Chantix (varenicline) is an effective and safe therapy to quit smoking, according to researchers from the Charles E. Schmidt College of Medicine at Florida Atlantic University. The therapy ultimately could have prevented heart attacks and deaths from cardiovascular disease.

The research-based commentary about Chantix is titled “Smoking Cessation: The Urgent Need for Increased Utilization of Varenicline,” and was published in the American Journal of Medicine.

More than 35 million people in the United States are trying to stop smoking cigarettes. Cigarette smoking causes 480,000 premature deaths annually, mainly due to a twofold increased risk of cardiovascular disease and a 20-fold increased risk of lung cancer.

In 2006, Chantix was approved by the U.S. Food and Drug Administration (FDA) for promoting long-term cessation rates of about 25%, a result significantly greater than other approved smoking cessation aids, such as bupropion or nicotine replacement therapy.

In 2009 the FDA issued a black box warning for Chantix based on reports of adverse neuropsychiatric reactions such as depression and suicidal thoughts. This resulted in a 76% decrease in the number of prescriptions dispensed, from approximately 2 million in the fourth quarter of 2007 to approximately 531,000 in the beginning of 2014.

In their comments, the FAU researchers highlighted that, until recently, the sum of randomized studies on Chantix’s safety was limited to eight small trials, all showing no significant association between the drug and serious neuropsychiatric symptoms.

At the FDA’s request, a large, 12-week, randomized, double-blind, placebo-controlled trial, in which 8,000 subjects with and without psychiatric disorders were randomized to receive either a nicotine patch, 21 mg per day with taper of Chantix (1 mg twice a day), and bupropion (150 mg twice a day).

Participants were long-term smokers and included equal subgroups of those with and without psychiatric disorders.

Participants receiving Chantix reached higher abstinence rates at 12 weeks, compared to those who received a placebo, nicotine patch or bupropion. Participants without psychiatric disorders under Chantix treatment also had less neuropsychiatric symptoms.

In December, the FDA removed the black box warning from Chantix.

“The existing totality of evidence suggests an urgent need to increase the use of varenicline in the general population as well as in those with serious mental illness who on average die about 20 years earlier than the general population, in part, because their smoking rates may be as high as 75 percent,” Charles H. Hennekens, MD, DrPH, said in a press release.

Rates of cardiovascular disease of nonsmokers are achieved within three to five years after quitting smoking.

In contrast, for lung and other cancers, reduction in risk does not emerge for years after smoking cessation and, even after 10 years, quitters have death rates only about midway between the continuing smoker and non-smoker.

“For reducing risks of cardiovascular disease it’s never too late to quit, but to reduce risks of cancer, it’s never too early,” said Hennekens.

With 35 million smokers attempting to quit in the U.S., 7 million would have succeeded with Chantix, the researchers asserted. They projected that about 17,000 annual premature deaths would have been avoided if prescription rates of Chantix had not dropped by 76% following the black box warning.