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1.
Nat Rev Endocrinol ; 15(6): 366-374, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30842650

RESUMO

Five years ago, an ambitious collaboration, the Consortium Linking Academic and Regulatory Insights on Toxicity of BPA (CLARITY-BPA; henceforth CLARITY), was launched by three US agencies. The goal was to provide a definitive evaluation of bisphenol A (BPA) and explain disparities between traditional regulatory studies and findings from independent investigators. BPA or vehicle-treated rats from an FDA facility were used in a guideline study and animals and/or tissues were provided to academic researchers for analysis. An interim summary released in February 2018 by the FDA concluded that currently authorized uses of BPA continue to be safe. We disagree. In this Perspectives, we summarize the goals, design and problems of CLARITY. We conclude that, despite its flaws, CLARITY provides important insight and, taken together, the data provide compelling evidence that low-dose BPA exposure induces marked adverse effects. Indeed, the greatest number of effects were observed at doses 20,000 times lower than the current 'safe' dose of BPA for humans.


Assuntos
Disruptores Endócrinos/toxicidade , Testes de Toxicidade/métodos , United States Food and Drug Administration/legislação & jurisprudência , Animais , Compostos Benzidrílicos/toxicidade , Avaliação Pré-Clínica de Medicamentos/métodos , Avaliação Pré-Clínica de Medicamentos/tendências , Humanos , Fenóis/toxicidade , Testes de Toxicidade/tendências , Estados Unidos , United States Food and Drug Administration/tendências
3.
Reg Anesth Pain Med ; 44(1): 100-106, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30640660

RESUMO

BACKGROUND AND OBJECTIVES: Dorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality. METHODS: We queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named 'Dorsal root ganglion stimulator for pain relief' reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections. RESULTS: We identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and 'other' complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively. CONCLUSIONS: The 'Dorsal root ganglion stimulator for pain relief' device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.


Assuntos
Bases de Dados Factuais , Gânglios Espinais , Manejo da Dor/métodos , Estimulação da Medula Espinal/métodos , United States Food and Drug Administration , Bases de Dados Factuais/tendências , Migração de Corpo Estranho/diagnóstico , Migração de Corpo Estranho/etiologia , Gânglios Espinais/fisiologia , Humanos , Dor/diagnóstico , Dor/etiologia , Manejo da Dor/efeitos adversos , Estudos Retrospectivos , Estimulação da Medula Espinal/efeitos adversos , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
4.
Clin Pharmacol Ther ; 105(1): 92-100, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30415479

RESUMO

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the US Food and Drug Administration (FDA) had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations for reform.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas/métodos , Indústria Farmacêutica/métodos , United States Food and Drug Administration , Medicamentos Biossimilares/química , Indústria Farmacêutica/tendências , Humanos , Medicamentos sob Prescrição/química , Medicamentos sob Prescrição/uso terapêutico , Estados Unidos , United States Food and Drug Administration/tendências
8.
Drug Saf ; 41(12): 1397-1410, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30167992

RESUMO

INTRODUCTION: Adverse drug reactions (ADRs) are associated with significant health-related and financial burden, and multiple sources are currently utilized to actively discover them. Social media has been proposed as a potential resource for monitoring ADRs, but drug-specific analytical studies comparing social media with other sources are scarce. OBJECTIVES: Our objective was to develop methods to compare ADRs mentioned in social media with those in traditional sources: the US FDA Adverse Event Reporting System (FAERS), drug information databases (DIDs), and systematic reviews. METHODS: A total of 10,188 tweets mentioning adalimumab collected between June 2014 and August 2016 were included. ADRs in the corpus were extracted semi-automatically and manually mapped to standardized concepts in the Unified Medical Language System. ADRs were grouped into 16 biologic categories for comparisons. Frequencies, relative frequencies, disproportionality analyses, and rank ordering were used as metrics. RESULTS: There was moderate agreement between ADRs in social media and traditional sources. "Local and injection site reactions" was the top ADR in Twitter, DIDs, and systematic reviews by frequency, ranked frequency, and index ranking. The next highest ADR in Twitter-fatigue-ranked fifth and seventh in FAERS and DIDs. CONCLUSION: Social media posts often express mild and symptomatic ADRs, but rates are measured differently in scientific sources. ADRs in FAERS are reported as absolute numbers, in DIDs as percentages, and in systematic reviews as percentages, risk ratios, or other metrics, which makes comparisons challenging; however, overlap is substantial. Social media analysis facilitates open-ended investigation of patient perspectives and may reveal concepts (e.g. anxiety) not available in traditional sources.


