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					Zyban | THE FACTS
                                                                             MAY 2002

                                                                                                   | EDITORIAL

                                                                                                   Despite all the health warnings,
                                                                                                   which have been around for
                                                                                                   many years now, smoking
                                                                                                   remains the world’s leading
                                                                                                   cause of preventable death.
                                                                                                   There have been advances in
                                                                                                   treatments, but there is no
                                                                                                   miracle cure for tobacco
                                                                                                   addiction. Stopping smoking
                                                                                                   requires the commitment and
                                                                                                   motivation of the smoker and in
                                                                                                   many cases, the help and
                                                                                                   advice of healthcare

                                                                                                   The much welcomed recent
                                                                                                   guidance from the National
                                                                                                   Institute for Clinical Excellence
                                                                                                   reaffirms the important role of
                                                                                                   pharmaceutical intervention in
                                                                                                   significantly increasing smokers’
A medicine that saves lives                                                                        chances of stopping. Both
                                                                                                   nicotine replacement therapies
Since its launch in the US in 1997, it is      whether there was an increased risk                 (NRT) and Zyban have been
estimated that Zyban (bupropion                associated with Zyban use[4].                       shown to be twice as effective
hydrochloride), has helped over two million                                                        in helping patients stop
smokers worldwide to stop smoking[1].          The review included a comprehensive                 smoking compared to will
                                               evaluation of the reports of death and              power alone.
Zyban is the first non-nicotine prescription   the pattern of reporting between countries,
treatment designed to help smokers quit[2].    as well as an epidemiological analysis of           It is important for health care
It was first launched in Europe in the         reported death rates in the UK and US. This         professionals to remember the
Netherlands in late 1999, with most other      has enabled the company to compare the              tremendous toll smoking is
European countries launching this tablet-      number of deaths expected in the general            taking: smoking kills one in two
form medicine during the year 2000.            population and the more ‘at risk’ smoking           of all lifelong smokers. In the
                                               population[4].                                      UK alone, more than 120,000
The product had a promising launch in the                                                          people will die this year from
UK in June 2000 and attracted a great deal     The review has not revealed any new safety          smoking related illnesses (NICE
of positive media coverage. From around        issues and the evidence available does not          2002) – nearly 14 people every
February 2001, however, its safety has         suggest that Zyban carries any increased            hour of every day.
been questioned in some newspapers,            risk of death, if used in accordance with
through reports on a number of deaths          the labelling. It indicates that treatment          As with any medicine, it is
that have been supposedly associated with      with bupropion for smoking cessation is             important to balance the
its use[3].                                    not associated with any greater risk of             benefit versus the risks. In the
                                               death than smokers are exposed to                   case of smoking cessation
GSK’s mission is to improve the quality of     through their use of tobacco products.              treatments, it is clear that the
human life by enabling people to do more,      And, finally, it has confirmed that treatment       benefits far outweigh the risks
feel better and live longer. As with all its   with bupropion for all indications carries no       for the vast majority of smokers
medicines, the company is fully committed      greater risk of death compared to the               and they are among the most
to understanding the safety profile of         general population[4].                              cost effective of all health
Zyban and it closely monitors reports of all                                                       interventions.
adverse events, regardless of severity.        More details of the review can be found
Indeed, GSK has conducted a thorough           inside this document.                               Gay Sutherland
review of all spontaneous reports of death                                                         Tobacco Research Section,
up to December 2001, to determine              GSK is confident in the role of Zyban in            Institute of Psychiatry, National
                                                                              CONTINUES OVERLEAF   Addiction Centre and Hon.
                                                                                                   Consultant Clinical Psychologist
                                                                                                   at Maudsley Hospital Smoking
                                                                                                   Cessation Clinic

