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Smoking cessation: FDA has approved Chantix


The FDA ( Food and Drug Administration ) has approved Chantix ( Varenicline ) tablets, to help cigarette smokers stop smoking.

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with Varenicline.
Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking.
These smokers had previously averaged 21 cigarettes a day for approximately 25 years.
In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban ( Bupropion ).

The approved course of Chantix treatment is 12 weeks. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of Chantix treatment to further increase the likelihood of long-term smoking cessation.

In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence, insomnia, abnormal dreams, and dysgeusia.

According to the Centers for Disease Control and Prevention ( CDC ), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.

Source: FDA, 2006


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