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Head-to-head Study Results Demonstrated No Significant Difference Between NicoDerm(R) CQ(R) and Chantix (Varenicline Tartrate) in Long Term Quit Rates

Monday, July 28, 2008 General News
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PITTSBURGH, July 28 New data published today in theAugust issue of Thorax shows no significant differences in 6-month and 1-yearquit rates between the NicoDerm(R) CQ(R) Clear Patch and Chantix (vareniclinetartrate) despite statistically higher quit rates for Chantix (vareniclinetartrate) at 12 weeks. According to the official 2008 U.S. Public HealthService Guideline, longer-term quit rates at the 6-month milestone are themost predictive of long-term success.
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The Thorax paper, entitled, "Varenicline versus transdermal nicotine patchfor smoking cessation: results from a randomised open-label trial", reports ona 52-week study that is the first-ever direct comparison of the NicoDerm CQClear Patch to Chantix (varenicline tartrate). The study was conducted usingan "open-label" design, meaning that subjects knew what medication they weretaking. Though this design may have favored the new pill, Chantix (vareniclinetartrate) did not demonstrate long-term superiority to NicoDerm CQ.
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"This study confirms that there is no magic bullet when it comes tosmoking cessation and that both therapeutic nicotine and Chantix (vareniclinetartrate) demonstrate long-term effectiveness," stated Dr. Howard Marsh, vicepresident of Worldwide Medical Affairs for GlaxoSmithKline ConsumerHealthcare. "There is also no single approach that will work for everyone. Forexample, a substantial proportion of quit attempts are made spontaneously,without much planning. Therapeutic nicotine is widely available without theneed for a prescription or a visit to a doctor's office."

Each smoking cessation medicine has been proven effective. In separatedouble blind placebo-controlled studies for NicoDerm CQ and Chantix(varenicline tartrate), NicoDerm CQ patch had a 45 percent success rate (vs.18 percent for placebo) at the end of 10-week treatment and Chantix(varenicline tartrate) had a success rate of 44 percent (vs. 18 percent forplacebo) at the end of 12-week treatment.

In fact, the recently updated 2008 U.S. Public Health Service Guidelinerecommends these products as well as Commit(R) lozenge and Nicorette(R) gum asfirst-line therapy for quitting, as they significantly increase rates oflong-term smoking abstinence.

Dr. Howard Marsh continued, "The aim of all quitters is to quit for good,so although short-term quit rates are useful indicators of efficacy, long-termabstinence will prolong improved health. These results confirm that NicoDermCQ patch enables a significant proportion of patients to quit for a year."

Over-the-counter therapeutic nicotine products like NicoDerm CQ patch,Nicorette gum and Commit lozenge are first-line treatments for smokingcessation and are thoroughly researched, well-understood and highly accessiblestop smoking therapies. Unfortunately, the majority of smokers try to quitwith no assistance at all and only 3-5 percent of smokers who quit "coldturkey" are successful long-term.

GlaxoSmithKline Consumer Healthcare's family of over-the-countertherapeutic nicotine products, NicoDerm CQ patch, Nicorette gum and Commitlozenge have helped more than six million smokers around the world quitsuccessfully. Of these smokers, over three million have successfully quitsmoking specifically with the help of the NicoDerm CQ patch.

Consistent with their FDA-approved labeling, the GlaxoSmithKline ConsumerHealthcare's therapeutic nicotine products help reduce nicotine withdrawalsymptoms, including nicotine craving, associated with quitting smoking.Therapeutic nicotine products are designed to allow smokers to wean offnicotine gradually and safely. GlaxoSmithKline Consumer Healthcare'stherapeutic nicotine products are available without a doctor's prescription,in flexible dosing options at over 35,000 retail outlets across the country.So a smoker who wants to quit doesn't have to wait to see a doctor to gethelp.

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