Assuntos
Adalimumab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Bases de Dados de Produtos Farmacêuticos/normas , Estudo de Prova de Conceito , Mídias Sociais/normas , United States Food and Drug Administration/normas , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Anti-Inflamatórios/efeitos adversos , Bases de Dados de Produtos Farmacêuticos/tendências , Humanos , Mídias Sociais/tendências , Revisão Sistemática como Assunto , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
9.
PLoS Negl Trop Dis ; 12(8): e0006695, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30092022

RESUMO

Congress created the tropical disease priority review voucher program to stimulate new drug development for tropical diseases. An analysis of the pharmaceutical pipeline indicates that the development of drugs for these tropical diseases has increased. However, the effects of the program are not uniform across all diseases, as malaria and tuberculosis have seen significant new drug development, while other diseases have not.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Descoberta de Drogas/legislação & jurisprudência , Descoberta de Drogas/tendências , Indústria Farmacêutica/tendências , Medicina Tropical , United States Food and Drug Administration/legislação & jurisprudência , Humanos , Estados Unidos , United States Food and Drug Administration/tendências
10.
Curr Opin Crit Care ; 24(5): 379-384, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30156568

RESUMO

PURPOSE OF REVIEW: Regulatory guidance for design, conduct and analysis of studies of nosocomial pneumonia, including ventilator-associated pneumonia, has undergone substantial evolution over the past three decades. This review summarizes this evolutionary process and the current status of guidance. RECENT FINDINGS: The US Food and Drug Administration and the European Medicines Agency have taken different approaches to defining endpoints for studies of nosocomial pneumonia, especially with regard to the primary endpoint. Both agencies accept a noninferiority design. Independent efforts to develop new endpoints and bridge existing discordances have been fruitful. SUMMARY: Transatlantic differences in the approach to study of nosocomial pneumonia complicate study design and analysis, but they will hopefully be resolved in future iterations of regulatory agency guidance.


Assuntos
Pneumonia Associada a Assistência à Saúde , United States Food and Drug Administration/estatística & dados numéricos , Análise de Variância , Europa (Continente) , Pneumonia Associada a Assistência à Saúde/diagnóstico , Pneumonia Associada a Assistência à Saúde/prevenção & controle , Humanos , Guias de Prática Clínica como Assunto , Estados Unidos , United States Food and Drug Administration/tendências
11.
Nicotine Tob Res ; 20(8): 940-948, 2018 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-29986104

