DARWIN EU® - Suicidality incidence rates in adult male patients and in patients treated with finasteride and dutasteride

Study type

• Study topic:
  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:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FINASTERIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AX10) finasteride

  finasteride

  (G04CB02) dutasteride

  dutasteride
• Medical condition to be studied:
  Androgenetic alopecia

  Benign prostatic hyperplasia

Population studied

• Short description of the study population:
  The study population will include all adult male patients (≥ 18 years old) present in the data source during the study period (Objective 1). ; Within this population 2 sub-cohorts will be nested namely one of adult male patients newly diagnosed with androgenetic alopecia and one consisting of adult male patients newly diagnosed with BPH (Objectives 2 and 4). ; Within these cohorts of adult males newly diagnosed with androgenetic alopecia and BPH, we will nest cohorts of individuals initiating treatments of interest for the first time in the study period (Objectives 3 and 5).;

Study design details

• Study design:
  Population-Level Cohort
• Main study objective:
  The specific objectives are to describe overall incidence rates of suicide-related events and stratified by age group, history of psychiatric disorder, history of sexual dysfunction, and calendar year (for the general adult male population) and follow-up year (for indication and treatment cohorts) in: ; 1. The general adult male population. ; 2. Adult male patients with newly diagnosed androgenetic alopecia.; 3. Adult male patients with newly diagnosed androgenetic alopecia initiating treatment for this condition (finasteride, dutasteride, topical minoxidil, and non-treated with prescribed study treatments).; 4. Adult male patients with newly diagnosed benign prostatic hyperplasia (BPH).; 5. Adult male patients with newly diagnosed BPH initiating treatment for this condition (finasteride, dutasteride, alpha blockers, tadalafil, and non-treated with prescribed study treatments).;
• Outcomes:
  Outcome of interest was a composite suicidality outcome which included the first recorded occurrence of any of the following events: completed suicide, attempted suicide, suicide ideation, and intentional self harm.
• Summary results:
  CONCLUSION ; In this epidemiological analysis of suicide-related events among adult male patients with androgenetic alopecia and BPH, treated with medicines of interest, as well as the general male population in the UK, the Netherlands, Spain, Croatia, Germany, and Denmark, we observed variability in suicidality incidence rates across European healthcare data sources. Higher incidence rates were consistently reported among patients with a history of psychiatric disorders across all cohorts. Also, higher incidence rates were reported among patients with prior sexual dysfunction and a diagnosis of BPH, however, estimates for treatment cohorts were affected by low counts of events and limited follow-up time in most of the data sources. Higher suicidality rates were observed in younger age groups in the general adult male population, but this trend was less obvious in BPH patients as the age distribution shifted towards older individuals. There was substantial uncertainty around the incidence rates of suicide-related events for androgenetic alopecia patients and those prescribed with finasteride, dutasteride, or minoxidil due to the scarcity of events and the limited size of cohorts, which made these estimates uninformative. ; Although certain treatment groups, such as patients receiving alpha blockers for BPH, exhibited slightly higher rates, the overall findings suggest that suicidality risks in these populations remain low and not different to rates as reported in the general male population, with possible underreporting and differences in healthcare systems contributing to variations across regions.