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 subsequently return to it, a common
problem for the approximately 23 million people who try to quit smoking each
year in the US. 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(R) (bupropion HCl) Sustained-Release 150 mg
"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(R), or Wellbutrin SR(R), 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 - prescription or over-the-
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
1. American Lung Association Seven Steps to a Smoke-Free Life, Edwin B.
Fisher Jr., PhD with Toni Goldfarb, John Wiley & Sons, Inc. 1998.