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No benefit to varenicline beyond 12 weeks or combined with nicotine replacement therapy for smoking cessation
Clinical Question
Is there any benefit to extending varenicline (Chantix) therapy beyond 12 weeks, or to combining varenicline with nicotine replacement therapy, for increasing smoking cessation?
Bottom line
OVERUSE ALERT: This study found no additional benefit with varenicline plus NRT versus varenicline monotherapy, or with varenicline treatment for 24 weeks versus 12 weeks for increasing smoking cessation rates. These results were not affected by sex, race, treatment site, or level of tobacco dependence. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry + govt
Setting: Outpatient (any)
Synopsis
Evidence remains unclear whether combining varenicline with nicotine replacement therapy (NRT) or extending its use beyond 3 months increases smoking cessation rates. These investigators identified 1251 adults, 18 years or older, who smoked at least 5 cigarettes per day during the last 6 months, with an exhaled carbon monoxide (CO) level of 5 ppm or greater. Consenting participants who expressed a desire to quit smoking randomly received (concealed) assignment to 1 of 4 treatment groups: (1) varenicline monotherapy for 12 weeks; (2) varenicline plus patch NRT for 12 weeks; (3) varenicline monotherapy for 24 weeks; or (4) varenicline plus patch NRT for 24 weeks. Varenicline treatment (using a standard dosing titration schedule) began 1 week before the target quit date and nicotine patch treatment (one 14-mg patch per day) started 2 weeks before the target quit date. All participants received 24 weeks of varenicline pills and 26 weeks of nicotine patches (active and placebo-matched medications). All patients also received six 15-minute counseling sessions focused on instructions, support, and coping skills to improve motivation to quit. The primary outcome was self-reported 7-day abstinence biochemically confirmed with exhaled CO level measured by individuals masked to treatment group assignments. Complete follow up occurred for 70.4% of patients at 52 weeks. Individuals who did not complete follow-up were analyzed according to randomization group (intention to treat) and were assumed to be still smoking. Approximately 25% of patients met the criteria for biochemically confirmed abstinence at the 52-week follow-up, with no significant differences in quit rates among the 4 treatment groups. Additional secondary analyses found no significant effect of any prespecified covariates including sex, race, treatment site, or level of tobacco dependence (based on the Fagerstrom Test for Nicotine Dependence score).
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Vareniciline for smoking cessation - could there be a differ
Regarding the lack of effect of extended courses of varenicline, while this may apply to a general population, I still wonder if a population subset may have a different outcome. The POEM references not finding an effect even correcting for several typical demographic variables. However, I wonder if a self-selected group of patients who asked for a longer treatment course, might prove to have a different outcome. We don't have genetic profiles of the patients, to be able to identify subsets with genes that may predispose to differing responses to treatment. One way to identify such a population indirectly could be by self-selection/ self-perceived benefit of continued treatment.
champix not effective over 1 wks of therapy
nicotine in combination after 12 weeks did not help either, for smoking cessation