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Varenicline is safe and effective to help smokers with current or past major depression quit smoking. Approximately half of smokers seeking treatment have a history of depression. This is a clinically important relationship because depression and smoking are among the leading causes of disability and death in the world and having depression makes quitting smoking more difficult. Varenicline has proven more effective than bupropion for smoking cessation, but because of its mechanism of action, there are concerns about the safety of varenicline in patients with psychiatric disorders.
In a phase 4* double-blind, randomized trial, 525 adult smokers with stably treated current or past major depression and no recent cardiovascular events were assigned to either varenicline, 1 mg twice daily, or placebo for 12 weeks, followed by 40 weeks of no treatment. Patients were evaluated for smoking abstinence and changes in mood and anxiety levels.
The researchers found that patients in the varenicline group were about twice as likely to quit smoking than those in the placebo group, with the effects persisting throughout the 40-week follow-up phase. There were no clinically relevant differences in mood, anxiety, or overall worsening of depression in either group. The verenicline group had more adverse events including nausea, headache, abnormal dreams, irritability, and insomnia.
*Phase 4 trials are conducted after an intervention has already been approved and marketed. These trials are used to evaluate long-term safety and effectiveness, and can also help to determine optimal use.
News from the Annals of Internal Medicine: Sept. 17, 2013
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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6 Dec. 2013. <http://www.medicalnewstoday.com/releases/266185>
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