Status:
UNKNOWN
Nicotine Replacement Therapy and Cardiovascular Disease
Lead Sponsor:
Research in Real-Life Ltd
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-75 years
Brief Summary
The aim of this study is to compare the cardiovascular disease event rate in smokers undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with the event rate in smo...
Detailed Description
Preliminary study data have indicated a possible increased cardiovascular disease risk in patients exposed to nicotine replacement therapy compared with controls (i.e. non-nicotine replacement therapy...
Eligibility Criteria
Inclusion
- The analysis will include an exposure group comprising smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose first recorded smoking cessation intervention was a cessation attempt assisted by either nicotine replacement therapy (using any of, or a combination of products) or another pharmacological smoking cessation intervention (e.g. bupropion, varenicline) at the index date.
- Patients must also meet the following inclusion criteria:
- Aged: 18-75 years.
- Have at least one year of up-to-standard baseline data as defined by Clinical Practice Research Datalink (prior to the index smoking cessation attempt) and at least one year of up-to-standard outcome data (following the index smoking cessation attempt) or up-to-standard data up to the time of death if death occurred within the outcome period.
Exclusion
- Patients will be excluded from the analysis if they:
- Have had exposure to any nicotine replacement therapy or other pharmacological smoking cessation interventions in the baseline period (year prior to the index smoking cessation attempt), and/or
- Switched between types of smoking cessation interventions (i.e. nicotine replacement therapy to other pharmacological smoking cessation interventions or vice versa) during the outcome period(s). Switching between different nicotine replacement therapy products, or use of multiple nicotine replacement therapy products, will be permissible and analysis may involve a comparison of outcomes relative to nicotine exposure over the various outcome periods.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
61050 Patients enrolled
Trial Details
Trial ID
NCT02195739
Start Date
September 1 2013
End Date
December 1 2014
Last Update
October 1 2014
Active Locations (1)
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1
Research in Real Life Ltd
Cambridge, United Kingdom, CB24 3BA