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CHANTIX (CHAMPIX): CLINICAL STUDIES

The efficacy of Chantix (Varenicline) in smoking cessation was demonstrated in six clinical trials in which a total of 3659 chronic cigarette smokers (>=10 cigarettes per day) were treated with this medicine. In all clinical studies, abstinence from smoking was determined by patient self-report and verified by measurement of exhaled carbon monoxide (CO <= 10 ppm) at weekly visits. Among the Chantix-treated patients enrolled in these studies, the completion rate was 65%. Except for the dose-ranging study (Study 1) and the maintenance of abstinence study (Study 6), patients were treated for 12 weeks and then were followed for 40 weeks post-treatment. Most patients enrolled in these trials were white (79-96%). All studies enrolled almost equal numbers of men and women.

The average age of patients in these studies was 43 years. Patients on average had smoked about 21 cigarettes per day for an average of approximately 25 years. Patients set a date to stop smoking (target quit date) with dosing starting 1 week before this date.

Three additional studies were conducted in patients with cardiovascular disease, in patients with chronic obstructive pulmonary disease, and in patients instructed to select their quit date within days 8 and 35 of treatment.

In all studies, patients were provided with an educational booklet on smoking cessation and received up to 10 minutes of smoking cessation counseling at each weekly treatment visit according to Agency for Healthcare Research and Quality guidelines.

Initiation of Abstinence

Study 1: This was a six-week dose-ranging study comparing Chantix (Varenicline) to placebo. This study provided initial evidence that this medication at a total dose of 1 mg per day or 2 mg per day was effective as an aid to smoking cessation.

Study 2: This study of 627 patients compared Chantix (Champix) 1 mg per day and 2 mg per day with placebo. Patients were treated for 12 weeks (including one week titration) and then were followed for 40 weeks post-treatment. Chantix (Varenicline Tartrate) was given in two divided doses daily. Each dose of this drug was given in two different regimens, with and without initial dose titration, to explore the effect of different dosing regimens on tolerability. For the titrated groups, dosage was titrated up over the course of one week, with full dosage achieved starting with the second week of dosing. The titrated and nontitrated groups were pooled for efficacy analysis.

Forty-five percent of patients receiving Varenicline (Chantix) 1 mg per day (0.5 mg twice daily) and 51% of patients receiving 2 mg per day (1 mg twice daily) had CO-confirmed continuous abstinence during weeks 9 through 12 compared to 12% of patients in the placebo group. In addition, 31% of the 1 mg per day group and 31% of the 2 mg per day group were continuously abstinent from one week after TQD through the end of treatment as compared to 8% of the placebo group.

Study 3: This flexible-dosing study of 312 patients examined the effect of a patient-directed dosing strategy of Varenicline Tartrate (Chantix) or placebo. After an initial one-week titration to a dose of 0.5 mg twice daily, patients could adjust their dosage as often as they wished between 0.5 mg once daily to 1 mg twice daily per day. Sixty-nine percent of patients titrated to the maximum allowable dose at any time during the study. For 44% of patients, the modal dose selected was 1 mg twice daily; for slightly over half of the study participants, the modal dose selected was 1 mg/day or less.

Of the patients treated with Chantix, 40% had CO-confirmed continuous abstinence during weeks 9 through 12 compared to 12% in the placebo group. In addition, 29% of the Chantix (Varenicline) group were continuously abstinent from one week after TQD through the end of treatment as compared to 9% of the placebo group.

Study 4 and Study 5: These identical double-blind studies compared Chantix (Champix) 2 mg per day, bupropion sustained-release (SR) 150 mg twice daily, and placebo. Patients were treated for 12 weeks and then were followed for 40 weeks post-treatment. The Chantix (Varenicline Tartrate) dosage of 1 mg twice daily was achieved using a titration of 0.5 mg once daily for the initial 3 days followed by 0.5 mg twice daily for the next 4 days. The bupropion SR dosage of 150 mg twice daily was achieved using a 3-day titration of 150 mg once daily. Study 4 enrolled 1022 patients and Study 5 enrolled 1023 patients. Patients inappropriate for bupropion treatment or patients who had previously used bupropion were excluded.

