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

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 …