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Varenicline Added to Counseling on Cessation Among African American Smokers
Quick Takes
- Among African American daily smokers, varenicline added to counseling produced statistically significantly greater smoking abstinence compared with placebo and counseling.
- Overall, these findings support the use of varenicline for the treatment of African American adults who are daily smokers.
- Of note, participants in this study were restricted to those interested in stopping smoking and without major psychiatric comorbidities, limiting wider generalizability.
Study Questions:
What is the efficacy of varenicline versus placebo among African American adults who are light, moderate, and heavy daily smokers?
Methods:
The investigators conducted the KIS-IV (Kick It at Swope IV) trial, a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015–December 2017; final follow-up was completed in June 2018. Participants were provided six sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). The primary outcome was salivary cotinine–verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Logistic regression was used to model the main effects of treatment and smoking level along with their interaction to determine whether there was a significant interaction between treatment and smoking level.
Results:
Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users); 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs. 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; p = 0.002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs. 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; p < 0.001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs. 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; p = 0.004) and among moderate to heavy smokers (15.1% vs. 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; p = 0.02), with no significant smoking level × treatment interaction (p = 0.96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]).
Conclusions:
The authors report that among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo.
Perspective:
This randomized clinical trial among African American adults who smoked daily reports that varenicline added to counseling produced statistically significantly greater verified 7-day point prevalence smoking abstinence compared with placebo and counseling. Overall, these findings support the use of varenicline for the treatment of Black adults who are daily smokers. Of note, participants in this study were restricted to those interested in stopping smoking and without major psychiatric comorbidities, limiting wider generalizability.
Clinical Topics: Cardiovascular Care Team, Dyslipidemia, Prevention, Lipid Metabolism, Smoking
Keywords: African Americans, Cigarette Smoking, Cotinine, Counseling, Menthol, Nausea, Primary Prevention, Smoking, Smoking Cessation, Tobacco Products, Varenicline
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