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CHANTIX® (varenicline tartrate) Clinical Studies

14 CLINICAL STUDIES

The efficacy of CHANTIX 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 CHANTIX. 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.

Seven additional studies evaluated the efficacy of CHANTIX in patients with cardiovascular disease, in patients with chronic obstructive pulmonary disease [see Clinical Studies (14.7)], in patients instructed to select their quit date within days 8 and 35 of treatment [see Clinical Studies (14.4)], patients with major depressive disorder [see Clinical Studies (14.9)], patients who had made a previous attempt to quit smoking with CHANTIX, and either did not succeed in quitting or relapsed after treatment [see Clinical Studies (14.6)], in patients without or with a history of psychiatric disorder enrolled in a postmarketing neuropsychiatric safety outcome trial [see Warnings and Precautions (5.1), Clinical Studies (14.10)], and in patients who were not able or willing to quit abruptly and were instructed to quit gradually [see Clinical studies (14.5)].

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.

14.1 Initiation of Abstinence

Study 1

This was a six-week dose-ranging study comparing CHANTIX to placebo. This study provided initial evidence that CHANTIX 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 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 was given in two divided doses daily. Each dose of CHANTIX 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 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 (Figure 1). 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 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 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 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 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 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 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 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 (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.

Figure 1: Continuous Abstinence, Weeks 9 through 12
Figure 1
Table 7. Continuous Abstinence, Weeks 9 through 12 (95% confidence interval)
CHANTIX
0.5 mg BID
CHANTIX
1 mg BID
CHANTIX
Flexible
Bupropion SR Placebo
BID = twice daily
Study 2 45%
(39%, 51%)
51%
(44%, 57%)
12%
(6%, 18%)
Study 3 40%
(32%, 48%)
12%
(7%, 17%)
Study 4 44%
(38%, 49%)
30%
(25%, 35%)
17%
(13%, 22%)
Study 5 44%
(38%, 49%)
30%
(25%, 35%)
18%
(14%, 22%)

14.2 Urge to Smoke

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

14.3 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 (Figure 2, Table 8).

Figure 2: Continuous Abstinence, Weeks 9 through 52
Figure 2
Table 8. Continuous Abstinence, Weeks 9 through 52 (95% confidence interval) Across Different Studies
CHANTIX
0.5 mg BID
CHANTIX
1 mg BID
CHANTIX
Flexible
Bupropion SR Placebo
BID = twice daily
Study 2 19%
(14%, 24%)
23%
(18%, 28%)
4%
(1%, 8%)
Study 3 22%
(16%, 29%)
8%
(3%, 12%)
Study 4 21%
(17%, 26%)
16%
(12%, 20%)
8%
(5%, 11%)
Study 5 22%
(17%, 26%)
14%
(11%, 18%)
10%
(7%, 13%)

Study 6

This study assessed the effect of an additional 12 weeks of CHANTIX therapy on the likelihood of long-term abstinence. Patients in this study (N=1927) were treated with open-label CHANTIX 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 CHANTIX (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 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%).

In Figure 3 below, the x-axis represents the study week for each observation, allowing a comparison of groups at similar times after discontinuation of CHANTIX; post-CHANTIX follow-up begins at Week 13 for the placebo group and Week 25 for the CHANTIX group. The y-axis represents the percentage of patients who had been abstinent for the last week of CHANTIX treatment and remained abstinent at the given timepoint.

Figure 3: Continuous Abstinence Rate during Nontreatment Follow-Up
Figure 3

14.4 Alternative Instructions for Setting a Quit Date

CHANTIX 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 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 CHANTIX 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%).

14.5 Gradual Approach to Quitting Smoking

CHANTIX was evaluated in a 52-week double-blind placebo-controlled study of 1,510 subjects who were not able or willing to quit smoking within four 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 post-treatment through week 52. Subjects were instructed to reduce the number of cigarettes smoked by at least 50 percent by the end of the first four weeks of treatment, followed by a further 50 percent reduction from week four to week eight 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. Subjects treated with CHANTIX had a significantly higher Continuous Abstinence Rate compared with placebo at weeks 15 through 24 (32% vs. 7%) and weeks 15 through 52 (24% vs. 6%).

14.6 Re-Treatment Study

CHANTIX was evaluated in a double-blind, placebo-controlled trial of patients who had made a previous attempt to quit smoking with CHANTIX, and either did not succeed in quitting or relapsed after treatment. Subjects were randomized 1:1 to CHANTIX 1 mg twice daily (N=249) or placebo (N=245) for 12 weeks of treatment and followed for 40 weeks post-treatment. Patients included in this study had taken CHANTIX for a smoking-cessation attempt in the past (for a total treatment duration of a minimum of two weeks), at least three months prior to study entry, and had been smoking for at least four weeks.

