Smoking Cessation
Conditions
Brief summary
The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.
Detailed description
Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Interventions
DRUGVarenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Legal adult age * Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking * Evidence of a personally signed and dated Informed Consent document.
Exclusion criteria
* Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Abstained From Smoking at Week 12 | Week 12 | The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Nicotine Dependence Measured by the Fagerstrom Test | Baseline | Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence). |
Participant flow
Pre-assignment details
A total of 1391 participants were screened and 1177 participants were assigned to the treatment.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity. | 1,173 |
| Total | 1,173 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 40 |
| Overall Study | Lack of Efficacy | 43 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Ongoing | 21 |
| Overall Study | Other | 43 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Study terminated by sponsor | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age Continuous | 49.4 years STANDARD_DEVIATION 12 |
| Sex/Gender, Customized Female | 503 participants |
| Sex/Gender, Customized Male | 669 participants |
| Sex/Gender, Customized Unspecified | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 1,177 |
| serious Total, serious adverse events | 7 / 1,177 |
Outcome results
Primary
Percentage of Participants Who Abstained From Smoking at Week 12
The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.
Time frame: Week 12
Population: The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants Who Abstained From Smoking at Week 12 | 71.1 percentage of participants |
Secondary
Level of Nicotine Dependence Measured by the Fagerstrom Test
Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).
Time frame: Baseline
Population: The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Varenicline | Level of Nicotine Dependence Measured by the Fagerstrom Test | 5.30 Scores on a scale | Standard Deviation 2.31 |