RESUMO

Introduction: In 2011 the US Food and Drug Administration launched the Population Assessment of Tobacco and Health (PATH) Study to gather information for regulatory activities authorized by the Family Smoking Prevention and Tobacco Control Act (TCA). Methods: Data were drawn from the first wave of the PATH survey, involving interviews of 32 320 civilian and non-institutionalized adults. In addition to conventional classifications for current, former and never smoking and e-cigarette use, we used PATH questions to classify former and current triers of these products. Descriptive statistics were used to describe the prevalence, patterns of, and reasons for e-cigarette use, and the perceptions of nicotine and e-cigarettes among user groups, according to smoking status. Results: The prevalence of current smoking was 18%; an additional 3.1% of participants were current triers. The prevalence of current e-cigarette use was 2.4% (1.0% every day, 1.4% some days), with another 3.2% as current triers. The majority of nonsmokers who were current e-cigarette users were already current (56%) or former (34%) cigarette triers. Reasons for e-cigarette use were similar across subgroups, but patterns of use were different. Majorities of participants believed that nicotine is the main substance driving tobacco use, that nicotine causes most cancers, and that e-cigarettes were less harmful than cigarettes. Conclusions: E-cigarettes were used primarily by current smokers and recent former smokers. The main reasons for use center around perceptions that e-cigarettes are less harmful than cigarettes to users and others. Implications: This study reports detailed information about the prevalence, patterns of, and reasons for e-cigarette use in the first (baseline) wave of the PATH Study in 2014. In addition to conventional categories for current, former and never smoking and e-cigarette use, the PATH questionnaire facilitated classification of new usage groups consisting of current and former triers of these products, which may impact prevalence estimates.


Assuntos
Inquéritos Epidemiológicos/tendências , Vigilância da População , Vaping/epidemiologia , Vaping/tendências , Adulto , Fumar Cigarros/epidemiologia , Fumar Cigarros/terapia , Fumar Cigarros/tendências , Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Feminino , Inquéritos Epidemiológicos/métodos , Humanos , Masculino , Vigilância da População/métodos , Prevalência , Prevenção do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar/tendências , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências , Vaping/terapia , Adulto Jovem
12.
J Manag Care Spec Pharm ; 24(7): 682-690, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29952714

RESUMO

BACKGROUND: Data on adverse drug events (ADEs) observed at the population level provide important evidence regarding the safety of a pharmaceutical product in real-world settings. Recent patterns in serious and fatal ADE reporting have not been documented. OBJECTIVE: To assess recent patterns in serious and fatal ADE reports in the United States. METHODS: We conducted a retrospective analysis of the publicly available 2006-2014 FDA Adverse Event Reporting System database. Non-U.S. reports, reports from clinical trials, and reports with missing outcome data were excluded. The annual numbers of ADEs with reported outcome of death, disability, and other serious outcomes were determined. Types (direct, manufacturer expedited, or manufacturer periodic) and sources (consumer, health professional, or other) of these serious ADE reports were also identified. The distribution of serious ADE reports by patient age groups (< 18, 18-44, 45-64, and ≥ 65 years) was determined. Drugs listed as primary suspects in serious ADEs (death, disability, and other serious outcomes) were identified and ranked. Descriptive statistics were used to characterize the patterns in serious or fatal ADE reporting. RESULTS: From 2006 to 2014, the number of serious ADEs reported to the FDA increased 2-fold. A total of 902,323 serious outcomes were reported over the 9-year study period: 244,408 deaths, 72,141 disabilities, and 585,774 other serious outcomes. The relative percentage of reports of deaths was highest during 2012 (32.4%). The percentage of reports of disability was highest during 2006 (12.1%). Overall, the "other serious outcomes" category accounted for almost 65% of serious ADEs reports. Expedited reports from drug manufacturers were most common (about 72%) of the serious ADEs with available data on report type. Health professionals (47.3%) were the most common source of report followed by consumers (36.1%) and other sources (16.6%). A disproportionately high number of reported ADEs was among patients aged 45-64 years (40%) and ≥ 65 years (32.6%). Antineoplastic drugs were more frequently reported with deaths. Three antidepressant drugs were among the top 10 drugs reported with disability. During 2006-2014, there were 38 drugs with more than 1,000 reports of serious ADEs in a given year: 2 drugs currently withdrawn from the market (rofecoxib and parecoxib), 10 drugs with an FDA risk evaluation and mitigation strategies (REMS) program, 13 biologic or specialty drugs, and 14 others. CONCLUSIONS: An overall increase in the trend of the number of serious ADE reports was observed from 2006 to 2014. Drugs with a REMS program and biologic and specialty drugs were involved in a significant number of reported serious ADEs. Data on reporting patterns can guide surveillance and pharmacoepidemiological studies to understand the public health burden of serious ADEs. DISCLOSURES: No outside funding supported this study. Hansen has received consulting fees from and has provided expert testimony for Daichii Sankyo and Takeda. The other authors have nothing to disclose.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Produtos Biológicos/efeitos adversos , Farmacoepidemiologia/estatística & dados numéricos , Retirada de Medicamento Baseada em Segurança/estatística & dados numéricos , United States Food and Drug Administration/estatística & dados numéricos , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Fatores Etários , Idoso , Humanos , Pessoa de Meia-Idade , Farmacoepidemiologia/tendências , Estudos Retrospectivos , Retirada de Medicamento Baseada em Segurança/tendências , Estados Unidos , United States Food and Drug Administration/tendências , Adulto Jovem
13.
Prev Med ; 113: 153-155, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29866276

