We acknowledge the proposition raised by Dr Rose that a comparison of nicotine replacement therapy (NRT) and varenicline using equal pre-cessation treatment regimens may result in different efficacy outcomes from those found in our trial. However, we would like to reiterate that our open-label comparison of varenicline with NRT was a pragmatic trial based on current treatment regimen recommendations by the manufacturers of the products and in accordance with current recommendations for transdermal NRT use in established health guidelines.1 2

Dr Rose suggests that the imbalance in pre-cessation treatment between products in our trial reflects a flaw in the design of our study. The objective of this study was to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal NRT. As the differentiation in treatment between products is openly acknowledged and justified, we would argue that differences in pre-cessation treatment do not reflect a design flaw but, rather, a potential limitation. Even though pre-cessation treatment was not directly referred to, our paper discusses the possibility of a treatment bias resulting from differences in treatment periods between products and recognises this as a limitation of the study.

While use of pre-cessation NRT may be being adopted in some cases, its use is not currently general practice. A standard regimen comparison, as with this open-label design, is therefore more likely to reflect results found in real-world settings. Indeed, recent real-world data from Stop Smoking Services in England provide further support for our findings of greater efficacy with varenicline compared with NRT.3 The 4-week quit rates in participants set a quit date between April and September 2007 were: varenicline 64% (n = 32 879), bupropion SR 53% (n = 12 767) and NRT 48% (n = 243 123).

The evidence of improved efficacy of transdermal NRT when used during a pre-cessation period in comparison with NRT use without a pre-cessation period4 5 may provide a rationale for conducting a comparison of varenicline versus NRT with equal pre-cessation treatment periods. The authors of the currently discussed open-label trial agree that this would certainly be an interesting study for future research.

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.