From the Journals

E-cigarettes beat nicotine patch for smoking cessation

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Long-term safety unclear

Any smoking cessation benefit of e-cigarettes needs to be balanced against short- and long-term safety risks of using these products, according to authors of an editorial.

In the study by Hajek et al., the 1-year abstinence rate of 18% in the e-cigarette group compares favorably to what has been reported for Food and Drug Administration–approved smoking cessation treatments, according to Belinda Borelli, PhD, and George T. O’Connor, MD.

The short-term safety data in the trial are “reassuring,” with a low incidence of oropharyngeal irritation, no excess wheezing or dyspnea, and greater declines in cough and phlegm production versus the nicotine replacement group, Dr. Borelli and Dr. O’Connor said.

However, a notable finding was that 80% of participants in the e-cigarette group were still using the product at 1 year, versus just 9% in the nicotine replacement group. “This differential pattern of long-term use raises concerns about the health consequences of long-term e-cigarette use,” they said.

E-cigarette vapor generally has lower levels of toxins and fewer biologic effects than does tobacco smoke, but it has produced adverse biologic effects in animal models and human cells in vitro, according to the authors.

“These findings argue against complacency in accepting the transition from tobacco smoking to indefinite e-cigarette use as a completely successful smoking cessation outcome,” they wrote. Policy analysts need to be careful and do their due diligence to ensure all consequences of the policy options are fully understood, especially as pharmaceuticals account for greater costs in the Medicare program. Future policy analyses must account for changes to Medicare costs as well as beneficiary costs to understand the overall effects of policy changes.

Dr. Borelli is with the Center for Behavioral Science Research, department of health policy and health services research at the Henry M. Goldman School of Dental Medicine, Boston University. Dr. O’Connor is with the Pulmonary Center at Boston University and with the division of pulmonary, allergy, sleep, and critical care medicine at Boston Medical Center. Dr. Borelli had no disclosures; Dr. O’Connor reported disclosures with AstraZeneca and Janssen Pharmaceuticals. They made these comments in an accompanying editorial (N Eng J Med. 2019. doi: 10.1056/NEJMe1816406).



E-cigarettes might be more effective for smoking cessation than nicotine replacement therapy, results of a randomized study of almost 900 adults suggest.

E-cigarette ArminStautBerlin/Thinkstock

Rates of abstinence at 1 year were 18% for adults who used refillable e-cigarettes to wean themselves off smoking, according to the reported results, compared with about 10% for those who tried nicotine replacement therapies.

“This is particularly noteworthy given that nicotine replacement was used under expert guidance, with access to the full range of nicotine replacement products, and with 88.1% of participants using combination treatments,” said investigator Peter Hajek, PhD, of Queen Mary University of London, and his coauthors in the New England Journal of Medicine.

The findings contrast with those of earlier studies, which showed a lesser effect of e-cigarettes as a stop-smoking strategy, Dr. Hajek and coauthors wrote.

In previous studies, participants used first-generation cartridge-based e-cigarettes, while in the present study, they were given second-generation refillable e-cigarettes and free choice of e-liquids, the authors noted. Moreover, those previous studies provided limited face-to-face support, they said, but this study included weekly behavioral support for at least 4 weeks in both the e-cigarette and nicotine replacement groups.

The randomized study by Dr. Hajek and his colleagues included 886 adults in the United Kingdom attending stop-smoking services provided by the U.K. National Health Service. They were randomized to receive either an e-cigarette starter pack and one bottle of nicotine-containing e-liquid, or 3 months’ worth of nicotine replacement products of their own choosing. At the 52-week validation visits, the study participants received about the equivalence of about $26 U.S. dollars for their travel and time.

Abstinence from smoking at 52 weeks, which was verified by measuring expired carbon monoxide levels, was achieved in 18.0% of the e-cigarette group and 9.9% of the nicotine replacement group (relative risk, 1.83; 95% confidence interval, 1.30-2.58; P less than .001), according to the report.

However, the rate of continued e-cigarette use was “fairly high,” investigators wrote. Eighty percent of the e-cigarette group was still using their assigned product at 52 weeks, compared with just 9% in the nicotine replacement group.

“This can be seen as problematic if e-cigarette use for a year signals long-term use, which may pose as-yet-unknown health risks,” they said.

Tobacco withdrawal symptoms were less severe and satisfaction ratings were higher with e-cigarettes versus nicotine replacement therapy, similar to what had been observed in previous studies, investigators said.

They cited several limitations. For example, product assignments were not blinded. However, the investigators said they tried to “limit expectation effects by recruiting only participants with no strong product preference.”

Dr. Hajek reported grants and fees from Pfizer unrelated to the present study. Coauthors reported disclosures related to Pfizer and Johnson and Johnson, along with grants from the U.K. National Institute for Health Research.

SOURCE: Hajek P et al. N Engl J Med. 2019;380:629-37. doi: 10.1056/NEJMoa1808779.

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