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  • Dosing
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    Efficacy
    Learn about CHANTIX efficacy
    Safety
    Review the full safety information for CHANTIX
    Quit Approaches
    Patients can set a quit date after 1 week, in up to 1 month, or gradually, in up to 12 weeks 1

    Efficacy

    Please be advised that CHANTIX is currently out of stock. For medical questions on CHANTIX and for supply updates, please contact Pfizer Medical Information at 1-800-438-1985.

    CHANTIX proven superior to bupropion SR and NRT patch1,2


    ​​​​​​​In EAGLES, a neuropsychiatric safety study and the largest pharmacotherapy study in smoking cessation, CHANTIX had superior CO-confirmed abstinence (CO ≤10 ppm) during weeks 9-12 compared with patients treated with bupropion SR, NRT patch, and placebo.1,2*

    *Carbon monoxide exhaled ≤10 ppm.
    Patients received up to 10 minutes of counseling at each clinic visit.
    ”n” and analyses based on all randomized populations in the EAGLES trial published in Lancet (2016).
    EAGLES=Evaluating Adverse Events in a Global Smoking Cessation Study.
    CO=carbon monoxide; NRT=nicotine replacement therapy; SR=sustained release.

    Click here to view safety information from the EAGLES study.

    Study Design: EAGLES

    Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) was a randomized, double-blind, active and placebo-controlled postmarketing neuropsychiatric safety outcome trial of CHANTIX. It included subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3912) and with a history of psychiatric disorder (psychiatric cohort, N=4003). Subjects aged 18 to 75 years, smoking 10 or more cigarettes per day, were randomized 1:1:1:1 to CHANTIX 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper, or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks posttreatment. A composite safety endpoint intended to capture clinically significant neuropsychiatric (NPS) adverse events included the following NPS adverse events: anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, irritability, suicidal ideation, suicidal behavior, or completed suicide. CHANTIX was also evaluated for comparative efficacy vs bupropion SR, NRT patch, and placebo as measured by carbon monoxide confirmed abstinence during weeks 9 through 12 of treatment.1

    CHANTIX reduces the urge to smoke1 to help patients quit1

    Beginning at week 1 and continuing through week 12, the urge to smoke was significantly reduced with CHANTIX vs placebo3
    ​​​​​​​
    ||Factor 1 comprises questions which reflect a strong desire and intention to smoke, with smoking perceived as rewarding.

    Study Design: Fixed Quit (Pooled Pivotal Trials)

    Results from data pooled from 2 identically designed, 52-week (12 weeks' pharmacotherapy, 40 weeks' nonpharmacotherapy follow-up), randomized, double-blind, parallel-group, multicenter trials (N=2052) in which CHANTIX titrated to 1 mg BID was compared with Zyban® (bupropion SR) titrated to 150 mg BID and placebo for efficacy and safety in smoking cessation. For trial inclusion, participants were required to be adults who smoked at least 10 cigarettes per day over the previous year, with no period of abstinence greater than 3 months, and must have been bupropion SR naive. Individuals were excluded if they had clinically significant CV disease within the previous 6 months; uncontrolled hypertension; severe COPD; active depression requiring treatment, history of panic disorders, psychosis, bipolar disorder, eating disorders, alcohol or drug abuse/dependency within the previous year. The primary efficacy endpoint in both trials was the carbon monoxide (CO)-confirmed, 4-week continuous abstinence rate for weeks 9 through 12, defined as the percentage of participants who reported no smoking (not even a puff), confirmed by an exhaled CO measurement of 10 ppm or less at each clinic visit, or use of any nicotine-containing products. (Data pooled from studies 4 and 5 from the CHANTIX package insert.) Participants were provided with an educational booklet on smoking cessation at baseline and received up to 10 minutes of smoking cessation counseling at each clinic visit in accordance with Agency for Healthcare Research and Quality (AHRQ) guidelines.1,4 Urge to smoke was evaluated using the Brief Questionnaire of Smoking Urges and the Minnesota Nicotine Withdrawal scale "urge to smoke" item.1

    Zyban® (bupropion SR) tablets is a registered trademark of Glaxo Group Limited.

    ​​​​​​​
    ​​​​​​​References
    1. CHANTIX [package insert]. New York, NY: Pfizer Inc. 
    2. Anthenelli RM, Benowitz NL, West R, 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-controlled clinical trial. Lancet. 2016;387(10037):2507-2520. 
    3. Data on file. Pfizer Inc., New York, NY.
    4. Nides M, Glover ED, Reus VI, et al. Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav. 2008;32(6):664-675.

