Researchers from the Department of Veterans Affairs conducted a retrospective cohort study to compare the risk of mental health episodes requiring hospitalization or outpatient clinic visits, associated with varenicline vs. nicotine patch use during the time prior to psychiatric boxed warnings. Findings from the study are published in Addiction

Participants in the study included VA patients with or without psychiatric comorbidities, and a new prescription for varenicline, whose propensity score matched new users of a nicotine patch between May 2006 and September 2007. A total of 11,774 patients in the varenicline group and 23,548 patients in the nicotine patch group were evaluated. The study’s primary outcomes were hospitalizations with a primary discharge diagnosis of mental health disorders (depression, schizophrenia, bipolar disorder, suicide attempt, post-traumatic stress disorder, other psychosis, drug-induced mental disorders). Secondary outcomes included outpatient clinic visits with a primary diagnosis of the above list of mental health disorders. 

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Researchers found no statistically significant difference in the risk of hospitalization for any of the above mental health disorders for varenicline users vs. nicotine patch users. For secondary outcomes, there were more outpatient clinic visits  for schizophrenia among varenicline users (HR 1.27, 95% CI: 1.07, 1.51) who had a pre-existing mental health disorders.

For the time period prior to the implementation of psychiatric boxed warnings, study data indicate that there was no notable increase in hospitalization for any mental health outcomes associated with varenicline use for smoking cessation vs. nicotine patches. A higher rate of outpatient visits with a primary diagnosis of schizophrenia totaling 5 per 100 person years of treatment was observed; however, this increase was only seen in patients with a pre-existing mental health disorder. 

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