No Difference Found in Effectiveness of Common Smoking Cessation Aids

A study published January 26 in the JAMA has found no significant differences in the smoking abstinence rates of people who were treated with a nicotine patch, varenicline, or a combination of nicotine patch and lozenge therapy for 12 weeks.

According to the authors, “the results raise questions about the current relative effectiveness of intense smoking cessation pharmacotherapies” compared with less intense nicotine cessation aids such as the nicotine patch.

In 2009, the Food and Drug Administration (FDA) first added a black-box warning to varenicline after reports indicated that the medication may increase the risk of depression and suicidal thoughts. While recent evidence suggests that the medication can be used safely, it is recommended that clinicians ask patients about a history of psychiatric illness prior to initiating varenicline and closely monitor patients on the medication.

In contrast, past studies suggest that combination nicotine replacement therapy (C-NRT) poses no greater risk than that of nicotine replacement therapy (NRT) alone, which has been found to be safe and well tolerated.

“Smoking is the leading preventable cause of mortality and morbidity in developed countries,” said the study’s lead author Timothy Baker, Ph.D., a professor of medicine at the University of Wisconsin School of Medicine and Public Health, in an interview with Psychiatric News. “Therefore, it is extremely important that we discover the most effective ways to help individuals quit smoking successfully.”

To compare the effectiveness of varenicline with nicotine replacement therapy, Baker and colleagues randomized 1,086 smokers (participants smoked at least five cigarettes a day) to one of three 12-week open-label groups: nicotine patch only, varenicline only, and C-NRT (nicotine patch and nicotine lozenges). All participants received six counseling sessions over the course of the 12-week period, consisting of motivational, supportive, and skill-training elements.

When the participants were asked about their past-week smoking habits at 26 and 52 weeks, the data showed that there was no significant difference between the three groups in achieving abstinence, with smoking cessation rates among the groups ranging from 23 percent to 27 percent at 26 weeks and 19 percent to 21 percent at 52 weeks (abstinence was confirmed by a carbon monoxide breath test). While all medications were well tolerated, varenicline produced more frequent adverse events such as vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion.

Douglas Ziedonis, M.D., M.P.H., chair of the Department of Psychiatry at the University of Massachusetts Medical School, said that although most patients who are trying to quit smoking engage in treatment plans that often span from six months to a year, the findings suggest that even 12-week treatment with “some of the most commonly prescribed and used treatment options [approved by the FDA] for nicotine addiction are effective” for some people.

Baker noted that although earlier research suggested the superior effectiveness of varenicline and C-NRT compared with the nicotine patch, this was not evident in the current findings, which shows that the nicotine patch is just as effective as varenicline and C-NRT. However, he told Psychiatric News that “it is important to bear in mind that our [investigation] by itself does not negate the prior promising evidence supporting the use of varenicline and combination nicotine replacement therapy … and does not suggest that varenicline or combination nicotine replacement therapies are ineffective.”

Baker concluded that it is critical that health care professionals ensure that patients are encouraged to use both counseling and medications in their efforts to quit smoking and assist patients with finding the most comfortable method to achieve abstinence.

This research was funded by the National Heart, Lung, and Blood Institute. ■

The abstract of “Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks” can be accessed here.