EAGLES
Evaluating Adverse Events in a Global Smoking Cessation Study
Patient / Population Intervention / Exposure Comparison Outcome
In 8,144 smokers with and without psychiatric disorders, varenicline produced higher continuous abstinence at weeks 9–12 than bupropion, nicotine patch or placebo, without excess neuropsychiatric events.
N
8,144
Design
Multicentre 4-arm RCT
Endpoint
Continuous abstinence weeks 9–12; neuropsychiatric adverse events
Relevance
2
ResultAbstinence varenicline 33.5%, bupropion 22.6%, NRT 23.4%, placebo 12.5%. No excess NPS adverse events.
Anthenelli RM, et al. Lancet. 2016;387(10037):2507-2520. 10.1016/S0140-6736(16)30272-0
Discussion & critique
FDA removed the neuropsychiatric black-box warning for varenicline; remains the most effective monotherapy for tobacco dependence.