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Publication - Dr Kyla Thomas

    What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes?

    Protocol for a prospective cohort study

    Citation

    Davies, NM, Taylor, GMJ, Taylor, AE, Thomas, KH, Windmeijer, F, Martin, RM & Munafo, MR, 2015, ‘What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes?: Protocol for a prospective cohort study’. BMJ Open, vol 5.

    Abstract

    Introduction:
    Smoking is a major avoidable cause of ill-health and premature death.
    Treatments that help patients successfully quit smoking
    have an important effect on health
    and life expectancy. Varenicline is a medication that can help smokers
    successfully quit
    smoking. However, there are concerns
    that it may cause adverse effects, such as increase in the occurrence
    of depression,
    self-harm and suicide and
    cardiovascular disease. In this study we aim to examine the effects of
    varenicline versus other
    smoking cessation pharmacotherapies
    on smoking cessation, health service use, all-cause and cause-specific
    mortality and physical
    and mental health conditions.




    Methods: In
    this project we will investigate the effects of varenicline compared to
    nicotine replacement therapies on: (1) long-term
    smoking cessation and whether these
    effects differ by area level deprivation; and (2) the following
    clinically-important outcomes:
    rate of general practice and
    hospital attendance; all-cause mortality and death due to diseases of
    the respiratory system
    and cardiovascular disease; and a
    primary care diagnosis of respiratory illness, myocardial infarction or
    depression and anxiety.
    The study is based on a cohort of
    patients prescribed these smoking cessation medications from the
    Clinical Practice Research
    Datalink (CPRD). We will use three
    methods to overcome confounding: multivariable adjusted Cox regression,
    propensity score
    matched Cox regression, and
    instrumental variable regression. The total expected sample size for
    analysis will be at least
    180 000. Follow-up will end with the
    earliest of either an ‘event’ or censoring due to the end of
    registration or death.




    Ethics and dissemination:
    Ethics approval was not required for this study. This project has been
    approved by the CPRD's Independent Scientific Advisory
    Committee (ISAC). We will
    disseminate our findings via publications in international peer-reviewed
    journals and presentations
    at international conferences


    Full details in the University publications repository