Tobacco use is the leading cause of preventable early death in the United States as well as a major risk factor for cardiovascular disease, many cancers, COPD, and type 2 diabetes. Approximately 18% of the U.S. population currently smokes, leading to 480,000 premature deaths each year, accounting for almost one in five deaths. The U.S. Preventive Services Task Force (USPSTF) 2015 guidelines update the 2009 guidelines and include recent data on the use of behavioral interventions, tobacco cessation pharmacotherapies, and electronic nicotine delivery systems (ENDS) in pregnant and nonpregnant adults.
Minimal and intensive behavioral interventions (BI) have both been found to increase tobacco abstinence rates, and there is a dose-response relationship between the intensity of BI and tobacco abstinence rates. The types of counseling studied included in-person, group, and telephone sessions primarily provided by physicians, advanced practice professionals, nurses, cessation counselors, or social workers. Even brief (less than 20 minutes in one visit) physician advice interventions help improve cessation rates, while longer physician interventions are more effective, with a dose-response relationship between the intensity and frequency of counseling and cessation rates. If possible, several sessions should be provided. Cessation training can be done effectively by physicians, nurses, psychologists, social workers, and counselors. There is high degree of certainty that the net benefit of behavioral interventions in the treatment of tobacco dependence is substantial.
The only pharmacotherapies currently approved for use in the treatment of tobacco dependence in nonpregnant adults are nicotine replacement therapies (NRT: transdermal patches, gum, lozenges, nasal spray, or inhalers), bupropion SR, and varenicline. The efficacy of pharmacotherapy is substantial. For NRT, cessation rates are 10% in control groups vs. 17% in NRT groups. For bupropion SR,cessation rates are 11% in the control groups and 19% among those using bupropion SR. For varenicline, it is 12% in control groups and 28% in the varenicline groups. The use of multiple types of nicotine replacement therapy is more effective than use of a single type (cessation rates 21% vs. 16%, respectively). Some studies suggest that the combination of NRT and bupropion SR is similar in efficacy to NRT alone but superior to bupropion SR alone. In total, the USPSTF concluded with a high degree of certainty that the net benefit of pharmacotherapy in the treatment of tobacco dependence is substantial.
Side effects of NRT include an increased risk for minor cardiovascular adverse events (tachycardia), but no significant increase in major cardiovascular adverse events or mortality. Findings from studies of bupropion SR use showed mixed evidence for cardiovascular adverse events, with some trials finding a decreased risk for cardiovascular adverse events and others showing increased risk for such events (with borderline clinical significance). Despite the presence of a black-box warning about serious neuropsychiatric events in users of bupropion SR, the task force’s review found no significant increase in serious psychiatric events. Varenicline data suggested no significant increase in cardiovascular adverse events (minor or major). The data about serious neuropsychiatric events in patients using varenicline were insufficient to draw conclusions, though evidence suggested this may be an issue.
Combination of behavioral and pharmacotherapies
There is convincing evidence that combination therapy with BI and FDA-approved pharmacotherapies is superior to either intervention alone. Studies have compared nicotine replacement therapy alone to BI plus NRT with abstinence rates of 18% and 21%. The Task Force concluded (with a high degree of certainty) that the net benefit of providing combined interventions for smoking cessation is substantial.
The task force found insufficient evidence to support the use of pharmacotherapy in pregnancy. There were few data available regarding the benefits or harms (maternal or fetal) of the use of these therapies in pregnancy.
Electronic nicotine delivery systems
There is insufficient evidence to support the use of electronic nicotine delivery symptoms (ENDS, so-called “e-cigarettes”) in the treatment of tobacco dependence. There have been only two randomized controlled trials (RCTs) of these devices that were rated as “fair quality.” One of these studies suggested an increased risk for serious adverse events with ENDS compared to nicotine patch, but no increase in total adverse events. No data were available surrounding the potentially harmful ingredients in ENDS. As for efficacy, of the two RCTs reviewed, one showed higher abstinence rates at 12 months while the larger study found no significant difference in abstinence rates at 6 months.
The 2015 recommendations are: