ST LOUIS (MD Consult) - On October 30, 2009, Eli Lilly announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Byetta (exenatide) injection. Byetta is now approved for use as monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously, the drug was approved for use only as part of combination therapy for patients with type 2 diabetes whose glycemic-control goals went unmet despite the use of other common medications.
The approval of Byetta as a monotherapy treatment was granted on the basis of results from a study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. The results showed that patients treated with 5 µg or 10 µg of Byetta as monotherapy underwent reductions in their hemoglobin A1c measurements by 0.7 percentage points and 0.9 percentage points, respectively, and lost 6.0 lbs and 6.4 lbs, respectively. The results of this study were published in the August 2008 issue of Clinical Therapeutics.
In the clinical study, nausea was reported with the greatest incidence (5 µg, 3%; 10 µg, 13%) among treatment-emergent adverse events. Hypoglycemia was reported in 5% of patients taking 5 µg and in 4% of patients taking 10 µg of Byetta, though no severe hypoglycemic events were reported.
In addition to the monotherapy indication, the FDA approved changes to the Byetta product label to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions section. This update addresses the alert issued by the FDA in August 2008. The new label also expands upon existing language regarding use of Byetta in patients with renal impairment.
Byetta exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). The actions of GLP-1 in the body lead to improvement in postprandial glucose blood levels through multiple effects that work in concert on the stomach, liver, pancreas, and brain.
Byetta is not indicated for use by persons with type 1 diabetes, nor by persons with diabetic ketoacidosis.
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圣路易(MD Consult) —— 2009年10月30日，Eli Lilly宣布美国食品药品管理局(FDA)已批准扩大Byetta (exenatide)注射剂的适应证。Byetta现已获准用于成年2型糖尿病患者的单药治疗，在饮食控制和运动疗法的基础上进一步改善患者的血糖控制情况。之前，该药仅获准作为联合治疗的一部分，用于那些经其他常用降糖药物治疗后达不到血糖控制目标的2型糖尿病患者。
之所以批准Byetta用于2型糖尿病的单药治疗是基于一项试验结果，该试验是在经单纯饮食控制和运动疗法后血糖控制不佳的2型糖尿病患者中展开的。结果显示，经Byetta 5 µg或10 µg单药治疗后，患者的血红蛋白A1c水平分别下降了0.7%和0.9%，体重分别下降了6.0磅和6.4磅。该试验结果发表于《临床治疗学》(Clinical Therapeutics)2008年8月刊上。
临床试验报告称，在所有治疗引发不良事件中，恶心的发生率最高(5 µg组3%；10 µg组13%)。5 µg组和10 µg组分别有5%和4%的患者出现了低血糖，但没有出现重度低血糖事件。
除了批准Byetta用于单药治疗的适应证外，FDA还批准修改Byetta的产品标签，补充更新后的安全性信息包括在警告与注意事项部分增加有关胰腺炎的文字说明。这次更新解答了FDA 2008年8月提出的警示信息。新的产品标签还进一步补充了有关Byetta用于肾功能不全患者的文字说明。
Byetta表现出来的许多效应都与人肠降血糖素胰高血糖素样肽-1(GLP-1)的作用相似。在体内，GLP-1可作用于胃、肝脏、胰腺和大脑而发挥多重效应，进而改善餐后血糖水平。
Byetta不适用于1型糖尿病或糖尿病酮症酸中毒患者。
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