                  Science against smoking
                  Smoking kills                                                                                OVER 2 MILLION
                  4 million people die each year from a smoking related                                        PEOPLE GLOBALLY
                  disease – equivalent to 10,000 each day. This number will                                    HAVE STOPPED
                  reach 10 million by the late 2020s[5].
                  worldwide, 33% of all deaths among 40 to 69-year-olds and
                                                                                                               SMOKING USING
                  30% of all cancer deaths are caused by smoking[5].
                  more people die from tobacco-related diseases than from
                  alcohol, cocaine, heroin, suicide, murder, car accidents, fires
                  and AIDS combined[5].
                  1.1 billion people still use tobacco products globally[5].
                  46% of men and 26% of women aged 15 and over in
                  Europe smoke – that’s more than 214 million people in
                                                                                    Zyban makes a difference
                  half of all long-term smokers will die from a smoking-            31 million people worldwide are estimated to have used
                  related illness[6].                                               bupropion in all its indications – 9 million of them as an aid
                  an estimated 70% of smokers want to quit[5] – only 20-30%         to stop smoking[11].
                  try quitting each year[5] and just 3-5% of them actually          over 2 million people globally are estimated to have
                  succeed with will power alone[7]. Many of these start             stopped smoking using Zyban[1].
                  smoking again in the future[8,9].                                 in Europe, it is estimated that more than 1.7 million people
                  global purchases of anti-smoking drugs (including nicotine        have used Zyban as an aid to stop smoking and around
                  replacement therapy products) are estimated to be                 425,000 are estimated to have remained smoke-free after
                  $1.3 billion[10].                                                 12 months[12].
                  smoking related diseases reduce quality of life and place a       an extensive programme of clinical trials has included over
                  significant burden on healthcare resources[5, 39-41].             eight large, double-blind, placebo controlled studies
                                                                                    demonstrating the efficacy and tolerability of Zyban in
                                                                                    more than 7,000 smokers[13].
                                                                                    studies show that smokers using Zyban to help them quit
                                                                                    are twice as likely to stay free of tobacco for up to a year
                                                                                    as they are with placebo[13-15,19,24,33].
                  Safety profile confirmed                                          Zyban is effective at reducing cravings and alleviating
                  bupropion, the active ingredient in Zyban, is well                withdrawal symptoms[13,14,19].
                  tolerated, with experience in over 31 million patients[11].       Zyban offers the best chance of success when quitting and
                  GSK has conducted a thorough analysis of the spontaneous          is the most effective smoking cessation product
                  reports of death received for bupropion and has identified        available[14,18].
                  no new safety issues than when the product was first              Zyban is among the most cost-effective health
                  launched in 1989[4].                                              interventions available[24].
                  all available evidence indicates that treatment with Zyban
                  for smoking cessation is not associated with an increased
                  risk of death when compared to the smoking population[4].
                  all evidence available indicates that treatment with
                  bupropion in all indications is not associated with an
                  increased risk of death when compared to the general              Zyban is safe when used appropriately[13,22]. It should not,
                  population[4].                                                    however, be prescribed to anyone who has:
                  Zyban is associated with low discontinuation rates due to
                  adverse events – the most common side effects are                 • hypersensitivity to active ingredient (bupropion
                  insomnia, dry mouth, headache and nausea; these are                 hydrochloride) or other ingredients
                  generally mild to moderate and often disappear within a           • current seizure disorder or history of seizure disorder
                  few weeks of treatment[13].                                       • CNS tumour
                  Zyban has a favourable cardiovascular profile. In a study of      • abrupt withdrawal from alcohol or any medicine
                  smokers with cardiovascular disease, the adverse event              associated with seizure risk on withdrawal (in particular
                  profile with Zyban was similar to that seen in studies              benzodiazepines or benzodiazepine-like agents)
                  conducted in a general population[20].                            • current or previous eating disorder
                  the risk of seizure associated with Zyban, when used in           • severe hepatic cirrhosis
                  accordance with product information, is rare (0.1%) and           • recent or current use of MAOIs (monoamine oxidase
                  similar to or less than other commonly used drugs such as           inhibitors)
                  anti-depressants[21].                                             • history of bipolar disorder


                  Review reveals no increased risk of death with bupropion[4]
                  GlaxoSmithKline develops and manufactures medicines that not only
                  work, but also do not put the people taking them at any
                  unacceptable risk of serious side effects. With all of its products, GSK
                  regularly monitors reports of adverse events from all over the world,
                  to ensure they remain safe to use. Prescribing information is regularly
                  reviewed by GSK in close collaboration with regulatory bodies and,
                  whenever necessary, modified.

