Nicotine Patch Treatment for 52 Weeks May Be Safe, but May Not Be More Effective than 24 Week Treatment for Smoking Cessation

EBM Focus - Volume 10, Issue 17

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Reference: JAMA Intern Med 2015 Apr 1;175(4):504 (level 2 [mid-level] evidence)

Cigarette smoking is a leading cause of preventable morbidity and mortality. Approximately 20% of adults in the United States smoke cigarettes and although 69% of smokers report a desire to quit, only 4-7% are successful each year (MMWR Morb Mortal Wkly Rep 2012 Jun 15;61 Suppl:38). Nicotine replacement therapy with transdermal nicotine patches is considered a first-line medication option for the treatment of tobacco use (Am J Prev Med 2008 Aug;35(2):158). While transdermal nicotine replacement significantly increases the likelihood of smoking cessation compared to placebo, the 6-month abstinence rates are usually only around 20% with treatment (Cochrane Database Syst Rev 2012 Nov 14;(11):CD000146, Addiction 2008 Apr;103(4):557). Extending the duration of treatment from the standard 8 weeks to 24 weeks was associated with an increased rate of abstinence at 24 weeks, but no significant differences in abstinence at 52 weeks (Ann Intern Med 2010 Feb 2;152(3):144), suggesting extended treatment may increase the duration of smoking abstinence, but only temporarily. A recent randomized trial attempted to determine the effect of even longer use by comparing nicotine patch treatment for 8 weeks vs. 24 weeks vs. 52 weeks in 525 adult smokers (mean age 46 years) interested in quitting. All included patients smoked ≥ 10 cigarettes per day and received patches containing 21 mg nicotine plus smoking cessation counseling.

Only 67% of patients completed the assessment at 24 weeks and 60% completed the assessment at 52 weeks, but all randomized patients were included in the analysis. Seven-day point-prevalence abstinence rates were confirmed using breath CO levels at weeks 8, 24, and 52. At week 24, 7-day point-prevalence abstinence was 21.7% with 8 weeks of treatment vs. 27.2% with extended treatment (24 week and 52 week treatment groups combined). Compared to 8 week standard therapy, extended therapy was associated with a longer duration of abstinence before relapse (mean 89 days vs. 72 days, p < 0.001), more abstinence days (mean 80.5 days vs. 68.2 days, p = 0.02), and fewer cigarettes per day on nonabstinent days (mean 5.8 cigarettes vs. 6.4 cigarettes, p = 0.02). At week 52, there were no significant differences in 7-day point prevalence abstinence, duration of abstinence before relapse, or abstinence days comparing 8 or 24 week treatment to 52 week treatment, but treatment for 52 weeks was associated with fewer cigarettes per day on nonabstinent days (mean 5.4 cigarettes vs. 7.5 cigarettes, p = 0.01). There were no significant differences in adverse events among groups. In a secondary analysis comparing 8 week treatment vs. 24 week treatment, 24 week treatment was associated with significantly increased abstinence rates at 24 weeks, but not 52 weeks.

The results of this study suggest that nicotine replacement therapy with a transdermal nicotine patch may be safe for 52 weeks of use, but it may not be more effective than 24 weeks of treatment for increasing smoking abstinence rates. While there were no significant differences in abstinence rates at 24 weeks comparing 8 week treatment to both extended therapy groups, there was a significant difference in the abstinence rate comparing 24 weeks vs. 8 weeks at this time point. Similar to previous results, there were no significant differences comparing 8 vs. 24 week treatment in abstinence rates at 52 weeks. These results suggest that it is safe for patients to use nicotine patches for up to 1 year, although any benefit beyond 6 months remains unproven. Nicotine replacement therapy should be tailored to individual patients for maximum effectiveness.

For more information, see the Nicotine replacement therapy for smoking cessation topic in DynaMed.