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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5ARI Users |
| ||
| Non 5ARI users |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5ARI | Drug | Exposure to finasteride/dutasteride |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07". | Through study completition, an average of 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) |
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 |
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Inclusion Criteria:
Exclusion Criteria:
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All men >66 years of age in Ontario between 2003-2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 5ARI Users | 5ARI: Exposure to finasteride/dutasteride |
| FG001 | Non 5ARI Users |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5ARI Users | 5ARI: Exposure to finasteride/dutasteride |
| BG001 | Non 5ARI Users | Matched patients without 5ARI usage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) |
i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07". | Posted | Count of Participants | Participants | Through study completition, an average of 18 months. |
|
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Please note that only mortality from suicide was assessed, all-cause mortality could not be determined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5ARI Users | 5ARI: Exposure to finasteride/dutasteride | 160 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blayne Welk | ICES Western | 5196466000 | blayne.welk@sjhc.london.on.ca |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
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| Through study completition, an average of 18 months. |
| Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) |
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) | Through study completition, an average of 18 months. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prior depression | Count of Participants | Participants |
|
| OG001 | Non 5ARI Users |
|
|
| Secondary | Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) |
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 | Posted | Count of Participants | Participants | Through study completition, an average of 18 months. |
|
|
|
| Secondary | Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) |
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) | This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population. | Posted | Count of Participants | Participants | Through study completition, an average of 18 months. |
|
|
|
| 93,197 |
| 0 |
| 93,197 |
| 0 |
| 93,197 |
| EG001 | Non 5ARI Users | Matched control patients with no exposure to 5ARI | 139 | 93,197 | 0 | 93,197 | 0 | 93,197 |
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