University of Florida College of Pharmacy, Gainesville, FL, USA.
Clin Ther. 2013 Jan;35(1):A3-17. doi: 10.1016/j.clinthera.2012.12.012.
Type 2 diabetes, dyslipidemia, and obesity continue to be common disorders that many clinicians and patients struggle to control. There are likely numerous reasons for poor control of these diseases, including medication efficacy and adverse effects, access to medications and health care, poor adherence, and lack of lifestyle changes by patients. Several new and emerging medications may help resolve these issues.
The goal of this article is to review new and emerging medications for type 2 diabetes mellitus, dyslipidemia, and obesity.
The Food and Drug Administration drug approval list for 2011 and 2012 was searched to identify newly approved drugs for type 2 diabetes, dyslipidemia, and obesity. New drug entities or existing drug entities with a new indication were included. To identify emerging therapies, we performed targeted searches on clinicaltrials.gov using the listed disease states and Phase III studies. PubMed was searched with these drug names to identify clinical trials for inclusion in this review. Preclinical trials and non-English-language publications were excluded, as were trials not evaluating the efficacy of these agents. The websites goodRx.com and rxpriceverify.com were used to identify pricing.
For type 2 diabetes, exenatide extended-release causes fewer adverse effects and better efficacy than the daily exenatide formulation. The new sodium-glucose cotransporter 2 inhibitor drug class has a unique mechanism of action, hemoglobin A(1c) reductions near 1%, and seemingly few adverse effects. With respect to dyslipidemia, icosapent ethyl effectively lowers triglyceride levels by ∼20% to 45% (depending on baseline triglyceride level), with little effect on LDL-C. For treatment of obesity, lorcaserin is a novel anorexic agent that results in an ∼5.5-kg mean weight loss, and phentermine-topiramate controlled-release reduces weight by ~12.2 kg.
Although these agents certainly add to our armamentarium, none appear to offer significant advantages over currently available options. High costs will likely prevent these novel agents from being used as first-line agents in most patients. Further studies will help to more clearly define their roles in therapy.
2 型糖尿病、血脂异常和肥胖仍然是许多临床医生和患者难以控制的常见疾病。这些疾病控制不佳的原因可能有很多，包括药物的疗效和不良反应、药物和医疗保健的可及性、患者的依从性差以及缺乏生活方式的改变。一些新出现的药物可能有助于解决这些问题。
本文旨在综述 2 型糖尿病、血脂异常和肥胖的新型和新兴药物。
搜索了 2011 年和 2012 年美国食品和药物管理局的药物批准清单，以确定新批准用于 2 型糖尿病、血脂异常和肥胖的药物。包括新的药物实体或具有新适应症的现有药物实体。为了确定新兴疗法，我们在 clinicaltrials.gov 上针对列出的疾病状态和 III 期研究进行了有针对性的搜索。使用这些药物名称在 PubMed 上搜索，以确定纳入本综述的临床试验。排除了临床前试验和非英语语言出版物，以及未评估这些药物疗效的试验。还使用了 goodRx.com 和 rxpriceverify.com 网站来确定价格。
对于 2 型糖尿病，艾塞那肽延长释放制剂比每日艾塞那肽制剂引起的不良反应更少，疗效更好。新型钠-葡萄糖协同转运蛋白 2 抑制剂类药物具有独特的作用机制，血红蛋白 A1c 降低近 1%，不良反应似乎很少。关于血脂异常，icosapent ethyl 可有效降低甘油三酯水平 20%至 45%（取决于基线甘油三酯水平），对 LDL-C 影响较小。对于肥胖的治疗，lorcaserin 是一种新型的厌食药，可使体重平均减轻约 5.5kg，而 phentermine-topiramate 控释剂可使体重减轻约 12.2kg。
尽管这些药物无疑增加了我们的治疗手段，但与目前可用的药物相比，它们似乎都没有明显的优势。高昂的价格可能会阻止这些新型药物成为大多数患者的一线治疗药物。进一步的研究将有助于更清楚地确定它们在治疗中的作用。
