A review of the efficacy of smoking-cessation pharmacotherapies in nonwhite populations

Clinical Therapeutics/Volume 30, Number 5, 2008

A Review of the Efficacy of Smoking-Cessation Pharmacotherapies in Nonwhite Populations Gisela I. Robles, PharmD1; Devada Singh-Franco, PharmD1; and Hoytin Lee Ghin, PharmD, BCPS2 1Department

of Pharmacy Practice, College of Pharmacy, Nova Southeastern University, Ft. Lauderdale, Florida; and Mario School of Pharmacy, Rutgers University, Piscataway, New Jersey 2Ernest

ABSTRACT 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–December 2007), International Pharmaceutical Abstracts (1980–January 2008), Database of Abstracts of Reviews of Effectiveness (1990–December 2007), and EMBASE Drugs & Pharmacology (1991–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% (Δ, 17%; 95% CI, 9.7–24.4; P < 0.001) and 21.0% versus 13.7% 800

(Δ, 7.3%; 95% CI, 1.0–13.7; 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 (≤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% (χ2 = 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 Accepted for publication January 30, 2008. doi:10.1016/j.clinthera.2008.05.010 0149-2918/$32.00 © 2008 Excerpta Medica Inc. All rights reserved.

Volume 30 Number 5

G.I. Robles et al. (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–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 ≥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. (Clin Ther. 2008;30:800–812) © 2008 Excerpta Medica Inc. Key words: smoking cessation, nicotine replacement therapy, bupropion SR, minority groups, ethnic groups, race, nonwhite, African American, black, Hispanic, American Indian, Alaska Native, Pacific Islander, cotinine, nicotine.

INTRODUCTION To date, cigarette smoking continues to be the leading cause of preventable morbidity and mortality in the United States and accounts for 1 in 5 deaths each year (438,000 people).1 Approximately $167 billion is spent each year in the United States to manage direct and indirect costs of smoking-related illnesses.1 In 2006, the prevalence of cigarette smoking in US adults was 20.8% (45.3 million), with the highest rates in the Native American population (32.4%), followed by the black (23.0%), white (21.9%), Hispanic (12.2%), and Asian (10.4%) populations.2 Due to the addictive properties of nicotine, quitting is difficult, thereby making smoking a leading behavMay 2008

ioral health problem.3 Research findings suggest that smoking-cessation self-help strategies alone are ineffective and that counseling and pharmacotherapy either alone or in combination can improve abstinence rates.4 Smoking-cessation pharmacotherapy studies that have measured the efficacy of nicotine-replacement therapy (NRT),5 bupropion sustained release (SR),6 and varenicline7,8 have reported increased smoking-cessation rates by up to 2-fold.6,7,9 Regardless of the efficacy data with these agents, pharmacotherapeutic interventions for smoking cessation have been understudied in nonwhite populations compared with the white population. In studies conducted to assess the efficacy and tolerability of transdermal nicotine patches (2 studies; N = 932),10,11 lozenges (1 study; N = 1818),12 bupropion SR (2 studies; N = 888),13,14 and varenicline (2 studies; N = 2052),7,8 85% to 89%, 94%, 97%, and 80% to 85% of participants, respectively, were white. The abstinence rates in those who received the transdermal patch 21 mg/d versus placebo at 4 weeks were 12.0% versus 5.5% (P = 0.001).10 However, a 2-fold dose was not found to be more effective compared with 21 mg: the abstinence rates in those who received the transdermal patch 21 mg/d versus 42 mg/d at 36 weeks were 16.9% versus 9.2%; this difference did not reach statistical significance.11 In those who received a 4-mg lozenge versus placebo, the abstinence rates at 6 weeks were 48.7% versus 20.8% (P < 0.001); when the dose was reduced by half, the 6-week abstinence rate was still significantly higher with the lozenge (2 mg, 46.0% vs placebo, 29.7%; P < 0.001).12 In those who received bupropion SR 100, 150, or 300 mg/d versus placebo, short-term (7-week) abstinence rates were 28.8%, 38.6%, and 44.2%, respectively, versus 19.0% (all, P < 0.001).14 The long-term (52-week) abstinence rates at the highest dose (300 mg/d) versus placebo were 55.1% versus 42.3% (P = 0.008).13 In 2 studies comparing the effectiveness of varenicline 1 mg BID and bupropion SR 150 mg BID, 4-week abstinence rates were 44.0% and 29.5%, respectively, versus 17.7% with placebo (both, P < 0.001),7 and 43.9% and 29.8%, respectively, versus 17.6% with placebo (both, P < 0.001).8 The lack of studies in nonwhite US populations has been accompanied by reports in nonwhite groups, especially the black population (39.7 million),15 who experience more smoking-related health complications, such as lung cancer16 and cardiovascular disease, compared with whites; ~47,000 black people die 801