                  After an apparent increase in spontaneous adverse event reports
                  involving deaths, particularly sudden deaths, among patients taking
                  Zyban, the company initiated a cumulative review of all reported
                  deaths associated with bupropion, to determine whether there were
                  any increased risks involved.

                  Data from three different areas were investigated:
                  • a comprehensive evaluation of reports of death
                  • the pattern of reporting of deaths between countries
                  • an epidemiological analysis of the number of reports of death in
                    the UK and US, in comparison to the number of deaths expected
                    in both the general population and the more ‘at risk’ smoking                      WE KNOW FOR A FACT
                    population.                                                                        THAT ONE OUT OF TWO
                                                                                                       SMOKERS WILL DIE FROM
                  The work was done over several months, so that the most recent                       SMOKING. THAT SAME
                  follow-up information could be included. The findings relate to cases                URGENCY DOESN’T APPEAR
                  initially received up to 31 December 2001, as it takes several months                IN THE MEDIA AT ALL
                  to obtain adequate data for evaluation.                                              AND YOU HAVE TO ASK,
                                                                                                       WHY IS THAT?Dr Fenton Howell
                                                                                                                                ASH Ireland

                  A medicine that saves lives | CONTINUED FROM FRONT COVER

                  helping smokers quit and keeping them               The risk of dying from smoking is far
                  smoke-free over the long term. It believes          greater than the risk involved with Zyban.
                  Zyban offers the best chance of success             And it would be wrong for a few press
                  when quitting and is the most effective             reports, which do not detail the risks of
                  smoking cessation product available[14,19].         smoking or the effectiveness and safety of
                                                                      Zyban, to put some patients off what is
                                                                      potentially a life-saving medicine.

                  Benefits of stopping smoking
                  Time after stopping:        20 minutes              8 hours                       24 hours                     48 hours
                                              BP, HR and peripheral   Nicotine and CO levels fall   All Nicotine eliminated.     CO normal, mucociliary
                                              circulation improve.    by 50%. PaO2 – N.             Taste and smell improved.    clearance, risk of MI falls.

                                                   BUPROPION IS, FOR THE TIME BEING, THE MOST
                                                   EFFECTIVE (REGISTERED) METHOD OF STOPPING
                                                   SMOKING…IT IS REGRETTABLE IF BIASED REPORTING
                                                   IN THE PRESS SHOULD UNDERMINE THESE FAVOURABLE
                                                   DEVELOPMENTS. Wagena/De Graaf/Chavannes/Van Grootheest/Van Schayck
                                                                                  Nederlands Tijdschrjft voor Geneeskunde, 4 August 2001

