Researchers question relative effectiveness of smoking cessation drug therapies

Comparison of nicotine patch, varenicline and combination NRT showed no difference in abstinence rates.

Doctor applying a nicotine patch to an older woman's arm

Researchers have questioned the effectiveness of some smoking cessation drugs after they found there was no difference in abstinence rates between three different therapies.

The study, published in JAMA
(online, 26 January 2016), involved three groups of adults who wanted to quit smoking; the participants smoked an average of 17 cigarettes a day.

A group of 241 smokers were given a nicotine patch; 424 were given the drug varenicline; and the third group of 421 relied on a nicotine patch and nicotine lozenges. The therapies were given for 12 weeks and all 1,086 participants, whose average age was 48, were also offered six stop-smoking counselling sessions. Smoking abstinence was checked at 26 and 52 weeks by measuring the participants’ levels of exhaled carbon monoxide.

At 26 weeks, the abstinence rates were 22.8% [55/241] for the nicotine patch; 23.6% [100/424] for varenicline and 26.8% [113/421] for those smokers on combined nicotine replacement therapy (NRT). The results were similar at 52 weeks, with abstinence rates of 20.8% [50/241] for the nicotine patch; 19.1% [81/424] for varenicline; and 20.2% [85/421] for combined NRT.

“Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or combine NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks,” the researchers report. “The results raise questions about the current relative effectiveness of intense smoking cessation pharmacotherapies.”

Compared with the nicotine patch, both varenicline and combined NRT significantly reduced withdrawal and craving symptoms during the early post-target quit day period, according to the researchers. “Combined NRT produced higher initial abstinence rates than did the other two pharmacotherapies. However, neither of these early post-target quit day effects translated into superior 26 or 52-week abstinence,” they say.

Robert West, a health psychologist at the department of epidemiology and public health at University College London, questioned the study’s methodology. “The study was conducted by a well established research group but the sample size was too small to have a good chance to detect differences of the size expected. It also did not involve placebos and that may have biased the results. A much larger double-blind study comparing varenicline with nicotine patches will be reporting later this year.”

Guidance from the National Institute for Health and Care Excellence (NICE) recommends that varenicline be used as an option for smoking cessation but that it should be offered in addition to advice from a healthcare professional or other support to help smokers quit.


[1] Baker T B, Piper ME, Stein JH et al. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks A Randomized Clinical Trial. JAMA. 2016;315(4):371-379. doi:10.1001/jama.2015.19284

Last updated
The Pharmaceutical Journal, Researchers question relative effectiveness of smoking cessation drug therapies;Online:DOI:10.1211/PJ.2016.20200592

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