Clinical Therapeutics each year from smoking-related diseases.17 In the Hispanic US population, which comprises 40.4 million people,18 ~21.1% of Hispanic males and 11.1% of Hispanic females are current smokers.19 The rate of lung cancer–related death is 2-fold in Hispanic men (33.4 per 100,000 persons) versus Hispanic women (14.3 per 100,000 persons).20 As of July 1, 2005, the estimated US population of Native Americans was 4.5 million (1% of the total US population).15 Data from a telephone survey in ~3000 US adults ≥55 years of age (Behavioral Risk Factor Surveillance System [BRFSS], 2001 and 2002, a descriptive study of data from a 5-item health behavior and status survey) found that 26.7% (95% CI, 22.9%–30.5%; N = 3107) of Native Americans versus 13.9% (95% CI, 13.6%–14.2%; N = 126,967) of whites were current smokers, suggesting that Native Americans were almost twice as likely to be smokers compared with whites (adjusted odds ratio [OR], 1.78; 95% CI, 1.46–2.19).21 In a random, digit-dialed telephone survey study of data from 286,482 women from BRFSS 1998–2000, 27.8% (95% CI, 2.6%) of Native American women (n = 4633) and 20.8% (95% CI, 0.2%) of non–Native American women (n = 281,849) were current cigarette smokers.22 The crude death rate due to heart disease in the Native American US population is 160 per 100,000, and heart disease is considered the leading cause of death in this population.23 Various factors may play a role in the smoking patterns of nonwhite groups. In the black population, smoking rates have been reported to be higher in those with less than a high school education (34.8%) compared with those with a college education (16.7%).4 In Hispanic smokers,24 predictors of smoking, as determined using data from a cross-sectional digitdialed telephone survey, 666 current cigarette smokers (312 Hispanic and 354 white smokers) in 1990 included younger age (mean [SD], 36.6 [11.7] vs 39.6 [13.3] years; P < 0.01); less education (11.0 [4.3] vs 14.3 [2.2] years; P < 0.001); and <$20,000 annual household income (55.0% vs 26.9%; P < 0.001). In the study in Native Americans aged ≥55 years described previously,21 predictors of smoking included: (1) annual income <$25,000 (42.1% vs 27.3%); (2) unemployment (15.4% vs 4.6%); and (3) <12 years of education (29.3% vs 13.0%) (all, P < 0.01). An additional contributor to smoking in these nonwhite groups was a lack of access to health care. BRFSS 200025 reported that 26% of black smokers (375/ 802

1450 total respondents) and 35% of Hispanic smokers (277/794 total respondents) reported not having health insurance compared with 20% of white smokers (2328/11,360 total respondents) (both, P < 0.01). BRFSS 200025 also reported that 69% of current smokers (N = 14,089) reported ever being advised to stop smoking by a health care professional—73% of non-Hispanic white smokers (8310/11,360 total respondents; P = NS), 64% of black smokers (934/ 1450 total respondents; P < 0.01 vs white smokers), 57% of Hispanic smokers (452/794 total respondents; P < 0.01 vs white smokers), and 6% of Native American smokers (31/485 total respondents). This finding is concerning because counseling and other behavioral therapy, minimal clinician interventions (those lasting <3 minutes), and intensive interventions lasting longer, together with pharmacotherapy, have been reported to increase abstinence rates.26

METHODS Pertinent English-language articles were identified through a search of MEDLINE (1966–December 2007), International Pharmaceutical Abstracts (1980– January 2008), Database of Abstracts of Reviews of Effectiveness (1990–December 2007), and EMBASE Drugs & Pharmacology (1991–third quarter 2007). The search terms included smoking cessation, nicotine replacement therapy, bupropion SR, varenicline, minority groups, ethnic groups, nonwhite, black, Hispanic, American Indian, Alaska Native, nicotine, and cotinine. Articles were selected for review if they described studies about the efficacy of smoking-cessation pharmacotherapy in black, Hispanic, and Native American populations; studies in Asians and studies that used cognitive and behavioral interventions will not be discussed.

RESULTS Nine studies were identified and assessed. Six studies looked at smoking-cessation treatment in black smokers, 1 study in Hispanic smokers, 1 study in Native American smokers, and 1 study in white and nonwhite smokers. Differences in smoking habits between white and black smokers have been reported.9,27,28 A questionnaire distributed to white (n = 2791) and black (n = 377) smokers during a hospital-based case– control study of tobacco-related cancers reported the following: (1) 56% and 85% smoked ≤20 cigarettes per day (cpd), respectively; 43% and 15% smoked Volume 30 Number 5

G.I. Robles et al. >20 cpd; (2) 52% and 78% smoked high-tar (≥15 mg) cigarettes; (3) 22% and 40% smoked mentholated cigarettes ≥1 year (up to ≥15 years); (4) 71% and 64% smoked ≥30 years; and (5) 66% and 64% smoked within 30 minutes of awakening.9 Although blacks reported smoking fewer cigarettes daily, a similar percentage (to whites) smoked within 30 minutes of awakening (a behavioral indicator of nicotine dependence). Data from a baseline telephone survey of 8 Community Intervention Trial for Smoking Cessation (COMMIT) sites that had a larger sample size of black people, ethnic differences in smoking for whites (n = 8550) versus blacks (n = 3418) were as follows: (1) 58.8% and 81.8%, respectively, smoked <25 cpd (light/moderate smokers); (2) 36.3% and 43.3% had ≥1 serious quit attempt in the previous year and stopped smoking for ≥24 hours. In light/moderate smokers, the rate of smoking within 10 minutes of awakening was 1.6-fold higher in black compared with white smokers after adjusting for age, sex, and educational level (95% CI, 1.39–1.76), suggesting a high dependence on nicotine in black light/moderate smokers. In black versus white heavy smokers, the likelihood of smoking within 10 minutes of awakening was 1.2-fold higher in blacks versus whites (95% CI, 1.03–1.46).27 A pharmacokinetic analysis of nicotine metabolism in 40 black and 39 white smokers with a mean (SD) daily nicotine intake of 16.7 (8.8) and 15.0 (12.0) mg found that plasma cotinine per cigarette was significantly higher in black smokers (19.3 [10.3] vs 13.0 [7.7] ng/mL; P = 0.003); the total clearance of cotinine was lower in black versus white smokers, at 0.56 (0.17) versus 0.68 (0.24) mL ⋅ min/kg (P = 0.009); and the nicotine intake per cigarette was higher in black compared with white smokers, at 1.41 (0.89) versus 1.09 (0.74) mg/cigarette (P = 0.02) with log transformation. However, the steady-state volume of distribution (Vdss) and t1/2 values for cotinine were similar between the 2 groups (Vdss, 0.75 [0.11] vs 0.80 [0.19] L/kg [P = NS]; t1/2, 17.7 [4.28] vs 15.8 [4.9] hours [P = NS]). Therefore, higher levels of cotinine per cigarette in black smokers may be explained by slower clearance and higher intake of nicotine per cigarette.28 Although not statistically significant, black smokers reported initiating smoking at a later age and smoking fewer cigarettes daily and were more likely to smoke high-tar, mentholated cigarettes, compared with white smokers9,27; in the pharmacokinetic study,28 in which May 2008

