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Clinically significant outcomes in smoking cessation
  1. T Hillman,
  2. K Rajakulasingam,
  3. A Bhowmik
  1. Homerton University Hospital NHS Trust, London, UK
  1. Dr T E Hillman, Homerton University Hospital NHS Trust, Homerton Row, London E9 6SR, UK; tobyh{at}

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The study by Aubin et al1 published in this issue comparing varenicline with nicotine replacement therapy (NRT). The authors have shown a significant difference in continuous abstinence rate at the end of treatment of 12 (or 11) weeks, favouring varenicline. However, the beneficial effect is not maintained in a significant fashion up to the end of the study period at 52 weeks. In this context, we would question the validity of measuring abstinence at 12 (or 11) weeks as a primary outcome. It is the long-term outcomes of a smoking cessation therapy that should be most clinically relevant, and therefore the most important finding in this trial. Indeed, the Russell standard recommends that, as a bench mark, quit rates should be assessed at 6 and 12 months and biochemically verified at each point.2 Other comparative studies using NRT have also used 6- or 12-month periods to assess the efficacy.3

Given the fact that there was no significant difference in the abstinence rates at 12 months between the two treatments, it calls into question the cost-effectiveness of varenicline as a pharmacotherapy for smoking cessation. The courses of treatment used in the trial cost £163.80 and £76.31 for varenicline and NRT, respectively.4 Clinicians are under pressure at all times to cut costs and be evidence-based, and this trial seems to show that there is currently no compelling reason to use the newer, more expensive agent in the smoking cessation clinic, apart from its apparent benefit in reducing craving and some other non-specific effects in the early phases of treatment.

We think the conclusions of the trial are presented in such a way as to give more emphasis to the efficacy of varenicline compared with NRT. But it seems that what this study really tells us is that there is no significant difference in long-term abstinence when comparing varenicline with NRT in an open-label comparison.



  • Competing interests: None.