N/A
N=186,394
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
BPH · Depression · Suicide
Bottom Line
View on ClinicalTrials.gov: NCT02876757 ↗Enrolled (actual)
186,394
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database) — 38; 36 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 5ARI (Drug)
- Age
- Older Adult · 66+ yrs
- Sex
- Male
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database) |
38; 36 | — |
| SECONDARY Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) |
169; 130 | — |
| SECONDARY Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) |
1750; 1231 | — |
Summary
In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.
Eligibility Criteria
Inclusion Criteria
- All men >66 years of age in Ontario between 2003-2013
Exclusion Criteria
- Non Ontario residents
- No prescriptions filled in prior 180 days
- Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.
- Prescription initiated during hospital admission or ER visit.
Data sourced from ClinicalTrials.gov (NCT02876757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.