the mean number of cigarettes per day smoked by black versus white patients was 14.0 (95% CI, 11.4–16.6) versus 14.7 (95% CI, 11.0–18.3) (P = NS), the mean time to first cigarette of the day in black versus white smokers was 43.8 minutes (95% CI, 20.3–67.2 minutes) versus 111.7 minutes (95% CI, 53.7–169.8 minutes) (P = 0.03). The mean tar content of cigarettes was higher in blacks (15.9 mg [95% CI, 15.1–16.6 mg] vs 14.1 mg [95% CI, 12.8–15.5 mg]; P = 0.03), with 78% of black smokers choosing mentholated cigarettes versus 5% of white smokers (P < 0.001). In addition, higher plasma levels of cotinine per cigarette (P = 0.003) and lower total clearance of the metabolite (P = 0.009) were found in black versus white smokers.28

Clinical Studies in the Black Population A total of 6 studies (3 original studies29–31 and 3 secondary analyses of the original studies32–34) in black patients were identified. Demographic characteristics, smoking-related variables, and patients lost to follow-up of the 3 original studies29–31 are outlined in the table. Ahluwalia et al29 conducted a 10-week, randomized, double-blind, placebo-controlled study to determine the efficacy of nicotine transdermal patches37 in addition to counseling and education in an inner-city black population of smokers (n = 410). The quit date was defined as the date when the patch was first applied. The nicotine transdermal patch 21 mg/d was administered for 6 weeks followed by 14 mg/d for 2 weeks and 7 mg/d for the last 2 weeks of treatment (10 weeks total). At the screening and randomization visits, patients were educated with culturally sensitive materials (manual and audiocassette) that described cigarette smoking characteristics among black smokers, instructions on how to quit smoking and use nicotine patches, suggestions on how to involve the community to combat cigarette smoking, coping/relaxation techniques, and behavioral changes. The primary outcome measure was continuous abstinence (self-reported abstinence rates) from the end of treatment (week 10) to 6 months. A secondary outcome was the 30-day abstinence rate at the end of treatment (self-reported complete abstinence over the prior 30 days). Patches were packaged in unlabeled boxes that held a 2-week supply. At follow-up visits, patients were asked about adherence to patch use. At baseline, both groups were comparable (Table), with the exception that in the active-treatment group, the mean age was significantly higher (49 vs 46 years; 803

804 30–59

Hensel et al36 –

241.8 (140.0)** 256.6 (171.5)** 229.9 (147.1)** 248.6 (157.2)**

287.2 (138.8)§ 296.5 (147.0)§

–

–

–

–

20.0 (8.9) –

13.7 (9.0) 14.0 (8.5) 14.2 (9.8) 13.5 (8.4)

22.1 (13.2) 23.3 (15.2)

20.9

21.5

–

4.5 (2.2)

4.1 (2.16) 4.2 (2.2) 4.3 (2.0) 4.5 (2.2)

4.6 (2.1) 4.7 (1.9)

5.68

5.87

–

–

30 (21/71)

31‡‡ (49/156) 227

23.9 –

25.0

29.1

14.8

15.3

13.7

46 vs 26††

3.4 (5.6)   26

78.7

30.7

16.9

21.1

19.0

21.0¶

11.7

17.1

–

2.8 (5.1)   21

83.0

3.6 (5.8)

4.0 (10.0)   39

83.6

–

2.8 (4.4)   32

81.4

2.2 (4.2)   94

78.7

36.0 ∥

13.7

51.2%†   58 2.1 (4.7)   95

21.5‡

56.1%†   53

78.3

72.1

77.1

F = female; cpd = cigarettes per day; CO = carbon monoxide; EOT = end of treatment; SR = sustained release; MI = motivational interviewing; HE = health education. * Fagerström score for nicotine dependence. Scale, 0–10; ≥5 indicated greater levels of nicotine dependence. † Percentage of patients with ≥3 serious quit attempts in the past. ‡ P = 0.03 (end of treatment = 10 weeks). § Measured in saliva. ∥ P < 0.001 (end of treatment = 6 weeks). ¶ P = 0.02. # EOT = 8 weeks. ** Measured in serum. †† P = 0.05 (active patch vs placebo at 10 weeks). ‡‡ At 3 months.



