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Pharmacotherapeutic Options for the Treatment of Patients with Obesity

机译:肥胖症患者的药物治疗选择

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摘要

Objective: To assess the safety and efficacy of FDA-approved and in-development antiobesity agents.Data Sources: Literature was accessed through MEDLINE (1950-current) and EMBASE using the terms anti-obesity agent, diethylpropion, phentermine, orlistat, topiramate, lorcaserin, bupropion, and naltrexone. In addition, reference citations from publications identified were reviewed. Files related to FDA expert panel hearings were retrieved from the FDA website.Study Selection and Data Extraction: Randomized double-blind trials assessing the efficacy and safety of antiobesity agents compared with placebo in the treatment of overweight and obese adults were reviewed. Only English-language or English-translated literature was reviewed. Medications were selected based on FDA approval status.Data Synthesis: Ten double-blind clinical trials were reviewed. There are currently 5 FDA-approved antiobesity agents and 1 agent recently rejected by the FDA. Study results for all agents showed statistically significant weight loss compared with placebo, but with varying adverse effects. The combination of phentermine and topiramate is the most efficacious antiobesity agent approved by the FDA. However, this combination has various neurologic, cardiovascular, and teratogenic safety risks that may limit its use. Based on its safety profile, orlistat is the preferred antiobesity medication, despite the lesser extent to which it induces weight loss versus newer agents. The incidence of unwanted gastrointestinal adverse effects limits its use.Conclusions: Despite a glaring medical need for options to treat obesity, available medications are limited. No current drug option is ideal; each has either safety risks or efficacy concerns. Safe agents that meet FDA efficacy standards are needed to help treat the obesity epidemic.
机译:目的:评估FDA批准的和正在开发的抗肥胖药的安全性和有效性。数据来源:文献通过MEDLINE(1950年至今)和EMBASE使用抗肥胖药,二乙基丙酸,芬特明,奥利司他,托吡酯,氯色林,安非他酮和纳曲酮。此外,还对已鉴定出版物的参考文献进行了审查。从FDA网站检索了与FDA专家小组听证会有关的文件。研究选择和数据提取:评估抗肥胖药与安慰剂相比在超重和肥胖成年人中的疗效和安全性的随机双盲试验。仅审查了英语或英语翻译文学。根据FDA批准状态选择药物。数据综合:审查了十项双盲临床试验。当前有5种FDA批准的抗肥胖药,最近有1种被FDA拒绝。与安慰剂相比,所有药物的研究结果均显示出统计学上显着的体重减轻,但副作用有所不同。芬特明和托吡酯的组合是FDA批准的最有效的减肥药。但是,这种组合具有多种神经,心血管和致畸安全性风险,可能会限制其使用。基于其安全性,奥利司他是首选的抗肥胖药,尽管与新药相比,奥利司他的减肥作用较小。不良胃肠道不良反应的发生限制了它的使用。结论:尽管医学上对肥胖的治疗方案有强烈的需求,但可用药物仍然有限。目前没有药物是理想的选择;每个都有安全风险或功效问题。需要符合FDA功效标准的安全药物来帮助治疗肥胖病。

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