BACKGROUND: Cigarette smoking continues to be the leading cause of preventable morbidity and mortality in the United States. Research suggests that behavioral support strategies and pharmacotherapy can improve abstinence rates. However, both approaches, especially pharmacotherapy, have been understudied in nonwhite US populations. OBJECTIVE: The aim of this review was to evaluate the efficacy of smoking-cessation pharmacotherapy in nonwhite US populations. METHODS: Using search terms smoking cessation, nicotine replacement therapy, bupropion SR, varenicline, minority, ethnicity, African American, black, Hispanic, American Indian, and Alaska Native, a literature search was conducted to identify English-language studies that evaluated the use of smoking-cessation pharmacotherapies in nonwhite patients in MEDLINE (1966\2-December 2007), International Pharmaceutical Abstracts (1980\2-January 2008), Database of Abstracts of Reviews of Effectiveness (1990\2-December 2007), and EMBASE Drugs & Pharmacology (1991\2-third quarter 2007). RESULTS: Nine studies were identified and assessed. Six studies looked at smoking-cessation pharmacotherapy in black smokers, 1 in Hispanic smokers, 1 in Native American smokers, and 1 in white and nonwhite smokers. In black smokers (N = 410; mean cigarettes per day [cpd], 20.4) who received the nicotine patch versus placebo, the 30-day self-reported abstinence rates were 21.5% versus 13.7% (P = 0.03) at 10 weeks and 17.1% versus 11.7% (P = NS) at 6 months. In black smokers (N = 600; mean [SD] cpd, 16.1 [7.5]) who received sustained-release (SR) bupropion 150 mg BID versus placebo for 7 weeks, the 7-day biochemically verified abstinence rates at weeks 6 and 26 were 36.0% versus 19.0% (Delta, 17%; 95% CI, 9.7\2-24.4; P < 0.001) and 21.0% versus 13.7% (Delta, 7.3%; 95% CI, 1.0\2-13.7; P = 0.02). Predictors of smoking cessation included use of bupropion SR (abstinence rate, 41.5% vs 21.1%; P<0.001); smoking nonmentholated cigarettes (abstinence rate, 28.3% in mentholated smokers [n = 417] vs 41.5% in nonmentholated smokers [n = 118]; P = 0.006); not smoking within 30 minutes of awakening (abstinence rate, 26.4% [n = 420] in those who did vs 48.7% [n = 115] in those who did not; P < 0.001); and lower baseline salivary cotinine levels (256.8 [137.0] ng/mL in those who became abstinent vs 305.6 [143.4] ng/mL in those who remained smokers; P < 0.001). In black light (<or=10 cpd) smokers (N = 753) who received nicotine gum 2 mg, the biochemically verified 7-day abstinence rates at weeks 8 and 26 in mentholated versus nonmentholated smokers were 22.6% versus 26.8% (P = NS) and 11.2% versus 18.8% (P = 0.015), respectively; at week 26, the abstinence rates in those who received gum + mentholated cigarettes (n = 309) versus gum + nonmentholated cigarettes (n = 67) were 14% versus 24% (P = 0.031). In Hispanic smokers (N = 108; mean [SD] cpd, 18.8 [10.2]) who received nicotine patch versus placebo for 10 weeks, 46% versus 26% (chi(2) = 4.01; P = 0.05) were abstinent from weeks 2 to 10 (completed all doses of patch); patients who were more acculturated and received active treatment had a higher abstinence rate than less acculturated patients (63% vs 47%; P value not provided). In Native American smokers (N = 252; cpd not provided) who received nicotine patch + counseling and were followed up at 3, 6, 9, and 12 months, selfreported abstinence rates were 31% (49/156), 30% (21/71), 24% (13/55), and 21% (4/19), respectively (P values not provided). In a 6-month study in white (n = 191) and nonwhite (n = 108) smokers (mean [SD] cpd, 21 [11]) randomized to receive a nicotine patch (n = 144) versus nasal spray (n = 155) for 8 weeks, the carbon monoxide\2-verified 7-day abstinence rates were 34.7% versus 29.0%; at 6 months, these rates were 18.1% versus 15.5% (P = NS). In nonwhite patients, logistic regression analysis at 6 months found that a higher proportion of patients randomized to receive nasal spray did not smoke for >or=7 consecutive days (odds ratio, 0.20; 95% CI, 0.05-0.77; P = 0.02). CONCLUSIONS: Data from the studies in this review support the use of smoking-cessation pharmacotherapy (nicotine patch and bupropion SR) in nonwhite patients. Black patients, who smoked within 30 minutes of awakening, smoked mentholated cigarettes, and had high salivary cotinine levels may have difficulty quitting regardless of the number of cigarettes smoked per day; therefore, determining the type of cigarettes smoked (mentholated vs nonmentholated) and salivary cotinine levels may be helpful in assessing the severity of smoking addiction and guide pharmacotherapy (eg, starting at higher doses of nicotine-replacement therapy in a light smoker). Other than smoking-cessation behavioral studies, there is a lack of congruent smoking-cessation pharmacotherapy studies in American Indian/Alaska Native, Hispanic, and other ethnic populations.