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Smoking cessation medications do not pose serious cardiovascular risks

Smoking cessation pharmacotherapies, including varenicline, bupropion and nicotine replacement therapy, do not increase the risk for major adverse cardiovascular events, according to a study published in JAMA Internal Medicine.

“Quitting smoking is enhanced by the use of pharmacotherapies, but concerns have been raised regarding the cardiovascular safety of such medications,” Neal L. Benowitz, MD, from the University of California, San Francisco, and colleagues wrote.

Benowitz and colleagues conducted a double-blind, triple-dummy, active-controlled trial to investigate the relative cardiovascular safety risk of smoking cessation medications including varenicline, bupropion and nicotine replacement therapy in comparison placebo. The researchers enrolled 8,058 smokers (mean age, 46.5 years; 44.1% male), 3,984 had an established psychiatric diagnosis. A subset of patients (n = 4,595) were followed for an additional 28 weeks after the initial 12 weeks of follow-up.

Participants were randomly assigned to receive either 1 mg of varenicline twice daily (n = 2,016), 150 mg of bupropion hydrochloride twice daily (n = 2,006), a 21mg nicotine patch with tapering (n = 2,022) or placebo (n = 2,014) for 12 weeks.

The researchers assessed the incidence of and time to development of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, and MACE or new or worsening peripheral vascular disease that led to unstable angina and require intervention, coronary revascularization or hospitalization (MACE+).

The results showed that MACE and MACE+ did not occur often during treatment and follow-up (< 0.5% and < 0.8%, respectively). There was no significant difference among treatments in the incidence of cardiovascular events.

Time to cardiovascular events, BP and heart rate did not significantly differ by treatment.

Additionally, time to onset of MACE did not significantly differ for either varenicline (HR = 0.29; 95% CI, 0.05-1.68) or bupropion treatment (HR = 0.5; 95% CI, 0.1-2.5), compared with placebo.

“Quitting smoking is arguably the most important action a smoker can take to reduce the risk of CV and other smoking-induced diseases,” they concluded. “National guidelines recommend that health care professionals offer smoking cessation behavioral support and pharmacotherapy to their patients who smoke; such treatment substantially increases the likelihood of long-term tobacco abstinence and can significantly lower CV risk.”

“We conclude that, in the general population of individuals who smoke, the benefit of improved CV health from pharmacotherapy-assisted smoking cessation exceeds any risk of medication-induced CV harm,” they added. – by Alaina Tedesco

Disclosure: Benowitz reports consulting for Pfizer and being a paid expert witness in litigation against tobacco companies. Please see study for all other authors’ relevant financial disclosures.