RESUMO

In July 2017, the Food and Drug Administration (FDA) announced that it wants to reduce the nicotine in cigarettes to make them less addictive. Also, it is delaying for several years a key regulation affecting cigars and e-cigarettes, including flavored vaping products that tend to appeal to younger consumers. Specifically, it postponed the requirement that such products be approved by the agency. Both actions are part of a comprehensive plan to eventually wean smokers off conventional cigarettes and steer them toward less harmful alternative forms of nicotine. With its new approach to the fight against smoking, the FDA has unquestionably made great strides toward more effectively addressing the prevalence of related deaths and diseases in the U.S. However, much important work must be undertaken before this ultimate goal can be accomplished. For instance, further research into long-term effects of e-cigarettes must be conducted before these products can truly be seen as safer alternatives to combustible cigarettes. Additionally, public education is necessary to inform smokers about the range of tobacco products available and the actual harms associated with their use. Finally, the agency might have to work alongside the powerful tobacco industry to minimize potential legal challenges and to convince businesses that a shift to low-nicotine products and e-cigarettes is best for their future success and for the health of the American citizenry.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Redução do Dano , Produtos do Tabaco/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Comportamento Aditivo , Humanos , Nicotina/análise , Saúde Pública , Prevenção do Hábito de Fumar , Dispositivos para o Abandono do Uso de Tabaco , Estados Unidos , United States Food and Drug Administration/tendências
14.
J Am Assoc Nurse Pract ; 30(6): 312-319, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29878963

RESUMO

BACKGROUND AND PURPOSE: In 2013, the Advisory Committee of the Food and Drug Administration determined hydrocodone combination medications (HCMs) needed tighter regulation due to high abuse potential; they recommended upscheduling HCMs from Schedule III to II. The purpose of this study was to examine the effect of upscheduling of HCMs on pain management practices of advanced practiced registered nurses (APRNs) in Oklahoma. METHODS: In this qualitative study, 25 participants described their primary care experiences after the upscheduling. A thematic analysis was used to understand the effects on APRN pain management practices. CONCLUSIONS: The upscheduling of HCMs has greatly affected the pain management practices of APRNs in a state where Schedule II narcotic prescribing is forbidden. Findings will assist APRNs with improving patient access to care, implementing practice regulations, and exploring options for alternative pain therapies in primary care. IMPLICATIONS FOR PRACTICE: Upscheduling of HCMs has had a severe impact on APRNs, affecting their prescribing practices and leading to increased referrals. They noted limited treatment options, increased health care costs, and decreased access to care. The APRNs understand the problem of prescription opioid abuse, diversion, and misuse. A consensus model could standardize the regulatory process for APRNs, increase interstate mobility for practice, and increase access to APRN care nationwide.


