Use of Selincro® and impact on usual practice (USE-PACT)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N07BB05) nalmefene

  nalmefene
• Medical condition to be studied:
  Alcohol abuse

Population studied

• Short description of the study population:
  Adult patients with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification initiated treatment with Selincro® (nalmefene).
• 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:
  1000

Study design details

• Main study objective:
  To evaluate the evolution of alcohol consumption at one year in patients initiating Selincro® in usual practice.
• Outcomes:
  The evolution of alcohol consumption at 1 year will be defined as the relative evolution of Total Alcohol Consumption (TAC) between inclusion and end of follow-up at 1 year.The TAC (g/day) is equal to the number of standard drinks consumed in previous week by patient multiplied by a factor of ten (one standard drink corresponding to about 10g of alcohol), then divided by 7 (days number of week). At the different times of follow-up (1, 3, 6, 9 and 12 months) the evolution of alcohol consumption will be evaluated with respect to inclusion day in terms of: relative and absolute evolution of TAC and Heavy Drinking Days (HDD, number of days with a high consumption of alcohol), at least 70% reduction in TAC, change in the alcohol consumption risk level according to the WHO.
• Data analysis plan:
  Statistical analysis will be performed after database lock using SAS® software.The representativeness of the cohort in terms of patient characteristics will be evaluated by an analysis in a representative French health insurance database, the EGB (Echantillon Généraliste de Bénéficiaires).Statistical analysis will provide a description of : the total population, and according to prescriber specialty, and pevious medicinal treatment, the treated patient characteristcs, the evolution in alcohol consumption, the follow-up, Selincro® treatment, and adverse events.