Smoking Cessation Resource Center: Clinical Studies

Nicotine patch and lozenge are effective for women

Saul Shiffman, Christine T. Sweeney, Carolyn M. Dresler
June 21, 2004

It has been hypothesized that women may be less likely to obtain therapeutic benefit from nicotine replacement therapy (NRT). The present study tested this hypothesis, using two different types of NRT medications. A secondary analysis of two randomized clinical trials was performed: One compared active 21-mg nicotine patch with placebo among 193 men and 309 women, and the other compared active 2-mg or 4-mg nicotine lozenge with placebo among 788 men and 1,030 women. Using logistic regression analysis of 6-month continuous abstinence and survival analysis, we assessed the efficacy of patch and lozenge among women and tested for a gender x treatment interaction. Active NRT was more effective than placebo among women, for both patch and lozenge. In the lozenge trial, women were less successful than men. The gender x treatment interaction was not significant in either study, whether assessed by logistic regression or survival analysis. In the lozenge trial, gender moderated the effects of smoking rate and dependence (but not treatment) on outcome: These variables affected success rates only among women. Treatment with nicotine patch or lozenge is effective for women, and the analysis did not reveal significant gender differences in efficacy. Gender differences in outcome may be moderated by nicotine dependence.

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