Researchers gave more than 1,000 smokers counseling to help them
quit and randomly assigned them to receive three months of treatment
with either lozenges plus patches, patches alone or varenicline, a
cessation drug sold as Chantix in the U.S. and Champix in many other
countries including Canada and Europe.
After a year, roughly one in five smokers successfully kicked the
habit regardless of which treatment they used, the researchers
report in JAMA, though there were more side effects such as
insomnia, nausea, and constipation with varenicline.
“The results suggest that the widely available, simple to use,
nicotine patch can produce long-term smoking cessation rates that
are similar to those produced by more intense treatments,” said lead
study author Timothy Baker, a public health researcher at the
University of Wisconsin.
At the start of the study, participants were around 48 years old and
had been smokers for about two decades. They smoked 17 cigarettes a
day on average, a bit less that a typical pack in the U.S.
After 26 weeks, researchers asked them if they had smoked at all in
the previous seven days and did lab tests to see if the level of
carbon monoxide in their breath was low enough to confirm they had
indeed refrained from smoking.
Among 241 people assigned to use nicotine patches, 55 of them, or
about 23 percent, were confirmed non-smokers at 26 weeks.
In the group of 424 people given varenicline, 100 of them, or about
24 percent, were confirmed abstinent at that point in the study. So
were 113 of the 421 people who used a combination of patches and
lozenges, or about 27 percent of this group.
The differences between the groups were too small to be
After one year, 21 percent of the people using patches had quit, as
had 19 percent of people taking varenicline and 20 percent of
individuals given a combination of patches and lozenges. At this
point, too, the differences weren’t statistically significant.
Some side effects were more common with varenicline, with about 29
percent of people on the drug reporting nausea, 23 percent reporting
vivid dreams and 22 percent reporting insomnia. The drug label
carries warnings of serious psychiatric side effects and suicidal
thoughts; people with a history of psychosis, serious depression or
suicide attempts were excluded from the study.
The most common side effects with the patch were itching, vivid
dreams, and insomnia. Itching, nausea and vivid dreams were the most
common side effects with combined patch and lozenge use.
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One shortcoming of the study is that more than half of the patients
in each treatment group stopped therapy before the 12-week regimen
was completed, the authors note.
It’s also possible that the intense counseling participants received
and their less than a pack-a-day smoking habits made it harder to
uncover differences between the treatments that might be seen
without counseling or with heavier smokers, Dr. Neal Benowitz, a
nicotine addiction researcher at the University of California San
Francisco, said by email.
Some previous research has found both varenicline and combination
nicotine replacement therapy more effective than patches alone, the
study authors note.
“For high dependence smokers, I would give the choice of varenicline
or combined nicotine replacement therapy,” added Benowitz, who
wasn’t involved in the study but has advised Pfizer, the company
that makes the drug.
One advantage of nicotine patches and lozenges is that unlike
varenicline, they don’t require a prescription, noted Dr. Carlos
Roberto Jaen of the University of Texas Health Science Center in San
Antonio. Some patients still might prefer a pill, particularly if
they have skin conditions or allergies.
“The benefits of nicotine replacement are access and cost,” Jaen,
who wasn’t involved in the study, said by email. “This study
provides important evidence to use varenicline as a second-line
medication or at least hold it as an option after patients have
attempted to use nicotine replacement first.”
The study was supported by the U.S. National Heart, Lung, and Blood
SOURCE: http://bit.ly/1c9i5E4 JAMA, online January 26, 2016.
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