Quit Smoking Drug From Eastern Europe Better Than Nicotine Tx?
Cytisine clinical trial says yes.
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Editorialist: Nancy A. Rigotti, MD
Cytisine, a smoking cessation medication available only in Eastern Europe, worked better than conventional nicotine-replacement therapy in a clinical trial.
The drug yielded a 1-month continuous abstinence rate of 40% compared with 31% among quit line callers provided nicotine patches along with gum or lozenges (P<0.001), Natalie Walker, PhD, of the University of Auckland, New Zealand, and colleagues found.
The number needed to treat with cytisine versus was 11, they reported in the New England Journal of Medicine.
The 25-day course of treatment remained superior to 8 weeks of nicotine replacement at the 6-month follow-up on one of the two typical measures of long-term efficacy (continuous abstinence 22% versus 15%, P=0.002).
The 7-day point prevalence of quitting -- defined without any allowance for slip-ups, unlike the continuous measure which allows for up to five cigarettes -- showed no difference between groups at 6 months.
The Drug
Cytisine is a partial agonist that binds the nicotinic acetylcholine receptor, similar to varenicline (Chantix), and has been on the market -- now as a generic -- since the 1960s, largely in Eastern Europe.
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Its low cost compared with other quit-smoking medications is a big draw, Walker's group noted. Cytisine sells for $20 to $30 for a 25-day course compared with $112 to $685 for the required 8 to 10 weeks of nicotine replacement therapy and $474 to $501 for a 12-week supply of varenicline.
Nancy A. Rigotti, MD, of the Tobacco Research and Treatment Center at Massachusetts General Hospital and Harvard in Boston, agreed in an editorial accompanying the NEJM paper.
"The compelling rationale for bringing cytisine to market is not that its efficacy is superior to that of current pharmacotherapies but that current pharmacotherapies are unavailable to so many smokers -- especially those in low-income and middle-income countries -- because of their cost," she wrote.
"Stakeholders in high-income countries seeking to contain healthcare costs would also benefit from a lower-cost pharmacotherapeutic option."
However, getting the drug to the U.S. market could be a challenge, Rigotti told MedPage Today.
The manufacturer in Bulgaria never saw a market for the drug in the U.S. and so never tried for approval, she explained.
"We're sort of stuck here," she said in an interview. "We need to find a sponsor for the drug who can take it through the licensing process, but once it went through the licensing process that sponsor would probably make it more expensive. So we might end up with another drug that is just as expensive as others."
She called instead for "creative collaboration" among regulators, pharma, research funding agencies, and other stakeholders interested in the public health benefit of smoking cessation in order to find some novel pathway through the system for the drug.
Cytisine Trial
The trial findings were likely widely generalizable, Rigotti added
The pragmatic open-label clinical trial used a real-world setting -- smokers calling New Zealand's national telephone quit line wanting to quit -- with minimal behavioral support and few exclusion criteria, Rigotti wrote in the editorial. "The advantage of this design is that an intervention found to be truly effective is likely to work in many settings."
All 1,310 adult daily smokers got an average of three calls of 10 to 15 minutes each from quit line advisers over a period of 8 weeks for behavioral support.
Those randomized to the nicotine-replacement group got vouchers redeemable from community pharmacies for nicotine patches and for gum, lozenges, or both at a cost of about U.S. $2.50 for an 8-week supply of each item.
The cytisine group got their 25-day course of tablets via mail and were instructed to target day five as their quit date. They also got vouchers for nicotine replacement therapy to use if they hadn't been able to quit by the end of the 25-day course of treatment.
Adverse events were more common with cytisine than with nicotine-replacement therapy, but only 5% of patients stopped taking cytisine because of them.
The side effect profile mirrored that of varenicline, with the most common symptoms being nausea and vomiting and sleep disorders, but without the psychiatric events.
While the study was too small to detect rare events, decades of use of cytisine in Eastern Europe hadn't turned up psychiatric risks either, Rigotti noted.
The lack of biochemical verification of self-reported tobacco abstinence was a limitation, she cautioned, though, saying further trials would be needed to determine true superiority over nicotine-replacement therapy, as well as to compare cytisine against other first-line pharmacotherapies.
Other Options
Walker's group had previously reported that electronic cigarettes were at least as good for smoking cessation as were nicotine patches in a similarly-designed pragmatic trial in New Zealand, although neither helped substantially more than placebo.
A Cochrane review by the group, also released Wednesday, found just one other randomized controlled trial to meta-analyze with theirs but also concluded that e-cigarettes help smokers quit.
Electronic cigarettes increased the 6-month quit rate 2.29-fold in the pooled analysis by the most strict criteria -- biochemically-verified continuous abstinence (9% versus 4% on placebo).
More people were able to at least halve their conventional cigarette consumption as well (36% versus 27% on placebo, and 61% versus 44% with patch in the one very low quality study).
Neither of the randomized trials and none of the 11 cohort studies reported any serious adverse events considered to be plausibly related to electronic cigarettes.
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