Study: Smoking Cessation Drugs May Not Raise Psychiatric Event Risk

Varenicline and bupropion, 2 smoking cessation drugs, are not associated with increased risk of moderate-to-severe adverse neuropsychiatric events indicated on boxed warning descriptions for both drugs, according to a recent study.

The researchers conducted a randomized, double-blind, triple-dummy, placebo-controlled and active-controlled trial of varenicline and bupropion, administering the drugs for 12 weeks with 12-week nontreatment follow-up, to 8144 participants from 140 medical centers in 16 countries.
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Participants were randomized to receive varenicline, bupropion, nicotine patch, or placebo, and 4116 had a psychiatric disorder that was either stable or in remission.

Overall, 13 of 990 participants reported moderate and severe neuropsychiatric adverse events in the varenicline group, 22 of 989 in the bupropion group, 25 of 1006 in the nicotine patch group, and 24 of 999 in the placebo group.

The only significant difference observed in the study was in the nonpsychiatric cohort, in which varenicline users were at a significantly lower risk for neuropsychiatric events than placebo users.

“The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo,” the researchers concluded. “Varenicline was more effective than placebo, nicotine patch, and bupropion in helping smokers achieve abstinence, whereas bupropion and nicotine patch were more effective than placebo.”

—Michael Potts

Reference:

Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial [published online April 22, 2016]. Lancet. DOI:http://dx.doi.org/10.1016/S0140-6736(16)30272-0.