Transdermal Nicotine for 24 Weeks vs 8 Weeks May Improve Abstinence

Laurie Barclay, MD

February 02, 2010

February 2, 2010 — Transdermal nicotine for 24 weeks compared with 8 weeks is more effective in achieving and maintaining abstinence and reduces the risk for lapses in smoking, according to the results of a parallel randomized, double-blinded, placebo-controlled trial reported in the February 2 issue of Annals of Internal Medicine.

"Tobacco dependence is a chronic, relapsing condition that may require extended treatment," write Robert A. Schnoll, PhD, from the University of Pennsylvania in Philadelphia, and colleagues. "We evaluated the relative efficacy of extended (24 weeks) versus standard (8 weeks) transdermal nicotine therapy for promoting biochemically confirmed point-prevalence abstinence at weeks 24 and 52 among adult smokers."

From September 2004 to February 2008, a total of 568 adult smokers seen at an academic center were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks), with use of an unstratified small block–randomization scheme.

The main endpoint of the study was biochemically confirmed point-prevalence abstinence at weeks 24 and 52, and secondary endpoints were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, adverse effects, and adherence.

Compared with standard therapy, extended therapy was associated with higher rates at week 24 of point-prevalence abstinence (31.6% vs 20.3%; odds ratio [OR], 1.81; 95% confidence interval [CI], 1.23 - 2.66; P = .002), prolonged abstinence (41.5% vs 26.9%; OR, 1.97; CI, 1.38 - 2.82; P = .001), and continuous abstinence (19.2% vs 12.6%; OR, 1.64; CI, 1.04 - 2.60; P = .032). The extended therapy group also had lower risk for lapse (hazard ratio [HR], 0.77; 95% CI, 0.63 - 0.95; P = .013), higher likelihood of recovery from lapses (HR, 1.47; 95% CI, 1.17 - 1.84; P = .001), and slower time to relapse (HR, 0.50; 95% CI, 0.35 - 0.73; P < .001).

However, at week 52, extended therapy was associated with higher quit rates only for prolonged abstinence (P = .027). The extended-treatment evaluation revealed no between-group differences in adverse effects and adverse events.

"Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy," the study authors write. "Additional research on the optimal duration of therapy and the possible addition of other treatment components (for example, more intensive counseling, precessation use of nicotine patches) from an efficacy, patient acceptance, and cost perspective should be a priority."

Limitations of this study include low generalizability because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence between treatment groups.

"Some participants did not provide complete abstinence data," the editors write. "Extended therapy with transdermal nicotine helps some adults quit smoking, but benefits may persist only while treatment is maintained."

The National Cancer Institute and the National Institute on Drug Abuse, National Institutes of Health, supported this study. The senior study author (Caryn Lerman, PhD) has disclosed various financial relationships with GlaxoSmithKline, AstraZeneca, Pfizer, and Novartis.

Ann Intern Med. 2010;152:144-151.

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