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Executive Summary

NICORETTE LIMITATION TO ADJUNCT USE with intensive smoking-cessation programs is reiterated by the results of a study of 315 patients published in the March 3 issue of the Journal of the American Medical Association. The article, by John Hughes, MD, University of Vermont et al., maintains "that the therapeutic effects of nicotine are limited to when the gum is given to dependent smokers along with intensive therapy." The study results reflect current labeling for the product. Nicorette labeling states that the gum is to be used only in conjunction with a behavioral modification program. Lakeside Pharmaceuticals, the U.S. marketer of Nicorette, said that "the study confirms the need for a motivated patient -- one who wants to quit -- a physician, dentist or health care professional who understands how to properly dose and instruct in the correct use of the medication and who is willing to follow up with the patient to ensure correct usage of this medication." Lakeside also stated that "the study reaffirms the importance of the correct use of Nicorette to help smokers stop smoking." The JAMA article further suggests a nicotine dependence pre-screening before Nicorette use "so that dependent smokers can be identified and successfully persuaded to enroll in psychological therapies for smoking cessation before nicotine gum use can be shown to be effective in medical settings." The study concludes that when Nicorette is used "with a nonselected group of smokers and a brief intervention in general medical practice, the pharmacologic effects of nicotine gum (2 mg) to increase smoking cessation are either small or nonexistent." The study contends that "a large majority (>99%) of smokers are not screened for nicotine dependence and receive nicotine gum with a brief intervention." The study was designed to determine whether Nicorette has an effect on smoking cessation when prescribed in a loosely structured physician office visit. The study investigators maintain that this is the manner in which the gum is generally used versus the manner in which it is intended to be used. The 315 smokers viewed a slide/tape which presented guidelines from the package insert on the proper use of the gum. The subjects were then randomized to receive nicotine gum or placebo gum in a 2:1 ratio. Gum was dispensed free of charge and in a blinded fashion from a clinic pharmacy. One to two weeks after their quit date, subjects attended a follow up session. They were also sent follow-up forms one week, 1, 6, and 12 months after their cessation date. Results of the investigation show that "at the one- and six-month follow-up visits about 10% more subjects in the nicotine gum group were abstinent than in the placebo group (P>.05)." At one month, 113 subjects were abstinent in the nicotine group versus 43 subjects in the placebo group. At six months, 61 subjects using Nicorette versus 20 subjects on placebo had ceased smoking. At one year, "the nicotine gum group had quit rates 2% to 5% greater than those of the placebo group," the study states. When the investigators adjusted for life-style differences the quit rates were determined to be 10% for the nicotine group and 7% for the placebo group. The company noted that "the one month and six month quit rates reported in this study were statistically significant between the active drug and the placebo (p</=.05)."

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