6/28/23, 11:52 PM KIS-IV Pathway Feedback Search Clinical Topics Home Studies KIS IV KIS IV Disease Tobacco use Trial question What is the effect of varenicline as an addition to counseling in African-American adults who are daily smokers? Study design Single center Double blinded RCT Population Characteristics of study participants 52.0% female N = 500 48.0% male 500 patients (262 female, 238 male) Inclusion criteria: African-American adults who were daily smokers of all smoking levels Key exclusion criteria: renal impairment; clinically significant allergic reactions to varenicline; cardiovascular event in the past month; history of panic disorder; psychosis; bipolar disorder or eating disorders Interventions N=300 varenicline (1 mg BID added to smoking cessation counseling for 12 weeks) N=200 placebo (matching placebo added to smoking cessation counseling for 12 weeks) Primary outcome Smoking abstinence at week 26 15.7 % 15.7 https://web.pathway.md/studies/recDoY30wcrWWahRp 1/2 6/28/23, 11:52 PM KIS-IV Pathway 11.8 % 7.8 % 6.5 Significant increase 3.9 % NNH = 11 0.0 % Varenicline Placebo Significant increase in smoking abstinence at week 26 (15.7% vs. 6.5%; OR 2.7, 95% CI 1.4 to 5.1) Secondary outcomes Significant increase in smoking abstinence at week 12 (18.7% vs. 7%; OR 3, 95% CI 1.7 to 5.6) Significant increase in smoking abstinence among light smokers at week 12 (22.1% vs. 8.5%; OR 3, 95% CI 1.4 to 6.7) Significant increase in smoking abstinence among moderate to heavy smokers at week 12 (15.1% vs. 5.3%; OR 3.1, 95% CI 1.1 to 8.6) Safety outcomes No significant difference in adverse events. Conclusion In African-American adults who were daily smokers of all smoking levels, varenicline was superior to placebo with respect to smoking abstinence at week 26. Reference Lisa Sanderson Cox, Nicole L Nollen, Matthew S Mayo et al. Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial. JAMA. 2022 Jun 14;327(22):2201-2209. Open reference URL https://web.pathway.md/studies/recDoY30wcrWWahRp 2/2