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Carcinogenicity Study of Bupropion

Post-marketing Carcinogenicity Study of Bupropion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01077596
Enrollment
50430
Registered
2010-03-01
Start date
2008-06-30
Completion date
2010-03-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Depressive Disorder

Keywords

Carcinogenicity, Case control, Bupropion

Brief summary

There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.

Detailed description

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Interventions

DRUGRegular bupropion use

Regular use of bupropion is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUGRegular SSRI (Selective serotonin reuptake inhibitors) use

Regular use of SSRI is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUGRegular TCA (Tricyclic antidepressants) use

Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUGRegular use of any other antidepressant

Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An other antidepressant would be any antidepressant other than bupropion, a SSRI or a TCA.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\-

Exclusion criteria

* Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer. * Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period) * Any antidepressant use within 6 months of January 1, 1996

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Secondary

MeasureTime frameDescription
Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantJanuary 1, 1996 - December 31, 2006In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Participant flow

Recruitment details

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Participants by arm

ArmCount
New Antidepressant Exposure in Colorectal Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
350
New Antidepressant Exposure in Colorectal Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
1,050
New Antidepressant Exposure in Lung Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
457
New Antidepressant Exposure in Lung Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
1,370
New Antidepressant Exposure in Bladder Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
294
New Antidepressant Exposure in Bladder Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
882
New Antidepressant Exposure in Uterine Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
308
New Antidepressant Exposure in Uterine Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
837
New Antidepressant Exposure in Breast Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
2,842
New Antidepressant Exposure in Breast Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
28,420
New Antidepressant Exposure in Prostate Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
2,215
New Antidepressant Exposure in Prostate Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
22,150
Total61,175

Baseline characteristics

CharacteristicNew Antidepressant Exposure in Colorectal Cancer: ControlsNew Antidepressant Exposure in Lung Cancer: CasesNew Antidepressant Exposure in Lung Cancer: ControlsNew Antidepressant Exposure in Bladder Cancer: CasesNew Antidepressant Exposure in Bladder Cancer: ControlsNew Antidepressant Exposure in Uterine Cancer: CasesNew Antidepressant Exposure in Uterine Cancer: ControlsNew Antidepressant Exposure in Breast Cancer: CasesNew Antidepressant Exposure in Breast Cancer: ControlsNew Antidepressant Exposure in Colorectal Cancer: CasesNew Antidepressant Exposure in Prostate Cancer: CasesNew Antidepressant Exposure in Prostate Cancer: ControlsTotal
Age, Customized
45-54 years
102 Participants47 Participants140 Participants17 Participants51 Participants59 Participants172 Participants678 Participants6780 Participants34 Participants193 Participants1930 Participants10203 Participants
Age, Customized
55-64 years
219 Participants102 Participants306 Participants63 Participants189 Participants90 Participants245 Participants849 Participants8490 Participants73 Participants669 Participants6690 Participants17985 Participants
Age, Customized
65-74 years
357 Participants159 Participants477 Participants104 Participants312 Participants84 Participants224 Participants707 Participants7070 Participants119 Participants877 Participants8770 Participants19260 Participants
Age, Customized
>=75 years
372 Participants149 Participants447 Participants110 Participants330 Participants75 Participants196 Participants608 Participants6080 Participants124 Participants476 Participants4760 Participants13727 Participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever diagnosed (dx) with depression
329 participants108 participants408 participants83 participants273 participants119 participants319 participants1091 participants10541 participants110 participants677 participants6700 participants20758 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever dx with inflammatory bowel disease (IBD)
9 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants1 participants0 participants0 participants10 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever smokers
643 participants428 participants772 participants247 participants573 participants142 participants389 participants0 participants0 participants252 participants0 participants0 participants3446 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Exposed to multiple antidepressants
160 participants62 participants191 participants44 participants147 participants53 participants162 participants564 participants5756 participants47 participants340 participants3782 participants11308 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Unknown smoking status
70 participants5 participants183 participants1 participants29 participants4 participants27 participants0 participants0 participants4 participants0 participants0 participants323 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of hormone replacement therapy (HRT)
225 participants0 participants0 participants0 participants0 participants153 participants441 participants1796 participants17184 participants57 participants0 participants0 participants19856 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of NSAIDs
859 participants370 participants1123 participants0 participants0 participants0 participants0 participants2340 participants23730 participants269 participants1800 participants17887 participants48378 participants
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of oral contraceptives (OC)
7 participants0 participants0 participants0 participants0 participants8 participants45 participants236 participants1987 participants6 participants0 participants0 participants2289 participants
Sex: Female, Male
Female
378 Participants175 Participants525 Participants91 Participants273 Participants308 Participants837 Participants2842 Participants28420 Participants126 Participants0 Participants0 Participants33975 Participants
Sex: Female, Male
Male
672 Participants282 Participants845 Participants203 Participants609 Participants0 Participants0 Participants0 Participants0 Participants224 Participants2215 Participants22150 Participants27200 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant

