Cigarette smoking is a common habit associated with detrimental health consequences; this is especially true among African American adults, who have higher documented morbidity and mortality from smoking than White adults, explains Lisa Sanderson Cox, PhD. Furthermore, African American smokers are considerably underrepresented in studies of smoking cessation interventions.
Varenicline, a partial nicotinic receptor agonist, is well-established as an effective smoking cessation tool in some populations. The Kick It at Swope (KIS-IV) trial series aimed to better understand strategies for smoking cessation among African American smokers specifically.
Patients Who Previously Tried Smoking Cessation Medications Were Excluded
For a study published in JAMA Network, Dr. Cox and colleagues conducted the double-blinded, randomized, controlled trial. Eligible participants were self-identified African American adults who had smoked at least one cigarette in 25 of the past 30 days and were motivated to quit. Patients who had previously tried smoking cessation medications (ie. nicotine replacement therapy, bupropion, or varenicline) were excluded, as were patients with concurrent mental health disorders.
A total of 500 participants were randomized, with 300 receiving varenicline and 200 receiving placebo. Participants randomized to the varenicline group were significantly more likely to have been abstinent at both 12 weeks and at 26 weeks follow-up.
The primary outcome 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 the patients taking varenicline and 6.5% of the
placebo group: the OR for achieving the primary outcome in the varenicline versus control group was 2.6 (95% CI, 1.4-5.1).
Success of Varenicline Was More Pronounced in Light Smokers
The researchers observed that the difference in abstinence rates was also statistically significant at 12 weeks, with 18.7% of the varenicline group and 7.0% of the placebo group abstaining at this time (OR, 3.0; 1.7-5.6).
The OR for achieving the primary outcome in the varenicline versus placebo groups after 12 weeks was 3.0 (1.4-6.7) among those considered light smokers and was 3.1 (1.1-8.6) among moderate or heavy smokers. A total of 22.1% of light smokers were abstinent at 12 weeks, compared with 15.1% of moderate/ heavy smokers. No serious adverse events were reported in either group, and the side effects experienced were quite similar other than nausea (55.6% of varenicline users and 45.9% of placebo participants) at 16 weeks.
This trial demonstrated that varenicline may be an effective smoking cessation intervention among African American daily smokers, the study authors noted. “These findings are logical, given the established role of varenicline as a helpful smoking cessation adjunct in the population at large,” they wrote. “This work is important in establishing evidence for an intervention [that] can, eventually, improve health outcomes among
a group who have been historically excluded from large trials.”
A primary limitation of this work is the stringent eligibility criteria, which reduces the external validity of these findings. However, the findings are strengthened by the large sample size and randomized trial design used.
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