    Efficacy results for Fixed, Flexible, and Gradual Quit Studies

    Fixed Quit Study Results

    In pooled clinical trials in which patients were instructed to stop smoking 1 week after starting treatment, CHANTIX helped significantly more patients quit during weeks 9 through 12 vs placebo.1,2

    Patients set a quit date and began taking CHANTIX 1 week before that date. Patients received up to 10 minutes of counseling at each clinic visit.
    CAR=continuous abstinence rate.


    Study Design: Fixed Quit (Pooled Pivotal Trials)

    Results from data pooled from 2 identically designed, 52-week (12 weeks' pharmacotherapy, 40 weeks' nonpharmacotherapy follow-up), randomized, double-blind, parallel-group, multicenter trials (N=2052) in which CHANTIX titrated to 1 mg BID was compared with Zyban® (bupropion SR) titrated to 150 mg BID and placebo for efficacy and safety in smoking cessation. For trial inclusion, participants were required to be adults who smoked at least 10 cigarettes per day over the previous year, with no period of abstinence greater than 3 months, and must have been bupropion SR naive. Individuals were excluded if they had clinically significant CV disease within the previous 6 months; uncontrolled hypertension; severe COPD; active depression requiring treatment, history of panic disorders, psychosis, bipolar disorder, eating disorders, alcohol or drug abuse/dependency within the previous year. The primary efficacy endpoint in both trials was the carbon monoxide (CO)-confirmed, 4-week continuous abstinence rate for weeks 9 through 12, defined as the percentage of participants who reported no smoking (not even a puff), confirmed by an exhaled CO measurement of 10 ppm or less at each clinic visit, or use of any nicotine-containing products. (Data pooled from studies 4 and 5 from the CHANTIX package insert.) Participants were provided with an educational booklet on smoking cessation at baseline and received up to 10 minutes of smoking cessation counseling at each clinic visit in accordance with Agency for Healthcare Research and Quality (AHRQ) guidelines.1,2 Urge to smoke was evaluated using the Brief Questionnaire of Smoking Urges and the Minnesota Nicotine Withdrawal scale "urge to smoke" item.1

    View the Quit Approach details.


    ​​​​​​​Flexible Quit Study Results ​​​​​​​

    In a study in which patients chose a quit date between days 8 and 35 after starting treatment, CHANTIX helped significantly more patients quit during weeks 9 through 12 vs placebo.1,3

    §Patients chose a quit date within a month (between days 8 and 35) after starting CHANTIX. Patients received up to 10 minutes of counseling at each clinic visit.
    CAR=continuous abstinence rate.


    Study Design: Flexible Quit 

    Results from a 24-week (12 weeks' pharmacotherapy, 12 weeks' nonpharmacotherapy follow-up), randomized, double-blind, parallel-group, multicenter clinical trial (N=651) in which CHANTIX titrated to 1 mg BID (n=486) was compared with placebo (n=165) for efficacy and safety in smoking cessation. Trial participants were instructed to choose a quit date between day 8 and day 35 of treatment (”alternate quit date instruction trial”). For trial inclusion, participants were required to be adults who smoked at least 10 cigarettes per day over the previous year, with no period of abstinence greater than 3 months during that time. Individuals were excluded if they had clinically unstable cardiovascular disease within the previous 6 months; severe chronic obstructive pulmonary disease; depressive disorders requiring treatment within the previous year; history of psychosis, panic attacks with anxiety disorder, or bipolar disorder; or if they used a nicotine replacement product, bupropion, clonidine, or nortriptyline for a quit attempt within the previous 3 months. The primary efficacy endpoint was the carbon monoxide (CO)-confirmed, 4-week continuous abstinence rate for weeks 9 through 12, defined as the percentage of participants who reported no smoking (not even a puff), confirmed by an exhaled CO measurement of 10 ppm or less at each clinic visit, or use of any nicotine-containing products. Participants were provided with an educational booklet at baseline on smoking cessation and received up to 10 minutes of smoking cessation counseling at each clinic visit or telephone contact in accordance with Agency for Healthcare Research and Quality (AHRQ) guidelines.1,3

    View the Quit Approach details.


    ​​​​​​​Gradual Quit Study Results​​​​​​​

    In a study of patients who were not willing or able to quit within a month but were willing to reduce smoking with the goal of quitting after 12 weeks, CHANTIX helped ~4.5x more patients quit at weeks 15 through 24 vs placebo.1,4||
    ​​​​​​​

    ||Patients were not able or willing to quit within 4 weeks, but were willing to gradually reduce their smoking over a 12-week period before quitting. Patients received up to 10 minutes of counseling at each clinic visit and telephone call. Patients were instructed to reduce the number of cigarettes smoked by at least 50% by the end of the first 4 weeks of treatment followed by a further 50% reduction from week 4 to week 8 of treatment, with the goal of reaching complete abstinence by 12 weeks. After the initial 12-week reduction phase, subjects were to continue treatment for another 12 weeks for a total of 24 weeks.
    CAR=continuous abstinence rate. 

