BPH, Depression, Suicide
Conditions
Brief 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.
Interventions
DRUG5ARI
Exposure to finasteride/dutasteride
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
66 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Through study completition, an average of 18 months. | 1. Ontario Registrar General Death database. Use the COD\_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84. 2. NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event. 3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event. 4. CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp=07. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) | Through study completition, an average of 18 months. | 1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm). 2. OMHRS: admission with suicide ideation. i. Self injury attempts: D1A or selfinjury\_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury\_intent=1 iii. Self injury considered: D1C or selfinjury\_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide\_plan=1 |
| Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) | Through study completition, an average of 18 months. | 1. Any CIHI-DAD/SDS ICD 10 code, OR 2. Any OMRHS code Axis1\_dsm4code1-19 or Axis2\_dsm4code 1-7 OR 3. Look for any OHIP record billed by Mainspecialty = PSYCHIATRY with a diagnosis of depression OHIP dxcode 311, OR 4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311 i. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5ARI Users 5ARI: Exposure to finasteride/dutasteride | 93,197 |
| Non 5ARI Users Matched patients without 5ARI usage | 93,197 |
| Total | 186,394 |
Baseline characteristics
| Characteristic | 5ARI Users | Non 5ARI Users | Total |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 6.7 | 75.5 years STANDARD_DEVIATION 6.9 | 75.5 years STANDARD_DEVIATION 6.8 |
| Prior depression | 3353 Participants | 3353 Participants | 6706 Participants |
| Region of Enrollment Canada | 93197 participants | 93197 participants | 186394 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 93197 Participants | 93197 Participants | 186394 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 160 / 93,197 | 139 / 93,197 |
| other Total, other adverse events | 0 / 93,197 | 0 / 93,197 |
| serious Total, serious adverse events | 0 / 93,197 | 0 / 93,197 |
Outcome results
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)
1. Ontario Registrar General Death database. Use the COD\_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84. 2. NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event. 3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event. 4. CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp=07.
Time frame: Through study completition, an average of 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5ARI Users | 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 Participants |
| Non 5ARI Users | 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) | 36 Participants |
Secondary
Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
1. Any CIHI-DAD/SDS ICD 10 code, OR 2. Any OMRHS code Axis1\_dsm4code1-19 or Axis2\_dsm4code 1-7 OR 3. Look for any OHIP record billed by Mainspecialty = PSYCHIATRY with a diagnosis of depression OHIP dxcode 311, OR 4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311 i. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)
Time frame: Through study completition, an average of 18 months.
Population: This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5ARI Users | Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) | 1750 Participants |
| Non 5ARI Users | Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) | 1231 Participants |
Secondary
Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm). 2. OMHRS: admission with suicide ideation. i. Self injury attempts: D1A or selfinjury\_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury\_intent=1 iii. Self injury considered: D1C or selfinjury\_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide\_plan=1
Time frame: Through study completition, an average of 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5ARI Users | Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) | 169 Participants |
| Non 5ARI Users | Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) | 130 Participants |