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Drugs to quit smoking do not increase neuropsychiatric side-effects

Drugs to quit smoking do not increase neuropsychiatric side-effects

Publication date: Friday, 13 May 2016
Contributor(s): Jeremy Bray

Varenicline and bupropion do not appear to significantly increase the incidence of serious neuropsychiatric side-effects compared to placebo. Substantial concerns have been raised previously about the neuropsychiatric safety of these drugs. This new study compared the neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders.

The double blind randomised trial is the largest study to date looking at the safety and efficacy of these treatments and lead author Professor Robert Anthenelli (University of California, San Diego, USA) said, “Our study shows that all three first-line smoking cessation medications are effective in helping people stop smoking, with varenicline being the most effective.” 

The study included >8000 participants aged 18-75 who smoked >10 cigarettes a day and were motivated to stop smoking (82% had made at least one attempt to quit). Half of them had a history of a past or current stable psychiatric condition including a mood, anxiety, psychotic, or borderline personality disorder. All participants were assessed to see whether they suffered any moderate-to-severe adverse neuropsychiatric events during and after treatment, including agitation, aggression, panic, anxiety, depression and suicide ideation among others. There were no significant increases in neuropsychiatric events in either group (Table).

Varenicline was more effective in helping people stop smoking than bupropion, nicotine patches, or placebo. Bupropion was about as effective as nicotine patches, and both were more effective than placebo. Overall, at 9-24 weeks, 21.8% of people on varenicline were continuously abstinent (16.2% for bupropion; 15.7% nicotine patches; 9.4% placebo). Smokers with a psychiatric disorder achieved slightly lower abstinence rates than smokers without a psychiatric disorder.

Treatment groups With psychiatric disorders Without psychiatric disorders
Varenicline 6.5% 1.3%
Bupropion 6.7% 2.2%
Nicotine patch 5.2% 2.5%
Placebo 4.9% 2.4%


Table: Incidence of neuropsychiatric events


Clinical guidelines recommend that the most effective way to give up smoking is by using smoking cessation medication and counselling. This study shows that varenicline and bupropion can be used with confidence as they do not increase the risk of moderate-to-severe neuropsychiatric side-effects in smokers without psychiatric disorders. Patients should be made aware of the small chance of changes in mood and psychiatric well-being and all patients should be monitored.

Anthenelli RM, 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. Lancet 2016, published online 22 April   DOI: http://dx.doi.org/10.1016/S0140-6736(16)30272-0

Topics covered:
Category: Evidence in Practice
Edition: Volume 1, Number 5, BJPCN Online 2016
Contributor(s): Jeremy Bray

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