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Zyban, developed by Glaxo Wellcome Inc., is indicated as an aid to smoking cessation treatment and will be available by prescription in six to eight weeks. The medicine includes a personalized patient support program called the Zyban Advantage Plan(TM). The support program will be available at no additional cost to the patient.
Zyban is distinctly different from existing therapies to treat nicotine addiction in that it is a nicotine-free tablet. The current alternative involves replacing cigarettes with either a nicotine patch or nicotine gum.
In addition, patients start Zyban before they quit smoking. They are advised to set a date to stop smoking during the second week of therapy to allow Zyban to reach adequate blood levels. Nicotine replacement products require users to quit smoking completely on the day therapy begins.
Experts in smoking cessation say that smoking is a biochemical addiction, not just a bad habit. While it is not clear how Zyban works, it does effect noradrenergic and/or dopaminergic mechanisms in the brain which have been implicated as pathways of nicotine addiction.
Zyban is the first nicotine - free prescription medicine to treat tobacco dependence by affecting the biology of addiction. Combining this medication with social support and some simple skills to quit smoking gives individuals new hope in overcoming tobacco addiction.
Success is highly dependent on the smoker's level of commitment and ability to manage triggers associated with smoking.
It is for this reason that the Zyban Advantage Plan was developed. The Zyban Advantage Plan is offered at no cost to patients taking Zyban and provides additional support and specific smoking cessation techniques. The makers of Zyban recommend that the drug therapy and the Zyban Advantage Plan be used as part of a comprehensive smoking cessation treatment program as recommended by a healthcare professional.
Efficacy of Zyban
The effectiveness of Zyban as an aid to smoking cessation was demonstrated in two placebo-controlled, double-blind studies involving over 1,500 chronic smokers who smoked at least 15 cigarettes a day. In one study, Zyban was compared to placebo; in the other study, Zyban was evaluated versus placebo, a nicotine patch (Ciba-Geigy Corporation's Habitrol(R)), and the if Zyban with the nicotine patch. In both studies, all patients received brief individual smoking cessation counseling.
In the study involving the patch, patients treated with Zyban had significantly higher four-week quit rates than those treated with the patch. Patients treated with the combination of Zyban and the patch had significantly higher quit rates than those treated with the patch alone. Quit rates with combination therapy, while higher, were not statistically higher than quit rates with Zyban alone. The four-week quit rates from this study were 23% for placebo; 36% for the patch; 49% for Zyban; and 58% for the combination of Zyban and the patch.
Results from the two studies demonstrated that patients treated with Zyban 300 mg/day had more than a two-fold chance of quitting than patients treated with placebo. Quit rates in clinical trials are affected by the population selected and may be lower for the general population.
For many patients, treatment with Zyban reduced withdrawal symptoms. Withdrawal symptoms showing the most pronounced reductions were: irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and depressed mood or negative affect. In patients treated with Zyban, there also was evidence of a reduction in craving for cigarettes or urge to smoke.
The most common side effects associated with the use of Zyban are dry mouth and insomnia. These side effects are generally mild and often disappear after a few weeks.
The use of Zyban also 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), Wellbutrin(R) SR, or any other medications that contain bupropion.
Zyban also should not be used in patients with a seizure disorder who have a history or are currently diagnosed with bulimia or anorexia nervosa. It also should not be used in people who are taking or have recently taken a monoamine oxidase inhibitor (MAOI). It is important that patients tell their healthcare professional about all medicines -- prescription or over-the-counter -- they are taking or plan to take.
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