Study type

Study type

Non-interventional study
Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

100000095647
minoxidil
100000095655
finasteride
100000095963
Alpha-adrenoreceptor antagonists
100000116235
alfuzosin and finasteride
100000116236
tamsulosin and dutasteride
100000095968
finasteride
100000095969
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.