Recently published data indicating nicotine replacement therapy efficacy has diminished over the years with OTC availability is at odds with "authoritative reviews and conclusions" supporting the use of such products, GlaxoSmithKline maintained.

In response to a study published in the Sept. 11 Journal of the American Medical Association, the Nicorette and NicoDerm CQ marketer pointed to the 2000 U.S. Public Health Service clinical practice guideline on treating tobacco dependence, which recommends OTC NRT "for all smokers interested in quitting except for special considerations."

Specifically, GSK noted, the guideline also "suggests pharmacotherapy for lighter smokers (i.e., those smoking 10 or fewer cigarettes per day) and simply recommends considering using the lower dose of NRT to start."

The study by John Pierce, PhD, et al., University of California-San Diego, suggests decreased effectiveness rates for NRT in recent years may correlate with increased use of the products by light smokers, for whom there is "no consensus of benefit." The research is based on a comparison of the California Tobacco Surveys of 1992, 1996 and 1999.

Pierce et al. report a 25% rise between 1996 and 1999 in the number of respondents using smoking cessation products. Of the additional NRT users, 37% were light smokers, indicating the "successful recruitment" of such consumers through extensive OTC marketing programs.

However, an analysis of the duration of smoking abstinence among pharmaceutical aid users and nonusers found "no advantage" in 1999 - either short-term or long-term - from NRT use for the approximately 60% of California smokers classified as light smokers, the researchers state.

For moderate to heavy smokers using NRT, "in contrast with 1992 and 1996, the effect in 1999 was only short-term," according to the study. After roughly three months, efficacy rates among heavier smokers were about the same as for those who did not use smoking cessation aids, the researchers conclude.

Pierce et al. indicate the lack of counseling by a healthcare professional also may have contributed to diminished effectiveness rates, noting in 1992 "NRT was prescribed by physicians only, and physicians or pharmacists may have provided counseling about product use."

The results of the study "add to concerns that the efficacy of pharmaceutical aids observed in clinical trials may not extend to effectiveness in the general population," the researchers note, concluding there is a need "for more research nationwide concerning barriers to more appropriate use of NRT in the non-clinical setting."

However, GSK maintained a recent study analyzing data collected from quitters prior to the switch of smoking cessation products found OTC NRTs "safely yield short- and long-term smoking cessation success rates at least as good as when administered under a physician's supervision."

Conducted by GSK consultant Saul Shiffman, PhD, Pinney Associates, Bethesda, Md., the study was published in the May issue of Addiction (¹ 'The Tan Sheet' May 6, 2002, In Brief).

Smokers reported use of multiple cessation aids in the UC-San Diego surveys. In 1999, 10.7% used a nicotine patch, 5.4% used nicotine gum, no respondents reported use of a nicotine inhalant and 5.2% used an antidepressant, according to the study. The survey administrators collected responses from more than 15,000 adult smokers.

Duration of product use varied widely, the researchers note, and "was related to payment mode."

The study found 39.5% of smokers whose insurance completely covered the cost of NRT used such products for six weeks or longer and 44.3% of those who shared the expense continued use for six weeks. Only 21.8% of smokers who paid the entire cost reported using NRT six weeks or longer.

From 1992-1999, the number of smokers attempting to quit grew from 38.1% to 61.5%, and the use of smoking cessation products increased more than threefold, Pierce et al. report.

The study was funded in part by a grant from the University of California Tobacco Related Disease Research Program.

NRT Outcomes In California Study Counter “Authoritative” Data – GSK

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