Chicago (August 7, 2000) -- Data presented today from an analysis of a study evaluating maintenance use of ZYBAN® (bupropion HCl) Sustained-Release 150 mg Tablets may shed some light on the challenges faced by people who try to quit smoking but subsequen

The analysis, presented at the 11th World Congress on Tobacco or Health, found that people who used placebo to quit smoking cited "overwhelming cravings" as the most frequent reason for returning to smoking; whereas craving was the sixth most reason cited among people who used the smoking cessation aid Zyban (bupropion HCl) Sustained-Release 150 mg Tablets. "Although some people can successfully quit smoking on their first attempt, understanding the person who returns to smoking has been a challenging issue for researchers and public health advocates," said Michael Durcan, Ph.D., Principal Clinical Research Scientist for the Central Nervous System Clinical Research Group of Glaxo Wellcome, the maker of Zyban, the only non-nicotine pill approved by the FDA as an aid to smoking cessation treatment. On average, smokers attempt to quit five times before succeeding.1* In acknowledgement of that fact, the US Public Health Service recently issued a definitive guideline advising medical professionals to treat tobacco dependence more like a chronic condition. In the maintenance use study, 784 smokers were placed on seven weeks of therapy with Zyban and given brief counseling. At week seven, the 432 patients who had not smoked in the past seven days then continued for 45 weeks on either the drug or placebo. At the end of the study, the smokers who returned to smoking (128 in the placebo group and 116 in the group treated with Zyban) were asked to choose factors they felt contributed to their return to smoking. The placebo users most frequently cited "overwhelming craving" (49.2%) as the reason they returned to smoking, followed by "stress" (48.4 %), "presence of other smokers" (44.5%), "situation where I normally smoke" (29.7%) and "frustration" (26.6%). However, for the patients treated with Zyban who subsequently returned to smoking, the most frequently cited reason was "presence of other smokers" (44.5%), followed by "stress" (41.4%), "situation where I normally smoke" (26.7%), "frustration" (23.3%) and "anger" (23.3%). "Overwhelming craving" was cited by 22.4 percent of patients using Zyban, compared to 49.2 percent of the placebo group. "These results are a step forward in helping us understand how cravings can affect the smoker beyond the initial cessation phase and throughout the cycle of tobacco dependence," said Dr. Durcan. "This gives medical professionals more knowledge about how to treat smokers, and shows us that some of the hurdles may be best addressed by modifying behavior or changing habits, such as not spending time around other smokers and avoiding situations where they normally smoke." Zyban should only be taken as directed by a doctor. The most common side effects associated with Zyban are dry mouth and insomnia. 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.

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