Study evaluates Zyban in smokeless tobacco users

August 06, 2000

Chicago (August 7, 2000) -- Data presented today at the 11th World Congress on Tobacco or Health evaluated the use of ZYBAN (bupropion HCl) Sustained Release 150 mg Tablets as a cessation aid for users of smokeless tobacco. Zyban is indicated as an aid to smoking cessation treatment in smokers 18 years and older; it is not indicated for treating smokeless tobacco addiction.

Approximately 12 million people in the U.S. use smokeless tobacco and annual consumption of smokeless tobacco has tripled since the 1970s.1*, 2* Smokeless tobacco contains at least 28 known cancer-causing chemicals and the addictive drug nicotine. 3*

"Although not as widespread as cigarette smoking, the use of smokeless tobacco is increasing, especially among youth," said Elbert Glover, Ph.D., Director of the Tobacco Research Center at West Virginia University.

In this 12-week study, Dr. Glover evaluated Zyban in smokeless tobacco users who had averaged at least one-half can of moist snuff per day for the past year. Seventy smokeless tobacco users were randomized to one of two treatment groups (35 patients in each group), either Zyban or a sugar pill, also known as a placebo, for seven weeks of treatment. Patients took Zyban once daily for the first three days, then twice daily thereafter. At the end of seven weeks, 49% of the patients treated with Zyban had not used tobacco for the previous four weeks versus 26% in the placebo group. At three months, 40% of the patients on Zyban had still not used tobacco versus 26% of the placebo patients. The three-month figures were not statistically significant. Quit rates in clinical trials are influenced by the population selected and may be lower in an unselected population.

The data in this study may be of interest to those smokeless tobacco users who are trying to quit. The effect of bupropion SR for smokeless tobacco cessation has not thoroughly been evaluated. Further study is necessary to determine conclusively the short-term and long-term effect of bupropion SR as a cessation aid for smokeless tobacco.

Zyban should only be taken as directed by a doctor. The most common side effects associated with Zyban are dry mouth and insomnia. The most common side effects observed in this study were dry mouth (0 placebo; 4 active), cold (10 placebo; 3 active), and heartburn (0 placebo; 3 active). The use of bupropion is associated with a dose-dependent risk of seizure. Therefore, higher than recommended doses should not be prescribed and Zyban should not be used in people who are already taking Wellbutrin®, or Wellbutrin SR®, or any other medications containing bupropion. Zyban should be used with extreme caution in patients with severe liver disease; in these patients, a reduced frequency of dosing may be required.

Zyban should also not be used in patients who have or have had a seizure disorder or who have a history of or are currently diagnosed with bulimia or anorexia nervosa. It should also not be used in people who are taking or have recently taken a monoamine oxidase inhibitor (MAO-I). It is important that patients tell their healthcare professionals about all medicines they are taking ¡V prescription or over-the-counter.

Zyban is the first nicotine-free prescription medicine available as an aid to quitting smoking and was cleared by the Food and Drug Administration (FDA) for this use in May 1997. Zyban and the Zyban Advantage Plan®, a free counseling and personalized patient support program, are to be used as part of an overall plan recommended by a healthcare professional to help patients quit smoking. For more information on Zyban, see your health care provider.
-end-
Release:
00-050

Contact: Holly Russell
919-483-2839

Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is one of the nation's leading research-based pharmaceutical firms. A subsidiary of London-based Glaxo Wellcome plc, the company is committed to fighting disease by bringing innovative medicines and services to patients and to the healthcare providers who serve them.

1* National Cancer Institute ¡V Tobacco Control Research Branch, "Spit Tobacco." ttp://dccps.nci.nih.gov/tcrb/spit_facts.html
2* "Smokeless Tobacco Use Among Adults in the Southeast," Ronny A. Bell, PhD, John G. Spangler, MD, Sara A. Quandt, PhD, Departments of Public Health Services and Family and Community Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
3* National Oral Health Information Clearinghouse, "Spit Tobacco: Know the Score," June 1997, http://www.health.org/pubs/qdocs/tobacco/nohic.htm.




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