Citation

Prescrire Int. 2017; 26(184): 183-185.

Copyright

(Copyright © 2017, Association Mieux Prescrire)

DOI

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PMID

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Abstract

In 2006, varenicline, a nicotinic acetylcholine receptor partial agonist, was authorised for use in smoking cessation, without any demonstrable advantage over nicotine in terms of the harm-benefit balance. Clinical trials versus placebo, involving about 3000 patients, showed various neuropsychiatric adverse effects. Since varenicline was introduced to the market, mood disorders and suicidal or aggressive behaviour have been reported. Drug regulatory agencies issued a range of warnings. In the US, the FDA then called for a comparative trial, with the objective of better determining the neuropsychiatric effects of varenicline. The Eagles trial, conducted by the company that markets varenicline, compared varenicline versus nicotine versus bupropion versus placebo in about 8000 patients. The FDA published and analysed the results in 2016. Exclusion of some at-risk patients, the rarity of some adverse effects such as suicide or homicidal ideation, along with the methodological weaknesses in data collection identified by the FDA, all undermine the results of this trial. Overall, no statistically significant difference was observed between the treatments in terms of new psychiatric disorders. The European and US Summaries of Product Characteristics (SPCs) continue to warn about the neuropsychiatric adverse effects of varenicline. The results of the Eagles trial are not sufficiently robust to exclude an increased risk of neuropsychiatric disorders with varenicline, particularly suicidal behaviour. © Prescrire.

Language: en