Pregabalin abuse in France : a national cohort study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PREGABALIN

  GABAPENTIN

  DULOXETINE

Population studied

• Short description of the study population:
  French adult population of both gender, naive of any study medication or medication used in the same indication with abuse potential.; Patients must have the following criteria:; 1. Aged 18 or more; 2. New users of pregabalin, gabapentin of duloxetine between the first date of inclusion (15th of June 2006) and until 31th December 2012 (to grant a two-years minimum follow-up),; 3. Subjects being reimbursed at least two delivery of medication group, at different dates (two delivery or more the same day, only once, will be considered as single time user)
• Age groups:
  • 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:
  15000

Study design details

• Main study objective:
  The main objective of this study will be to assess pregabalin abuse and its frequency in the French general population, in comparison to other drugs with similar indications (gabapentin and duloxetine), in a pharmacoepidemiological, observational, French national retrospective cohort study.The secondary objective is to determine the factors associated with abuse of each drug.
• Outcomes:
  Occurrence of drug abuse along time will be the main outcome (abuse of pregabalin in pregabalin group, etc.). The abuse will be defined by the exceeding of maximum daily dose recommended. For every 3 drugs studies, this maximum corresponds to 2 daily DDD
• Data analysis plan:
  Outcome will be abuse of the cohort study drug, defined as a daily abuse above the maximum recommended dose. Abuse will be investigated through a Kaplan-Meier survival model. Factors associated with abuse will be investigated through a Cox proportional hazard regression model with time dependent covariates.