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Champix has been studied in a range of patient types.1-4

Patients with no psychiatric history

Champix offers greater odds of quitting vs. buproprion, NRT patch (NiQuitin®) and placebo for smokers without a psychiatric history at weeks 9-12 and 9-241†

*CHAMPIX versus placebo, weeks 9-12, 0R=4.00 (95% Cl 3.20-5.00), p<0.0001, weeks 9-24 0R=2.99 (95% Cl 2.33-3.83), p<0.0001; versus NRT patch, weeks 9-12 OR=1.7 4 (95% Cl 1.43-2.10), p<0.0001, weeks 9-24 OR=1.52 (95% Cl 1.23-1.89), p=0.0001; versus bupropion, weeks 9-12 OR=1.77 (95% Cl 1.46-2.14), p<0.0001, weeks 9-24, OR=1.49 (95% Cl 1.20-1.85), p=0.0003. 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. 


Eagles: adverse events1

Across the cohorts, the most frequent adverse events by treatment group were as follows:

  • CHAMPIX: nausea (25%) 
  • Bupropion: insomnia (12%) 
  • NRT patch (NiQuitin®): abnormal dreams (12%) 
  • Placebo: headache (10%) 

Refer to the full publication for additional information. 

1. 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-contra lied clinical trial. Lancet, 2016;387:2507-2520.

Patients with a psychiatric history

Champix offers greater odds of quitting vs. buproprion, NRT patch (NiQuitin®) and placebo for smokers with a psychiatric history at weeks 9-12 and 9-241†

The most common psychiatric disorders in the EAGLES study psychiatric cohort were: primary affective disorders, anxiety disorders, psychotic disorders and personality disorders.1†

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).1†

*CHAMPIX versus placebo, weeks 9-12, 0R=4.00 (95% Cl 3.20-5.00), p<0.0001, weeks 9-24 0R=2.99 (95% Cl 2.33-3.83), p<0.0001; versus NRT patch, weeks 9-12 OR=1.7 4 (95% Cl 1.43-2.10), p<0.0001, weeks 9-24 OR=1.52 (95% Cl 1.23-1.89), p=0.0001; versus bupropion, weeks 9-12 OR=1.77 
(95% Cl 1.46-2.14), p<0.0001, weeks 9-24, OR=1.49 (95% Cl 1.20-1.85), p=0.0003. 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. 

Please refer to the Warnings and Precautions.


Eagles: adverse events1

Across the cohorts, the most frequent adverse events by treatment group were as follows:

  • CHAMPIX: nausea (25%) 
  • Bupropion: insomnia (12%) 
  • NRT patch (NiQuitin®): abnormal dreams (12%) 
  • Placebo: headache (10%) 

Refer to the full publication for additional information. 

1. 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-contra lied clinical trial. Lancet, 2016;387:2507-2520.

Patients with Chronic Obstructive Pulmonary Disorder (COPD)

Champix is efficacious in patients with mild to moderate COPD1

For smokers with mild-to-moderate COPD, CHAMPIX offers: 

  • Greater odds of quitting smoking at 12 weeks vs. placebo1 (47.0% vs. 13.9%; OR=6.11; 95% Cl: 4.18-8.93; p<0.0001) 
  • Greater odds of remaining abstinent at 1 year vs. placebo1 (19.2% vs. 7.2%; OR=3.14; 95% Cl: 1.93-5.11; p<0.0001) 
  • A favourable tolerability profile with discontinuation rates similar to placebo (CHAMPIX 5.2% vs. placebo 5.6%)1


Champix and COPD adverse events 

The most frequently reported adverse events (AEs) in the CHAMPIX vs. placebo groups (15% in either group)1

  • Nausea (27% vs. 8.0%) 
  • Abnormal dreams (10.9% vs 2.8%)
  • Upper-respiratory tract infection (9.7% vs 8.4%) 
  • Insomnia (9.7% vs. 6.0%) 
  • Headache (8.1 % vs. 8.0%) 
  • Flatulence (7.3% vs. 5.2%) 
  • Vomiting (6.5% vs. 2.4%) 

Refer to the full publication for additional information. 

1 . Ebbert JO, et al, Effect of varenicli ne on smoking cessation through smoking reduction: A randomised clinical trial. JAMA 2015; 313:687-694. 

Patients with Cardiovascular Disease (CVD)

Champix offers greater odds of quitting vs. placebo for smokers with stable cardiovascular disease (CVD)1

For smokers with stable CVD, CHAMPIX offers: 

  • Greater odds of quitting smoking at 12 weeks vs. placebo1 (47.0% vs. 13.9%; OR=6.11; 95% Cl: 4.18-8.93; p<0.0001)  

  • Greater odds of remaining abstinent at 1 year vs. placebo1 (19.2% vs. 7.2%; OR=3.14; 95% Cl: 1.93-5.11; p<0.0001) 

Please refer to the Warnings and Precautions.


Champix and CVD adverse events

Adjudicated serious cardiovascular events occurring in ≥1% in either group2*

  Champix Placebo
  n=353 n=350
During treatment (or 30-day period after treatment)
Non-fatal MI 1.1 0.3
Hospitalisation for angina 0.6 1.1
During non-treatment follow-up (up to 52 weeks)
Need for coronary revascularisation 2.0 0.6
Hospitalisation for angina 1.7 1.1
New diagnosis of PVD or admission for PVD procedure 1.4 0.6
Over the course of the 52-week study
Cardiovascular death 0.3 0.6

PVD: Peripheral Vascular Disease 
Ml: Myocardial Infarction 
* Death and serious cardiovascular events were adjudicated by a blinded committee. Some of the smokers requiring coronary revascularisation underwent the procedure as part of management of non-fatal Ml and hospitalisation for angina.

1.  Rigotti NA et al. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease. A randomised trial. Circulation. 2010;121 :221-229.
2. CHAMPIX Summary of Product Characteristics.

Please refer to the summary of product characteristics for further information on the safety profile of Champix

1. Anthenelli RM. 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;387:2507-2520.
2. Tashkin DP, et al. Effects of varenicline on smoking cessation in patients with mild-moderate COPD. Chest. 2011;139(3):591-599.
3. Rigotti NA et al. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease. A randomised trial. Circulation. 2010;121: 221-2 29.
4.  Mills EJ, et al. Comparisons of high dose and combination nicotine replacement therapy, varenicline and bupropion for smoking cessation: A systematic review and multiple treatment meta-analysis. Ann Med. 2012;44:588-597.

PP-CHM-GBR-1787. April 2018.

CHAMPIX in different patient cohorts