Head-to-Head Study Results Demonstrated No Significant Difference Between NiQuitin(R) Patch and Champix (Varenicline Tartrate) in Long Term Quit Rates

    Therapeutic nicotine (TN) remains first-line treatment option

    PARSIPPANY, N.J., July 28 /CNW/ -- New data published today in the August
issue of Thorax, entitled 'Varenicline versus transdermal nicotine patch for
smoking cessation: results from a randomised open-label trial,' shows that,
despite significantly higher rates for Champix (varenicline tartrate) at 12
weeks, the longer term 6-month and 1-year quit rates showed no significant
differences.(1)  According to the 2008 Cochrane Systematic Review of NRT for
smoking cessation, quit rates at the 6 month and 1 year milestones are
recognized as appropriate measures of long-term success.(2)  This 52-week
randomised open-label trial is the first-ever direct comparison of the
NiQuitin patch (Nicabate patch in Australia) to Champix (varenicline
tartrate).  The open-label design of the study meant subjects knew what they
were taking during the study, therefore it was likely to favor the new pill,
but despite this, Champix (varenicline tartrate) did not demonstrate long-term
superiority to NiQuitin.(1)
    In separate double blind placebo-controlled Rx approval studies for
NiQuitin and Champix (varenicline tartrate), NiQuitin had a 45 percent success
rate (vs. 18 percent for placebo) at the end of 10 week treatment and Champix
(varenicline tartrate) had a success rate of 44 percent (vs. 18 percent for
placebo) at the end of 12-week treatment.(3) This is notable because of the
standard double-blinded placebo controlled design of the studies which
provides a more controlled structure.
    "This study confirms that there is no magic bullet when it comes to
smoking cessation and that both therapeutic nicotine (TN) and Champix
(varenicline tartrate) demonstrate long-term efficacy," stated, Dr. Howard
Marsh, vice president of Worldwide Medical Affairs for GlaxoSmithKline
Consumer Healthcare.  "There is also no single approach that will work for
everyone.  For example, a substantial proportion of quit attempts are made
spontaneously, without much planning.  Therapeutic nicotine is widely
available without the need for a prescription or a visit to a doctor's
    No treatment -- prescription or OTC -- has proven more effective than
GSK's therapeutic nicotine products in helping smokers quit, long term
    Therapeutic nicotine products like NiQuitin patch and lozenge are
first-line treatments for smoking cessation and are thoroughly researched,
well-understood and highly accessible stop smoking therapies.(2)  These
products help reduce nicotine withdrawal symptoms, including nicotine craving,
associated with quitting smoking.(2)  Therapeutic nicotine products are
designed to allow smokers to wean off nicotine gradually and safely.(2)
Therapeutic nicotine products are readily available in flexible dosing options
to meet the needs of even heavy smokers.
    Many smokers will need help to quit successfully
    Smoking is one of the most difficult addictions to break, and we believe
there should be multiple options, including both prescription and
over-the-counter products, available to smokers who are trying to quit.
Unfortunately, the issue is that the majority of smokers try to quit with no
assistance at all and only 3-5 percent of smokers who quit "cold turkey" are
successful long-term.(4)
    GlaxoSmithKline Consumer Healthcare's family of therapeutic nicotine
products, NiQuitin patch and lozenge, Nicabate(R) brands in Australia and
NicoDerm(R) CQ(R) patch, Nicorette(R) gum and Commit(R) lozenge, in the United
States, have helped more than six million smokers around the world quit
successfully.(5)  Of these smokers, over three million have successfully quit
smoking specifically with the help of the NiQuitin patch.(5)
    When it comes to smoking cessation, there is no new 'magic bullet.'  With
more than 10 years of experience in smoking cessation therapy, GlaxoSmithKline
Consumer Healthcare understands successful quitting requires breaking the
dependence on tobacco and changing behaviors associated with smoking.
GlaxoSmithKline Consumer Healthcare recommends that quitters wanting to
improve their chances of success use behavioral support programs in
combination with our therapeutic nicotine products.
    1. Aubin et al, Varenicline versus transdermal nicotine patch for smoking
cessation.  In Thorax online, 8 Feb 2008.
    2. Stead LF, Perera R, BullenC, Mant D, Lancaster T. Nicotine replacement
therapy for smoking cessation.  Cochrane Database of Systematic Reviews 2008,
Issue 1. Art. No.: CD000146. DOI: 10.1002/14651858.CD000146.pub3.
    3. Transdermal nicotine for smoking cessation.  Six-month results from
two multicenter controlled clinical trials.  Transdermal Nicotine Study Group.
JAMA.  1991.  266(22): 3133-8.
    4. Hughes JR, Keely J, Naud S.  Shape of the relapse curve and long-term
abstinence among untreated smokers.  Addiction.  2004 Jan; 99(1): 29-38.
    5. GSK data on file.

     U.S. Media      Samantha Schwarz, GolinHarris
     Contacts:       312 622 1124, sschwarz@golinharris.com

     Media contacts  Claire Dixon EU , 44 20 8047 4296, Claire.E.Dixon@gsk.com
     outside of
     U.S.:           Loic Andre, Colombia, 56 2 3829139, Loic.Andre@gsk.com

                     Andrew Macmillen, Brazil, 54 11 4725 8925,

                     Hader Perez, Mexico, 52 55 5483 8910,


For further information:

For further information: U.S. Media, Samantha Schwarz of GolinHarris,
+1-312-622-1124, sschwarz@golinharris.com, for GlaxoSmithKline; or Media
outside of U.S., EU, Claire Dixon, 44 20 8047 4296, Claire.E.Dixon@gsk.com, or
Colombia, Loic Andre, 56 2 3829139, Loic.Andre@gsk.com, or Brazil, Andrew
Macmillen, 54 11 4725 8925, Andrew.N.Macmillen@gsk.com, or Mexico, Hader
Perez, 52 55 5483 8910, Hader.A.Perez@gsk.com, all of GlaxoSmithKline

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