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2010 International Pharmaceutical Federation PSWC and AAPS Annual 
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PULMONARY DISORDERS                                         Devra K. Dang, Section Advisor

Extended duration nicotine transdermal therapy may be more effective than standard duration

Key point: According to a study recently published in Annals of Internal Medicine, tobacco abstinence rates were significantly higher when transdermal nicotine was used for 24 weeks (extended duration) as opposed to 8 weeks (standard duration).

Finer points: From September 2004 to February 2008, 568 adult smokers participated in this parallel, placebo-controlled, randomized trial comparing abstinence rates in patients using extended duration and standard duration transdermal nicotine therapy. All patients in the study were blinded to the randomization, as were the research personnel, with the exception of the database manager. A total of 287 patients were randomized to standard duration therapy with Nicoderm CQ (GlaxoSmithKline), consisting of 21 mg for 8 weeks, then placebo for 16 weeks; 288 patients were randomized to extended therapy with Nicoderm CQ, consisting of 21 mg for 24 weeks. The primary outcome measure was complete biochemically confirmed abstinence from nicotine at 24 and 52 weeks. Secondary outcome measures included continuous and prolonged abstinence, relapse and recovery events, cost per smoker associated with quitting, adverse events, and adherence.

At 24 weeks, extended duration therapy was associated with higher rates of abstinence (31.6% vs. 20.3%; odds ratio [OR] 1.81 [95% CI 1.23–2.66], P = 0.002), prolonged abstinence (41.5% vs. 26.9%; OR 1.97 [1.38–2.82], P = 0.001), and continuous abstinence (19.2% vs. 12.6%; OR 1.64 [1.04–2.60], P = 0.032) compared with standard therapy. The extended duration therapy group also had a lower risk for relapse (hazard ratio [HR] 0.77 [0.63–0.95], P = 0.013), higher likelihood of recovery from relapses (HR 1.47 [1.17–1.84], P = 0.001), and slower time to relapse (HR 0.50 [0.35–0.73], P < 0.001). At 52 weeks, extended duration therapy only produced higher quit rates for prolonged abstinence (29.1% vs. 21.3%; OR 1.55 [1.05–2.28], P = 0.027). No differences in adverse events were noted between the two groups.

What you need to know: The investigators acknowledged several limitations to the study. First, none of the patients had comorbid conditions (e.g., diabetes, heart disease, or alcohol dependence). Second, many patients in both groups stopped using the transdermal nicotine patches within the first few weeks of starting the study. Third, some patients did not provide complete abstinence data at follow-up.

In a response letter published online by Annals, a nicotine cessation educator from WhyQuit.com opposed the concept of using nicotine to treat nicotine addicts. He noted that counseling and support are more important components of a nicotine cessation therapy and reported that 2 weeks of intense, abrupt cessation counseling and support lasting for at least 12 to 14 hours are key to the success of long-term nicotine cessation programs.

What your patients need to know: Explain to patients that nicotine dependence is a chronic, relapsing condition that may require extended treatment. Extended duration transdermal nicotine therapy can benefit some patients more than standard duration therapy. Regardless of the duration of therapy, many patients resume smoking once they stop treatment with nicotine patches or other forms of nicotine replacement therapy. Therefore, the benefits of extended duration nicotine transdermal therapy appear to be short lived and may cease when treatment is stopped. Repeated smoking cessation attempts are often necessary and lead to greater success.

 

Posted by Carli Richard (crichard@aphanet.org)
March 11, 2010