Patients treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (45%) compared to patients treated with placebo (12%) and from weeks 9 through 52 (20%) compared to subjects treated with placebo (3%).

Table 9. Continuous Abstinence (95% confidence interval), Re-Treatment Study
Weeks 9 through 12 Weeks 9 through 52
CHANTIX
1 mg BID
Placebo CHANTIX
1 mg BID
Placebo
BID = twice daily
Retreatment Study 45%
(39%, 51%)
12%
(8%, 16%)
20%
(15%, 25%)
3%
(1%, 5%)

14.7 Subjects with Chronic Obstructive Pulmonary Disease

CHANTIX 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 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 CHANTIX 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%).

Table 10. Continuous Abstinence (95% confidence interval), Studies in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Weeks 9 through 12 Weeks 9 through 52
CHANTIX
1 mg BID
Placebo CHANTIX
1 mg BID
Placebo
BID = twice daily
COPD Study 41%
(34%, 47%)
9%
(6%, 13%)
19%
(14%, 24%)
6%
(3%, 9%)

14.8 Subjects with Cardiovascular Disease and Other Cardiovascular Analyses

CHANTIX 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 CHANTIX 1 mg twice daily (N=353) or placebo (N=350) for a treatment period of 12 weeks and then were followed for 40 weeks post-treatment. Subjects treated with CHANTIX 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%).

Table 11. Continuous Abstinence (95% confidence interval), Studies in Patients with Cardiovascular Disease (CVD)
Weeks 9 through 12 Weeks 9 through 52
CHANTIX
1 mg BID
Placebo CHANTIX
1 mg BID
Placebo
BID = twice daily
CVD Study 47%
(42%, 53%)
14%
(11%, 18%)
20%
(16%, 24%)
7%
(5%, 10%)

In this study, all-cause and CV mortality was lower in patients treated with CHANTIX, but certain nonfatal CV events occurred more frequently in patients treated with CHANTIX than in patients treated with placebo [see Warnings and Precautions (5.5), Adverse Reactions (6.1)]. Table 12 below shows mortality and the incidence of selected nonfatal serious CV events occurring more frequently in the CHANTIX arm compared to the placebo arm. These events were adjudicated by an independent blinded committee. Nonfatal serious CV events not listed occurred at the same incidence or more commonly in the placebo arm. Patients with more than one CV event of the same type are counted only once per row. Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal MI and hospitalization for angina.

Table 12. Mortality and Adjudicated Nonfatal Serious Cardiovascular Events in the Placebo-Controlled CHANTIX Trial in Patients with Stable Cardiovascular Disease
Mortality and Cardiovascular Events CHANTIX
(N=353)
n (%)
Placebo
(N=350)
n (%)
Mortality (Cardiovascular and All-cause up to 52 weeks)
  Cardiovascular 1 (0.3) 2 (0.6)
  All-cause 2 (0.6) 5 (1.4)
 
Nonfatal Cardiovascular Events (rate on CHANTIX > Placebo)
  Up to 30 days after treatment
    Nonfatal myocardial infarction 4 (1.1) 1 (0.3)
    Nonfatal Stroke 2 (0.6) 0 (0)
  Beyond 30 days after treatment and up to 52 weeks
    Nonfatal myocardial infarction 3 (0.8) 2 (0.6)
    Need for coronary revascularization 7 (2.0) 2 (0.6)
    Hospitalization for angina pectoris 6 (1.7) 4 (1.1)
    Transient ischemia attack 1 (0.3) 0 (0)
    New diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure 5 (1.4) 2 (0.6)

Following the CVD study, a meta-analysis of 15 clinical trials of ≥12 weeks treatment duration, including 7002 patients (4190 CHANTIX, 2812 placebo), was conducted to systematically assess the CV safety of CHANTIX. The study in patients with stable CV disease described above was included in the meta-analysis. There were lower rates of all-cause mortality (CHANTIX 6 [0.14%]; placebo 7 [0.25%]) and CV mortality (CHANTIX 2 [0.05%]; placebo 2 [0.07%]) in the CHANTIX arms compared with the placebo arms in the meta-analysis.

The key CV safety analysis included occurrence and timing of a composite endpoint of Major Adverse Cardiovascular Events (MACE), defined as CV death, nonfatal MI, and nonfatal stroke. These events included in the endpoint were adjudicated by a blinded, independent committee. Overall, a small number of MACE occurred in the trials included in the meta-analysis, as described in Table 13. These events occurred primarily in patients with known CV disease.

