Healthcare Industry News:  GSK 

Biopharmaceuticals Cardiology

 News Release - March 26, 2007

New Study Indicates Nicotine Patches May be Safe for Helping Patients with Coronary Artery Disease to Quit Smoking

Study Presented at the American College of Cardiology's 56th Annual Scientific Session

NEW ORLEANS--(HSMN NewsFeed)--A new study presented today at the American College of Cardiology's 56th Annual Scientific Session, a gathering of over 30,000 cardiovascular experts, indicates that nicotine patches may be safe to use in patients with coronary artery disease (CAD).(1) Currently, 40 percent of smokers continue to smoke after a coronary event.(2) Quitting smoking can reduce the risk of subsequent mortality and further cardiac events in smokers with coronary artery disease by as much as 50 percent in the first year.(3)

"Smokers with CAD and ischemia can achieve significant health benefits from quitting," says Craig Pratt M.D., cardiologist and lead study investigator who is Director of Research at The Methodist DeBakey Heart Center, The Methodist Hospital, Houston. "The results of this study are important and should reassure smokers and physicians about the safety of nicotine replacement therapy (NRT) in patients with CAD."

The study evaluated patients with greater than nine percent ischemic perfusion defect size (PDS, a measure of the amount of reduction in myocardial tissue blood flow) and the effects of nicotine patches on stress-induced myocardial ischemia using single photon emission computed tomography (SPECT), an imaging technique to show how well blood flows through the body to tissues and organs. The people who smoked more than 20 cigarettes per day were randomized to receive either 21mg NicoDerm® CQ® nicotine patches or placebo patches while continuing to smoke. After one week, a SPECT scan was repeated and patients were then encouraged to reduce smoking while continuing to use the patch. At week four, a SPECT scan was repeated and despite an increase in nicotine levels in the active patch group no significant changes in total or ischemic PDS were observed from baseline, when compared to patients receiving the placebo patches (15.1 vs. 13.3 percent, compared to 12.1 vs. 10.6 percent).(1)

Carbon monoxide (CO) levels were measured prior to each SPECT and researchers compared the results of active patch-using patients to those given a placebo. Patients using the nicotine patch in the study showed a reduction in carbon monoxide levels over those using placebo. When compared to baseline, active patch users showed a greater rate of CO reduction (22.3 vs. 11.5 parts per million, or ppm) versus those administered placebo (23 vs. 18.6 ppm), which paralleled their decreased cigarette use.(1)

"More than 100 clinical studies involving thousands of smokers have demonstrated a consistent safety and efficacy profile for NRT,"(4) says Rajesh Mishra, MD, PhD, Director, Medical Affairs, GlaxoSmithKline Consumer Healthcare. "What many people and even physicians sometimes misunderstand is that the cardiovascular risk associated with smoking is from the components of burned tobacco smoke, not from the smoking cessation aids that help smokers quit. These misperceptions in particular may prevent more physicians from recommending and using these proven safe and effective smoking cessation aids to help their patients quit."

Widespread myths held by consumers, and even some physicians about the safety and efficacy of NRT continue to present a public health challenge. These misperceptions prevent people from using smoking cessation aids and/or using them as directed, thus jeopardizing their chances of successfully quitting. Overcoming these myths would aid further progress against the world's leading cause of avoidable death and disease. Consider the following when treating those who have not been treated with cardiovascular disease:
  • Studies show that using NRT to quit smoking is far safer than smoking cigarettes.(5)

  • Within three months of quitting smoking, the risk of heart attack begins to drop.(6,7)

  • Quitting smoking also provides benefits to the smoker in the long term. Within 15 years of quitting, the risk of coronary heart disease is that of a nonsmoker.(5,6)

  • The Surgeon General recommends using a combination of behavioral therapy and medications such as NRT,(5) which can double a smoker's chances of successfully quitting versus "cold turkey."(8)
According to the U.S. product label, it is recommended that people with heart disease, recent heart attack or irregular heartbeat should consult their doctor before using the product. Whereas smoking cigarettes is known to increase health risks for those with established heart disease, studies using NRT in populations with heart disease have shown no increased risk of further cardiovascular events.(5,9)

