Primary Care Corner with Geoffrey Modest MD: Smoking Cessation Comparison of Therapies

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By Dr. Geoffrey Modest

A randomized controlled trial was compared different therapies to aid in smoking cessation (see JAMA. 2016;315(4):371).

Details:

  • 1086 smokers (mean age 48, 52% women, 67% white/28% black/3% latino, mean income >$35K in 46%) who had been smoking a mean of 17 cigarettes/d​ over mean of 29 years. Fagerstrom Test of Nicotine Dependence (FTND) score of 4.8, reflecting low-to-moderate dependence, with 77% smoking within 30 minutes of awakening
  • Randomized to open-label varenicline, titrating up to 1mg bid as tolerated; nicotine replacement patch (NRT), starting with 8 weeks of 21-mg patch, then 2 weeks of 14-mg patch, then 2 weeks of 7-mg patch (but in those smoking 5-10 cigarettes/d, 10 weeks of 14-mg patch then 2 of 7-mg patch); or patch plus nicotine lozenges (C-NRT group), with patches as in other group plus 2 or 4mg lozenges and asked to use at least 5/day. All interventions were for 12 weeks.
  • All received 5 counseling sessions at the times of visits, and 1 telephone call.
  • Smoking assessment was at 26 and 52 weeks post quit date by telephone interview; quit rates confirmed by exhaled carbon monoxide <= 5 ppm, which “optimally distinguishes smokers from nonsmokers”.
  • Results (none of these showed any significant difference for one method over another):
    • Medication adherence rates were similar: at week 8 — 45.2% for patch; 49.3% for varenicline; and 49.6% (patch) and 43.0% (lozenges) for C-NRT
    • 7-day point-prevalence abstinence at 26 weeks post-quit date were:
      • 8% for nicotine patch alone
      • 6% for varenicline
      • 6% for C-NRT (patch plus lozenges)
    • 7-day point-prevalence abstinence at 52 weeks post-quit date were:
      • 8% for nicotine patch alone
      • 1% for varenicline
      • 2% for C-NRT (patch plus lozenges)
    • Prolonged abstinence at 26 weeks (no smoking from day 7 to day 181 after quit date):
      • 9% for nicotine patch alone
      • 5% for varenicline
      • 4% for C-NRT (patch plus lozenges)
    • ​Adverse events: more rash (11%) and itching/hives (20%)with patch. More vivid dreams (23%), insomnia (22.2%)/sleepiness (16%), and nausea (28.5%) with varenicline

So, a few points:

  • Though there were some minor differences early in the study (varenicline and C-NRT were better than patch alone in reducing withdrawal and craving symptoms; C-NRT had higher initial abstinence rates), there was no difference at the 26 and 52-week marks
  • This study does call into question the model of basal nicotine and rapid-acting lozenges for “break-through” urges, since there really was no difference in terms of clinically-relevant outcomes. Also, this study, unlike some others, did not show clinical superiority for varenicline over other treatments, with pretty clearly increased significant adverse events.
  • And, putting this in perspective, in terms of preventing cardiovascular disease, the single most effective intervention is smoking cessation for those who are smokers, more efficacious than lowering blood pressure, improving diabetic control, or using a statin or aspirin. This study confirms the efficacy of differing modalities in helping patients stop smoking. I would add that for some patients combination therapies work better (NRT plus bupropion, or even NRT plus varenicline), though I usually try a single intervention first to minimize adverse events. Also, I would stress that motivational interviewing is really helpful both in helping patients get ready for smoking cessation as well as helping them through the process. And, at risk of my devolving (?again) to be a pariah, I have had some reasonable success with some patients by encouraging e-cigarettes as a crutch to stopping smoking (though I usually suggest the more traditional medical therapies, as above, first).

See prior blogs:

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