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March 2012 · Vol. 24, No. 3

Nicotine patches don’t help pregnant women stop smoking

Compliance is low and the rate of smoking abstinence doesn’t increase with the patch


The addition of nicotine-replacement therapy to behavioral cessation support does not increase the rate of smoking abstinence in pregnant women, according to a study published in the March 1 issue of the New England Journal of Medicine.

Tim Coleman, MD, of the University of Nottingham in the United Kingdom, and colleagues studied 1,050 women (aged 16 to 50 years) with pregnancies of 12 to 24 weeks’ gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to eight weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. Safety assessment included monitoring for adverse pregnancy and birth outcomes.

The researchers found no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96). At one month, the rate of abstinence was higher in the nicotine-replacement group than in the placebo group (21.3% versus 11.7%). Compliance was low, with only 7.2% of the nicotine-replacement group and 2.8% of the placebo group using patches for more than one month. Rates of adverse pregnancy and birth outcomes were similar between the groups.

“Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes,” the authors write.

The author of the editorial disclosed financial ties the biopharmaceutical industry.

The abstract is available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1109582

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