By Walter Alexander
DUBLIN, Ireland -- April 29, 2009 -- Smoking cessation rates are highest when nicotine patches are combined with nicotine lozenges, according to a study presented here at the 2009 Joint Conference of the Society for Research on Nicotine and Tobacco (SRNT) and SRNT-Europe.
Direct evidence on relative efficacies of different smoking cessation pharmacotherapies is lacking, and only 1 published study has evaluated the nicotine lozenge.
To provide some empirically based guidance for clinicians and smokers, Megan Piper, PhD, University of Wisconsin Medical School, Madison, Wisconsin, and colleagues conducted the Wisconsin Transdisciplinary Tobacco Use Research Center study. Results were presented on April 28.
The randomised, placebo-controlled study involved 1,504 individuals (628 men, 876 women) motivated to quit smoking who had been smoking at least 10 cigarettes a day for the past 6 months.
Patients were randomised to 1 of 6 different pharmacotherapy options: bupropion SR 150 mg BID for 9 weeks post quit (n = 264); nicotine lozenge 2 or 4 mg per dependence level for 12 weeks post quit (n = 260); nicotine patch titrated down from 21 to 14 to 7 mg over 8 weeks post quit (n = 262); bupropion + nicotine lozenge (n = 262); nicotine patch + nicotine lozenge (n = 267); or placebo (n = 189).
All participants received six 10 to 20 minute individual counselling sessions.
Outcomes included initial cessation (24 hours smoke-free in the first 7 days post quit date), cessation at end of treatment (8 weeks, but lozenges up to 12 weeks), and cessation at 6-months post quit.
Most patients were Caucasian (83.9%), 13.6% were African American, and 2.8% were Hispanic. Mean age was 44.7 years, with a mean of 21.43 cigarettes smoked per day and a mean of 5.72 prior quit attempts.
The highest initial cessation rates, all showing highly significant advantages versus placebo (P < .005), were achieved with patch + lozenge (89.8%), patch alone (86.3%), and bupropion + lozenge (82.0%).
At 8 weeks, cessations rates versus placebo remained significant high with patch + lozenge (53.6%), bupropion + lozenge (50.4%), and patch alone (44.7%). At 6 months, however, only the patch + lozenge group retained a highly significant rate of cessation (P < .005) over placebo (40.1% vs 22.2%).
Compared with combined monotherapies, the patch + lozenge had significantly greater cessation rates initially and at 8 weeks. Monotherapies were similar to each other, as were combination therapies similar to each other.
The most common adverse events were nausea in 7.9% of individuals receiving the patch + lozenge, and sleep disturbance in 16.8% of patients receiving bupropion.
"The findings support the safety and patient acceptance of combination nicotine replacement therapy," said Dr. Piper.
Funding for this study was provided by the National Institutes of Health and by an Institutional Clinical and Translational Science Award.
[Presentation title: Efficacy of Three Single and Two Combination Pharmacotherapies Among Daily Smokers: A Randomized Placebo-Controlled Clinical Trial. Abstract PA2-4]
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