Trial Outcomes & Findings for Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial (NCT NCT00794573)

NCT ID: NCT00794573

Last Updated: 2019-05-23

Results Overview

7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 302 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2019-05-23

Participant Flow

Participant milestones

Measure	Varenicline 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Study STARTED	151	151
Overall Study COMPLETED	113	106
Overall Study NOT COMPLETED	38	45

Reasons for withdrawal

Measure	Varenicline 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Study Death	3	0
Overall Study Withdrawal by Subject	9	12
Overall Study Lost to Follow-up	26	33

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Varenicline n=151 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Total n=302 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 8.4 • n=151 Participants	55.3 years STANDARD_DEVIATION 10.3 • n=151 Participants	55.0 years STANDARD_DEVIATION 9.3 • n=302 Participants
Sex: Female, Male Female	39 Participants n=151 Participants	36 Participants n=151 Participants	75 Participants n=302 Participants
Sex: Female, Male Male	112 Participants n=151 Participants	115 Participants n=151 Participants	227 Participants n=302 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	104 participants n=151 Participants	96 participants n=151 Participants	200 participants n=302 Participants
Region of Enrollment United States	47 participants n=151 Participants	55 participants n=151 Participants	102 participants n=302 Participants
Smoking duration	35.1 years STANDARD_DEVIATION 11.4 • n=151 Participants	36.7 years STANDARD_DEVIATION 11.8 • n=151 Participants	35.9 years STANDARD_DEVIATION 11.6 • n=302 Participants
Cigarettes per day at baseline	21.9 Cigarettes smoked/day STANDARD_DEVIATION 10.9 • n=151 Participants	21.0 Cigarettes smoked/day STANDARD_DEVIATION 10.3 • n=151 Participants	21.4 Cigarettes smoked/day STANDARD_DEVIATION 10.6 • n=302 Participants
Fagerstrom Test for Nicotine Dependence score 0-3 (mild)	30 Participants n=150 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	29 Participants n=151 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	59 Participants n=301 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.
Fagerstrom Test for Nicotine Dependence score 4-6 (moderate)	77 Participants n=150 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	79 Participants n=151 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	156 Participants n=301 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.
Fagerstrom Test for Nicotine Dependence score 7+ (severe)	43 Participants n=150 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	43 Participants n=151 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.	86 Participants n=301 Participants • One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.
Other smoker(s) at home	73 participants n=151 Participants	53 participants n=151 Participants	126 participants n=302 Participants
Hyperlipidemia	96 participants n=151 Participants	106 participants n=151 Participants	202 participants n=302 Participants
Hypertension	79 participants n=151 Participants	70 participants n=151 Participants	149 participants n=302 Participants
Diabetes	33 participants n=151 Participants	26 participants n=151 Participants	59 participants n=302 Participants
Prior use of antidepressants	16 participants n=151 Participants	9 participants n=151 Participants	25 participants n=302 Participants
Prior myocardial infarction	25 participants n=151 Participants	28 participants n=151 Participants	53 participants n=302 Participants
Prior percutaneous coronary intervention	18 participants n=151 Participants	28 participants n=151 Participants	46 participants n=302 Participants
Prior coronary artery bypass graft	4 participants n=151 Participants	5 participants n=151 Participants	9 participants n=302 Participants
Prior transient ischemic attack or cerebrovascular accident	3 participants n=151 Participants	6 participants n=151 Participants	9 participants n=302 Participants
ST-segment elevation myocardial infarction (at baseline admission)	86 participants n=151 Participants	83 participants n=151 Participants	169 participants n=302 Participants
Non ST-segment elevation myocardial infarction (at baseline admission)	53 participants n=151 Participants	61 participants n=151 Participants	114 participants n=302 Participants
Unstable angina (at baseline admission)	12 participants n=151 Participants	7 participants n=151 Participants	19 participants n=302 Participants
Cardiac catheterization (at baseline admission)	149 participants n=151 Participants	148 participants n=151 Participants	297 participants n=302 Participants
Percutaneous coronary intervention (at baseline admission)	126 participants n=151 Participants	129 participants n=151 Participants	255 participants n=302 Participants
Coronary artery bypass graft (at baseline admission)	14 participants n=151 Participants	4 participants n=151 Participants	18 participants n=302 Participants
Length of stay (baseline admission)	3 days n=151 Participants	3 days n=151 Participants	3 days n=302 Participants
Time from admission to first dose of study medication (baseline admission)	2 days n=151 Participants	2 days n=151 Participants	2 days n=302 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

Outcome measures

Measure	Varenicline n=148 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
7-Day Point Prevalence Smoking Abstinence	70 Participants	49 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 24.