–

41.0 51 (8.5)

Leischow et al35 18.8 (10.2)

45.2 66.1   7.8 (10.7) (3.5) 46.5 65.1   7.5 (10.0) (3.5) 43.5 68.3   7.5 (11.8) (2.9) 45.2 68.1   7.3 (10.0) (2.8)

16.1 (7.5) 17.1 (8.5)

19.8

Ahluwalia et al31#    Nicotine gum + MI     (n = 189)    Placebo + MI     (n = 189)    Nicotine gum + HE     (n = 189)    Placebo + HE     (n = 188)

64.4

46.4

20.4

44.0 70.7 (10.9) 44.4 69.3 (11.3)

65.9

48.7

Smoking Expired Smoked Serious Lost to Abstinent Abstinent Habit, CO, Cotinine, Fagerström Mentholated Quit Follow-Up, at at cpd ppm ng/mL Score* Cigarettes, % Attempts No. EOT, % 6 Mo, %

Ahluwalia et    Bupropion SR     (n = 300)    Placebo     (n = 300)

al30

Ahluwalia et al29    Patch     (n = 205)    Placebo     (n = 205)

Study/ Age, F, Study Group y %

Table. Baseline demographic characteristics, including smoking-related variables, in selected studies of smoking cessation in nonwhite populations.

Clinical Therapeutics

Volume 30 Number 5

G.I. Robles et al. P = 0.04) and the level of education was lower (49% vs 32% with less than high school education; P = 0.01). At least 50% of patients in both groups had low annual household incomes (<$8000); >70% smoked mentholated cigarettes and had their first cigarette of the day within the first 5 minutes of awakening. The mean score on the Fagerström test was 6 (the Fagerström test is a 6-item questionnaire structured to help health care professionals determine a patient’s degree of nicotine dependence; a score of ≥5 of 10 indicates a high level of nicotine dependence).38 Based on the last 2 findings (>70% of patients smoking within 5 minutes of awakening, and a mean Fagerström test score of 5.87), these patients were considered highly dependent on nicotine. In addition, hypertension, asthma, and chronic obstructive pulmonary disease (COPD) were smoking-related illnesses frequently reported in both groups (50%, 16%–18%, and 12%–13%, respectively). After adjusting for baseline differences in age and educational level, a significantly higher percentage of patients reported 30-day abstinence in the activetreatment group compared with placebo at week 10 (21.5% [44/205] vs 13.7% [28/205]; P = 0.03). However, at 6 months, the abstinence rates reported by patients were not significantly different between the 2 groups (17.1% [35/205] vs 11.7% [24/205]). The adherence rates for return visits were 52% (212/410) at week 10 and 31% (128/410) at 6 months (adherence rate data were not presented separately for each group). No significant differences in follow-up rates between the 2 groups were found. Five patients in the active-treatment group and 3 in the placebo group reported itching, redness, and/or burning with patch use. Although a significant percentage of those receiving the patch abstained from smoking during 10 weeks of treatment (P = 0.03), only a small number (n = 44) were successful and only for those 10 weeks. The researchers attempted to contact participants (n = 111) via the telephone multiple times but were unsuccessful, resulting in a reduction in sample size and an inability to provide additional counseling in these patients; these patients were considered smokers at study end. Lastly, the lack of biochemical testing to confirm abstinence at follow-up visits and reliance on patients’ self-reporting were potential limitations of the study. To determine the efficacy and tolerability of bupropion SR39 in black smokers, Ahluwalia et al30 conMay 2008

ducted a double-blind, placebo-controlled study in which 600 patients were randomized to receive bupropion SR 150 mg or placebo for 7 weeks (patients set a quit date and a week before this quit date, patients were allowed to smoke while titrating bupropion SR 150 mg/d for 3 days and then increasing the dose to BID; after 1 week of smoking and bupropion treatment, patients were asked to stop smoking [quit day] and continue use of bupropion SR or placebo for the remaining 6 weeks); in addition, all patients participated in 8 counseling sessions about smoking cessation. These counseling sessions discussed steps to quit, medication adherence, and problem-solving of difficult situations. The primary outcome was the 7-day point prevalence of smoking cessation at week 26. Abstinence was confirmed with expired carbon monoxide assessment (≤10 ppm) and saliva for cotinine analysis (≤20 ng/mL). Patients were instructed to continue using the study drug (bupropion SR or placebo) for the entire 7-week study period, regardless of smoking status. Study drugs were packaged in blister packets containing a 1-week supply and were distributed to patients at follow-up visits. Patients were excluded if they had a contraindication to bupropion SR use, were being treated for depression, had concomitant use of psychotropic medications, and/or were enrolled in a drug treatment program within the 6 months before the study. Demographic data and smoking-related variables were comparable between the bupropion and placebo groups at baseline (Table). In each group, 52.6% versus 54.6% of patients had low monthly family incomes (≤$1800), 50.3% versus 49.7% had less than a high school level of education, and 78.3% versus 78.7% reported smoking mentholated cigarettes and >70% smoked mentholated cigarettes (78.3% vs 78.7%). Approximately 20% of patients reported failing bupropion SR treatment in the past, and 50% reported having previously failed NRT. At week 6 (end of treatment), the 7-day point prevalence abstinence was 36.0% (108/300) of patients in the bupropion SR group versus 19.0% (57/300) in the placebo group (Δ, 17%; 95% CI, 9.7–24.4; P < 0.001). In patients who did not completely abstain, the between-group difference in change from baseline in the mean (SD) number of cigarettes smoked was not significant (11.5 [8.4] vs 10.1 [9.1]). At week 26, 7-day point prevalence abstinence rates were 21.0% (63/300) in the bupropion SR group 805