Table 13. Number of MACE cases, Hazard Ratio and Rate Difference in a Meta-Analysis of 15 Clinical Trials Comparing CHANTIX to Placebo*
CHANTIX
N=4190
Placebo
N=2812
*
Includes MACE occurring up to 30 days post-treatment.
MACE cases, n (%) 13 (0.31%) 6 (0.21%)
Patient-years of exposure 1316 839
Hazard Ratio (95% CI)
1.95 (0.79, 4.82)
Rate Difference per 1,000 patient-years (95% CI)
6.30 (-2.40, 15.10)

The meta-analysis showed that exposure to CHANTIX resulted in a hazard ratio for MACE of 1.95 (95% confidence interval from 0.79 to 4.82) for patients up to 30 days after treatment; this is equivalent to an estimated increase of 6.3 MACE events per 1,000 patient-years of exposure. The meta-analysis showed higher rates of CV endpoints in patients on CHANTIX relative to placebo across different time frames and pre-specified sensitivity analyses, including various study groupings and CV outcomes. Although these findings were not statistically significant they were consistent. Because the number of events was small overall, the power for finding a statistically significant difference in a signal of this magnitude is low.

Additionally, a cardiovascular endpoint analysis was added to the postmarketing neuropsychiatric safety outcome study along with a non-treatment extension, [see Warnings and Precautions (5.5), Adverse Reactions (6.1), Clinical Studies (14.10)].

14.9 Subjects with Major Depressive Disorder

CHANTIX was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged 18 to 75 years with major depressive disorder without psychotic features (DSM-IV TR). If on medication, subjects were to be on a stable antidepressant regimen for at least two months. If not on medication, subjects were to have experienced a major depressive episode in the past 2 years, which was successfully treated. Subjects were randomized to CHANTIX 1 mg twice daily (N=256) or placebo (N=269) for a treatment of 12 weeks and then followed for 40 weeks post-treatment. Subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (36%) compared to subjects treated with placebo (16%) and from week 9 through 52 (20%) compared to subjects treated with placebo (10%).

Table 14. Continuous Abstinence (95% confidence interval), Study in Patients with Major Depressive Disorder (MDD)
Weeks 9 through 12 Weeks 9 through 52
CHANTIX
1 mg BID
Placebo CHANTIX
1 mg BID
Placebo
BID = twice daily
MDD Study 36%
(30%, 42%)
16%
(11%, 20%)
20%
(15%, 25%)
10%
(7%, 14%)

14.10 Postmarketing Neuropsychiatric Safety Outcome Trial

CHANTIX was evaluated in a randomized, double-blind, active and placebo-controlled trial that 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 18–75 years, smoking 10 or more cigarettes per day were randomized 1:1:1:1 to CHANTIX 1 mg BID, bupropion SR 150 mg BID, NRT patch 21 mg/day with taper or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment. [See Warnings and Precautions (5.1)]

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.

As shown in Table 15, the use of CHANTIX, bupropion, and NRT in the non-psychiatric cohort was not associated with an increased risk of clinically significant NPS adverse events compared with placebo. Similarly, in the non-psychiatric cohort, the use of CHANTIX was not associated with an increased risk of clinically significant NPS adverse events in the composite safety endpoint compared with bupropion or NRT.

Table 15. Number of Patients with Clinically Significant or Serious NPS Adverse Events by Treatment Group Among Patients without a History of Psychiatric Disorder
CHANTIX
(N=975)
n (%)
Bupropion
(N=968)
n (%)
NRT
(N=987)
n (%)
Placebo
(N=982)
n (%)
Clinically Significant NPS 30 (3.1) 34 (3.5) 33 (3.3) 40 (4.1)
Serious NPS 1 (0.1) 5 (0.5) 1 (0.1) 4 (0.4)
Psychiatric Hospitalizations 1 (0.1) 2 (0.2) 0 (0.0) 1 (0.1)

As shown in Table 16, there were more clinically significant NPS adverse events reported in patients in the psychiatric cohort in each treatment group compared with the non-psychiatric cohort. The incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo: Risk Differences (RDs) (95%CI) vs placebo were 2.7% (-0.05, 5.4) for CHANTIX, 2.2% (-0.5, 4.9) for bupropion, and 0.4% (-2.2, 3.0) for NRT transdermal nicotine.

Table 16. Number of Patients with Clinically Significant or Serious NPS Adverse Events by Treatment Group Among Patients with a History of Psychiatric Disorder
CHANTIX
(N=1007)
n (%)
Bupropion
(N=1004)
n (%)
NRT
(N=995)
n (%)
Placebo
(N=997)
n (%)
Clinically Significant NPS 123 (12.2) 118 (11.8) 98 (9.8) 95 (9.5)
Serious NPS 6 (0.6) 8 (0.8) 4 (0.4) 6 (0.6)
Psychiatric hospitalizations 5 (0.5) 8 (0.8) 4 (0.4) 2 (0.2)

There was one completed suicide, which occurred during treatment in a patient treated with placebo in the non-psychiatric cohort. There were no completed suicides reported in the psychiatric cohort.

