Suicide and suicidality after exposure to finasteride (Suicidality with finasteride)

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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (D11AX01) minoxidil

  (D11AX10) finasteride

  (G04CA) Alpha-adrenoreceptor antagonists

  (G04CA51) alfuzosin and finasteride

  (G04CA52) tamsulosin and dutasteride

  (G04CB01) finasteride

  (G04CB02) dutasteride
• Medical condition to be studied:
  Suicidal ideation

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  To assess if use of finasteride is associated with increased risk of suicidality.
• Outcomes:
  The primary outcome will be a composite consisting of the first occurrence of any of the following events: completed suicide, attempted suicide, and suicidal ideation. The secondary outcomes will be the component parts of the primary outcome, following up until the first event of each of the following: (i) completed suicide, (ii) completed or attempted suicide. In addition, all-cause deaths will be used as a sensitivity analysis because of the risk of misclassification of cause of death.
• Data analysis plan:
  Multivariable survival modelling (most likely a Cox proportional hazards model) will be used to calculate adjusted Hazard Ratios associated with medication of interest use vs comparators, adjusting for potential confounders measured at baseline. Covariates will be included in the analysis by contributing to a propensity score for each patient and will be included in the model as inverse probability of treatment weights.