Varenicline ups risk of cardiovascular events
Varenicline, while effective for smoking cessation, appears to significantly elevate the risk of cardiovascular hospitalization and emergency department visits, particularly for new users, a recent study shows.
The research team examined the incidences of cardiovascular and neuropsychiatric hospitalizations in 56,851 new users of varenicline. Within 1 year before to 1 year after the receipt of the drug, they found a total of 6,317 cardiovascular and 10,041 neuropsychiatric events.
The incidence of cardiovascular events was significantly higher during the 12 weeks following varenicline initiation (risk interval) than during all other observation periods (control interval; relative incidence [RI], 1.34; 95 percent CI, 1.25–1.44; p<0.001). This trend remained significant even when the risk interval was changed to 4 weeks (RI, 1.30; 1.15–1.46; p<0.001), 8 weeks (RI, 1.42; 1.31–1.55; p<0.001), and 16 weeks (RI, 1.30; 1.22–1.39; p<0.001) following varenicline initiation.
Analysis by patient subgroup did not significantly change the observed association, with both <65-year (RI, 1.22; 1.10–1.34; p<0.001) and ≥65-year (RI, 1.53; 1.38–1.70; p<0.001) age groups showing significantly higher cardiovascular event incidence during the risk interval. Males and females also had similarly elevated incidences of cardiovascular events.
On the other hand, the incidence of neuropsychiatric events was also significantly elevated when the risk interval was set at 12 weeks (RI, 1.06; 1.00–1.13; p=0.042) or 16 weeks (RI, 1.06; 1.01–1.12; p=0.025) following varenicline initiation. In contrast, the incidence was not significantly higher 4 weeks and 8 weeks after initiation. Subgroup analysis also attenuated the association, with only individuals aged ≥65 years showing elevated incidence of neuropsychiatric events (RI, 1.44; 1.15‒1.80; p=0.002).