Varenicline versus transdermal nicotine patch for smoking cessation: Results from a randomised, open-label trial

Henri-Jean Aubin
03 aug 2008--Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). Here we compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.
Methods: In this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, the Netherlands, United Kingdom and United States, participants were randomly assigned (1:1) to receive varenicline up-titrated to 1 mg twice daily for 12 weeks or transdermal nicotine (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to Week 52. The primary outcome was biochemically confirmed (exhaled carbon monoxide of 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of therapy. Secondary outcomes included CAR from the last 4 weeks of treatment through Weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.
Results: In total, 376 and 370 participants assigned to varenicline and NRT respectively were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; odds ratio [OR] 1.70, 95% confidence interval [CI] 1.26 to 2.28, p<0.001). The Week 52 CAR (NRT,Weeks 8-52; varenicline,Weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI, 0.99 to 1.99, p=0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) versus NRT. The most frequent adverse event was nausea (varenicline, 37.2%, NRT, 9.7%).
Conclusions: The outcomes of this registered clinical trial (Clinical Trials Identification Number: NCT00143325) established that abstinence from smoking was greater, and craving, withdrawal symptoms and smoking satisfaction less, at the end of treatment with varenicline than with transdermal nicotine.

FDA Cites Suicide Ideation in Smokers Taking Varenicline (Chantix)


ROCKVILLE, Md., Nov. 20 -- The FDA said today it has received reports of suicidal thoughts and aggressive and erratic behavior among patients taking varenicline (Chantix) as an aid to quitting smoking.
In what it characterized as an early communication about an ongoing safety review, the agency it was reviewing recently submitted post-marketing reports of cases describing suicidal ideation and occasional suicidal behavior among patients taking varenicline, plus similar press reports and others on Internet sites.
"A preliminary assessment reveals that many of the cases reflect new onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment," the FDA said.
"The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking."
The FDA also said it was aware of "a highly publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking, although other factors, including alcohol consumption, appear to have played a part in this specific case."
In addition, the FDA said it was "evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery."
As a result, the FDA said health care professionals "should monitor patients taking Chantix for behavior and mood changes," patients taking varenicline should get in touch with their doctors if they experience behavior or mood changes, and "patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them."
The FDA said it was "considering, but has not reached a conclusion about whether this information warrants any regulatory action."