Long-term Nicotine Replacement Therapy: A randomized clinical trial

Justin Kyei-Frimpong, PharmD. candidate 2015, Mercer University College of Pharmacy

According to the Centers for Disease Control and Prevention (CDC), each year approximately 443,000 Americans die from tobacco-related illnesses. For every person who dies from tobacco use, 20 more people suffer with at least one serious tobacco-related illness.1 Current guidelines established by the US Department of Health and Human Service Public Health Services (PHS) recommend eight weeks of transdermal nicotine therapy.2 Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit; this study attempts to help fill this void.

Title: Long-term Nicotine Replacement Therapy: A randomized clinical trial 3
Design Randomized, placebo-controlled clinical trial; 525 participants
Objective

(Primary)

To compare 8, 24, and 52 weeks of nicotine patch treatment for promoting tobacco abstinence
Study Groups Three groups:

·         Standard treatment (8 weeks)

·         Extended treatment (24 weeks)

·         Maintenance treatment (52 weeks)

Methods Participants were selected at random for 8 (standard treatment), 24 (extended treatment), or 52 (maintenance treatment) weeks of nicotine

patch therapy. All participants received 12 standardized, manual-based behavioral counseling sessions for smoking cessation in accordance with established treatment guidelines. Adverse events during treatment were given points and recorded. Mean weekly patch use across the three treatment durations for each treatment arm and the number of counseling sessions completed were computed. Self-reports of smoking were obtained using the timeline follow-back measure for smoking. At weeks 8, 24, and 52, participants were asked to provide a breath sample for biochemical verification of smoking status.

Duration Enrollment from June 22, 2009 through April 15, 2014
Primary outcome measure The primary outcome was seven-day point prevalence abstinence, confirmed with breath levels of carbon monoxide (CO) at weeks 24 and 52.
Baseline Characteristics Participants were 18 years or older, smoked at least 10 cigarettes/day, and had interest in smoking cessation.
Results At week 24, 21.7% of participants in the standard treatment arm were abstinent compared with 27.2%of participants in the extended and maintenance treatment arms (x2= 1.98; P =0.17).

In a multivariate model controlled for covariates, extended and maintenance treatment arms reported significantly greater abstinence rates compared with participants in the standard treatment arm (odds ratio [OR], 1.70 [95%CI, 1.03-2.81]; P = 0.04), had a longer duration of abstinence until relapse (β = 21.30 [95%CI, 10.30-32.25]; P < 0.001), reported smoking fewer cigarettes per day if not abstinent (mean [SD], 5.8 [5.3] vs 6.4 [5.1] cigarettes per day; β = 0.43 [95%CI, 0.06-0.82]; P = 0.02), and reported more abstinent days (mean [SD], 80.5 [38.1] vs 68.2 [43.7] days; OR, 1.55 [95% CI, 1.06-2.26]; P = 0.02).

At 52 weeks, 23.8% of participants in the standard and extended treatment arms were abstinent compared with 20.3% of those in the maintenance treatment arm (x2= 0.8; P =.44).

In a multivariate model controlled for covariates, maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms (20.3%vs 23.8%; OR, 1.17 [95% CI, 0.69-1.98]; P = 0.57), Similarly, no difference was observed in week 52 abstinence rates between participants in the extended and standard treatment arms (26.0% vs 21.7%; OR, 1.33 [95%CI, 0.72-2.45]; P = 0.36). Participants in the maintenance treatment arm also reported smoking fewer cigarettes per day on smoking days (mean [SD], 5.4 [4.6] cigarettes per day) compared with those in the standard and extended treatment arms (mean [SD], 7.5 [6.3] cigarettes per day) (incidence rate ratio, 0.71 [95% CI, 0.54-0.93]; P = .01).

Adverse Events Common Adverse Events: not reported
Serious Adverse Events: (rapid heartbeat, pounding heart)

Standard = 4 (2.2%)

Extended = 2 (1.2%)

Maintenance = 8 (4.7%)

(P > .05)

Percentage that Discontinued due to Adverse Events: not reported
Study Author Conclusions The findings support the safety of long-term use of nicotine patch treatment, although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers.

This study suggests there is some benefit in increasing the use of nicotine patches beyond the recommended guideline use of eight weeks. The results of this study also imply there may be overall cost and health benefits for patients on extended nicotine therapy. The evidence from this study may also further support the policy change of the

US Food and Drug Administration and individual clinical recommendations allowing smokers to use nicotine patches beyond the standard 8 weeks to increase the potential for smoking cessation.

References

  1. gov. Cigarette Smoking Among Adults and Trends in Smoking Cessation — United States, 2008. 2015. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a2.htm. Accessed March 1, 2015.
  2. Fiore, M.C., Jaen, C.R., Baker, T.B., et al. (2008). Treating tobacco use and dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, May 2008.
  3. Schnoll RA, Goelz PM, Veluz-wilkins A, et al. Long-term Nicotine Replacement Therapy: A Randomized Clinical Trial. JAMA Intern Med. 2015.
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