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Therapeutic drug monitoring to adjust dosing in morbid obesity – a new use for an old methodology

机译:监测治疗性药物以调整病态肥胖的剂量–旧方法的新用途

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摘要

The phenomena of hunger and need at one end of the spectrum and obesity and plenty on the other is an anomaly of the 21st century, likely to be due to a combination of distributive inequities in food, social justice, access to education and other socio-economic factors. Both are major problems worldwide, although obesity has more media coverage due to the exponentially increasing incidence and the huge social and economic burden this is placing on Western society. For example, prevalence rates of obesity are currently exceeding 30% of adults in the USA with direct morbidity and mortality complications, in addition to the additional obesity-related health problems and death. Obesity is also rising in children. Obese people are thus a sizable group, and as with those with altered renal or liver function, require specific consideration with respect to the appropriate dosing of medications. However guidelines for how to do this in obesity are not currently available, due to the paucity of literature and regulatory rules for new medications which usually only request the demonstration of average population effectiveness. We believe it is timely for regulatory agencies worldwide to mandate studies involving consideration of body size, particularly obesity, in approving new medications across the therapeutic spectrum. This will drive the pharmaceutical industry to consider these groups in studies and will encourage investigator-initiated research using therapeutic drug monitoring (TDM), target concentration therapy (TCI) and pharmacogenetic (PGx) studies to optimize drug dosing.
机译:饥饿和需求的一方面是肥胖,另一方面是大量的饥饿,这是21世纪的反常现象,这很可能是由于粮食分配不公,社会正义,受教育的机会和其他社会经济因素。这两者都是全世界的主要问题,尽管由于发病率呈指数级增长以及这给西方社会带来了巨大的社会和经济负担,肥胖症在媒体上的报道越来越多。例如,肥胖症的患病率目前超过30%,在美国,成年人患有直接的发病率和死亡率并发症,此外还有与肥胖症有关的其他健康问题和死亡。儿童肥胖症也在增加。因此,肥胖人群是相当大的人群,与那些肾或肝功能改变的人群一样,在适当的药物剂量方面需要特别考虑。然而,由于缺乏文献和新药的监管规则,因此目前尚无有关肥胖症治疗方法的指南,这些文献通常只要求证明平均人群的有效性。我们认为,对于全球监管机构而言,在批准整个治疗领域的新药物时,授权研究涉及体型,特别是肥胖症的研究是及时的。这将促使制药行业考虑在研究中考虑这些人群,并鼓励研究人员通过使用治疗药物监测(TDM),目标浓度治疗(TCI)和药物遗传学(PGx)研究来启动研究,以优化药物剂量。

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