Clinical Therapeutics versus 13.7% (41/300) in the placebo group (Δ, 7.3%; 95% CI, 1.0%–13.7%; P = 0.02). The week-26 mean (SD) reductions in the numbers of cigarettes smoked were 8.3 (10.3) in patients receiving bupropion SR and 7.9 (8.8) in the placebo group; this difference was not statistically significant. The most common adverse events reported by patients in the bupropion SR and placebo groups over 6 weeks of study drug administration were sleep disturbances (29% vs 21%; P = 0.02) and dry mouth (28% vs 24%; P = NS). Based on the literature search, this is the only study that evaluated the efficacy of bupropion SR solely in black patients. Future research designed to measure the efficacy and tolerability of combination bupropion SR and NRT in black patients who were either NRTnaive or had failed NRT monotherapy is needed to improve knowledge about combination therapy in this population of smokers. In a secondary analysis of the data32 of 471 mentholated cigarette smokers (bupropion, 235 patients; placebo, 236) and 129 nonmentholated cigarette smokers (bupropion, 65; placebo, 64),30 Okuyemi et al32 reported that both groups of patients had similar Fagerström scores (4.7 in mentholated cigarette smokers and 4.4 in nonmentholated cigarette smokers) and smoked a similar mean number of cigarettes per day (18 cpd); however, mentholated cigarette smokers were more likely to smoke within 30 minutes of awakening (81.7% vs 69.8%; P = 0.003). At 6 weeks (N = 535/600; 65 patients lost to follow-up), 28.3% of mentholated cigarette smokers (n = 417) compared with 41.5% of nonmentholated cigarette smokers (n = 118) were abstinent (P = 0.006) and the abstinence rates at 6 months (N = 518/600) were 21.4% and 27.0%, respectively; this difference did not reach statistical significance. At 6 weeks, the 7-day point prevalence abstinence rates in patients who received bupropion SR and smoked mentholated versus nonmentholated cigarettes (numbers of patients not provided were 36.2% versus 60.3%, respectively [P < 0.01]). In patients who received placebo, the abstinence rates were similar between mentholated cigarette smokers and nonmentholated cigarette smokers (20.5% vs 23.3%). To determine factors predictive of smoking cessation, Harris et al33 analyzed the data obtained from the bupropion SR study described above (bupropion, 265; placebo, 270).30 At 7 weeks, 167/535 (31.2%) were abstinent and 368/535 (68.8%) were still smok806

ing cigarettes. The categorical predictors of 7-day cessation at the end of the drug therapy phase between abstinent and smoking groups were: (1) current treatment with bupropion SR therapy versus placebo (abstinence rate, 41.5% [110/265; 35 patients lost to followup] vs 21.1% [57/270; 30 patients lost to follow-up]; P < 0.001); (2) smoking nonmentholated cigarettes (mentholated cigarette smokers, n = 417; nonmentholated cigarette smokers, n = 118; abstinence rate, 28.3% vs 41.5%; P = 0.006); and (3) not smoking within 30 minutes of awakening (420 patients smoked within 30 minutes of awakening; 115 patients did not; abstinence rate, 26.4% vs 48.7%; P < 0.001). Based on baseline characteristics, the continuous predictors of 7-day cessation at the end of the drug therapy phase between abstinent and smoking groups included older age (mean [SD] age, 46.5 [11.7] vs 43.7 [10.4] years; P = 0.009), smoking fewer cigarettes daily (mean [SD], 15.3 [6.92] vs 17.2 [8.3]; P = 0.004), and a lower salivary cotinine concentration (mean [SD], 256.8 [137.0] vs 305.6 (143.4) ng/mL; P < 0.001). Based on those results, black patients who smoked within 30 minutes of awakening, smoked mentholated cigarettes, and/or had high cotinine levels may have had difficulty quitting regardless of the number of cigarettes smoked daily. Ahluwalia et al31 conducted a randomized, placebocontrolled study in 755 black light smokers (≤10 cpd) to determine the effectiveness of nicotine gum 2 mg versus placebo on smoking cessation. In addition, all patients received counseling in the form of health education (HE) or motivational interviewing (MI). Patients received an 8-week supply of nicotine gum 2 mg40 or placebo gum and were provided instructions on how many doses to chew per day based on cigarettes smoked daily. The primary outcome measure was cotinine-verified 7-day abstinence at week 26, and the secondary outcome measure was 7-day abstinence at week 8. HE and MI were conducted in person at randomization and weeks 1 and 8 and by telephone at weeks 3, 6, and 16. HE consisted of information about the nature of nicotine addiction, health consequences of smoking, benefits of quitting, quitting strategies, and alternatives against triggers to smoking. MI consisted of reviewing the pros and cons of smoking cessation, motivation, and self-confidence in smoking cessation. The baseline characteristics of the nicotine gum (n = 378) and placebo (n = 377) groups were comparable (Table): ≥50% of patients in both groups (n = 433) had low monthly household incomes (<$1800) and Volume 30 Number 5

