E-cigarettes and varenicline (Chantix) helped long-time smokers quit conventional cigarettes at similar rates in the short term, but the benefit was more lasting with varenicline, according to a single-center randomized trial from Finland.
In individuals with moderate to heavy dependence on nicotine, confirmed 7-day abstinence from smoking at week 26 — the trial’s primary endpoint — was observed in 40.4% of the participants utilizing nicotine-containing e-cigarettes, 43.8% of those taking varenicline, and 19.7% of those on placebo (P<0.001 for both placebo comparisons).
The difference was not significant when comparing e-cigarettes versus varenicline directly, reported Anna Tuisku, PhD, of Lapland Central Hospital in Rovaniemi, Finland, and colleagues.
But rates of confirmed abstinence, as measured by exhaled carbon monoxide (CO), dropped to 28% and 37.9% at week 52 for the e-cigarette and varenicline groups, respectively, at which point only the benefit with varenicline was significantly greater than placebo, according to the findings in JAMA Internal Medicine.
The trial aimed to compare the relative effectiveness of nicotine-containing e-cigarettes with varenicline, the gold standard medication for smoking cessation, given that prior trials of vaping have often used nicotine patches or gum as a comparator.
“When balancing the benefits of nicotine-containing ECs [electronic cigarettes] in smoking cessation with the known harms as well as the uncertainty surrounding their long-term harm consumption, it seems that they may have a role in reducing tobacco-related damage to health in adults who substantially depend on nicotine and have been smoking for many years and, despite several attempts, have been unable to quit smoking conventional cigarettes,” the researchers wrote.
“However, it may be advisable to primarily recommend varenicline therapy to those adults who are hoping to terminate their smoking habit,” Tuisku and co-authors added.
Joan Burnham, MSN, RN, of Houston Methodist Sugar Land Hospital, noted that the success of e-cigarettes may be due, in part, to their similarities to traditional cigarettes, which may make them a more “appealing” option.
“While many people do benefit from the gums and patches, many still find the gums distasteful and the patches not effective,” she told MedPage Today. “The use of ECs mimic the behavior pattern for smoking with the inhalation and hand/oral connection, which many people who smoke find relaxing and calming.”
The EFFECT trial from Tuisku and colleagues randomized 458 participants at Lapland Central Hospital 1:1:1 to either nicotine-containing e-cigarettes, 18 mg/mL (plus placebo tablets); varenicline tablets (plus nicotine-free e-cigarettes), or placebo (nicotine-free e-cigarettes and placebo tablets) for 12 weeks. All patients also received a motivational interview by a trained nurse. Patients, nurses who came in contact with participants, and the researchers were blinded to the assigned arms.
Eligible participants had a 10-year history of smoking conventional cigarettes (plus at least 10 per day over the last 5 years) and an exhaled CO level at least 15 ppm at baseline.
Mean age was 51 years, 56% were women, and participants had been smoking for a median 33-34 years. About two-thirds smoked 11-20 cigarettes per day at baseline.
Participants were excluded if they had used e-cigarettes or pharmacotherapy to attempt smoking cessation within the previous year. Multiple conditions were among the exclusion criteria, including cancer, cardiovascular disease, substance or alcohol addiction, pregnancy, epilepsy, and others.
Commonly reported adverse events (AEs) in the study included nausea, depression, insomnia, and cough. No serious AEs were reported. AEs leading to discontinuation were most common in the varenicline group (27) compared with the e-cigarette group (15) or placebo group (14). Death occurred in two patients in the e-cigarette group and two patients in the placebo group at 52 weeks, but none were deemed related to the interventions, according to the researchers.
Study limitations cited by the authors included the single-center design, the somewhat small sample size and brief follow-up period, limits in how far back exhaled CO can detect previous smoking, and that other vaping products may have different concentrations of nicotine.
Still, Tuisku’s group argued that the success in achieving smoking cessation among participants in the trial “must be viewed as relatively impressive considering the durations of their smoking histories and the resulting intensity of their nicotine dependence.”
Disclosures
The trial was funded by GRAND with financial support from Pfizer. Electronic cigarettes were purchased with the grant from a local commercial enterprise. Varenicline and placebo tablets were provided by Pfizer.
Tuisku disclosed a relationship with Lapland Central Hospital. A co-author disclosed relationships with the Finnish Medical Foundation and the Research Foundation of the Pulmonary Diseases.
Burnham disclosed no relationships with industry.
Primary Source
JAMA Internal Medicine
Source Reference: Tuisku A, et al “Electronic cigarettes vs varenicline for smoking cessation in adults — a randomized clinical trial” JAMA Intern Med 2024; DOI: 10.1001/jamainternmed.2024.1822.