Assuntos
Hidrocodona/classificação , Profissionais de Enfermagem/psicologia , Manejo da Dor/tendências , Padrões de Prática Médica/normas , Prática Avançada de Enfermagem/métodos , Analgésicos Opioides/classificação , Analgésicos Opioides/uso terapêutico , Humanos , Hidrocodona/uso terapêutico , Entrevistas como Assunto/métodos , Profissionais de Enfermagem/legislação & jurisprudência , Profissionais de Enfermagem/normas , Manejo da Dor/métodos , Padrões de Prática Médica/tendências , Pesquisa Qualitativa , Transtornos Relacionados ao Uso de Substâncias/enfermagem , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Estados Unidos , United States Food and Drug Administration/organização & administração , United States Food and Drug Administration/tendências
15.
Drug Discov Today ; 23(8): 1469-1473, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29751111

RESUMO

An overview of drugs approved by the FDA in 2017 reflected a reversion to the mean after a low number of NME approvals in 2016. This reversal was largely driven by the largest number of biologics-based NMEs recorded to date, which offset an average number of small-molecule approvals. Oncology indications continued to dominate followed by novel treatments for infectious, immunologic and neurologic diseases. From a mechanistic standpoint, the industry has continued a trend of target diversification, reflecting advances in scientific understanding of disease processes. Finally, 2017 continued a period of relatively few mergers and acquisitions, which broke a more-than-a-decade-long decline in the number of organizations contributing to research and development.


Assuntos
Aprovação de Drogas , Descoberta de Drogas , United States Food and Drug Administration , Animais , Difusão de Inovações , Descoberta de Drogas/tendências , Humanos , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration/tendências
16.
Ugeskr Laeger ; 180(19)2018 May 07.
Artigo em Dinamarquês | MEDLINE | ID: mdl-29761775

RESUMO

The prestigious journal Biostatistics published in July 2017 six solicited commentaries on the role of the U.S. Food and Drug Administration (FDA), as times change, with ever developing technical tools for clinical trials and their evaluation, with increased focus on personalised medicine (possibly aided by genetic testing), and on patient self-determination. Two were written by American economists, four by leading biostatisticians, mostly from the USA. This paper summarises these texts for a Danish audience.


Assuntos
United States Food and Drug Administration/tendências , Ensaios Clínicos como Assunto , Liberdade , Humanos , Aprendizado de Máquina , Paternalismo , Preferência do Paciente , Medicina de Precisão , Estados Unidos
17.
Drug Saf ; 41(9): 849-857, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29644579

RESUMO

INTRODUCTION: Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. OBJECTIVE: The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. METHODS: We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015. We extracted data on SAEs and mortality from 15 pivotal trials from ClinicalTrials.gov and corresponding journal articles (the two index resources), and FDA medical reviews (reference standard). We estimated the magnitude of deviations in rates of SAEs and mortality between the index resources and the reference standard. RESULTS: We found deviations in rates of SAEs (30% in ClinicalTrials.gov and 30% in corresponding journal articles) and mortality (72% in ClinicalTrials.gov and 53% in corresponding journal articles) when compared with the reference standard. The intra-class correlation coefficient between the three resources was 0.99 (95% confidence interval [CI] 0.98-0.99) for SAE rates and 0.99 (95% CI 0.97-0.99) for mortality rates. CONCLUSION: There are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials.


Assuntos
Ensaios Clínicos como Assunto/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Publicações Periódicas como Assunto/normas , Estatística como Assunto/normas , United States Food and Drug Administration/normas , Ensaios Clínicos como Assunto/métodos , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Mortalidade/tendências , Publicações Periódicas como Assunto/tendências , Estatística como Assunto/métodos , Estatística como Assunto/tendências , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
18.
Clin Drug Investig ; 38(7): 573-577, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29651781

RESUMO

The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route. Despite these and other technologies, consensus regarding the effectiveness of these formulations in preventing non-medical use is lacking given the difficulty in obtaining post-marketing data. Researchers also question if the creation of abuse-deterrent drugs will have a positive effect on those struggling with a severe opioid-use disorder, fearing that current opioid users will simply find a new - perhaps more dangerous - drug of choice. Abuse-deterrent opioids are still opioids, and although they may make manipulation more difficult than non-ADF formulations, they are not "abuse proof." The introduction of ADFs could provide a false sense of security among prescribers and dispensers, and we fear that ADFs may have a minimal impact on non-medical use of prescription opioids. Further epidemiological studies will be required to determine the large-scale impact of abuse-deterrent opioids in preventing opioid use disorder and its downstream consequences.