Evaluation of reports of deaths                    leading to death took place after the                     related diseases (120,000 deaths each
                                                   patient had stopped taking bupropion.                     year in the UK alone[24]). A full
From the launch of bupropion to treat                                                                        epidemiology review showed there was
depression in 1989 to 31 December                  Other reports of death involved                           no increase in the risk of death in
2001 (nearly 13 years’ post marketing              chronic smoking related respiratory                       patients treated with bupropion.
experience), an estimated 31 million               diseases, cancer and other conditions.
people have used the medicine in all               There were isolated reports where the                     The safety profile for bupropion is well-
its indications. Nine million have                 cause of death was related to seizures,                   established and the most commonly
used it as an aid to stop smoking[11].             but only with patients who had                            reported reactions are consistent with
                                                   existing risk factors for seizure.                        experience from clinical trials. What’s
In that period, there have been                                                                              more, assessment of the UK population
spontaneous reports of deaths in                   The number of deaths reported for                         based on the Health and Economic
patients prescribed bupropion which                patients who have taken bupropion is                      Consequences of Smoking Model[34] has
have been reviewed and documented                  very small[42,23,4] compared with the                     demonstrated that, for smokers who
by both external regulatory agencies               mortality associated with smoking                         are motivated to quit and are treated
and GSK[42,23,4].                                                                                            with bupropion SR, 15,933 lives can be
                                                   A smoker’s best chance to quit                            saved and 48,537 cases of smoking-
In the majority of the reports                                                                               attributable morbidity can be avoided
received, there is an alternative                  Since its first launch in 1989 in the USA for             over a five-year period.
explanation for the patient's death,               the treatment of depression, it is estimated
such as the patient’s underlying                   that a total of 31 million people have used               Pattern of reporting
condition[42,23]. In the UK,                       bupropion worldwide. More than nine
cardiovascular disorders such as                   million have now taken Zyban as an aid to                 The pattern of reporting of deaths for
myocardial infarction, and                         quit smoking[11] and it is estimated that over            the UK appeared to be different from
cerebrovascular disorders such as                  two million of them have successfully kicked              the older North American markets, so
stroke, were the cause of death in 80              their addiction to tobacco[1].                            this was an area examined in the
per cent of reports[23]. These diseases                                                                      review. The pattern was looked at for
are common in smokers. In addition,                Tobacco addiction is serious. Tobacco is more             the UK, Canada and the US, from the
a number of patients were not taking               addictive than heroin or cocaine[6,25]. And               launch of Zyban in each country and
bupropion at the time of death.                    Zyban is a unique, non-nicotine tablet                    compared to the number of patients
                                                   therapy that is believed to act directly on two           using it on a monthly basis.
With patients who died suddenly, the               of the brain’s chemicals that are involved in
GSK review showed that several                     that addiction – firstly dopamine, which is               Reporting in Canada and the US was
patients had a history of                          associated with craving, and secondly                     fairly consistent over time, but it was
cardiovascular disease or risk factors             norepinephrine[26], which is thought to be                highly variable in the UK. It is not
for sudden death, or that the event                responsible for symptoms associated with                  unusual to receive a high number of
                                                   smoking cessation attempts and tobacco
                                                   withdrawal, such as agitation, anxiety, loss of
Bupropion HCI SR acts on the                       concentration, increased appetite, sweating
neurotransmitters involved in nicotine             and depressed mood[26].
Modifies                         Alters            Although most smokers want to quit, less
dopamine                         noradrenergic     than half actually attempt to stop each year
release in                       activity in       and only a fraction of them actually succeed.
‘reward’                         ‘withdrawal’
pathway                          pathway (locus    One of the reasons is that most smokers quit
(mesolimbic                      coeruleus)        just with their own willpower – a virtually
                                                   ineffective method that has only a three to
                                                   five per cent success rate[7]. Quitting smoking
                                                   is difficult and many people start smoking
                                                   again at some point, too, so repeated
                                                   attempts to quit are often needed[9].

                                                   With Zyban, however, real life data have
                                                   confirmed the clinical trial findings that up to
                                                   one in two people treated will quit smoking
                                                   and up to one in three will still be smoke-
                                                   free a year later[27,28,33]. That makes it the most
72 hours                                                                                                                      2-12 weeks
Breathing easier, bronchospasm                     effective smoking cessation product available.                             Circulation improves.
relaxes. Energy improves.


