September 23, 2015
Varenicline Does Not Appear to Raise Heart Attack, Depression Risks

Edinburgh, United Kingdom—Despite warnings from regulatory agencies, varenicline does not appear to increase the risk of heart attack and depression in users, according to a new international study.

The study, published recently in The Lancet Respiratory Medicine, simultaneously studied two reported negative effects among users of varenicline, which is marketed as Champix and Chantix. The results were in line with other recent research finding no increased risk of heart attack or depression.

Study authors, led by researchers from the University of Edinburgh in Scotland, suggest that varenicline is effective and can be prescribed more widely than previously suggested.

“On the basis of our extensive analysis, we believe it is highly unlikely that varenicline has any significant adverse effects on cardiac or mental health,” said co-author Aziz Sheikh, MD, co-director of the University of Edinburgh’s Centre for Medical Informatics.

“Regulators such as the United States Food and Drug Administration (FDA) should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid.”

For the study, the researchers reviewed anonymous health information from more than 150,000 smokers across England. The patients had been prescribed either varenicline or another antismoking drug, bupropion, to help them quit, or had used nicotine replacement therapy (NRT), such as patches, chewing gum, or lozenges.

After tracking participants for 6 months to assess any treatment side-effects, researchers found that patients taking either varenicline or bupropion were no more likely to suffer a heart attack than those using nicotine replacement therapy, and they were not at higher risk of depression or self-harm.

Between January 2007 and June 2012, “neither bupropion nor varenicline showed an increased risk of any cardiovascular or neuropsychiatric event compared with NRT (all hazard ratios [HRs] less than 1,” according to the study results. “Varenicline was associated with a significantly reduced risk of ischemic heart disease (HR 0·80 [95%CI 0·72–0·87]), cerebral infarction (0·62 [0·52–0·73]), heart failure (0·61 [0·45–0·83]), arrhythmia (0·73 [0·60–0·88]), depression (0·66 [0·63–0·69]), and self-harm (0·56 [0·46–0·68]).”

“Smokers typically lose three months of life expectancy for every year of continued smoking,” lead author Daniel Kotz, MPH, of the Heinrich-Heine-University Dusseldorf in Germany said in a University of Edinburgh press release. “Our research supports the use of varenicline as an effective and safe tool to help people quit.”
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