Assuntos
Formulações de Dissuasão de Abuso/métodos , Analgésicos Opioides/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , United States Food and Drug Administration , Formulações de Dissuasão de Abuso/tendências , Analgésicos Opioides/administração & dosagem , Química Farmacêutica/métodos , Composição de Medicamentos , Humanos , Naltrexona/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
20.
Nicotine Tob Res ; 20(12): 1457-1466, 2018 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-29059423

RESUMO

Introduction: The US cigar market is diverse, yet until recently most research studies and tobacco surveillance systems have not reported behavioral and related outcomes by cigar type. Methods: The 2013-2014 Population Assessment of Tobacco and Health Study collected data separately for filtered cigars (FCs), cigarillos, and traditional cigars, which were further distinguished as premium or nonpremium. Descriptive statistics for adult established current smokers of each cigar type and cigarettes were calculated for demographic characteristics, tobacco use patterns, purchasing behaviors and reasons for use. Adjusted prevalence ratios (APRs) using a marginal predictions approach with logistic regression assessed correlates of dual cigar and cigarette smoking. Results: Age, sex, race/ethnicity, education level, and poverty status of smokers varied according to cigar type. Daily cigar smoking prevalence and number of cigars smoked per day were higher for FCs (37.3%; median: 1.6 cigars/day, respectively), than all other cigar types (6.7%-25.3%, all p < .01; 0.1-0.4 cigars/day, all p < .01, respectively); daily smoking and cigars per day were similar for nonpremium cigars and cigarillos (p = .11; p = .33, respectively). Cigarette smoking was twice as common among smokers of nonpremium cigars, cigarillos, and FCs (58.0%-66.0%) than among premium cigars (29.9%). Among current cigar smokers, FC smokers (APR = 1.23, 95% confidence interval [CI] = 1.09-1.39), other tobacco product users (APR = 1.27, 95% CI = 1.15-1.41), and those with a GED/high school diploma or less (APR = 1.20, 95% CI = 1.09-1.33) were more likely to also smoke cigarettes. Conclusion: User characteristics, cigar smoking patterns, and dual smoking with cigarettes varied by cigar type highlighting the importance of adequately describing the cigar type studied and, where appropriate, differentiating results by cigar type. Implications: Despite the diversity of the cigar market place, historically many research studies and tobacco surveillance systems have treated cigars as a single product type. This study describes similarities and differences in the user characteristics, tobacco use patterns, and purchasing behaviors of premium, nonpremium, cigarillo, and filtered cigar smokers. To enhance tobacco regulatory science, sufficient descriptions of the cigar type(s) studied and, where appropriate, differentiation of the particular cigar type(s) studied should be undertaken to improve the interpretation of study findings, understanding of cigar use patterns and related behaviors and future approaches to reducing cigar-attributable morbidity and mortality.


Assuntos
Fumar Charutos/economia , Fumar Charutos/epidemiologia , Comportamento do Consumidor/economia , Vigilância da População , Produtos do Tabaco/economia , Adolescente , Adulto , Fumar Charutos/psicologia , Estudos de Coortes , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , National Institute on Drug Abuse (U.S.)/economia , National Institute on Drug Abuse (U.S.)/tendências , Vigilância da População/métodos , Fumantes/psicologia , Produtos do Tabaco/classificação , Estados Unidos/epidemiologia , United States Food and Drug Administration/economia , United States Food and Drug Administration/tendências , Adulto Jovem
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