The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantCases853 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantControls6332 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantCases4561 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantControls37831 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantCases1963 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantControls16574 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantControls21170 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantCases2570 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantCases1027 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated AntidepressantControls9096 participants
95% CI: [1, 1.2]
95% CI: [1, 1.3]
95% CI: [1, 1.2]
95% CI: [1.1, 1.3]
95% CI: [1, 1.2]
95% CI: [1.1, 1.3]
95% CI: [1.1, 1.4]
95% CI: [1, 1.3]
Secondary

Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with bladder cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases48 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls77 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases191 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls662 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases88 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls297 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls351 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases103 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases40 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls159 participants
95% CI: [1.7, 4.1]
95% CI: [1.3, 3.4]
95% CI: [1.4, 3.6]
95% CI: [1.1, 3]
95% CI: [1.5, 3.7]
95% CI: [1.1, 3]
95% CI: [1.5, 4.5]
95% CI: [1.3, 3.9]
Secondary

Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with breast cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls2966 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases302 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases2173 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls21188 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls9338 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases941 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases1265 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls12189 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases497 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls5141 participants
95% CI: [0.8, 1.1]
95% CI: [0.8, 1.1]
95% CI: [0.9, 1.2]
95% CI: [0.8, 1.1]
95% CI: [0.8, 1.1]
95% CI: [0.8, 1.1]
95% CI: [0.9, 1.3]
95% CI: [0.9, 1.2]
Secondary

Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with colorectal cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases37 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls89 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases234 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls739 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases111 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls321 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls411 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases134 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases35 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls166 participants
95% CI: [0.9, 2.2]
95% CI: [0.8, 2]
95% CI: [0.8, 2]
95% CI: [0.7, 1.9]
95% CI: [0.8, 2.1]
95% CI: [0.7, 1.9]
95% CI: [1.2, 3.9]
95% CI: [1.1, 3.6]
Secondary

Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with lung cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases115 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls125 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases250 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls922 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases109 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls389 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls532 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases138 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases47 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls186 participants
95% CI: [3.2, 6.3]
95% CI: [2, 4.4]
95% CI: [2.8, 5.8]
95% CI: [1.9, 4.5]
95% CI: [3.1, 6.3]
95% CI: [1.9, 4.5]
95% CI: [2.8, 7.2]
95% CI: [2.1, 5.9]
Secondary

Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with prostate cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls3224 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases326 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls15562 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases1480 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls6836 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases600 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases806 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls8306 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls3726 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases363 participants
95% CI: [1, 1.3]
95% CI: [1, 1.3]
95% CI: [0.9, 1.2]
95% CI: [1, 1.4]
95% CI: [1, 1.4]
95% CI: [0.9, 1.2]
95% CI: [0.9, 1.3]
95% CI: [0.8, 1.2]
Secondary

Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant

In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.

Time frame: January 1, 1996 - December 31, 2006

Population: Participants diagnosed with uterine cancer who were new antidepressant users.

ArmMeasureGroupValue (NUMBER)
Bupropion, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases25 participants
Bupropion, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls91 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases233 participants
All Non-bupropion Antidepressants, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls633 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases114 participants
Tricyclic Antidepressants (TCA), Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls257 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls360 participants
Selective Serotonin Reuptake Inhibitors (SSRI), Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases124 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantCases45 participants
Other Antidepressants, Regular UseNumber of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated AntidepressantControls165 participants
95% CI: [0.5, 1.3]
95% CI: [0.4, 1.2]
95% CI: [0.4, 1.1]
95% CI: [0.3, 1]
95% CI: [0.5, 1.4]
95% CI: [0.4, 1.4]
95% CI: [0.6, 2]
95% CI: [0.6, 1.9]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026