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E-Cigarettes vs. Varenicline and Nicotine Gum as Aid to Stop Smoking
Quick Takes
- Electronic cigarettes (ECs) were associated with similar smoking abstinence rates as varenicline.
- ECs were associated with higher rates of smoking abstinence at 6 months compared to nicotine chewing gum.
- No serious adverse events were reported for either ECs, varenicline, or nicotine chewing gum.
Study Questions:
Are electronic cigarettes (ECs) efficaciously superior to nicotine replacement therapy (NRT) or noninferior to varenicline for smoking cessation?
Methods:
The investigators used a randomized clinical trial (RCT) design to compare smoking cessation rates among participants randomized to ECs, NRT, or varenicline. Participants were enrolled in seven sites in China, had to smoke ≥10 cigarettes per day, and be motivated to quit. Those who were currently using smoking cessation medications or ECs were excluded. Participants randomized to ECs received 30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that, while those randomized to varenicline received 0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that. Those randomized to NRT received nicotine chewing gum 2 mg (for smokers of ≤20 cigarettes/day) or 4 mg (>20 cigarettes/day). All interventions were provided for 12 weeks accompanied by minimal behavioral support (i.e., an invitation to join a self-help internet forum). The primary outcome was sustained abstinence from smoking at 6 months, as validated by an expired-air carbon monoxide reading (<8 parts/million). Participants lost to follow-up were included as nonabstainers.
Results:
A total of 1,068 participants (33.5% female, mean age 33.9 [standard deviation 3.1] years) were included in the study, of which 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% confidence interval [CI], −1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the two other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded.
Conclusions:
The trial results showed that when all treatments were provided with minimal behavioral support, the efficacy of ECs was noninferior to varenicline and superior to nicotine chewing gum.
Perspective:
This RCT demonstrated similar efficacy for smoking cessation among participants randomized to ECs or varenicline, suggesting the need for further research in the use of ECs for smoking cessation. However, it is concerning that many participants continued to use ECs after completion of the 12-week intervention, suggesting that ECs may not lead to abstinence of nicotine.
Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Prevention, Smoking
Keywords: Electronic Nicotine Delivery Systems, Nicotine Chewing Gum, Varenicline
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