In Study 4, patients treated with Varenicline (Chantix) had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (44%) compared to patients treated with bupropion SR (30%) or placebo (17%). The bupropion SR quit rate was also superior to placebo. In addition, 29% of the Varenicline Tartrate (Chantix) group were continuously abstinent from one week after TQD through the end of treatment as compared to 12% of the placebo group and 23% of the bupropion SR group.

Similarly in Study 5, patients treated with this medicine had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (44%) compared to patients treated with bupropion SR (30%) or placebo (18%). The bupropion SR quit rate was also superior to placebo. In addition, 29% of the Chantix group were continuously abstinent from one week after TQD through the end of treatment as compared to 11% of the placebo group and 21% of the bupropion SR group.

Urge to Smoke

Based on responses to the Brief Questionnaire of Smoking Urges and the Minnesota Nicotine Withdrawal scale "urge to smoke" item, Chantix (Varenicline) reduced urge to smoke compared to placebo.

Long-Term Abstinence

Studies 1 through 5 included 40 weeks of post-treatment follow-up. In each study, Chantix-treated patients were more likely to maintain abstinence throughout the follow-up period than were patients treated with placebo.

Study 6: This study assessed the effect of an additional 12 weeks of Chantix (Champix) therapy on the likelihood of long-term abstinence. Patients in this study (n=1927) were treated with open-label Chantix (Varenicline Tartrate) 1 mg twice daily for 12 weeks. Patients who had stopped smoking for at least a week by Week 12 (n= 1210) were then randomized to double-blind treatment with this medication (1 mg twice daily) or placebo for an additional 12 weeks and then followed for 28 weeks post-treatment.

The continuous abstinence rate from Week 13 through Week 24 was higher for patients continuing treatment with Varenicline (Chantix) (70%) than for patients switching to placebo (50%). Superiority to placebo was also maintained during 28 weeks post-treatment follow-up (Chantix 54% versus placebo 39%).

Subjects with Cardiovascular and Chronic Obstructive Pulmonary Disease

Chantix (Varenicline) was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged 35 to 75 years with stable, documented cardiovascular disease (diagnoses other than, or in addition to, hypertension) that had been diagnosed for more than 2 months. Subjects were randomized to this drug 1 mg twice daily (n=353) or placebo (n=350) for a treatment of 12 weeks and then were followed for 40 weeks post-treatment. Subjects treated with Chantix (Champix) had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (47%) compared to subjects treated with placebo (14%) and from week 9 through 52 (20%) compared to subjects treated with placebo (7%).

Chantix (Varenicline Tartrate) was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged >= 35 years with mild-to-moderate COPD with post-bronchodilator FEV1/FVC < 70% and FEV1 >= 50% of predicted normal value. Subjects were randomized to Varenicline (Chantix) 1 mg twice daily (N=223) or placebo (N=237) for a treatment of 12 weeks and then were followed for 40 weeks post-treatment. Subjects treated with this medicine had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (41%) compared to subjects treated with placebo (9%) and from week 9 through 52 (19%) compared to subjects treated with placebo (6%).

Alternative Instructions for Setting a Quit Date

Chantix (Varenicline) was evaluated in a double-blind, placebo-controlled trial where patients were instructed to select a target quit date between Day 8 and Day 35 of treatment. Subjects were randomized 3:1 to Chantix (Champix) 1 mg twice daily (N=486) or placebo (N=165) for 12 weeks of treatment and followed for another 12 weeks post-treatment. Patients treated with this medicine had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (54%) compared to patients treated with placebo (19%) and from weeks 9 through 24 (35%) compared to subjects treated with placebo (13%).

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