Mark Twain once said, “Giving up smoking is easy… I’ve done it hundreds of times.” The quote illustrates the fact that, although many smokers have a strong desire to quit, kicking the habit is extremely difficult. A new study by South African researchers has reported that the combination of Chantix (varenicline), an oral smoking cessation medication, and a nicotine patch is more effective than Chantix alone. They published their findings July 9 in the Journal of the American Medical Association (JAMA).
The study authors note that behavior modification approaches combined with drug treatment have been proven to be effective in helping smokers quit; however, it is currently unclear whether combining nicotine replacement therapy with Chantix to improve abstinence is both effective and safe. Therefore, they conducted a study to assess the effectiveness and safety of combining Chantix and a nicotine patch vs. Chantix alone in a smoking cessation program.
The study group comprised 446 generally healthy smokers and was conducted at seven centers in South Africa from April 2011 through October 2012. The study was a randomized, blinded, placebo-controlled trial, meaning that the patients were randomly assigned to two groups and neither the subjects nor the investigators knew who was receiving the placebo. One group received a nicotine patch and the other group received a nicotine patch. Both groups received Chantix. The subjects underwent 12 weeks of treatment and then subjected to follow-up. The majority (435 subjects) were included in the efficacy and safety analyses.
Nicotine or placebo patch treatment began two weeks before a target quit date and continued for an additional 12 weeks. Chantix was begun one week before the target quit date, continued for an additional 12 weeks, and tapered off during week 13. The investigators documented tobacco abstinence by exhaled carbon monoxide measurements at the target quit date as well as at intervals thereafter up to 24 weeks. The primary end point was the four-week exhaled carbon monoxide, which was confirmed by a continuous abstinence rate for weeks 9 through 12 of treatment. This represented the proportion of subjects who were able to maintain complete abstinence from smoking during the last four weeks of treatment, Secondary end points included documented abstinence at six months, continuous abstinence rate from weeks 9 through 24, and adverse events.
The investigators found that the combination treatment was associated with a higher continuous abstinence rate at 12 weeks (55.4% vs. 40.9%) and 24 weeks (49.0% vs. 32.6%) and abstinence rate at six months (65.1% vs. 46.7%). The combination treatment group experienced a greater incidence of nausea, sleep disturbance, skin reactions, constipation, and depression; however, only skin reactions reached statistical significance (14.4% vs. 7.8%); the Chantix without nicotine patch group experienced more abnormal dreams and headaches.
The authors concluded that Chantix in combination with a nicotine patch was more effective than Chantix alone for the achievement of tobacco abstinence at 12 weeks (end of treatment) and at six months. They recommended that further studies should be conducted to evaluate long-term effectiveness and safety.
Chantix, manufactured by Pfizer comes with the warning that serious neuropsychiatric events have been reported in patients taking the medication; thus, the pharmaceutical manufacturer recommends:
- Advise patients and caregivers that the patient should stop taking Chantix and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior while taking Chantix or shortly after discontinuing Chantix.
- Weigh the risks of Chantix against benefits of its use. Chantix has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.