Letters Varenicline’s adverse events

Authors’ reply to Singh and Loke

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e4033 (Published 12 June 2012) Cite this as: BMJ 2012;344:e4033
  1. Joan F Hilton, professor1,
  2. Judith J Prochaska, associate professor2
  1. 1Department of Epidemiology and Biostatistics, University of California, San Francisco, USA
  2. 2Department of Psychiatry and Center for Tobacco Control Research and Education, University of California, San Francisco, CA 94143-0984, USA
  1. JProchaska{at}ucsf.edu

The principle in intention to treat analysis is that all trial participants be analysed as randomised and followed up to the study end point of interest.1 Both our meta-analysis and that of Singh et al analysed all participants as randomised.2 3 For assessment of cardiovascular safety, we identified the period of treatment exposure plus 30 days as biologically relevant and followed up both arms for equal duration.2 Indeed, the primary end point of the CATS study is major cardiovascular events occurring during the treatment phase. …

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