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March 02, 2020
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Smoking cessation pharmacotherapies not linked to cardiovascular, neuropsychiatric hospitalization

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Greg Carney

Varenicline did not appear associated with increased risk for cardiovascular or neuropsychiatric hospitalization compared with nicotine replacement therapies, according to a retrospective new-user cohort study published in Addiction.

“This is the largest observational study on the safety of smoking cessation medications,” Greg Carney, BSc, PhD, of the department of anesthesiology, pharmacology and therapeutics at the University of British Columbia in Vancouver, Canada, told Healio. “The results of this study will assist in alleviating long-running concerns about the cardiovascular and neuropsychiatric safety of varenicline, which should continue to be promoted and prescribed as a safe and effective aid to smoking cessation.”

Using the Truven Health MarketScan Research Database from January 2006 to December 2016, Carney and colleagues evaluated 618,497 adults with a prescription for a smoking cessation pharmacotherapy. The researchers used a composite of hospitalized cardiovascular events, including any hospitalization related to ischemic heart disease, heart failure, cerebral infarction, peripheral vascular disease, unstable angina or a procedure related to coronary revascularization, as the primary outcome. Secondary outcome measures included a composite of hospitalized neuropsychiatric events, including depression, schizophrenia, anxiety, bipolar disorder, suicide attempt, traumatic stress disorder, other psychosis and drug-induced mental disorders, and individual elements of the primary outcome.

The final study cohorts included 454,698 varenicline users, 131,562 bupropion users and 32,237 nicotine replacement therapy (NRT) users. Results showed that, compared with NRT, varenicline was associated with a 20% lower 1-year cardiovascular risk (adjusted RR [aRR] = 0.8; 95% CI, 0.75-0.85) and bupropion was associated with a 25% lower 1-year cardiovascular risk (aRR = 0.75; 95% CI, 0.69-0.81). For neuropsychiatric hospitalizations, varenicline was associated with a 35% lower 1-year risk (aRR = 0.65; 95% CI, 0.59-0.72) and bupropion was associated with a 21% increase in 1-year risk (aRR = 1.21; 95% CI, 1.09-1.35) vs. NRT.

Bupropion was associated with lower 1-year relative risks of hospitalization for peripheral vascular disease (aRR = 0.65; 95% CI, 0.57-0.74), cerebral infarction (aRR = 0.78; 95% CI, 0.64-0.96), ischemic heart disease (aRR = 0.79; 95% CI, 0.69-0.91) and heart failure (aRR = 0.84; 95% CI, 0.74-0.96) compared with NRT. Varenicline was associated with a 1-year relative risk reduction for hospitalization for cerebral infarction (aRR = 0.71; 95% CI, 0.6-0.84), hospitalization for heart failure (aRR = 0.72; 95% CI, 0.65-0.81) and hospitalization for peripheral vascular disease (aRR = 0.83; 95% CI, 0.75-0.92) compared with NRT.

“Although there have been clinical trials providing evidence of the safety of varenicline, we were surprised to find a substantial decreased risk for both cardiovascular and neuropsychiatric hospitalizations compared with NRT,” Carney told Healio Psychiatry. – by Erin T. Welsh

Disclosures: The authors report no relevant financial disclosures.