Carcinogenicity Study of Bupropion

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.

• Regular bupropion use (Drug): 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.
• Regular SSRI (Selective serotonin reuptake inhibitors) use (Drug): 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.
• Regular TCA (Tricyclic antidepressants) use (Drug): 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.
• Regular use of any other antidepressant (Drug): 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.

Primary outcomes

• Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.

Secondary outcomes

• Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.
• Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.
• Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.
• Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.
• Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.
• Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant [January 1, 1996 - December 31, 2006]: 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant (Primary), Number, participants: Bupropion, Regular Use 853; All Non-bupropion Antidepressants, Regular Use 4561; Tricyclic Antidepressants (TCA), Regular Use 1963; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 2570; Other Antidepressants, Regular Use 1027
• Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 37; All Non-bupropion Antidepressants, Regular Use 234; Tricyclic Antidepressants (TCA), Regular Use 111; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 134; Other Antidepressants, Regular Use 35
• Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 115; All Non-bupropion Antidepressants, Regular Use 250; Tricyclic Antidepressants (TCA), Regular Use 109; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 138; Other Antidepressants, Regular Use 47
• Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 48; All Non-bupropion Antidepressants, Regular Use 191; Tricyclic Antidepressants (TCA), Regular Use 88; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 103; Other Antidepressants, Regular Use 40
• Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 25; All Non-bupropion Antidepressants, Regular Use 233; Tricyclic Antidepressants (TCA), Regular Use 114; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 124; Other Antidepressants, Regular Use 45
• Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 302; All Non-bupropion Antidepressants, Regular Use 2173; Tricyclic Antidepressants (TCA), Regular Use 941; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 1265; Other Antidepressants, Regular Use 497
• Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant (Secondary), Number, participants: Bupropion, Regular Use 326; All Non-bupropion Antidepressants, Regular Use 1480; Tricyclic Antidepressants (TCA), Regular Use 600; Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use 806; Other Antidepressants, Regular Use 363

Adverse events

• GSK Clinical Trials, Study director, GlaxoSmithKline