Abstract

Objective: To determine the safety and efficacy of pharmacologic therapy for smoking cessation in pregnancy by conducting a review of current literature, focusing on controlled clinical trials. Data Sources: A MEDLINE search (1966–May 2006) of English-language, human clinical trials was conducted. Key search terms included nicotine, nicotine replacement therapy, bupropion, smoking cessation, and pregnancy. In addition, relevant articles were cross-referenced to screen for additional information. Study Selection/Data Extraction: Studies were chosen for further review if they were randomized, controlled, long-term evaluations of the safety and/or efficacy of pharmacologic therapy for smoking cessation in pregnancy. A total of 5 trials met the criteria for review. Data Synthesis: Controlled clinical trials of smoking cessation therapy in pregnant women are limited. Three trials have examined the long-term use of nicotine replacement products. Neither of the 2 placebo-controlled trials found a statistically significant difference in abstinence rates between women receiving transdermal nicotine replacement therapy (NRT) and placebo. However, transdermal nicotine products appeared to be safe in this population. No long-term studies have evaluated use of other nicotine replacement products in pregnant women. Bupropion has demonstrated efficacy in smoking cessation in pregnancy, but the data are limited. Conclusions: Transdermal NRT appears to be safe in pregnant women, although its efficacy is unclear. Information on other NRT formulations in pregnancy is unavailable. Bupropion may be a nonnicotine alternative for smoking cessation in pregnancy, but data are currently incomplete. Further studies are needed to determine the ideal population for treatment, the timing of initiation, appropriate monitoring, and the optimal length of therapy.

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