Varenicline’s adverse events

Flaws in analysis lead to misleading conclusions about varenicline’s safety in smoking cessation

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e3873 (Published 12 June 2012)
Cite this as: BMJ 2012;344:e3873

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  1. Sonal Singh, assistant professor1,
  2. Yoon K Loke, clinical senior lecturer2
  1. 1Johns Hopkins University, 680 B, 624 N Broadway, Baltimore, MD 21205, USA
  2. 2Norwich Medical School, University of East Anglia, Norwich, UK
  1. sosingh{at}jhsph.edu

The meta-analysis by Prochaska and Hilton has several methodological limitations in data analysis and interpretation, which lead to misleading conclusions.1 Despite the removal of cardiovascular events from the trials and a statistical approach that has limited power to detect a significant effect, there is an excess risk of cardiovascular events with varenicline in all five measures reported.

The risk difference model Prochaska and Hilton used is statistically …

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