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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  LYRICA
• Medical condition to be studied:
  Drug abuse

Population studied

• Short description of the study population:
  Entire population enrolled by each data source; EUROPAD Program:; The surveillance population consists of individuals seeking treatment for substance use disorders (other than alcohol) at sites that offer treatment for opioid use disorders in France, Germany, and Italy.; Treatment Center Programs Combined:; The surveillance population consists of patients entering treatment for opioid dependence in the United States.; GTNet Program:; The surveillance population consists of exposure cases recorded by participating poison centres in France, Germany, and Italy.; National Poison Data System:; The surveillance population consists of exposure cases recorded by 55 regional poison control centers in all 50 states covering 100% of the total United States population.; Survey of Non-Medical Use of Prescription Drugs Program:; The surveillance population consists of the adult general population via an online survey panel company. The sample is stratified by United States Census region and gender, mirroring the distribution of the population in both percentage and gender representation (approximately 50% female, 50% male within each region). The samples from France, Germany and Italy are stratified by gender and Nomenclature des unités territoriales statistiques (NUTS) 1 level regions.; Web Monitoring Program:; The Web Monitoring Program surveillance population consists of individuals within the United States who post statements related to misuse and abuse on public social media accounts, online blogs, web forums and other internet sites.
• 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:
  100

Study design details

• Main study objective:
  The primary objectives of this evaluation:1) Summarize misuse and abuse data for pregabalin and each comparator within each country for each data source2) Perform a statistical analysis of trends over time for pregabalin and each comparator to assess changes in misuse and abuse within each country and data source
• Outcomes:
  Non medical useAbuse
• Data analysis plan:
  The primary objective will be to 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.