G.I. Robles et al. >79% of patients in both groups smoked mentholated cigarettes (n = 615). Mean number of cigarettes smoked daily ranged from 4 to 11. At week 8, the carbon monoxide–verified 7-day abstinence rates in the gum + HE, gum + MI, placebo + HE, and placebo + MI groups were 30.7% (58/189), 21.2% (40/189), 25.0% (47/ 188), and 16.9% (32/189), respectively; at week 26, these values were 29.1% (55/189), 15.3% (29/189), 23.9% (45/188), and 14.8% (28/189). The salivary cotinine–verified 7-day abstinence (≤20 ng/mL) rates at week 26 were 18.0% (34/189), 10.1% (19/189), 15.4% (29/188), and 6.9% (13/189), respectively. Overall, biochemically verified abstinence rates with carbon monoxide and salivary cotinine levels were similar between the nicotine gum and placebo groups. However, patients who received HE had a significantly greater abstinence rate than patients who received MI (17% vs 9%; P < 0.001). In another analysis of the data by Okuyemi et al,34 there were 615 mentholated cigarette smokers and 138 nonmentholated cigarette smokers (2 smokers did not indicate whether they smoked mentholated or nonmentholated cigarettes). Approximately 40% of patients in both groups had a monthly family income ≥$1800, 83% had at least a high school education, and ~50% were employed. The mean (SD) duration of smoking habit in mentholated versus nonmentholated cigarette users was 22.5 (11.3) versus 30.0 (12.9) years, respectively (P < 0.001). The 7-day abstinence rates at weeks 8 and 26 in smokers of mentholated versus nonmentholated cigarettes were 22.6% and 26.8% (P = NS) and 11.2% and 18.8% (P = 0.015), respectively. At week 26, the 7-day abstinence rates in mentholated cigarette smokers who received gum (n = 309) versus nonmentholated cigarette smokers who received gum (n = 67), and mentholated cigarette smokers who received HE (n = 304) versus nonmentholated cigarette smokers who received HE (n = 72), were 14% versus 24% (P = 0.031) and 15% versus 25% (P = 0.037), respectively (data estimated from figure). The abstinence rates in patients who received placebo (10% vs 15%) or MI (8% vs 12%) were not significantly different between mentholated and nonmentholated cigarette smokers. At week 26, the 7-day abstinence rates for mentholated versus nonmentholated cigarette smokers who received MI + placebo, MI + gum, HE + placebo, and HE + gum were 6% versus 5%, 8% versus 16%, 15% versus 23%, and 16% versus 28%, respectively (data estimated from figure); none of these differences reached statistical significance. May 2008

In this sample of black light smokers, nicotine gum 2 mg was not significantly more effective for smoking cessation than placebo. Because patients were allowed to chew a maximum of 10 pieces per day (the manufacturer’s recommendation40 is a maximum of 24 pieces per day), it is difficult to determine whether product underutilization was a contributing factor to treatment failure. In addition, when the salivary cotinine levels of the light smokers (cpd, 8; mean [SD] salivary cotinine level, 244.2 [153.9] ng/mL) were compared with those of heavier smokers (cpd, 17; mean [SD] cotinine concentration, 287.2 [138.8] ng/mL),31 it was unclear whether the daily number of cigarettes smoked by light smokers was underreported. Finally, patients who smoked mentholated cigarettes had lower cessation rate at 26 weeks versus those who smoked nonmentholated cigarettes (P = 0.015).

Clinical Studies in the Hispanic Population A study of data from a 1990 San Francisco census tract of 312 Hispanic smokers and 354 non-Hispanic white smokers reported that the mean (SD) daily cigarette values were 11.1 (9.7) in Hispanic men (n = 198), 7.2 (7.6) in Hispanic women (n = 114), 21.1 (11.5) in white men (n = 186), and 19.1 (10.2) in white women (n = 168) (P < 0.001).24 In addition, a study of data from a California population-based cross-sectional survey (1979–1990) of 1088 Hispanic and 544 white people found that Hispanics with less than a high school education were less likely to smoke daily versus white people with a similar educational history (men, 30% vs 53%; women, 21% vs 46%; education × sex term significant at P < 0.002).41 A study of data from a randomized, populationlevel telephone survey of adults residing in Colorado found that 69.0% (211/306) of Hispanic adults versus 60.2% (1776/2949) of non-Hispanic white adults attempted to quit for >24 hours within the previous year (P = 0.005). In addition, 46.8% (104/222) of Hispanic smokers versus 56.1% (1223/2181) of nonHispanic white smokers reported that their physician advised them to quit smoking (P ≤ 0.05); 17.1% (36/211) of Hispanic smokers versus 31.9% (566/1776) of non-Hispanic white smokers reported having attempted to quit smoking with use of assistance (NRT and/or antidepressants) (10.0% [21/211] vs 26.2% [466/1776]; P < 0.001).42 Although Hispanic smokers may value the importance of smoking cessation to improve their health 807

Clinical Therapeutics and the health of their families,24 some may be uncomfortable with the idea of using smoking-cessation pharmacotherapy. In a study using a 1-time focused group discussion model, a sample of 49 Hispanic smokers43 reported that they believed that: (1) smoking is a character weakness and/or failure of will rather than an illness; (2) medications are to be avoided for various reasons (ie, medications are necessary for medical illness such as diabetes, concerns about side effects); (3) NRT was ineffective—they had tried the patch, gum, lozenge, or inhaler but found them unpleasant, or use meant trading 1 addiction for another; and (4) bupropion use was to be avoided because it suggested the presence of mental illness and concerns about side effects. In addition, some believed that the use of a pill represented a more intensive medication intervention versus willpower. The researchers noted that some of the participants had incomplete knowledge about cigarettes and smokingcessation pharmacotherapy and required education.43 Based on this information, Hispanic smokers might be motivated to quit smoking but receive less advice from physicians about smoking cessation and feel uncomfortable using smoking-cessation pharmacotherapy to help them quit.42,43 In a cross-sectional survey of 146 Hispanic and 1153 white male smokers in Veteran Affairs medical and ambulatory care centers in the United States,44 43% of participants in both groups indicated that they had attempted to quit for ≥24 hours within the previous year; however, 26% (38/146) of Hispanic smokers versus 50% (577/1153) of white smokers indicated that they had ever used NRT during a quit attempt (adjusted OR, 0.35; 95% CI, 0.23–0.52; P < 0.001). Both Hispanic and white patients indicated that methods used to seriously attempt quitting in the previous year included talking with a health care practitioner (51% [32/63] and 54% [266/493]; P = NS), followed by use of NRT (22% [14/63] and 34% [168/493]; unadjusted OR, 0.55; 95% CI, 0.29 to –1.02; P = NS).44 One study about the use of smoking-cessation pharmacotherapy (transdermal patch) in Hispanic smokers was identified. Leischow et al35 conducted a 10-week, randomized, double-blind, placebo-controlled pilot study to assess the efficacy of transdermal nicotine patch (21 mg/d for 5 weeks, 14 mg/d for 4 weeks, and 7 mg/d for 1 week) with counseling on preparing to quit and preventing relapse versus placebo patch with 808

