N/A
Completed N=61,175
Carcinogenicity Study of Bupropion
Source: ClinicalTrials.gov NCT01077596 ↗Enrolled (actual)
61,175
Serious AEs
—
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant — 853; 4561; 1963; 2570 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant |
853; 4561; 1963; 2570; 1027; 6332 | — |
| SECONDARY Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
37; 234; 111; 134; 35; 89 | — |
| SECONDARY Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
115; 250; 109; 138; 47; 125 | — |
| SECONDARY Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
48; 191; 88; 103; 40; 77 | — |
| SECONDARY Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
25; 233; 114; 124; 45; 91 | — |
| SECONDARY Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
302; 2173; 941; 1265; 497; 2966 | — |
| SECONDARY Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant |
326; 1480; 600; 806; 363; 3224 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01077596). 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. Informational only — not medical advice.