About The Use of NRT

Research shows that one-third of all quit attempts fail within 48 hours.(10) Smoking increases the receptors in a smoker's brain that respond to nicotine. Take that nicotine away, and the receptors "call out" for nicotine, something the smoker feels as cravings. Cravings can be quite intense and can derail a quit attempt.(11) NRT releases controlled, low doses of nicotine in a steady stream that help relieve cravings by teaching the brain to live with less nicotine and then eventually no nicotine. It helps reduce cravings and withdrawal symptoms during quitting, allowing a smoker to focus his willpower on behavior change.(5)Over-the-counter NRT products like NicoDerm® CQ®, Nicorette® gum and Commit® lozenge are first-line treatments for smoking cessation because they are thoroughly researched, well understood and available without a doctor's prescription, in 35,000 retail outlets across the country and under the NiQuitin® brand name in other countries. These products have helped more than six million people around the world successfully quit smoking. NRT can double a smoker's chances of quitting.(8)

Additional Smoking Cessation Resources

Giving up smoking is not easy. Smokers benefit from a combination of behavioral support and effective treatments. GSK Consumer Healthcare is offering to help smokers interested in quitting get started on a path to a smoke-free life through the "1-2-3 Second Chances to Quit for Free" program, open to all U.S. residents, 18 years of age or older. The offer is on a first come, first serve basis while supplies last. Details of the program are available at Web visitors choose either one of three types of nicotine replacement therapy products or $37 in coupons which can be redeemed over the course of Nicorette, NicoDerm CQ or Commit therapy. Not every flavor, size and strength is available. They are required to fill out a short enrollment form and answer questions about their smoking habit through the Committed Quitters® program, a support program designed to provide coping strategies, advice, and incentives to stay smoke-free. Each person will receive an individualized support plan and customized tips from experts and will have access to smoking cessation counselors through 1-877-NO-ASHES five days a week. is an educational Web site that enables smokers to develop an initial quit-smoking plan by completing various assessment tools online. The site includes helpful tips, quitting resources and virtual coaches, and access to Committed Quitters. Committed Quitters is a free, tailored Web-based behavioral support program that has been proven to increase a smoker's chances of quitting. Participants receive a customized smoking cessation plan after completing an online questionnaire that gathers information about their habits, behaviors and motivations for smoking and quitting.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the products Goody's, Nicorette, NicoDerm CQ, Commit, Abreva, Aquafresh, Sensodyne, and Tums, trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and consumer healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

NOTE: GlaxoSmithKline distributes Nicorette® gum, NicoDerm® CQ® patch and Commit® lozenge the United States. Outside of the U.S., its smoking cessation patch and lozenge are marketed as Nicabate® in Australia and NiQuitin® in other countries.

(1) Leja, M; Nicotine Patches are Safe to Use in Patients with Coronary Artery Disease and Stress Induced Myocardial Ischemia.

(2) Quist-Paulsen et al., 2003.Randomized Controlled Trial of Smoking Cessation Intervention After Admission for Coronary Heart Disease. BMJ v. 327, pg.1. 2003., 2) Quist-Paulsen et al., 2005 Predictors of smoking cessation in patients admitted for acute coronary heart disease. Eur J Cardiovasc Prev Rehabil.12,472-477.

(3) Critchley JA; Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart diseases: a systematic review. Journal of the American Medical Association. July 2003; Vol. 290, 1 (reprinted).

(4) Fiore MC; Bailey WC; Cohen SJ; et al. Treating tobacco use and dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000; 71-80.

(5) Benowitz NL. Summary: risks and benefits of nicotine. Nicotine Safety and Toxicity. Oxford University Press, New York, 1998:185-194.

(6) U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: what it means to you. Washington, DC: Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office of Smoking and Health. P. 20-5.

7 American Cancer Society "Guide to Quitting Smoking" Available at g_Smoking.asp (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

(8) Silagy et al. Nicotine replacement therapy for smoking cessation (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons,Ltd.

(9) Kimmel SE; Berlin JA; Miles C; Jaskowiak J; Carson JL; Strom BL. Risk of acute first myocardial infarction and use of nicotine patches in a general population. J Am Coll Cardiol. 2001 Apr;37(5):1297-302.

(10) Garvey A, et al. "Predictors of Smoking Relapse Among Self-Quitters: A Report from the Normative Aging Study." Addictive Behaviors. 1992. Vol 17,70.

(11) Breese CR, Marks MJ, Logel J, Adams CE, Sullivan B, Collins AC, Leonard S. Effect of smoking history on (3H)nicotine binding in human postmortem brain. Journal of Pharmacology and Experimental Therapeutics. 1997;282(1):7-13.

Source: GlaxoSmithKline

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