Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks

Catherine Lister, Mercer University College of Pharmacy

Tobacco is cited as the leading cause of preventable death, disease, and disability in the United States. [1]

It was reported that 68% of smokers in the United Stares in 2010 wanted to quit.  There are a number of different over the counter and prescription therapies shown to be effective in aiding patients quit smoking. [2]

Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial
Design Randomized clinical trial; N= 1,086
Objective To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates
Study Groups Nicotine patch only (n = 241), varenicline only including 1 prequit week (n = 424), C-NRT nicotine patch + nicotine lozenge (n = 421)
Methods Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups.  Six counseling sessions were offered. Fagerstorm test of nicotine dependence (FTND) was used to show baseline dependence.  Biochemical confirmation of abstinence required a carbon monoxide level of ≤5 ppm to distinguish smokers from nonsmokers.
Duration May 2012 to November 2015
Primary Outcome Measure Carbon monoxide–confirmed self-reported 7-day point-prevalence abstinence at 26 weeks
Baseline Characteristics   Overall Nicotine patch Varenicline Patch+ lozenge
Female % 52.1 51.9 52.4 52
White % 67 65.6 66.8 68.2
Native American % 0.6 0.8 0.2 0.7
Black % 28.4 29.9 28.3 27.8
Asian % 0.3 0.4 0 0.5
>1 Race % 2 2.5 2.6 1.2
Other % 1.7 0.8 2.1 1.7
Age years 48.1 49.4 48.5 47.1
FTND score 4.8 4.9 4.8 4.8
Results   Abstinence rates, %
  Nicotine patch Varenicline C-NRT
7-day point prevalence abstinence 26 weeks 22.8% 23.6% 26.8%
  Abstinence risk difference, %
  Patch vs varenicline Patch vs C-NRT Varenicline vs C-NRT
7-day point prevalence abstinence 26 weeks -0.75 -4.0 -3.3
p-value 0.82 0.25 0.28
  Unadjusted odds ratio
  Patch vs varenicline Patch vs C-NRT Varenicline vs C-NRT
7-day point prevalence abstinence 26 weeks 1.0 1.2 0.8
95% confidence interval 0.7-1.5 0.9-1.8 0.6-1.1
Adverse Events Common Adverse Events: patch: itching (22%), vivid dreams (16.6%), insomnia (14.5%), rash (11.2%); varenicline: nausea (28.5%), vivid dreams (23.1%), insomnia (22.2%), sleepiness (16%); C-NRT: itching (17.6%), nausea (14.7%), vivid dreams (13.1%), rash (11.4%), insomnia (10.7%)
Serious Adverse Events: None reported
Percentage that Discontinued due to Adverse Events: None reported
Study Author Conclusions Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks.  The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.

The Food and Drug Administration has previously issued warnings that varenicline may increase the risk of cardiovascular or neuropsychiatric events and use of this medication must be monitored.  Whereas, nicotine replacement therapy and combined nicotine replacement therapy is safe and well tolerated.  Earlier research suggested that varenicline and C-NRT were superior to the nicotine patch, but this study did not support that finding.  This study found no significant difference in the three therapies, showing that the nicotine patch, varenicline, and combined nicotine patch with nicotine lozenge may each be equally efficacious in helping patients quit smoking.  The authors conclude that this raises questions about relative effectiveness of smoking cessation treatments. [3]

References

  1. Centers for Disease Control and Prevention. Health Effects of Cigarette Smoking. Fact Sheets. CDC Website. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm. October 1, 2015. Accessed January 28, 2016.
  1. Centers for Disease Control and Prevention. Quitting Smoking Among Adults—United States, 2001–2010. Morbidity and Mortality Weekly Report 2011;60(44):1513–9 [accessed 2015 May 21].
  1. Baker TB, Piper ME, Stein JH, et al. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial. JAMA. 2016;315(4):371-9.
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