Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation

Nollen, Nicole L.; Ahluwalia, Jasjit S.; Cox, Lisa Sanderson; Okuyemi, Kolawole S.; Lawrence, David; Samuels, Larry D.; Benowitz, Neal L.

doi:10.1001/jamanetworkopen.2020.32053

Cited by 34 publications

(39 citation statements)

References 93 publications

(224 reference statements)

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“…Therefore, we expected to observe a significant reduction in abstinence in African American smokers in the Pharmacogenetic Study. The range of standardized effect estimates we observed, from ORs (95%CI) of 0.31 (0.14-0.69) in the CPD model to 0.34 (0.15-0.74) in the uNMR model, encompass estimates from studies with a variety of designs: randomized on gender and OMB race 42 , stratified by OMB race 6 , or stratified by psychiatric diagnosis 8 .…”

Section: Omb Race and Abstinencementioning

confidence: 90%

“…The copyright holder for this this version posted December 27, 2021. ; https://doi.org/10.1101/2021.12.24.21267950 doi: medRxiv preprint 5 Nollen et al identified cessation disparities and explanatory factors in analyses of US smokers in the randomized placebo-controlled trial called "Evaluating Adverse Events in a Global Smoking Cessation Study" (EAGLES, NCT01456936) 8,9 . EAGLES was designed to test the relative neuropsychiatric risks and efficacy of varenicline and bupropion to those of nicotine replacement therapy (NRT) and placebo; a total of N=8144 smokers (>=10 cigarettes per day, CPD) with and without psychiatric disorders were enrolled 9 .…”

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

“…Initial analyses demonstrated no significant increase in neuropsychiatric adverse events due to varenicline or bupropion compared to NRT or placebo, or across diagnostic cohorts; greatest effectiveness was observed with varenicline, and with bupropion and NRT versus placebo. In analyses of data from N=4109 US EAGLES participants (25.9% Black and 74.1% White) 8 , Nollen et al examined treatment group, psychiatric cohort, and race stratified groups for association with abstinence, then examined 41 participant and trial characteristics for association with race and with abstinence, and constructed a best joint model of abstinence. They observed reduced abstinence over all treatments and diagnostic cohorts in Black participants when compared to White participants (OR=0.53 (0.41-0.69) P<.001).…”

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

“…From 19 participant and trial characteristics associated with both race and abstinence, the final abstinence model retained six baseline variables (age, race, anxiety, Fagerström Test for Nicotine Dependence (FTND), CPD, and lifetime quit attempts) and three trial variables (study drug discontinuation, depression score change and emergent adverse events). These analyses have provided evidence that the social construct of race, and demographic, psychometric, smoking, socioeconomic and treatment measures are associated with cessation disparities 8,9 .…”

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

“…The primary outcome was continuous abstinence CPD, and lifetime quit attempts) and three trial variables (study drug discontinuation, depression score change and emergent adverse events). These analyses have provided evidence that the social construct of race, and demographic, psychometric, smoking, socioeconomic and treatment measures are associated with cessation disparities 8,9 .…”

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Smoking, race, ancestry and prospective abstinence

Bergen

Ervin

McMahan

et al. 2021

Preprint

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Background: Factors influencing cessation include biopsychosocial characteristics, treatments and responses to treatment. The first cessation trial designed to assess cessation disparities between African American and White cigarette smokers demonstrated that socioeconomic, treatment, psychosocial and smoking characteristics explained cessation disparities. Ongoing translational efforts in precision cessation treatment grounded in genetically informed biomarkers have identified cessation differences by genotype, metabolism, ancestry and treatment. Methods: In planned analyses, we evaluated six smoking-related measures, demographic and socioeconomic covariates, and prospective abstinence (7-day point prevalence at 12 weeks with bupropion, nicotine replacement and counseling treatments). We assessed concurrent and predictive validity in two covariate models differing by inclusion of Office of Management and Budget (OMB) race/ethnicity or genomic ancestry. Results: We studied Pharmacogenetic Study participants (N=456, mean age 49.5 years, 41.5% female, 7.4% African American, 9.4% Multiracial, 6.5% Other, and 6.7% Hispanic). Cigarettes per day (OR=0.95, P<.001), Fagerström score (OR=0.89, P≤.014), Time-To-First-Cigarette (OR=0.75, P≤.005) and predicted urinary nicotine metabolite ratio (OR=0.57, P≤.039) were associated with abstinence. OMB African American race (ORs from 0.31 and 0.35, p-values≤.007) and African genomic ancestry (ORs from 0.21 and 0.26, p-values≤.004) were associated in all abstinence models. Conclusions: Four smoking-related measures exhibited association with abstinence, including predicted nicotine metabolism based on a novel genomic model. African genomic ancestry was independently associated with reduced abstinence. Treatment research that includes social, psychological, treatment and biological factors is needed to reduce cessation disparities.

