)

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

Study drug and medical condition

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

  Hyperemesis gravidarum

Population studied

• Short description of the study population:
  All pregnant women with no prior diagnosis of cancer are identified, and all use of ondansetron during pregnancy in women with no prior diagnosis of cancer is captured. Pregnant women with excessive vomiting in pregnancy are then specifically identified, and use of ondansetron in these women is captured.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  This aim was to identify use of ondansetron in women during pregnancy in France and Germany as identified in the IMS Disease Analyzer (DA) databases. Due to concern that ondansetron may be increasingly used for hyperemesis gravidarum a further aim was to study the yearly proportion of women with a diagnosis of excessive vomiting of pregnancy treated with ondansetron between 2005 and 2018.
• Data analysis plan:
  The yearly number of pregnant women was calculated and the number of pregnant women with a prescription for ondansetron during the time of pregnancy was presented. The proportion of women with a diagnosis of hyperemesis gravidarum that had received a prescription for ondansetron was calculated.