Champix safety information
Prescribe Champix (varenicline) with confidence thanks to the results from EAGLES: the largest comparative study of approved smoking cessation medicines.1
Over 12 weeks of treatment with 12-week non-treatment follow up, in 8,144 smokers with or without a diagnosis of psychiatric disorders,† EAGLES has shown that CHAMPIX (varenicline) has:
- No significantly increased neuropsychiatric (NPS) safety risk‡ vs. placebo, in smokers with or without a history of psychiatric disorders1
- Significantly superior continuous abstinence rates vs. bupropion, NRT patch (NiQuitin® 21mg, with taper) and placebo at weeks 9-12 and 9-24 in both cohorts1
CHAMPIX was not associated with a significantly increased risk of NPS adverse events vs. placebo in smokers with or without a history of psychiatric disorders.†1.
Participants reporting NPS Events n/N,%1
Continuous Abstinence Rates (CAR)
CHAMPIX provides significantly superior abstinence rates vs. bupropion, NRT patch (NiQuitin® 21mg, with taper) and placebo in patients with or without a history of psychiatric disorders at weeks 9-12 (p<0.001) and at weeks 9-24 (p<0.005).1
Adapted from Anthenelli RM, et al. Lancet 2016.
Based on the all-randomised patient population. ** The primary efficacy endpoint was the CO-confirmed CAR from weeks 9-12. †† The main secondary endpoint was the CO-confirmed CAR from weeks 9-24. The other secondary endpoint was the 7-day point prevalence of abstinence at each assessment visit, which yielded results consistent with the continuous abstinence rates.
Treatment types included 1mg of varenicline twice daily vs. 150mg of bupropion twice daily vs. 21mg with taper of NiQuitin®, vs. placebo. All medications were up- or down-titrated according to prescribing information. NRT treatment was for 11 weeks.
*Evaluating Adverse Events in a Global Smoking Cessation Study
† In the psychiatric cohort, participants met DSM-IV-TR diagnostic criteria for primary affective disorders (70%), anxiety disorders (19%), psychotic disorders (9.5%) or personality disorders (0.6%). Patients had to be considered clinically stable for inclusion (i.e., no exacerbations ≤6 months; on stable treatment ≥3 months, with no treatment change anticipated during the study). In the non-psychiatric cohort, subjects were aged 18-75 years without a history of psychiatric disorders. All participants from both cohorts were randomised 1:1:1:1 to one of the 4 study treatments. One additional participant (Psychiatric/NRT group) who reported suicidal ideation was identified after clinical database lock and was not included in this analysis.
‡ The primary safety endpoint was the incidence of a composite measure of 16 moderate and severe NPS adverse events (AEs), including anxiety, depression, feeling abnormal, and hostility (all rated as severe), and agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour, and completed suicide (all rated as moderate or severe).
1. Anthenelli RM, et al. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0
PP-CHM-GBR-2710. April 2019