Impact of rosiglitazone safety alerts on oral antidiabetic sales trends: a country-wide study in Portugal

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:
  Other
• Non-interventional study design, other:
  Ecological

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BG02) rosiglitazone

  rosiglitazone

Population studied

• Short description of the study population:
  Diabetic population using oral antidiabetic drugs.
• 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:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral anti diabetic drugs.
• Outcomes:
  Sales of rosiglitazone in Portugal from January 2002 to December 2012, Sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012
• Data analysis plan:
  We conducted an ecological study, using temporally aggregated data and linking safety alerts to country-wide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012