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

2008-07-26 00:39 1804

Therapeutic nicotine (TN) remains first-line treatment option

PARSIPPANY, N.J., July 28 /Xinhua-PRNewswire/ -- 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 office."

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.

References:

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.

Source: GlaxoSmithKline
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