EAGLES
Evaluating Adverse Events in a Global Smoking Cessation Study
Patient / Population Intervention / Exposition Comparaison Critère de jugement
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
Schéma
Multicentre 4-arm RCT
Critère
Continuous abstinence weeks 9–12; neuropsychiatric adverse events
Pertinence
2
RésultatAbstinence 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 et critique
FDA removed the neuropsychiatric black-box warning for varenicline; remains the most effective monotherapy for tobacco dependence.