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Section: Omb Race and Abstinencementioning

confidence: 90%

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

Section: (Which Was Not Certified By Peer Review) Preprintmentioning

confidence: 99%

mentioning

confidence: 99%

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Smoking, race, ancestry and prospective abstinence

Bergen

Ervin

McMahan

et al. 2021

Preprint

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Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation

Baker

Piper

Smith

et al. 2021

JAMA

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IMPORTANCE Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness.OBJECTIVE To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).DESIGN, SETTINGS, AND PARTICIPANTS Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized.INTERVENTIONS All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). MAIN OUTCOMES AND MEASURESThe primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. RESULTS Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, −0.4% [95% CI, −5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, −4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.CONCLUSIONS AND RELEVANCE Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.

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Trends in Prevalence of Cigarette Smoking Among US Adults With Major Depression or Substance Use Disorders, 2006-2019

Han

Volkow

Blanco

et al. 2022

JAMA

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IMPORTANCE Tobacco use is highly concentrated in persons with mental illness.OBJECTIVES To assess trends in past-month prevalence of cigarette smoking among adults with vs without past-year depression, substance use disorders (SUDs), or both, using nationally representative data. DESIGN, SETTING, AND PARTICIPANTS Exploratory, serial, cross-sectional study based on data from 558 960 individuals aged 18 years or older who participated in the 2006-2019 US National Surveys on Drug Use and Health. EXPOSURE Past-year major depressive episode (MDE) and SUD using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. MAIN OUTCOMES AND MEASURES Past-month self-reported cigarette use, adjusted for sociodemographic characteristics. RESULTSOf the sampled 558 960 adults, 41.4% (unweighted) were aged 18 to 25 years, 29.8% (unweighted) were aged 26 to 49 years, and 53.4% (unweighted) were women. From 2006 to 2019, the past-month self-reported cigarette smoking prevalence declined significantly among adults with MDE from 37.3% to 24.2% for an average annual percent change of −3.2 (95% CI, −3.5 to −2.8; P < .001), adults with SUD from 46.5% to 35.8% for an average annual percent change of −1.7 (95% CI, −2.8 to −0.6; P = .002), and adults with co-occurring MDE and SUD from 50.7% to 37.0% for an annual average annual percent change of −2.1 (95% CI, −3.1 to −1.2; P < .001). The prevalence declined significantly for each examined age, sex, and racial and ethnic subgroup with MDE and with SUD (all P < .05), except for no significant changes in American Indian or Alaska Native adults with MDE (P = .98) or with SUD (P = .46). Differences in prevalence of cigarette smoking between adults with vs without MDE declined significantly for adults overall from 11.5% to 6.6%, for an average annual percent change of −3.4 (95% CI, −4.1 to −2.7; P < .001); significant average annual percent change declines were also seen for men (−5.1 [95% CI, −7.2 to −2.9]; P < .001); for women (−2.7 [95% CI, −3.9 to −1.5]; P < .001); for those aged 18 through 25 years (−5.2 [95% CI, −7.6 to −2.8]; P < .001); for those aged 50 years or older (−4.7 [95% CI, −8.0 to −1.2]; P = .01); for Hispanic individuals (−4.4 [95% CI, −8.0 to −0.5]; P = .03), and for White individuals (−3.6 [95% CI, −4.5 to −2.7]; P < .001). For American Indian or Alaska Native adults, prevalence did not significantly differ between those with vs without MDE during 2006-2012 but was significantly higher for those with MDE during 2013-2019 (difference, 11.3%; 95% CI, 0.9 to 21.7; P = .04). Differences among those with vs without SUD declined for women for an average annual percent change of −1.8 (95% CI, −2.8 to −0.9; P = .001). CONCLUSIONS AND RELEVANCEIn this exploratory, serial, cross-sectional study, there were significant reductions in the prevalence of self-reported cigarette smoking among US adults with major depressive episode, substance use disorder, or both, between 2006 and 2019. However, continued efforts are needed to reduce the prevalence fur...

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Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation

Cited by 34 publications

References 93 publications

Smoking, race, ancestry and prospective abstinence

Smoking, race, ancestry and prospective abstinence

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation

Trends in Prevalence of Cigarette Smoking Among US Adults With Major Depression or Substance Use Disorders, 2006-2019

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