 Balancing benefit over risk

 All medicines that treat conditions connected
 with the central nervous system (CNS) have
 varying degrees of side effects. And, since               adverse event reports with any new               expected number in the smoking
 serious CNS illnesses such as addiction                   medicine, because they are more likely           population.
 necessarily require serious medications,                  to attract attention and, in some
 Zyban is no exception.                                    countries, they are monitored more               In the US, both the total number of
                                                           closely. But the increased awareness of          reports of deaths and the number of
 Dry mouth, insomnia, headache and nausea                  Zyban in the UK created by the                   reports of deaths due to specific causes
 are the most common side effects                          significant coverage in the lay media is         received for all indications of bupropion
 experienced by people taking the medicine,                believed to have generated a                     was considerably lower than the
 all of which are usually well-tolerated. But,             corresponding increase in the number             expected number for the general
 on rare occasions, it has also been linked to             of reports of adverse events.                    population, so a comparison with the
 more serious reactions such as seizure and                                                                 smoking population was not carried out.
 severe hypersensitivity[13].                              Epidemiological analysis
                                                                                                            The evidence available, therefore,
 The risk of seizure associated with the                   The number of reports of death                   indicates that Zyban is not associated
 correct use of Zyban, however, is rare and is             received in the UK and US for Zyban –            with an increased risk of death
 similar to or lower than that associated with             both the total number of deaths and              compared to the general population.
 other commonly used drugs, such as anti-                  deaths due to specific causes – was
 depressants[21].                                          compared to the expected number of                 Key Points
                                                           deaths in the general population and
 Patients should always consult their physician            the more ‘at risk’ smoking population.             • bupropion is well tolerated and has a well
 about their health status and other                                                                            established safety profile. Total exposure is
 medications they are taking before using                  Given the high death rate of smokers,                approximately 31 million patient including
 Zyban, to make sure it is appropriate. The                it was expected that deaths reported                 9 million who have been treated for
 Zyban labelling clearly points out its non-               among bupropion users would be                       smoking cessation[11].
 suitability for certain patients (see panel on page 5).   higher than in the general population,             • all available evidence indicates that
                                                           but similar to that observed in the                  treatment with Zyban for smoking
 Smoking cessation attempts normally lead to a             smoking population.                                  cessation is not associated with an
 variety of withdrawal symptoms, such as                                                                        increased risk of death compared to the
 anxiety, depression, restlessness, poor                   In the UK, however, the total number                 smoking population[4].
 concentration and irritability/aggression, which          of reports of death, as well as the                • the evidence available indicates that
 might be interpreted as side effects of Zyban[30].        number of reports for most causes of                 bupropion treatment (taking all
                                                           death, was substantially lower than                  indications) is not associated with an
 In clinical studies with smokers, no significant          expected in the general population.                  increased risk of death compared to the
 product-related side effects have been                    The number of reports of sudden death                general population[4].
 reported in those that have a pre-existing                was higher than expected in the                    • no new safety issues associated with Zyban[4].
 cardiovascular disease[22] or chronic                     general population but below the                   • favourable benefit/risk with Zyban[24].
 obstructive pulmonary disease (COPD)[31].
 And studies show that there were no
 significant average changes in blood pressure
 with Zyban in the general smoker
 population[29] or in smokers with existing
                                                           I HAD TRIED TO QUIT SMOKING FOR MANY YEARS,
 cardiovascular disease[22].
                                                           BUT ONLY WITH ZYBAN DID I SUCCEED.
                                                           NOW I HAVEN’T SMOKED FOR MORE THAN A YEAR.
 The overall benefit/risk balance of Zyban                 IT IS FANTASTIC.Bjarne, 52
 hasn’t changed since the product was first                                        The Netherlands
 licensed in the US in 1997, with the drug’s
 effectiveness and the health and economic
 benefits of quitting smoking in general,
 clearly outweighing any known risk. This
 view was recently endorsed by an
 independent third party[24].

