1. A double-blind, randomized controlled trial found that varenicline significantly improved smoking abstinence rates in African American patients for up to at least 6 months.
2. The main adverse event associated with varenicline was nausea.
Assessment of the level of proof: 1 (Excellent)
Summary of the study: Smoking is a common habit associated with adverse health consequences; this is especially true among African American adults, who have higher documented smoking-related morbidity and mortality than white adults. Additionally, African American smokers are significantly underrepresented in studies of smoking cessation interventions. Varenicline (“Champix”) is a partial nicotinic receptor agonist that is well established as an effective smoking cessation tool in certain populations. The Kick It at Swope (KIS-IV) series of trials aimed to better understand smoking cessation strategies among African American smokers in particular. 500 participants were randomized in total, 300 receiving varenicline and 200 receiving a placebo. Participants randomized to the varenicline group were significantly more likely to have been abstinent at both 12 weeks and 26 weeks of follow-up, as evidenced by a biochemical measure of 7-day smoking prevalence in saliva samples. The success of varenicline in aiding smoking cessation was more pronounced in light smokers than in moderate or heavy smokers. Rates of self-reported adverse events were similar in the two groups, although nausea was more common among varenicline users. This randomized controlled trial demonstrated that varenicline can be an effective smoking cessation intervention in African American daily smokers. These results are logical, given the established role of varenicline as a useful adjunct to smoking cessation in the general population. This work is important for establishing evidence for an intervention that may possibly improve health outcomes among a group that has historically been excluded from large trials. A main limitation of this work is the rigorous eligibility criteria which reduce the external validity of these results. However, the results are strengthened by the large sample size and the design of the randomized trials used.
In depth [randomized controlled trial]: A double-blind randomized controlled trial was conducted at the University of Kansas Medical Center. Eligible participants were self-identified African Americans over the age of 18 who had smoked at least 1 cigarette in 25 of the past 30 days and were motivated to quit. Importantly, patients who had previously tried smoking cessation medications (i.e., nicotine replacement therapy, bupropion, or varenicline) were excluded, as were patients with smoking cessation disorders. concurrent minds. The included participants were randomized in a 3:2 ratio to receive either varenicline or a placebo. The trial involved 12 weeks of medical treatment (with varenicline or placebo) as well as 6 counseling sessions consisting of cognitive behavioral therapy and education on the importance of medication adherence. Participants were asked to quit smoking on day 8 of medical treatment. Participants received a small sum of money to attend the study visits. The primary outcome measure was biochemical evidence of smoking within 7 days (markers in saliva and urine samples) measured at 26 weeks. This was achieved by 15.7% of patients on varenicline and 6.5% of patients on placebo; the odds ratio for achievement of the primary endpoint in the varenicline group compared with the control group was 2.6 (95% confidence interval 1.4-5.1). This result was robust to sensitivity analyses. The difference in abstinence rates was also statistically significant at 12 weeks, with 18.7% in the varenicline group and 7.0% in the placebo group having abstained at this time (odds ratio 3.0, 1.7- 5.6). The odds ratio for achieving the primary outcome in the varenicline versus placebo groups after 12 weeks was 3.0 (1.4-6.7) among those considered to be light smokers and 3.1 (1.1- 8.6) among moderate or heavy smokers. 22.1% of light smokers were abstinent at 12 weeks, while 15.1% of moderate/heavy smokers were. No serious adverse events were reported in either group, and the observed side effects were quite similar with the exception of nausea (approved by 55.6% of varenicline users and 45.9% of placebo participants) at 16 weeks.
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