Trial Outcomes & Findings for Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking (NCT NCT00282984)
NCT ID: NCT00282984
Last Updated: 2017-04-05
Results Overview
Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
714 participants
Primary outcome timeframe
weeks 9 through 12
Results posted on
2017-04-05
Participant Flow
The study was conducted in outpatients. The target population was cigarette smokers with cardiovascular disease drawn from the communities surrounding the participating clinics.
714 smokers were randomized (ie, assigned to study treatment), 11 participants were randomized, but not treated. The reasons for participants being randomized, not treated included no longer willing to participate in the study (5 participants), protocol violation (3 participants), lost to follow-up (1 participant), and other (2 participants).
Participant milestones
| Measure |
Varenicline (Var)
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
350
|
|
Overall Study
COMPLETED
|
302
|
289
|
|
Overall Study
NOT COMPLETED
|
51
|
61
|
Reasons for withdrawal
| Measure |
Varenicline (Var)
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
14
|
10
|
|
Overall Study
Withdrawal by Participant
|
22
|
34
|
|
Overall Study
Participant stopped study medication
|
2
|
2
|
|
Overall Study
Participant only allowed phone follow-up
|
0
|
1
|
|
Overall Study
Participant used antipsychosis meds
|
0
|
1
|
|
Overall Study
lack of motivation
|
1
|
0
|
|
Overall Study
in prison
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Baseline characteristics by cohort
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Total
n=703 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
266 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
553 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 9 through 12Population: Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as "All Participants" population in this report.
Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
responders
|
167 participants
|
50 participants
|
|
Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
non-responders
|
186 participants
|
300 participants
|
SECONDARY outcome
Timeframe: Week 9 through Week 52Population: All participants population
Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO \> 10 ppm.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Responders With Continuous Abstinence (CA) Through Week 52
responders
|
70 participants
|
26 participants
|
|
Number of Responders With Continuous Abstinence (CA) Through Week 52
non-responders
|
283 participants
|
324 participants
|
SECONDARY outcome
Timeframe: Week 9 through Week 52Population: All participants population
Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Long-Term Quit Responders
responders
|
80 participants
|
34 participants
|
|
Number of Long-Term Quit Responders
non-responders
|
273 participants
|
316 participants
|
SECONDARY outcome
Timeframe: Week 12Population: All Participants population
Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
responders
|
192 participants
|
65 participants
|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
non-responders
|
161 participants
|
285 participants
|
SECONDARY outcome
Timeframe: Week 24Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
responders
|
124 participants
|
57 participants
|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
non-responders
|
229 participants
|
293 participants
|
SECONDARY outcome
Timeframe: Week 52Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
responders
|
102 participants
|
62 participants
|
|
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
non-responders
|
251 participants
|
288 participants
|
SECONDARY outcome
Timeframe: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])Population: All Participants population
Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
|
99 participants
|
57 participants
|
SECONDARY outcome
Timeframe: Week 9 through Week 24Population: All Participants population
Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO \> 10 ppm at any given timepoint.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Responders With Continuous Abstinence (CA) Through Week 24
|
100 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Day 21Population: All Participants population
Cigarettes smoked each day during the first 3 weeks of the treatment phase.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Cigarettes Smoked Per Day
Baseline
|
22.2 cigarettes per day
Standard Deviation 10.0
|
22.9 cigarettes per day
Standard Deviation 10.9
|
|
Cigarettes Smoked Per Day
Day 1
|
17.6 cigarettes per day
