March 2, 2009

Chantix side effects no worse with depression history

Group Health studies over 1,000 smokers in COMPASS trial

Seattle—People with a likely history of depression who take varenicline (Chantix®) do not report more severe mood symptoms, medication side effects, or less success quitting smoking compared to people with no history of depression taking this drug.  

The findings by Group Health, Free & Clear, and SRI International researchers are reported in a Journal of General Internal Medicine article published online (www.springerlink.com/content/77207452k3822r3v/). The National Cancer Institute (NCI)-funded, randomized COMPASS trial tracked more than 1,100 Group Health patients receiving behavioral treatment and varenicline to quit smoking. It's the first "real-world" examination of varenicline use since the original Food and Drug Administration (FDA) studies that the manufacturer funded.

"People tend to feel more depressed or irritable while quitting smoking, especially if they have had depression before," said lead author Jennifer McClure, PhD, Group Health Center for Health Studies' associate director for research. "And concerns have been raised that varenicline may increase neuropsychiatric symptoms including depressed mood in people with prior depression." Yet she and colleagues found using varenicline didn't worsen mood symptoms such as depression, anxiety, or irritability in people with a likely history of depression compared to others. "Still," she added, "it's prudent for clinicians to follow the FDA's advice of closely monitoring patients on this drug."

Varenicline is the latest drug the FDA has approved to help tobacco users quit. It seems more effective than other cessation medications, McClure explained, but post-marketing surveillance and case reports have raised concerns about its side effects. These include depression, agitation, and suicidal thoughts and actions, especially in people with a history of psychiatric problems. This has led to several FDA advisories.

COMPASS confirmed previous findings that varenicline side effects, especially nausea, are relatively common. At 3 weeks and 3 months after their target quit date, people with a likely history of depression tended to report these side effects slightly more often—although with no more intensity—than did people without a history of depression.

Feelings of stress and depression tended to decline in both groups—with and without a probable history of depression, said McClure. The trial detected only one serious psychiatric event involving suicidal thoughts and requiring hospitalization. It was in a person who had a previously undisclosed history of bipolar disorder.

Group Health Center for Health Studies
Group Health Research Institute does practical research that helps people like you and your family stay healthy. The Institute is the research arm of Seattle-based Group Health Cooperative, a consumer-governed, nonprofit health care system. Founded in 1947, Group Health Cooperative coordinates health care and coverage. Group Health Research Institute changed its name from Group Health Center for Health Studies in 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.

Free & Clear, Inc.
Free & Clear, Inc., the healthy behaviors company, specializes in phone-based cognitive behavioral coaching and web-based learning to help employers, government agencies and health plans measurably improve the overall health and productivity of their covered populations. Free & Clear is based in Seattle.

SRI International

Silicon Valley-based SRI International is one of the world's leading independent research and technology development organizations. SRI, which was founded by Stanford University as Stanford Research Institute in 1946 and became independent in 1970, has been meeting the strategic needs of clients and partners for more than 60 years. The nonprofit institute performs sponsored research and development for government agencies, businesses, and foundations. SRI also licenses its technologies, forms strategic alliances, and creates spinoff companies.

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