Among adults motivated to quit smoking, 12 weeks of treatment with a nicotine patch, the drug varenicline, or combination nicotine replacement therapy produced no significant differences in confirmed rates of smoking abstinence at 26 or 52 weeks, raising questions about the current relative effectiveness of intense smoking cessation pharmacotherapies, according to a study in the January 26 issue of JAMA.
Due to the profound health effects of tobacco smoking, it is important to identify treatments that increase rates of long-term smoking abstinence. Two pharmacotherapies for smoking seem particularly effective: combination nicotine replacement therapy (C-NRT) and varenicline. Because varenicline and C-NRT differ in cost, the need for a prescription, and the intensity of screening and ongoing monitoring, a comparison in a head-to-head randomized clinical trial appears warranted, as does the need to test their effectiveness relative to nicotine patch monotherapy, which might be considered a usual-care smoking cessation medication, according to background information in the article.
Timothy B. Baker, Ph.D., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues randomly assigned smokers to one of three 12-week smoking cessation pharmacotherapy groups: nicotine patch only (n = 241); varenicline only (including 1 prequit week; n = 424); and C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered. The primary measured outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence (the proportion of the study population abstinent at a specific point in time) at 26 weeks.
The researchers found that the treatments did not differ significantly on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 23 percent; varenicline, 24 percent; C-NRT, 27 percent) or at 52 weeks (nicotine patch, 21 percent; varenicline, 19 percent; C-NRT, 20 percent). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness and indigestion.
"To our knowledge, this open-label study is the first to directly contrast varenicline and C-NRT pharmacotherapies, both with one another and with the nicotine patch. Results showed no significant differences among these 3 pharmacotherapies in any of the 26- or 52-week abstinence measures," the authors write.
###(doi:10.1001/jama.2015.19284; Available pre-embargo to the media at http:/media.jamanetwork.com)
Editor's Note: This research was supported by a grant from the National Heart, Lung, and Blood Institute and the National Cancer Institute to the University of Wisconsin Center for Tobacco Research and Intervention. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.