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Varenicline does not increase risk for cardiovascular, neuropsychiatric events

Varenicline did not appear associated with increased risk for cardiovascular or neuropsychiatric events compared with nicotine replacement therapy, according to results of a retrospective cohort study.

Although varenicline is effective as a smoking cessation aid, concerns about potential associated risks for serious neuropsychiatric and cardiovascular events have limited its use, according to study background.

Daniel Kotz, PhD, of Institute of General Practice at Heinrich-Heine-University Düsseldorf in Germany, and colleagues used the QResearch database — a validated resource that contains data from 753 National Health Service general practices in England — to identify 164,766 patients who received a prescription for a smoking cessation drug between 2007 and 2012.

Of this group, 106,759 patients received nicotine replacement treatment, 51,450 received varenicline and 6,557 received bupropion.

Researchers followed patients for 6 months, recording cardiovascular events such as heart failure, ischemic heart disease, cerebral infarction and arrhythmia, as well as neuropsychiatric events such as depression and self-harm.

Kotz and colleagues reported no increased risk for cardiovascular or neuropsychiatric events for patients taking bupropion or patients taking varenicline compared with those who received nicotine replacement treatment.

Patients treated with varenicline demonstrated a significantly reduced risk for arrhythmia (HR = 0.73; 95% CI, 0.6-0.88), ischemic heart disease (HR = 0.8; 95% CI, 0.72-0.87), heart failure (HR = 0.61; 95% CI, 0.45-0.83) and cerebral infarction (HR = 0.62; 95% CI, 0.52-0.73) compared with nicotine replacement therapy.

Varenicline use also was associated with significantly reduced risks for depression (HR = 0.66; 95% CI, 0.63-0.69) and self-harm (HR = 0.56; 95% CI, 0.46-0.68).

“Varenicline is very unlikely to be associated with an increased risk of the measured cardiovascular or neuropsychiatric events compared with nicotine replacement therapy,” Kotz and colleagues wrote. “Although we cannot rule out adverse reactions that do not get recorded in general practice files, the findings from this study have clear implications for the safety warnings for varenicline and for clinical practice.”

Disclosure: The researchers report no relevant financial disclosures.