酒精使用障碍药物治疗试验的终点。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2024-07-01 Epub Date: 2024-07-05 DOI:10.1007/s40290-024-00526-x
Malia A Belnap, Kaitlin R McManus, Erica N Grodin, Lara A Ray
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引用次数: 0

摘要

酒精使用障碍(AUD)是一种使人衰弱的疾病,但目前已获批准的治疗 AUD 的药物疗法却未得到充分利用。美国食品和药物管理局(FDA)批准用于治疗 AUD 的三种药物是双硫仑、阿坎酸和纳曲酮。目前治疗 AUD 的药物疗法的现状表明还有改进的余地。研究 AUD 新型药物疗法的临床试验传统上使用戒酒结果或无大量饮酒天数作为试验终点,以确定药物疗法的疗效。这些结果通常通过患者对其饮酒情况的自我报告来衡量。除了这些传统的结果外,最近还出现了一些针对 AUD 药物疗法的新型终点。这些新型终点包括利用世界卫生组织(WHO)降低的风险饮酒水平来促进减少危害的终点,而不是基于戒断的终点。此外,与患者自我报告测量相比,酒精使用的生物标记物可作为 AUD 药物疗法试验的客观终点。最后,美国国家酒精滥用和酒精中毒研究所(NIAAA)对 AUD 康复的定义和以患者为导向的结果提供了新的框架,可考虑与酒精消费本身以外的终点相关的因素,如提供者和患者对新型药物疗法的体验。只要能证明终点的有效性和可靠性,这些针对 AUD 药物疗法的新终点的最新进展将为药物疗法的开发提供充满希望的未来机会。更广泛地使用终点可以更好地反映 AUD 症状的复杂性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Endpoints for Pharmacotherapy Trials for Alcohol Use Disorder.

Alcohol use disorder (AUD) is a debilitating disorder, yet currently approved pharmacotherapies to treat AUD are under-utilized. The three medications approved by the US Food and Drug Administration (FDA) for the indication of AUD are disulfiram, acamprosate, and naltrexone. The current landscape of pharmacotherapies for AUD suggests opportunities for improvement. Clinical trials investigating novel pharmacotherapies for AUD traditionally use abstinence-based drinking outcomes or no heavy drinking days as trial endpoints to determine the efficacy of pharmacotherapies. These outcomes are typically measured through patient self-report endorsements of their drinking. Apart from these traditional outcomes, there have been recent developments in novel endpoints for AUD pharmacotherapies. These novel endpoints include utilizing the World Health Organization (WHO) risk drinking level reductions to promote a harm-reduction endpoint rather than an abstinence-based endpoint. Additionally, in contrast to patient self-report measurements, biological markers of alcohol use may serve as objective endpoints in AUD pharmacotherapy trials. Lastly, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) definition of recovery from AUD and patient-oriented outcomes offer new frameworks to consider endpoints associated with more than alcohol consumption itself, such as the provider-patient experiences with novel pharmacotherapies. These recent developments in new endpoints for AUD pharmacotherapies offer promising future opportunities for pharmacotherapy development, so long as validity and reliability measures are demonstrated for the endpoints. A greater breadth of endpoint utilization may better capture the complexity of AUD symptomatology.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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