Smoking Cessation Clinical Trial
Official title:
A Retrospective, Real-life Evaluation of the Cardiovascular Disease Risk Associated With Exposure to Pharmacological Smoking Cessation Interventions in a Representative UK Primary Care Patient Population.
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 smokers attempting smoking cessation assisted by pharmacological interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray, transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary care population.
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 exposed patients) of a magnitude that could not reasonably be accounted
for by differences in the cardiovascular risk profile of the two patient groups. Further
in-depth studies in this area are warranted.
This retrospective study will compare the cardiovascular disease event risk in a group of
smokers undertaking pharmacologically unaided smoking cessation attempts with the event rate
in a group of smokers attempting smoking cessation assisted by pharmacological interventions
(any of nicotine replacement therapy, bupropion or varenicline) in a representative UK
primary care population.
There are three main types of pharmacological interventions currently available for smoking
cessation, each of which has demonstrated efficacy when used in conjunction with behavioural
support: nicotine replacement therapy, bupropion, and varenicline. Other medications,
especially nortryptiline and clonidine, are considered to be effective adjunct therapy in
smoking cessation, but they remain second-line options at this time.
Nicotine replacement therapy has been available since the 1980s and bupropion since 2000.
Either approach to cessation doubles the chance of achieving abstinence when compared with
unsupported quit attempts. After being granted its European licence in 2006, varenicline
joined the pharmacological smoking cessation armamentarium. It is the first drug developed
specifically for the treatment of tobacco dependence that contains no nicotine, and it
triples smokers' chances of quitting compared with unsupported quit attempts.
As the fore-runner, nicotine replacement therapy is the longest-standing of the existing
pharmacological smoking cessation interventions currently available. It aims to alleviate
nicotine withdrawal symptoms by substituting the nicotine attained through tobacco smoking
via alternative means (e.g. nasal sprays, inhalers, gum and tablets, transdermal patches).
The various nicotine replacement therapy products available have differing durations of
action and allow patients to tailor their nicotine intake according to their particular
needs.For example, patches can be used to substitute for background nicotine and gums or
tablets can be used to help satisfy urges.
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Observational Model: Cohort, Time Perspective: Retrospective
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