counseling, on abstinence rates in Hispanic smokers (N = 108; mean [SD] cigarettes per day, 18.8 [10.2]). Outcomes measures included abstinence rates at 6 and 10 weeks. Smoking status and patch use were assessed by participant self-reporting and breath carbonmonoxide test. Abstinence was confirmed using expired carbon-monoxide assessment (≤10 ppm). All participants received behavioral support in English or Spanish (10-minute sessions) to assist with patients’ smoking-cessation attempts and prevent relapses after cessation. An acculturation scale45 was used to measure assimilation in Hispanic patients into the predominant cultural group in the area. The majority of patients were Mexican American (n = 95), followed by Puerto Rican (n = 5) and others of Hispanic descent (n = 8); based on an acculturation scale, 62% of participants were acculturated. Baseline characteristics are shown in the table. The percentages of smokers who smoked during the first 2 weeks of treatment but were abstinent from weeks 2 to 6 (21 mg/d) and 2 to 10 (completed all doses of patch) in the active-patch and placebo groups were 63% and 35% (χ2 = 7.26; P < 0.01) and 46% and 26% (χ2 = 4.01; P = 0.05), respectively. In patients who did not smoke during the first 2 weeks, abstinence rates were higher in the active-patch group at week 6 (35% vs 17%; χ2 = 3.91; P < 0.05) but not at week 10 (24% vs 15%; χ2 = 0.95). In the active-patch group, patients who were more acculturated had a higher abstinence rate than the less acculturated patients (63% vs 47%; P value not provided). In addition, at week 6, mean weight gain was significantly less in the active-patch group than in the placebo group (0.5 vs 2.4 kg; P < 0.05); however, the weight difference was not significant at week 10 (2.3 vs 3.0 kg). Those who received the patch with counseling were more likely to abstain during treatment (up to 10 weeks) compared with those who received the placebo patch plus counseling; however, this was a short-term study with a small sample size, so it is unclear whether the effects would be sustained over a longer period of time. The role of acculturation in Hispanic populations should be explored further to determine ways to optimize NRT and behavioral support techniques.

Clinical Study in the Native American Population Data from a study of 6 focus groups of Native American adult smokers (N = 41) in Kansas46 found that the mean (SD) number of cigarettes smoked daily Volume 30 Number 5

G.I. Robles et al. was 12.6 (12.0). Fifty-one percent of participants reported making a smoking-cessation attempt in the previous year, and 54% reported smoking for ≥5 years. The majority of participants (62%) wanted to quit smoking within the next 30 days. Reasons reported for wanting to quit smoking included family experiences, poor health, and cost. Of all participants, 22%, 20%, 17%, and 2% reported willingness to try pharmacotherapy in the form of the nicotine patch, bupropion SR, gum, and inhaler, respectively. One study of the use of smoking-cessation pharmacotherapy (transdermal patch) in Native American smokers was identified.37 In a 1-year, uncontrolled, observational study, Hensel et al36 evaluated the effects of transdermal nicotine patch and behavioral modification classes on smoking cessation rates in Native Alaskan patients and employees at the Alaska Native Medical Center (ANMC). A physician or pharmacist provided drug information and instructions on nicotine patch use. All participants received drug therapy and counseling free of charge. The ANMC computed pharmacy database tracked the number of nicotine patches dispensed for each patient. Patients were followed up via telephone calls at 3, 6, 9, and 12 months to determine smoking status. Of 252 initial enrollees (number of cigarettes smoked daily not provided), 193, 111, 64, and 24 participants were available for data collection at the 3, 6, 9, and 12-month follow-up telephone calls, respectively. Therefore, at 12 months, only 10% of the initial population was available for assessment, with the majority of patients lost to follow-up. Participants’ ages ranged from 30 to 59 years, with 2.4-fold as many women as men in the study. Abstinence rates were 31% (49/156), 30% (21/71), 24% (13/55), and 21% (4/19) at months 3, 6, 9, and 12, respectively (P values not provided). The high dropout rate should be considered when evaluating the reported abstinence rates. No adverse drug events were reported by the participants assessed at 12 months (10% of the initial population). Limitations of this study included the high dropout rate, lack of a control group, and lack of randomization. In addition, the lack of carbon monoxide or salivary measurements limited the verification of patients’ self-reported abstinence rates.

