An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union – 2019

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX16) pregabalin

  pregabalin

Population studied

• 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)
• Estimated number of subjects:
  60000

Study design details

• Main study objective:
  1) Summarize misuse and abuse data for pregabalin and each comparator within each country for each data source
• Outcomes:
  Summarize misuse and abuse data for pregabalin and each comparator within each country for each data source, 2) Summarize patterns of polysubstance use of drugs for pregabalin and each comparator to assess frequency of joint use of drugs within each country, data source, and time period of interest
• Data analysis plan:
  The market authorization holder will estimate rates or prevalence estimates for each of the outcomes (non-medical use, misuse, abuse, intentional exposures) by program for pregabalin and comparators within each country using descriptive statistics.