In both cohorts, subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo.

Table 17 Continuous Abstinence (95% confidence interval), Study in Patients with or without a History of Psychiatric Disorder
CHANTIX
1 mg BID
Bupropion SR
150 mg BID
NRT
21 mg/day with taper
Placebo
BID = twice daily
Weeks 9 through 12
Non-Psychiatric Cohort 38%
(35%, 41%)
26%
(23%, 29%)
26%
(24%, 29%)
14%
(12%, 16%)
Psychiatric Cohort 29%
(26%, 32%)
19%
(17%, 22%)
20%
(18%, 23%)
11%
(10%, 14%)
Weeks 9 through 24
Non-Psychiatric Cohort 25%
(23%, 28%)
19%
(16%, 21%)
18%
(16%, 21%)
11%
(9%, 13%)
Psychiatric Cohort 18%
(16%, 21%)
14%
(12%, 16%)
13%
(11%, 15%)
8%
(7%, 10%)

Cardiovascular Outcome Analysis

To obtain another source of data regarding the CV risk of CHANTIX, a cardiovascular endpoint analysis was added to the postmarketing neuropsychiatric safety outcome study along with a non-treatment extension. In the parent study (N=8027), subjects aged 18–75 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 (NRT) patch 21 mg/day or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment. The extension study enrolled 4590 (57.2%) of the 8027 subjects who were randomized and treated in the parent study and followed them for additional 28 weeks. Of all treated subjects, 1743 (21.7%) had a medium CV risk and 640 (8.0%) had a high CV risk, as defined by Framingham score. Note that one site from the parent study was excluded in the assessment of CV safety and two sites were excluded in the assessment of neuropsychiatric safety.

The primary CV endpoint was the time to major adverse CV event (MACE), defined as CV death, nonfatal myocardial infarction or nonfatal stroke during treatment. Deaths and CV events were adjudicated by a blinded, independent committee. Table 18 below shows the incidence of MACE and Hazard Ratios compared to placebo for all randomized subjects exposed to at least 1 partial dose of study treatment in the parent study.

Table 18. The Incidence of MACE and Hazard Ratios in the Cardiovascular Safety Assessment Trial in Subjects without or with a History of Psychiatric Disorder
CHANTIX
N=2006
Bupropion
N=1997
NRT
N=2017
Placebo
N=2007
[IR] indicates incidence rate per 1000 person-years
*
during treatment in the parent neuropsychiatric safety study
either the end of the extension study or the end of parent neuropsychiatric safety study for those subjects not enrolled into the extension study
During treatment*
MACE, n [IR] 1 [2.4] 2 [4.9] 1 [2.4] 4 [9.8]
  Hazard Ratio (95% CI) vs. placebo 0.24
(0.03, 2.18)
0.49
(0.09, 2.69)
0.24
(0.03, 2.18)
Through end of study
MACE, n [IR] 3 [2.1] 9 [6.3] 6 [4.3] 8 [5.7]
  Hazard Ratio (95% CI) vs. placebo 0.36
(0.10, 1.36)
1.09
(0.42, 2.83)
0.74
(0.26, 2.13)

For this study, MACE+ was defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. Incidence rates of MACE+ and all-cause mortality for all randomized subjects exposed to at least 1 partial dose of study treatment in the parent study are shown for all treatment groups during treatment, and through end of study in the Table 19 below.

Table 19. The Incidence of MACE+ and All-Cause Death in the Cardiovascular Safety Assessment Trial in Subjects without or with a History of Psychiatric Disorder
CHANTIX
N=2006
Bupropion
N=1997
NRT
N=2017
Placebo
N=2007
[IR] indicates incidence rate per 1000 person-years
*
during treatment in the parent neuropsychiatric safety study
either the end of the extension study or the end of the parent neuropsychiatric safety study for those subjects not enrolled into the extension study
During treatment*
MACE+, n [IR] 5 [12.1] 4 [9.9] 2 [4.8] 5 [12.2]
All-cause deaths, n [IR] 0 2 [4.9] 0 2 [4.9]
Through end of study
MACE+, n [IR] 10 [6.9] 15 [10.5] 10 [7.1] 12 [8.6]
All-cause deaths, n [IR] 2 [1.4] 4 [2.8] 3 [2.1] 4 [2.9]

The number of subjects who experienced MACE, MACE+ and all-cause death was similar or lower among patients treated with CHANTIX than patients treated with placebo. The number of events observed overall was too low to distinguish meaningful differences between the treatment arms.

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