Carcinogenicity Study of Bupropion

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cancer; Depressive Disorder

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01077596

111982

EPI40463

WEUKSTV1113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50,430 participants in 1 patient group

New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006

Description:

All new users of antidepressants January 1, 1996 through December 31, 2006. Individuals 18 years of age or older with medical and pharmacy benefits and at least 6 months of health plan enrollment before the first antidepressant prescription.

Treatment:

Drug: Regular SSRI (Selective serotonin reuptake inhibitors) use

Drug: Regular use of any other antidepressant

Drug: Regular bupropion use

Drug: Regular TCA (Tricyclic antidepressants) use