Pennington Biomedical Research Center Baton Rouge, LA, USA.
Obesity (Silver Spring). 2013 May;21(5):893-9. doi: 10.1002/oby.20394.
Obesity is a public health problem, which increases the risk of chronic diseases and mortality. Weight loss can reduce mortality and improve most of the detrimental health consequences of obesity.
This paper was developed from two presentations to the US Food and Drug Administration (FDA), which has responsibility for reviewing and approving drugs to treat obesity.
A weight loss of 5% or more is sufficient to significantly reduce health risks in individuals with impaired glucose tolerance, hypertension, or nonalcoholic fatty liver disease. Slightly more weight loss (16% on average, achieved by surgery) reduces mortality. The goal of medicating for obesity is to help more patients achieve more weight loss. A barrier to drug approval has been the concern that weight loss medications might be used by individuals with little or no health risks, thus mandating a low side effect profile for approval of any drug. This limits the options for patients who have obesity-related health problems that could improve with weight loss. Recently the FDA signaled interest in identifying health benefits in higher risk patients that might justify medications with higher risk; however, the potential impact on a large segment of the population has led the FDA to consider requiring a cardiovascular outcome trial for all obesity medications, either prior to or after approval.
This review argues that drugs are needed for obesity because they enhance behaviorally induced weight loss and that new medications for obesity are needed in the approval process.
肥胖是一个公共健康问题，它增加了患慢性病和死亡的风险。减肥可以降低死亡率，并改善肥胖对大多数健康的不利影响。
本文源自向美国食品和药物管理局（FDA）提交的两份报告，该机构负责审查和批准治疗肥胖症的药物。
体重减轻 5%或更多足以显著降低糖耐量受损、高血压或非酒精性脂肪肝患者的健康风险。稍多的体重减轻（平均 16%，通过手术实现）可降低死亡率。肥胖症药物治疗的目标是帮助更多患者实现更多的体重减轻。药物批准的一个障碍是担心减肥药可能被健康风险低或没有健康风险的人使用，因此批准任何药物的副作用谱都很低。这限制了那些有肥胖相关健康问题的患者的选择，这些问题可以通过减肥得到改善。最近，FDA 表示有兴趣在高风险患者中确定健康益处，这些益处可能证明具有更高风险的药物是合理的；然而，药物对人口中很大一部分人的潜在影响导致 FDA 考虑要求所有肥胖药物在批准前或批准后进行心血管结局试验。
本文认为，肥胖症需要药物治疗，因为它们可以促进行为诱导的体重减轻，而且在批准过程中需要新的肥胖症药物。
