Feb 192015

“Set a quit date to stop smoking,” goes the old bit of doctor’s advice. Experts argue people need to psyche themselves up, get serious, commit to quitting before the last butt goes in the ashtray.

A new study in JAMA suggests that advice may be outdated. Smokers unready to quit who took the cessation drug varenicline (Chantix) for several months, while continuing to smoke, eventually quit at much higher rates than smokers who took placebo.

Guidelines instruct physicians to counsel patients to choose an exact date of their last cigarette, before prescribing pharmaceutical aids like Chantix, bupropion, or nicotine replacement therapy. The thought was that the drugs would be wasted on people not serious about quitting -- since quitting smoking is so hard. Also, some insurance companies required documentation of a quit date before authorizing payment for smoking cessation drugs.

But mounting evidence suggests this all-or-nothing psychological dynamic may be unnecessary, if not counterproductive. For most, smoking is a lifelong addiction, a behavior not easily changed. Smokers usually require multiple attempts to quit smoking, and suffer from a sense of failure after relapsing. Many smokers also cut down slowly, going on-and-off cigarettes and nicotine replacement therapy for years before finally quitting for good.

Chantix Taken for Up to 6 Months Improved Quit Rates

The study enrolled about 1,500 smokers at 60 clinics in the U.S. and internationally. The interesting requirement for enrollment of recruited smokers: not being ready to quit. Smokers only acknowledged they’d like to smoke less, and wanted to quit in the near future (within 3 months). The participants were then randomized to take either varenicline (Chantix) or placebo twice daily.

After 6 months, one-third of patients who took Chantix had quit smoking — 4 times more than those taking placebo (7%). Continuous abstinence was confirmed by exhaled carbon monoxide at follow-up visits. A similar proportion successfully quit while taking varenicline, in previous trials enrolling smokers motivated to quit.

Among those who didn't quit, varenicline helped them cut back the number of cigarettes smoked. After 2 months, 26% of Chantix users slashed their cigarettes smoked by 3/4ths; 15% of placebo-takers achieved this.

Jon O. Ebbert, an internationally respected expert in smoking cessation from Mayo Clinic, was lead author. The study was funded by Pfizer, purveyors of varenicline, and Pfizer’s scientists contributed substantially to the trial design, statistical analysis and manuscript authorship.

It seems safe to believe Pfizer is delighted with the findings. There are about 42 million smokers in the U.S., and about 1/3 report in surveys they’d like to quit in the next 6 months. That’s a market of 14 million people; at $250 a month for Chantix, that’s a $42 billion potential yearly market. Capturing even a fraction of that would promote Chantix from second-string ($670 million annually in 2012) to superstar.

With almost 500,000 Americans dying every year from illnesses caused by smoking, Chantix starts to look like a bargain even at retail prices. The annual cost to society from smokers (medical care plus lost productivity) is estimated by CDC at $289 billion -- about $7,000 per smoker -- a tab we pay year after year after year.

It’s hard to understand smokers who say varenicline is too expensive, when a pack-a-day cigarette habit costs about $170, or over $2,000 a year. Using Chantix for 6 months costs about $1,250 (and less with the available coupons and payment assistance).

Chantix's Reputation for Side Effects Limits Wider Use

But it's Chantix's side effect profile, not its efficacy, that have limited its wide adoption. Chantix can cause notoriously weird, vivid dreams, and is believed by many to have darker psychiatric effects. Hundreds of suicides and attempted suicides among Chantix users have been reported to the FDA since its approval in 2006.

A causal relationship has never been proven, and follow-up safety studies have not shown increased psychiatric risk with Chantix. Nevertheless, the FDA mandated and has maintained a black box warning on varenicline stating its potential for psychiatric effects, and Pfizer is reportedly paying $200-300 million to settle more than 2,500 lawsuits by Chantix users and their families.

In this study, recorded suicidal ideation or behavior was lower in the group taking Chantix (0.8%) than in the placebo group (1.3%). More patients taking Chantix had abnormal dreams (12% vs 6%), nausea (28% vs 9%) and other minor adverse events. Only about 1% more patients taking varenicline stopped taking the drug due to adverse effects, compared to placebo (8% vs 7%).

takeawayClinical Takeaway: Quitting smoking can be lifesaving, and studies show varenicline offers smokers the best chance of quitting. On its way to blockbuster row, varenicline will have to undergo a public relations makeover and verification of its safety.

Jon O. Ebbert, MD, MSc et al. Effect of Varenicline on Smoking Cessation Through Smoking Reduction. A Randomized Clinical Trial. JAMA. 2015;313(7):687-694. doi:10.1001/jama.2015.280.

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Chantix works even if you’re just thinking of quitting smoking