Clinical Study in Combined Nonwhite Groups In a 6-month, randomized, open-label study, Lerman et al47 evaluated the effects of transdermal nicoMay 2008

tine patch versus nicotine nasal spray48 in addition to behavioral counseling (7 sessions of 1.5 hours each). Patients used NRT for 8 weeks with these instructions: patch (n = 144): 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, 7 mg/d for 2 weeks; nasal spray (n = 155): 0.5 mg/nostril, maximum 5 doses/h and 40 doses/d. After 4 weeks of nasal spray treatment, patients were instructed to taper down their doses by one-third for 2 weeks and by another third for the last 2 weeks of treatment. Patients were instructed to record their daily use of the assigned NRT. Three main outcomes were: (1) prolonged abstinence (<7 consecutive days of smoking at any time from target quit date to 6 months; ≥7 days of consecutive smoking was defined as treatment failure) without biochemical verification; (2) continuous abstinence (no brief relapses allowed from target quit date to 6 months) without biochemical verification; and (3) 7-day point prevalence of continuous abstinence (no smoking for ≥7 days), verified with carbon monoxide testing. The majority of participants were white (n = 191), followed by black (n = 81), “other” (n = 12), Hispanic (n = 9), and Asian (n = 6). Overall, the mean (SD) age was 46 (11) years, 54% were women, mean (SD) number of cigarettes smoked daily was 21 (11), mean (SD) cotinine concentration was 217.1 (137.1) nmol/L, and 29% and 36% of participants in the nicotine patch and nasal spray groups, respectively, reported Fagerström scores ≥7. Approximately 50% of all participants had previously failed the patch and 2% had previously failed the nasal spray in smoking-cessation attempts. During the first 2 weeks of treatment, the mean (SD) number of days per week of patch use was 6.4 (1.1), and the mean (SD) number of daily doses of nasal spray was 7.5 (6.9). At the end of treatment (8 weeks after target quit date with patients who received active treatment), prolonged abstinence, in which brief relapses were allowed, was reported by 62.5% of patients in the nicotine patch group versus 44.5% of patients in the nasal spray group (P = 0.002); however, at 6 months (target quit date to 6 months), the percentages of patients with prolonged abstinence were similar between the 2 treatment groups (28.5% vs 24.5%). Continuous abstinence rates were not significantly different between the patch versus nasal spray groups at the end of treatment (25.7% vs 21.3%) or 6 months (15.0% vs 12.2%). The 7-day point prevalence was not significantly different between the patch and nasal spray groups at the end of treatment (34.7% vs 29.0%) or 809

Clinical Therapeutics 6 months (18.1% vs 15.5%), respectively. In the nonwhite patients, logistic regression analysis at 6 months found that a higher proportion of patients randomized to receive nasal spray did not smoke for ≥7 consecutive days (OR, 0.20; 95% CI, 0.05–0.77; P = 0.02). Approximately 60% of the participants receiving NRT did not quit smoking regardless of their ethnic background. No major adverse events were reported. Limitations of this study included the open-label design, patient self-report of abstinence, and small sample of nonwhite participants.

DISCUSSION Results from clinical studies of the efficacy and tolerability of smoking-cessation pharmacotherapy in black patients suggested that smokers abstain at a significantly greater rate (P < 0.05) when using nicotine patches29 or bupropion SR versus placebo.30 Conversely, the abstinence rate in black light smokers (≤10 cpd) using the 2-mg nicotine gum strength was similar to that in the placebo group.31,34 Data from these studies suggest the following: (1) smokers of mentholated cigarettes were less likely to succeed in quitting compared with smokers of nonmentholated cigarettes32–34; (2) serum cotinine levels, in addition to smoking within 30 minutes of awakening, may help assess the level of patients’ nicotine dependence24,25,42­–44,49; and (3) studies are needed to address whether light smokers (≤10 cpd),34 especially light smokers of mentholated cigarettes, may need higher doses of NRT to abstain from smoking because mentholated cigarette smokers may have increased exposure to nicotine with each inhalation as an attempt to enhance the cooling and local anesthetic effects of menthol.50 This effect seems to be achieved through larger puffs, deeper inhalations, and holding breaths for longer periods of time.50 In the study of the efficacy of the nicotine patch in Hispanic smokers,35 those randomized to receive active treatment and who smoked during the first 2 weeks of treatment were twice as likely to abstain from smoking at weeks 6 and 10 (2 weeks after the end of patch treatment) compared with those who received placebo. Although head-to-head comparisons of smokingcessation therapies in white versus nonwhite populations were not identified, one study47 that included ~36% nonwhite smokers found that the proportion of patients who achieved smoking cessation was significantly greater with nicotine nasal spray compared with the nicotine transdermal patch in nonwhite patients 810

(P = 0.02). No significant findings favoring the use of nicotine transdermal patches were noted in the study with Native Alaskans.36 However, the benefits of NRT in the Native Alaskan population should not be ruled out based on that study because major study limitations were identified (lack of a control group, randomization, nicotine patch titration schedule, and high dropout rate). Smoking cessation has major health benefits in men and women of all ages, including decreasing the risks for cancer, cardiovascular disease, and COPD.51,52 The use of NRT, bupropion SR, and varenicline have been found to significantly improve cessation rates by relieving cravings and nicotine withdrawal symptoms.5,7,8,10–14 Despite these findings, compared with white smokers, nonwhite smokers reported less use of NRT, less participation in smoking-cessation programs, less use of physician services, less health insurance coverage, multiple unsuccessful quit attempts, and less smoking-cessation advice from providers regardless of their motivation to quit smoking.24,25,42–44,49

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 NRT in a light smoker). Other than smoking-cessation behavioral studies, there is a lack of congruent smokingcessation pharmacotherapy studies in American Indian/ Alaska Native, Hispanic, and other ethnic populations.

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Address correspondence to: Gisela I. Robles, PharmD, Nova Southeastern University, Health Professions Division, College of Pharmacy, 3200 South University Drive, Ft. Lauderdale, FL 33328. E-mail: [email protected] Volume 30 Number 5