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关于从普通医学/心血管药物转向的研发趋势的评论:美国食品药品监督管理局能否助力扭转这一趋势?

Commentary on R&D Trends Away from General Medicine/Cardiovascular Drugs: Can the FDA Help Reverse the Trend?

作者信息

Meyer R J

机构信息

Virginia Center for Translational and Regulatory Sciences (VCTRS), Charlottesville, Virginia, USA.

出版信息

Clin Pharmacol Ther. 2017 Aug;102(2):186-188. doi: 10.1002/cpt.735. Epub 2017 Jun 21.

DOI:10.1002/cpt.735
PMID:28636269
Abstract

In the latter part of the 20th century, drug development in cardiovascular diseases (CVDs) was a paragon of "modern" therapeutics, bringing about a substantial number of effective, well-tolerated agents targeting some of the most prevalent diseases of the Western world. These drugs were often examples of rational drug development targeting specific pathophysiologic pathways previously elucidated through basic research (e.g., targeting of the renin-angiotensin system or the cholesterol synthesis pathway). The widespread adoption of these ground-breaking medications in practice and into medical guidelines undoubtedly played a role in the fall of morbidity and mortality from CVD in the United States in recent decades. For instance, the combined, age-adjusted rates of death due to heart disease and CVD fell in the United States from an aggregate of 329.6 per 100,000 in 1999 to 203.5 in 2014. Although lifestyle trends (e.g., decreased smoking prevalence) contributed to this decline, the impact of safe and effective medications for common CVD conditions cannot be dismissed. Yet, despite the drop in CVD morbidity and mortality, CVDs remain a leading cause of morbidity and mortality in the United States and, therefore, a large area of unmet medical need.

摘要

在20世纪后半叶,心血管疾病(CVD)的药物研发堪称“现代”治疗学的典范,研发出了大量有效且耐受性良好的药物,针对西方世界一些最常见的疾病。这些药物往往是合理药物研发的典范,针对先前通过基础研究阐明的特定病理生理途径(例如,针对肾素 - 血管紧张素系统或胆固醇合成途径)。这些开创性药物在临床实践中的广泛应用以及被纳入医学指南,无疑在近几十年来美国心血管疾病发病率和死亡率的下降中发挥了作用。例如,美国经年龄调整后的心脏病和心血管疾病合并死亡率从1999年的每10万人329.6例降至2014年的203.5例。尽管生活方式趋势(例如吸烟率下降)促成了这种下降,但用于常见心血管疾病的安全有效药物的影响也不容忽视。然而,尽管心血管疾病的发病率和死亡率有所下降,但心血管疾病在美国仍然是发病和死亡的主要原因,因此,仍存在大量未满足的医疗需求。

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