Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial
| Autor: | Neal L. Benowitz, Michael Gaffney, Thomas McRae, Robert West, Alok Krishen, A. Eden Evins, David Lawrence, Cristina Russ, Robert M. Anthenelli, Lisa St Aubin |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Internationality medicine.medical_treatment 01 natural sciences Cohort Studies Substance Misuse chemistry.chemical_compound 0302 clinical medicine Psychiatric history 030212 general & internal medicine Prospective Studies Varenicline Suicidal ideation Smoking Cessation Agents Mental Disorders Absolute risk reduction Middle Aged Serious Mental Illness Tobacco Use Cessation Devices Substance abuse varenicline Mental Health 6.1 Pharmaceuticals neuropsychiatric adverse event Anxiety Female Patient Safety medicine.symptom Adult medicine.medical_specialty Nicotine patch Clinical Trials and Supportive Activities Clinical Sciences smoking cessation medication Article 03 medical and health sciences Double-Blind Method Clinical Research Predictive Value of Tests Internal medicine General & Internal Medicine Behavioral and Social Science Tobacco Internal Medicine medicine Tobacco Smoking Humans 0101 mathematics Bupropion Tobacco Smoke and Health business.industry Prevention 010102 general mathematics Evaluation of treatments and therapeutic interventions medicine.disease Brain Disorders Good Health and Well Being predictors chemistry Smoking cessation Smoking Cessation Drug Abuse (NIDA only) business |
| Zdroj: | Journal of general internal medicine, vol 34, iss 6 J Gen Intern Med |
| Popis: | BACKGROUND: Pre-treatment factors that increase smokers’ risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown. OBJECTIVE: To identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES. DESIGN: A prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial. PARTICIPANTS: Smokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders. INTERVENTIONS: Bupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up. MAIN MEASURES: Primary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression. KEY RESULTS: The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study. CONCLUSIONS: Irrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01456936 |
| Databáze: | OpenAIRE |
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