Smoking Cessation
Conditions
Keywords
A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.
Brief summary
To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers
Detailed description
No sampling method will be applied to this study.
Interventions
DRUGvarenicline
As prescribed by physician in usual clinical practice.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 | Week 3 through Week 7 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
| Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | Week 7 through Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
| Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | At least Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks. | 3,719 |
| Total | 3,719 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 68 |
| Overall Study | Lack of Efficacy | 555 |
| Overall Study | Lost to Follow-up | 962 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age Continuous | 49.4 Years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 340 Participants |
| Sex: Female, Male Male | 3379 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 342 / 3,719 |
| serious Total, serious adverse events | 4 / 3,719 |
Outcome results
Primary
Percentage of Participants With 7-day Point Prevalence for at Least Week 11
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
Time frame: At least Week 11
Population: Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | 77.02 Percentage of participants |
Primary
Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
Time frame: Week 3 through Week 7
Population: Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 | 59.55 Percentage of participants |
Primary
Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11
Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
Time frame: Week 7 through Week 11
Population: Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | 73.29 Percentage of participants |