    Study Design: Gradual Quit

    CHANTIX was evaluated in a 52-week, double-blind, placebo-controlled study of 1510 subjects who were not able or willing to quit smoking within 4 weeks, but were willing to gradually reduce their smoking over a 12-week period before quitting. Subjects were randomized to either CHANTIX 1 mg twice daily (n=760) or placebo (n=750) for 24 weeks and followed up posttreatment through week 52. Subjects were instructed to reduce the number of cigarettes smoked by at least 50% by the end of the first 4 weeks of treatment, followed by a further 50% reduction from week 4 to week 8 of treatment, with the goal of reaching complete abstinence by 12 weeks. After the initial 12-week reduction phase, subjects continued treatment for another 12 weeks (for a total of 24 weeks). Eligible subjects were 18 years or older, smoked an average of 10 or more cigarettes/day and had an exhaled carbon monoxide level higher than 10 ppm. Exclusions included a history of suicide attempt or suicide behavior in the previous 2 years as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), severe (lifetime, current, or unstable) major depressive disorder or anxiety, lifetime diagnosis of psychosis, panic disorder, posttraumatic stress disorder, or schizophrenia; alcohol or substance abuse in the past 12 months; severe COPD, clinically significant cardiovascular or cerebrovascular disease in the previous 2 months. The primary efficacy endpoint was carbon monoxide (CO)-confirmed, continuous abstinence rate during the last 10 weeks of treatment (weeks 15 through 24). Subjects were provided with an educational booklet and received up to 10 minutes of smoking-cessation counseling, consistent with the 2008 “Treating Tobacco Use and Dependence” clinical practice guidelines.​​​​​​​1,4

    View the Quit Approach details.


    ​​​​​​​
    ​​​​​​​References
    1. CHANTIX [package insert]. New York, NY: Pfizer Inc. 
    2. Nides M, Glover ED, Reus VI, et al. Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav. 2008;32(6):664-675. 
    3. Rennard S, Hughes J, Cinciripini PM, et al. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012;14(3):343-350. 
    4. Ebbert JO, Hughes JR, West RJ, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015;313(7):687-694.

    Review the safety profile of CHANTIX

    See the safety information from the clinical studies with CHANTIX

    Learn more

    INDICATION AND LIMITATIONS OF USE

    CHANTIX is indicated as an aid to smoking cessation treatment in adults.

    CHANTIX is contraindicated in patients with a history of serious hypersensitivity or skin reactions to CHANTIX.

    Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have been reported in patients treated with CHANTIX. These included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider immediately if they experience such adverse events.

    During clinical trials and the postmarketing experience, there have been reports of seizures in patients treated with CHANTIX, with or without a history of seizures. CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. Instruct patients to discontinue CHANTIX, and contact a healthcare provider immediately if they experience a seizure while on treatment.

    There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX, including unusual and sometimes aggressive behavior directed to oneself or to others and often accompanied by amnesia. Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol.

    Patients with underlying cardiovascular (CV) disease may be at increased risk of CV events; however, these concerns must be balanced with the health benefits of smoking cessation. Instruct patients to notify their healthcare providers of new or worsening CV symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction (MI) or stroke.

    Cases of somnambulism have been reported in patients taking CHANTIX. Some cases described harmful behavior to self, others, or property. Instruct patients to discontinue CHANTIX and notify their healthcare provider if they experience somnambulism.

    Patients should be informed that there have been reports of serious skin reactions, such as Stevens Johnson Syndrome and Erythema Multiforme and of angioedema, with swelling of the face, mouth, and neck that can lead to life-threatening respiratory compromise. Patients should be instructed to discontinue CHANTIX and immediately seek medical care if they experience these symptoms or at the first sign of rash with mucosal lesions or any other signs of hypersensitivity.

    The most common adverse reactions include nausea (30%), abnormal dreams, constipation, flatulence, and vomiting. Patients should be informed that they may experience vivid, unusual, or strange dreams during treatment with CHANTIX. Patients should be advised to use caution driving or operating machinery or engaging in other potentially hazardous activities until they know how CHANTIX may affect them.

    Safety and efficacy of CHANTIX in combination with other smoking cessation drug therapies have not been studied. Dosage adjustment with CHANTIX is recommended in patients with severe renal impairment or in patients undergoing hemodialysis.

    Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.

    CHANTIX is indicated as an aid to smoking cessation treatment in adults.