Quit-Smoking Pill Varenicline Needs No Assistance From Nicotine Patch

By Megan Brooks

October 21, 2021

NEW YORK (Reuters Health) - Combining varenicline with the nicotine patch or extending the duration of smoking-cessation treatment does not increase quit rates compared with the standard length of therapy with varenicline only, new research indicates.

"I think we have a general idea that more is always better," Dr. Michael Fiore of the Center for Tobacco Research and Intervention at the University of Wisconsin, Madison, noted in a phone interview with Reuters Health.

"But what this study found really convincingly is that smokers who want to quit have an incredibly effective treatment in varenicline. And if they use it for the recommended three months, without extending it and without combining it with any other medication they'll get as good a result as they would doing it in a more complex and more expensive way," Dr. Fiore said.

Until now, the data have been limited and contradictory on whether combining varenicline with a nicotine patch or extending the duration of treatment could enhance quit rates.

The current study addresses these questions in a double-blind randomized clinical trial of 1,251 adults smoking at least five cigarettes daily. They were randomly split into four groups: varenicline monotherapy for 12 weeks; varenicline plus nicotine patch for 12 weeks; varenicline monotherapy for 24 weeks; or varenicline plus nicotine patch for 24 weeks.

All participants received six cessation counseling sessions, each lasting about 15 minutes, focusing on medication use, support, coping skills, and motivation to quit.

The primary outcome was self-reported seven-day point prevalence abstinence (biologically confirmed with exhaled carbon monoxide level of 5 ppm or lower) at 52 weeks.

The results showed no statistically significant differences in the primary outcome, which was met by 25% of adults receiving 12 weeks of varenicline alone; 24% of those receiving 12 weeks of varenicline plus nicotine patch; 24% of those receiving 24 weeks of varenicline alone; and 25% of those receiving 24 weeks of varenicline plus nicotine patch.

Dr. Fiore noted that there are more than 30 million smokers in America today. "If they don't quit, half of them, or 15 million Americans, will be killed prematurely by their dependence upon cigarettes. There is nothing out there that puts Americans at greater risk from a health perspective," he said.

"What we can do with medicines like varenicline, counseling, the quit line, and the other treatments that are available, we can give those 30 million Americans a fighting chance. There's nothing else that I as a physician treat that kills half of my patients," Dr. Fiore said.

"The good news from this study is if you use varenicline in the simplest way, for the briefest period of time, without anything else, you get the same bang for the buck," he added.

The co-authors of a JAMA editorial say it's "important for clinicians to recognize that most cigarette smokers pass through repeated cycles of short-term abstinence followed by relapse before achieving long-term abstinence."

"Therefore, clinicians need to use a chronic disease management approach, which involves monitoring tobacco use over time and making frequent efforts to encourage and assist cigarette smokers in quitting tobacco products," advise Dr. Rajat Barua and Dr. Mohinder Vindhyal of the University of Kansas Medical Center in Kansas City, Missouri.

"As outlined in the clinical recommendations, all patients should have a tobacco use assessment at each visit, and based on their readiness to quit tobacco, the level of dependence, past quit attempts, and personal preferences, a stepwise tailored approach is needed to achieve successful tobacco cessation," they point out.

Pfizer supplied the study with free active and placebo varenicline as per an investigator-initiated research agreement. This research was supported by grants from the National Heart, Lung, and Blood Institute and the National Cancer Institute, both awarded to the University of Wisconsin Center for Tobacco Research and Intervention.

SOURCE: https://bit.ly/2Z7G5ry and https://bit.ly/3aOXcAE JAMA, online October 19, 2021.