More Evidence Drug Combo Helps Smokers Quit

Megan Brooks

July 03, 2014

Results of a new study support combination treatment with varenicline (Chantix, Pfizer Inc) and bupropion for smokers who fail to respond to the nicotine patch.

Investigators at Duke University Medical Center in Durham, North Carolina, also found that the study results support the value of an "adaptive" smoking cessation paradigm, which involves identifying smokers unlikely to succeed on the patch and having them switch to varenicline/bupropion treatment.

"Smokers who responded well to nicotine patch treatment could be quickly identified before their quit-smoking date; others who were unlikely to succeed using the patch could also be identified, and they responded better to alternative treatment (varenicline, or varenicline in combination with bupropion)," lead investigator Jed Rose, PhD, director, Center for Smoking Cessation, and professor, Department of Psychiatry and Behavioral Sciences at Duke, told Medscape Medical News.

"This adaptive treatment approach could be readily implemented by physicians using existing medications," he said.

The study was published online June 17 in American Journal of Psychiatry.

Sex Difference

The researchers identified 222 cigarette smokers who failed to show a reduction of more than 50% in smoking after 1 week on the nicotine patch. They randomly assigned 113 of these patients to 12 weeks of therapy with varenicline plus bupropion, and they assigned 109 patients to 12 weeks of therapy with varenicline plus placebo. The primary outcome was continuous smoking abstinence at weeks 8 to 11 after the target quit date.

The investigators note that both treatments were well tolerated and that the 2-drug combination was more effective.

Smokers who received varenicline with bupropion had a significantly higher abstinence rate (39.8%) than those who received varenicline with placebo (25.9%; odds ratio [OR], 1.89; 95% confidence interval [CI], 1.07 - 3.35).

The varenicline/bupropion combination had a significantly greater effect on the abstinence rate in men (OR, 4.26; 95% CI, 1.73 - 10.49) than in women (OR, 0.94; 95% CI, 0.43 - 2.05).

The combination also had a significantly greater effect in highly nicotine-dependent smokers (OR, 3.51; 95% CI, 1.64 - 7.51) than in smokers with lower levels of dependence (OR, 0.71; 95% CI, 0.28 - 1.80).

The finding in this study that highly dependent smokers showed higher success rates with the combination of varenicline and bupropion (vs varenicline alone) mirrors a recent study by Mayo Clinic investigators published in JAMA earlier this year and reported by Medscape Medical News at that time.

"Hence, it seems likely to be a consistent finding," Dr. Rose said. "This is the first report, however, that male smokers showed greater benefit using the combination treatment than female smokers," he noted.

"In any case, treatment providers have at their disposal the means to implement adaptive treatments tailored to the needs of these different smoking populations," Dr. Rose said.

Reduced Cost, Increased Efficacy

Reached for comment, Jaqueline Issa, MD, PhD, from the smoking cessation treatment program, Heart Institute, University of Sao Paulo Medical School, in Brazil, said the study provides more evidence that combining these 2 agents can be helpful.

"I think we should use combination therapies for patients that need it. In our service, we start varenicline for the first 2 weeks, and we combine bupropion if the patient cannot stop smoking in this period or if the patient has moderate abstinence symptoms," Dr. Issa told Medscape Medical News. "This is a pharmacoeconomic strategy way to reduce cost and increase efficacy."

"The efficacy of nicotine patches is very low in the patient with moderate to high nicotine dependence, so I think it was a good strategy to use nicotine patches in this trial in order to select patients with moderate to high level of dependence," Dr. Issa said.

The study was supported by grants from the National Institute on Drug Abuse and Philip Morris USA. The authors have consulting and patent purchase agreements with Philip Morris International for nicotine inhalation technology and consulting agreements with Targacept and Novartis. Dr. Issa has disclosed no relevant financial relationships.

Am J Psychiatry. Published online June 17, 2014. Abstract

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