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  1. H-J Aubin1,
  2. A Bobak2,
  3. J R Britton3,
  4. C Oncken4,
  5. C B Billing, Jr5,
  6. J Gong5,
  7. K E Williams5,
  8. K R Reeves5
  1. 1
    Hôpital Emile Roux, Assistance Publique-Hopitaux de Paris, Limeil-Brévannes, France; Centre d’Enseignement, de Recherche et de Traitement des Addictions, Hôpital Paul Brousse, Paris, France; Assistance Publique-Hôpitaux de Paris, Villejuif, France; INSERM, Paris, France
  2. 2
    Wandsworth Medical Centre, London, UK
  3. 3
    University of Nottingham, Nottingham, UK
  4. 4
    University of Connecticut Health Center, Farmington, Connecticut, USA
  5. 5
    Pfizer Global Research and Development, Groton, Connecticut, USA
  1. Dr H-J Aubin, Centre de Traitement des Addictions, Hôpital Emile Roux, F-94456 Limeil-Brévannes Cedex, France; henri-jean.aubin{at}erx.aphp.fr

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    We recognise the relevance of showing long-term outcomes of smoking cessation therapies. However, many drug trials use end of treatment measures as primary outcomes.1 2 Given the high attrition rates during the follow-up phase, choosing long-term primary outcomes has a high impact on the numbers of subjects needed. It is noteworthy that the study cited by Hillman et al failed to show any significant difference between the efficacy of a nicotine patch and placebo at 6 and 12 months of follow-up.3

    We would like to acknowledge that the Russell standard includes six standard criteria.4 One of these criteria is to use an “intent to treat” approach in which all randomised subjects are included in the analyses (unless they have died or moved to an untraceable address). Using an all-randomised population, our long-term quit rates are clearly significant, favouring varenicline over nicotine replacement therapy (NRT) (p = 0.04).

    In addition, while Hillman et al question the justification of the additional cost of varenicline over NRT, the NICE technology appraisal guidance concluded that, over a lifetime, varenicline is more cost-effective than both bupropion SR and NRT.5

    In conclusion, we feel that we honestly reported our results, not claiming any superiority of varenicline over NRT in the long term, either in the abstract or in the conclusion of the paper. Rather, we hoped to convey the message that any intervention shown to be at least as clinically effective as NRT is an important additional option for smokers attempting to quit.

    H-JA has received sponsorship to attend scientific meetings, speaker honoraria and consultancy fees from GlaxoSmithKline, Pierre-Fabre Sante, Sanofi-Aventis, Merck-Lipha and Pfizer. AB has received sponsorship to attend scientific meetings, speaker honoraria and consultancy fees from Boehringer Ingelheim, GlaxoSmithKline, Novartis and Pfizer. In the past 5 years JRB has received consultancy fees from Xenova and Novartis and his employing institution has received consultancy fees and honoraria on his behalf from Pfizer. CO has received honoraria and consulting fees from Pfizer; nicotine and placebo products for research studies at no cost from GlaxoSmithKline; and honoraria from Pri-Med and CME outfitters. CBB, JG, KEW and KRR are employees of Pfizer.

    REFERENCES

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      . Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Arch Intern Med 1999;159:2033–8.
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      . A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997;23:1195–202.
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      1. Jorenby DE,
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      3. Leischow SJ,
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      . A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med 1999;340:685–91.
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      1. West R,
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      . Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction 2005;100:299–303.
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      National Institute for Health and Clinical Excellence (NICE). Varenicline for smoking cessation. NICE Technology Appraisal Guidance 123. London: NICE, 2007. http://www.nice.org.uk/nicemedia/pdf/TA123Guidance.pdf (accessed 28 March 2008).

    Footnotes

    • Competing interests: H-JA has received sponsorship to attend scientific meetings, speaker honoraria and consultancy fees from GlaxoSmithKline, Pierre-Fabre Sante, Sanofi-Aventis, Merck-Lipha and Pfizer. AB has received sponsorship to attend scientific meetings, speaker honoraria and consultancy fees from Boehringer Ingelheim, GlaxoSmithKline, Novartis and Pfizer. In the past 5 years JRB has received consultancy fees from Xenova and Novartis and his employing institution has received consultancy fees and honoraria on his behalf from Pfizer. CO has received honoraria and consulting fees from Pfizer; nicotine and placebo products for research studies at no cost from GlaxoSmithKline; and honoraria from Pri-Med and CME outfitters. CBB, JG, KEW and KRR are employees of Pfizer.