Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
J Pharm Pharm Sci. 2012;15(1):1-30. doi: 10.18433/j3g883.
Recent investigations in finding new drugs in the treatment of diabetes have led to the discovery of several pathological pathways involved in diabetes. Exenatide a drug with incretin mimetic activity was studied in several in vivo and in vitro as well as human studies. It has shown promising results in controlling metabolic indices in type-2 diabetes and was approved by FDA but still there is an active safety alert on it. In this study we aimed to meta-analyze all placebo-controlled clinical trials on the efficacy or tolerability of exenatide in type 2 diabetes. The literature search provided 1016 articles while only 14 articles were eligible to be included in the meta-analysis with a total of 2583 patients enrolled in the study. According to the wide variation in design of various studies, the study duration of 16 weeks and less or more and dose (5 μg bid versus 10 μg bid) were considered and analyzed. The results of this meta-analysis show that exenatide decreases fasting plasma glucose and HbA1C significantly regardless of dose and study duration. The effect of exenatide on weight reduction was more prominent at the dose of 10 μg bid regardless of the study duration, however at the dose of 5 μg bid, significant results were observed after drug administration for more than 16 weeks. Exenatide usage decreased serum triglycerides indifferent to dose and study duration while its effect on cholesterol was not prominent. Along with these impacts, exenatide changed LDL and HDL cholesterol at the lower dose. The hemodynamic effect of exenatide was observed as significant decrements in systolic and diastolic blood pressure at the higher dose. The risk of nausea, vomiting and hypoglycemia was significant and indifferent to dose while headache and nasopharyngaitis were seen more at lower dose. It is concluded that exenatide can be considered as a good hypoglycemic agent in type-2 diabetic patients with benefits on lipid profile and blood pressure with partially questionable tolerability.
最近在寻找治疗糖尿病的新药方面的研究导致发现了几种与糖尿病有关的病理途径。Exenatide 是一种具有肠降血糖素模拟活性的药物，已在体内、体外和人体研究中进行了研究。它在控制 2 型糖尿病的代谢指标方面显示出了有希望的结果，并已获得 FDA 的批准，但仍对其有积极的安全性警告。在这项研究中，我们旨在对 exenatide 在 2 型糖尿病中的疗效或耐受性的所有安慰剂对照临床试验进行荟萃分析。文献检索提供了 1016 篇文章，但只有 14 篇文章符合纳入荟萃分析的标准，共有 2583 名患者纳入研究。由于各种研究设计的差异很大，研究持续时间为 16 周及以下或更长时间，以及剂量（5 μg bid 与 10 μg bid）被考虑并进行了分析。这项荟萃分析的结果表明，exenatide 可显著降低空腹血糖和 HbA1C，无论剂量和研究持续时间如何。exenatide 对体重减轻的影响在 10 μg bid 剂量时更为明显，无论研究持续时间如何，但在 5 μg bid 剂量时，在给药超过 16 周后观察到显著效果。exenatide 降低血清甘油三酯的作用与剂量和研究持续时间无关，但其对胆固醇的影响不明显。除了这些影响外，exenatide 在较低剂量时改变了 LDL 和 HDL 胆固醇。exenatide 的血液动力学效应表现为在较高剂量时收缩压和舒张压显著降低。恶心、呕吐和低血糖的风险是显著的，与剂量无关，而头痛和鼻咽炎则在较低剂量时更为常见。结论是，exenatide 可被视为 2 型糖尿病患者的一种良好的降糖药物，对血脂谱和血压有益，但其耐受性部分存在疑问。
