In light of trials reporting on the incidence of cardiovascular serious adverse events among those using varenicline and a call to evaluate the association of cardiovascular serious adverse events with the use of varenicline, two recent meta-analyses have reviewed existing evidence.
Whilst findings were not uniform, based on the findings of these reviews, the risk of cardiovascular events associated with the use of varenicline is judged to be minimal and clinically insignificant.
Note: The recent changes to the service product characteristics (SPC) for varenicline do not substantially change the points raised in this briefing nor the advice that it is safe and effective.