Standard Deviation 9.4
|
19.1 cigarettes per day
Standard Deviation 10.0
|
|
Cigarettes Smoked Per Day
Day 2
|
16.8 cigarettes per day
Standard Deviation 8.8
|
18.4 cigarettes per day
Standard Deviation 9.6
|
|
Cigarettes Smoked Per Day
Day 3
|
15.8 cigarettes per day
Standard Deviation 9.2
|
18.0 cigarettes per day
Standard Deviation 10.0
|
|
Cigarettes Smoked Per Day
Day 4
|
15.7 cigarettes per day
Standard Deviation 8.9
|
17.1 cigarettes per day
Standard Deviation 9.6
|
|
Cigarettes Smoked Per Day
Day 5
|
15.1 cigarettes per day
Standard Deviation 8.8
|
16.3 cigarettes per day
Standard Deviation 8.9
|
|
Cigarettes Smoked Per Day
Day 6
|
14.4 cigarettes per day
Standard Deviation 8.4
|
16.0 cigarettes per day
Standard Deviation 8.9
|
|
Cigarettes Smoked Per Day
Day 7
|
13.8 cigarettes per day
Standard Deviation 8.6
|
15.1 cigarettes per day
Standard Deviation 8.8
|
|
Cigarettes Smoked Per Day
Day 8
|
11.7 cigarettes per day
Standard Deviation 9.2
|
12.3 cigarettes per day
Standard Deviation 10.5
|
|
Cigarettes Smoked Per Day
Day 9
|
9.5 cigarettes per day
Standard Deviation 7.5
|
10.9 cigarettes per day
Standard Deviation 9.5
|
|
Cigarettes Smoked Per Day
Day 10
|
8.9 cigarettes per day
Standard Deviation 7.2
|
10.6 cigarettes per day
Standard Deviation 8.6
|
|
Cigarettes Smoked Per Day
Day 11
|
8.9 cigarettes per day
Standard Deviation 7.3
|
10.4 cigarettes per day
Standard Deviation 8.4
|
|
Cigarettes Smoked Per Day
Day 12
|
8.7 cigarettes per day
Standard Deviation 7.5
|
10.5 cigarettes per day
Standard Deviation 8.3
|
|
Cigarettes Smoked Per Day
Day 13
|
8.8 cigarettes per day
Standard Deviation 7.1
|
10.3 cigarettes per day
Standard Deviation 8.2
|
|
Cigarettes Smoked Per Day
Day 14
|
9.3 cigarettes per day
Standard Deviation 7.4
|
10.7 cigarettes per day
Standard Deviation 8.6
|
|
Cigarettes Smoked Per Day
Day 15
|
8.9 cigarettes per day
Standard Deviation 7.6
|
11.2 cigarettes per day
Standard Deviation 9.1
|
|
Cigarettes Smoked Per Day
Day 16
|
8.8 cigarettes per day
Standard Deviation 7.1
|
11.0 cigarettes per day
Standard Deviation 8.7
|
|
Cigarettes Smoked Per Day
Day 17
|
8.3 cigarettes per day
Standard Deviation 6.4
|
10.6 cigarettes per day
Standard Deviation 8.2
|
|
Cigarettes Smoked Per Day
Day 18
|
8.2 cigarettes per day
Standard Deviation 6.9
|
10.3 cigarettes per day
Standard Deviation 8.8
|
|
Cigarettes Smoked Per Day
Day 19
|
7.8 cigarettes per day
Standard Deviation 6.7
|
10.3 cigarettes per day
Standard Deviation 8.4
|
|
Cigarettes Smoked Per Day
Day 20
|
7.9 cigarettes per day
Standard Deviation 6.1
|
10.6 cigarettes per day
Standard Deviation 8.3
|
|
Cigarettes Smoked Per Day
Day 21
|
7.2 cigarettes per day
Standard Deviation 6.3
|
9.3 cigarettes per day
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Week 9 through Week 24Population: All Participants population
Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Outcome measures
| Measure |
Varenicline (Var)
n=353 Participants
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
n=350 Participants
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Number of Long-Term Quit Responders From Week 9 Through Week 24
responders
|
117 participants
|
42 participants
|
|
Number of Long-Term Quit Responders From Week 9 Through Week 24
non-responders
|
236 participants
|
308 participants
|
Adverse Events
Varenicline (Var)
Serious events: 23 serious events
Other events: 253 other events
Deaths: 0 deaths
Placebo (Pbo)
Serious events: 21 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline (Var)
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/353
|
0.29%
1/350
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/353
|
0.29%
1/350
|
|
Cardiac disorders
Acute myocardial infarction
|
0.57%
2/353
|
0.29%
1/350
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/353
|
0.57%
2/350
|
|
Cardiac disorders
Arrhythmia
|
0.28%
1/353
|
0.00%
0/350
|
|
Cardiac disorders
Atrial fibrillation
|
0.28%
1/353
|
0.57%
2/350
|
|
Cardiac disorders
Cardiac failure
|
0.28%
1/353
|
0.29%
1/350
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/353
|
0.29%
1/350
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/353
|
0.29%
1/350
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.28%
1/353
|
0.00%
0/350
|
|
Gastrointestinal disorders
Gingival recession
|
0.28%
1/353
|
0.00%
0/350
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/353
|
0.29%
1/350
|
|
Gastrointestinal disorders
Periodontal disease
|
0.28%
1/353
|
0.00%
0/350
|
|
General disorders
Chest pain
|
0.57%
2/353
|
0.57%
2/350
|
|
Infections and infestations
Cellulitis
|
0.28%
1/353
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.28%