3-9 months                                    1 year                             10 years                                        15 years
Cough and wheeze improve.                     Risk of MI reduced by 50%.         Risk of lung cancer reduced by 50%.             Risk of stroke back to normal.
                                                                                 Risk of MI back to normal.
                                  GlaxoSmithKline                                                                        References
                                                                                                                         [1] GSK data on file.
                                                                                                                         [2] Balfour DJK. The pharmacology underlying pharmacotherapy for tobacco
                                                                                                                              dependence: A focus on bupropion. Int J Clin Pract 2001;55:53-57.
Zyban THE FACTS                                                                                                          [3] Rachel Ellis. Anti Smoking Drug Deaths: 18 smokers die after treatment
                                                                                                                              with ‘wonder cure’ Zyban. Mail on Sunday, 18 February 2001.
                                                                                                                         [4] GSK data on file.
                                                                                                                         [5] World Health Organization, 1997. Tobacco or Health: a global status
                                                                                                                              report. Geneva, Switzerland. http://www.who.int. Craving and
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                                                                               …RISK OF                                       http://zyban.ibreathe.com
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                  For every 1,000 20-year-olds that smoke,                     DYING FROM                                     release bupropion, a nicotine patch, or both for smoking cessation. N
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                  around the world[5,24]. And the situation is                 than Zyban[38].                           [32] Tashkin D, Kanner R, Bailey W, et al. Smoking cessation in patients with
                                                                                                                              chronic obstructive pulmonary disease: a double-blind, placebo-
                  worsening: if the current rates of increasing                                                               controlled, randomised trial. Lancet 2001;357:1571-1575.
                  tobacco use continue, the annual number                      “The risk of dying from                   [33] Jarvis MJ, Powell S, Marsh H, et al. A meta-analysis of clinical studies
                                                                                                                              confirms the effectiveness of bupropion SR (Zyban) in smoking
                  of deaths caused by smoking globally will                    smoking is tens of                             cessation. Abstract presented at the Seventh Annual Conference of the
                                                                                                                              Society for Research on Tobacco and Nicotine, 2001 23-25 March,
                  reach 10 million by the late 2020s[5,31].                    thousands of times greater                     Seattle, Washington, USA.
                                                                                                                         [34] The Lewin Group. Health and Economic Consequences of Smoking
                                                                               than the risk from using                       (HECOS) model. (Available at URL: http://www.ea3.lewin.com/hecos)
                                                                                                                         [35] Jamerson BD, Nides M, Jorenby DE, et al. Late-term smoking cessation
                  Estimates suggest that 70 per cent of                        Zyban,” says ASH director,                     despite initial failure: An evaluation of bupropion sustained release,
                                                                                                                              nicotine patch, combination therapy, and placebo. Clin Ther 2001;23:744-
                  smokers want to quit, but only 20 to                         Clive Bates. “This drug has                    752.
                  40 per cent actually attempt to stop each                    a minimal risk when used                  [36] Hays JT, Hurt RD, Rigotti NA, et al. Sustained-release bupropion for
                                                                                                                              pharmacologic relapse prevention after smoking cessation. A
                  year[5] and just three to five per cent of                   properly and its safety is                     randomized, controlled trial. Ann Intern Med 2001;135:423-433.
                                                                                                                         [37] Anonymous. Bupropion to aid smoking cessation. Drug Ther Bull
                  them actually succeed[7].                                    comparable to the very                         2000;38:73-75.
                                                                                                                         [38] http://www.ash.org.uk/
                                                                               widely used anti-depressant               [39] Raw M, McNeill A, West R. Smoking cessation guidelines for health
                                                                                                                              professionals. A guide to effective smoking cessation intervention for the
                  The good news is that quitting smoking                       drugs.                                         health care system. Thoraxo 1998;53 (Suppl 5) Parts 1 and 2.
                  has substantial and immediate health                                                                   [40] American Thoracic Society. Cigarette smoking & health. Am J Respir Crit.
                                                                                                                              Med. 1996;153;861-865.
                  benefits for smokers of all ages. One year                   “No-one should be put off                 [41] McKenzie TD, Bartecchi CE, Schrier RW. The human costs of tobacco use
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                  after someone stops smoking, their excess                    using Zyban to help them                  [42] ADRAC 2001. (http:www.%20ADRAC.com)
                  risk of heart disease is half that of a                      stop smoking. Not only is it
                  smoker’s. Within five years, the risk is the                 effective in helping people
                  same as that of a non-smoker. The risk of                    quit, but it also helps
                  lung cancer is reduced by about 50 per                       prevent the heart disease,
                  cent after ten years. And the overall risk of                cancer and respiratory
                  death approaches that of someone who                         illnesses that are so often
                  has never smoked after ten to 15 years[5].                   the fate of smokers.”

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