PROJECT 2: SHORT-TERM CARDIOVSCULAR EFFECTS OF E-CIGARETTES: INFLUENCE OF DEVICE POWER AND E-LIQUID pH AND HOW E-CIGARETTES COMPARE WITH HEAT-NOT-BURN PRODUCTS

项目 2：电子烟的短期心血管影响：设备功率和电子烟液 pH 值的影响以及电子烟与加热不燃烧产品的比较

• 批准号: 10468883
• 负责人: Gideon St.Helen
• 金额: $ 37.93万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10468883
• 关键词: Acceleration; Acrolein; Acute; Aerosols; Affect; Aldehydes; Area; Atomizer; Behavior; Biological Markers; Blood Circulation; Cardiopulmonary; Cardiovascular Diseases; Cardiovascular system; Characteristics; Cigarette; Communication; Controlled Environment; Cross-Over Studies; Dangerousness; Deposition; Devices; Drug Kinetics; Electronic cigarette; Emerging Tobacco Products; Event; Exposure to; Flavoring; Generations; Goals; Health; Heart Rate; Heating; Hospitals; Human; Inflammatory; Kinetics; Knowledge; Lung; Modified Risk Tobacco Product; Nicotine; Oral cavity; Oxidative Stress; Persons; Pharmacology; Pharmacology Study; Pharyngeal structure; Poison; Power Sources; Process; Reactive Oxygen Species; Regulation; Research; Risk; Risk Factors; Science; Sensory; Smoke; Sympathetic Nervous System; Tobacco; Tobacco Industry; Tobacco smoke; Toxicant exposure; Toxicology; United States Food and Drug Administration; absorption; alkalinity; authority; base; behavioral economics; cardiovascular disorder risk; cardiovascular effects; cardiovascular risk factor; combustible cigarette; e-cigarette aerosols; electronic cigarette use; electronic cigarette user; electronic liquid; heated tobacco products; hemodynamics; human study; particle; thrombogenesis; tobacco products; toxicant; volatile organic compound; ward

PROJECT SUMMARY/ABSTRACT Components and parts of electronic cigarettes (e-cigarettes), such as batteries and e-liquids, are within the Food and Drug Administration's regulatory authority. There are, however, significant gaps in understanding of how specific aspects of these components and parts influence the overall health effects of e-cigarettes, including short-term cardiovascular effects. E-cigarette power is an important determinant of aerosol generation, nicotine delivery, and the type and amount of toxicants generated in e-cigarette aerosols, but the influence of power on these cardiovascular effects has not been described. In addition, the influence of e- cigarette liquid (e-liquid) pH on rate of systemic nicotine absorption, nicotine-induced sympathetic nervous system stimulation, and heart rate increase, a risk factor for cardiovascular disease, is not understood. There is a similar lack of knowledge about the health effects of heat-not-burn (HNB) products, which heat tobacco without combustion. It is expected that HNB products will compete with conventional cigarettes and e- cigarettes. Philip Morris Products S.A. has filed an application with the FDA to market its HNB product, iQOS, as a modified risk tobacco product in the U.S. Differences in the cardiovascular disease risks between e- cigarettes and HNB products are unknown. This project has three specific aims to fill these gaps: (1) Determine the impact of e-cigarette power on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects; (2) Determine the impact of changes in e- liquid pH on nicotine pharmacokinetics, cardiovascular, and subjective effects of e-cigarettes; and (3) Compare differences in nicotine pharmacology, systemic exposure to toxic VOCs, and short-term cardiovascular effects of e-cigarettes to heat-not-burn tobacco products. These aims will be achieved through three within-subject crossover human pharmacology studies, one study for each aim, which will be conducted on a hospital research ward with healthy users of e-cigarettes and/or iQOS. Power and e-liquid pH will be manipulated in aims 1 and 2, respectively, and the endpoints will be markers of cardiovascular disease risk. The third aim will be a within-subject comparison of toxicant exposure and the cardiovascular effects of e-cigarettes compared to iQOS. This study of health effects will contribute to knowledge of the influence of e-cigarette characteristics on their short-term cardiovascular effects, and the cardiovascular effects of e-cigarettes compared to iQOS as part of the UCSF TCORS integrated theme that “understanding combined health effects, behavior, and impact analysis will provide actionable information for regulation of and public communications about current and emerging tobacco products.” These studies will provide the FDA with detailed and specific information on short-term cardiovascular effects of e-cigarettes to inform regulation of e-cigarette power levels and a specific e-liquid characteristic (pH), as well as inform FDA regulation of emerging HNB products.

项目摘要/摘要 电子烟的组件和部分（电子烟）（例如电池和电子液体）在 然而，食品和药物管理局的规律权限在理解方面有很大的差距 这些组件和零件的具体方面如何影响整体健康电子烟， 包含短期心血管效应。 发电，尼古丁的递送以及电子烟气溶胶中产生的毒物的类型和数量，但是你 功率对这些心脉的影响尚未描述。 香烟液体（电子液体）pH值对全身性尼古丁吸收率，尼古丁引起的交感神经 尚不清楚系统刺激和心率增加，这是心血管疾病的危险因素。 关于热燃烧（HNB）产品的健康影响的类似知识，这些烟草的热量烟草 没有燃烧。 香烟。 作为美国在美国的风险烟草产品中的改良风险烟草产品，在E-之间的心血管疾病风险中 香烟和HNB产品尚不清楚。 确定电子烟功率对尼古丁药理学的影响，全身暴露于有毒的挥发性 有机化合物（VOC）和短期心血管效应； 尼古丁药代动力学，心血管和电子烟的主观作用的液体pH值； 尼古丁药理学，全身暴露有毒VOC和短期心血管效应的差异 电子烟的热量燃烧烟草产品。 跨界人类药理学研究，每种目标的一项研究，将在Hosspital上进行 与电子烟和/或IQO的健康使用者一起研究病房。 AIM 1和2，尊重者和终点将是心血管疾病风险的标志。 与电子烟的毒物息肉和电子烟的心血管效应进行比较 iqos。 与IQOS相比 UCSF TCOR的一部分集成了“了解健康效应，行为和 影响分析，提供可行的信息，以进行有关当前的监管和公共通信 和新兴的烟草产品。 电子烟的短期心血管效应，以告知电子烟功率水平的调节和特定 电子液体特征（pH），并告知新兴HNB产品的FDA调节。