Outcome measures

Measure	Varenicline n=148 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Continuous Smoking Abstinence	53 Participants	39 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

Outcome measures

Measure	Varenicline n=148 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
7-Day Point Prevalence Smoking Abstinence	59 Participants	44 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 52.

Outcome measures

Measure	Varenicline n=148 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Continuous Smoking Abstinence	46 Participants	32 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

Outcome measures

Measure	Varenicline n=149 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
7-Day Point Prevalence Smoking Abstinence	86 Participants	55 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 12.

Outcome measures

Measure	Varenicline n=149 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Continuous Smoking Abstinence	66 Participants	45 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

Outcome measures

Measure	Varenicline n=150 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
7-Day Point Prevalence Smoking Abstinence	90 Participants	57 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.

Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 4.

Outcome measures

Measure	Varenicline n=150 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Continuous Smoking Abstinence	78 Participants	49 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.

Outcome measures

Measure	Varenicline n=147 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Reduction in Daily Cigarette Consumption by 50% or Greater	85 Participants	75 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.

Outcome measures

Measure	Varenicline n=147 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Reduction in Daily Cigarette Consumption by 50% or Greater	99 Participants	84 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.

Outcome measures

Measure	Varenicline n=148 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Reduction in Daily Cigarette Consumption by 50% or Greater	115 Participants	93 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.

Outcome measures

Measure	Varenicline n=149 Participants 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 Participants placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Reduction in Daily Cigarette Consumption by 50% or Greater	130 Participants	113 Participants

Adverse Events

Varenicline

Serious events: 18 serious events

Other events: 92 other events

Deaths: 3 deaths

Placebo

Serious events: 17 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Varenicline n=151 participants at risk 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 participants at risk placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Cardiac disorders Major Adverse Cardiovascular Event (Any)	4.0% 6/151 • Number of events 6 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	4.6% 7/151 • Number of events 8 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Myocardial Infarction	2.0% 3/151 • Number of events 3 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	2.0% 3/151 • Number of events 3 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Unstable Angina	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	3.3% 5/151 • Number of events 5 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Vascular disorders Transient Ischemic Attack	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Arrhythmia	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Vascular disorders Pulmonary Embolism	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Ischemic Cardiomyopathy	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Sick Sinus Syndrome	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Psychiatric disorders Hospitalization for Depression	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Gastrointestinal disorders Gastrointestinal Bleed	1.3% 2/151 • Number of events 2 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Investigations Hospitalization for Suspected Unstable Angina - Ruled Out by Angiogram	1.3% 2/151 • Number of events 2 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Skin and subcutaneous tissue disorders Septic Cellulitis	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Surgical and medical procedures Hospitalization for Bowel Surgery	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Dehydration	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Syncope	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Infections and infestations Sternal Wound Infection	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Vascular disorders Ruptured Pseudoaneurysm	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Gastrointestinal disorders Partial Bowel Obstruction	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Respiratory, thoracic and mediastinal disorders Acute Exacerbation of Chronic Obstructive Pulmonary Disorder	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Musculoskeletal and connective tissue disorders Exacerbation of Rheumatoid Arthritis	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Motor Vehicle Collision	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Gastrointestinal disorders Melena	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Musculoskeletal and connective tissue disorders Non-Cardiac Chest Pain	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Immune system disorders Allergic Reaction	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.66% 1/151 • Number of events 1 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Cardiac disorders Cardiovascular Death	1.3% 2/151 • Number of events 2 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	0.00% 0/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)

Other adverse events

Measure	Varenicline n=151 participants at risk 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.	Placebo n=151 participants at risk placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
General disorders Insomnia	17.9% 27/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	12.6% 19/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Nausea	13.9% 21/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	8.6% 13/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Abnormal Dreams	15.2% 23/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	4.6% 7/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Nightmares	9.3% 14/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	4.6% 7/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Headache	5.3% 8/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	7.9% 12/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Irritability	4.0% 6/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	8.6% 13/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Increased Appetite	5.3% 8/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	6.0% 9/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
General disorders Constipation	6.0% 9/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)	4.0% 6/151 • All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)

Additional Information

Mark Eisenberg, MD MPH

Jewish General Hospital / McGill University

Phone: 5143408222

Email: mark.eisenberg@ladydavis.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place