1/353
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/353
|
0.29%
1/350
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.28%
1/353
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/353
|
0.29%
1/350
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/353
|
0.29%
1/350
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
1/353
|
0.29%
1/350
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/353
|
0.29%
1/350
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
2/353
|
0.00%
0/350
|
|
Nervous system disorders
Cervical root pain
|
0.28%
1/353
|
0.00%
0/350
|
|
Nervous system disorders
Complex partial seizures
|
0.28%
1/353
|
0.00%
0/350
|
|
Nervous system disorders
Syncope
|
0.28%
1/353
|
0.29%
1/350
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.28%
1/353
|
0.00%
0/350
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.28%
1/353
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/353
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
1/353
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.28%
1/353
|
0.00%
0/350
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/353
|
0.29%
1/350
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/353
|
0.29%
1/350
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/353
|
0.29%
1/350
|
|
Vascular disorders
Thrombosis
|
0.28%
1/353
|
0.00%
0/350
|
|
Cardiac disorders
Angina unstable
|
0.28%
1/353
|
0.00%
0/350
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/353
|
0.29%
1/350
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
1/353
|
0.00%
0/350
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/353
|
0.29%
1/350
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/353
|
0.29%
1/350
|
|
Infections and infestations
Infected cyst
|
0.28%
1/353
|
0.00%
0/350
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/353
|
0.29%
1/350
|
|
Infections and infestations
Pneumonia
|
0.00%
0/353
|
0.29%
1/350
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/353
|
0.29%
1/350
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/353
|
0.29%
1/350
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/353
|
0.29%
1/350
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/353
|
0.29%
1/350
|
|
Vascular disorders
Arteriosclerosis
|
0.28%
1/353
|
0.00%
0/350
|
Other adverse events
| Measure |
Varenicline (Var)
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
Placebo (Pbo)
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
3.4%
12/353
|
1.4%
5/350
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
7/353
|
0.86%
3/350
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
15/353
|
2.6%
9/350
|
|
Gastrointestinal disorders
Constipation
|
6.5%
23/353
|
2.0%
7/350
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
22/353
|
5.1%
18/350
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
13/353
|
2.0%
7/350
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
19/353
|
3.4%
12/350
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
8/353
|
2.0%
7/350
|
|
Gastrointestinal disorders
Nausea
|
29.5%
104/353
|
8.6%
30/350
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
29/353
|
1.1%
4/350
|
|
General disorders
Chest pain
|
2.0%
7/353
|
1.7%
6/350
|
|
General disorders
Fatigue
|
7.1%
25/353
|
4.0%
14/350
|
|
General disorders
Irritability
|
1.7%
6/353
|
2.6%
9/350
|
|
General disorders
Oedema peripheral
|
2.0%
7/353
|
1.1%
4/350
|
|
Infections and infestations
Influenza
|
4.2%
15/353
|
4.9%
17/350
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
23/353
|
8.6%
30/350
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
11/353
|
3.4%
12/350
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
13/353
|
2.3%
8/350
|
|
Nervous system disorders
Dizziness
|
6.2%
22/353
|
4.6%
16/350
|
|
Nervous system disorders
Dysgeusia
|
4.5%
16/353
|
2.3%
8/350
|
|
Nervous system disorders
Headache
|
12.7%
45/353
|
11.1%
39/350
|
|
Nervous system disorders
Somnolence
|
0.57%
2/353
|
2.0%
7/350
|
|
Psychiatric disorders
Abnormal dreams
|
7.9%
28/353
|
1.7%
6/350
|
|
Psychiatric disorders
Anxiety
|
2.3%
8/353
|
3.7%
13/350
|
|
Psychiatric disorders
Insomnia
|
11.9%
42/353
|
6.6%
23/350
|
|
Psychiatric disorders
Nicotine dependence
|
2.5%
9/353
|
1.4%
5/350
|
|
Psychiatric disorders
Sleep disorder
|
3.4%
12/353
|
1.4%
5/350
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
7/353
|
3.7%
13/350
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
9/353
|
1.1%
4/350
|
|
Vascular disorders
Hypertension
|
1.4%
5/353
|
2.6%
9/350
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 months (mo) from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER