| 美国食品药品管理局（FDA）近日批准Victoza (liraglutide，利拉鲁肽)注射剂用于部分成年患者2型糖尿病的治疗。Victoza属胰高血糖素样肽1(GLP-1)类似物药物（注射剂，每日注射一次），能够在患者进食后促使其胰腺分泌更多胰岛素，对于没有进行适当的饮食控制和运动的患者，Victoza不被推荐单独用于糖尿病的初期治疗。
FDA药品审评与研究中心新陈代谢与内分泌室主任、医学博士Mary Parks说，“糖尿病是引起死亡和致残的一个主要原因，每年新诊断出的糖尿病患者超过了1500万人。对于预防或控制长期的糖尿病并发症来看，控制血糖水平是非常重要的，Victoza为部分2型糖尿病患者提供了控制血糖水平的备选方案。” Victoza最常见的不良反应包括头痛、恶心和腹泻。其他不良反应包括荨麻疹等过敏样反应。有3900位患者参加的5个临床试验结果显示，使用Victoza的患者发生胰腺炎（胰腺的一种炎症）的可能性要大于使用其他治疗药物的患者。当患者出现严重腹痛，伴随或未伴随恶心、呕吐时，应停止使用Victoza，当确诊为胰腺炎后，不应再次使用Victoza进行治疗。有胰腺炎病史的患者应慎用。动物试验显示，Victoza会引起大鼠和小鼠出现甲状腺瘤。因此，尚不能确认是否会引起人甲状腺瘤或癌，为此，在继续进行研究以证明可以扩大使用之前，Victoza不能作为治疗2型糖尿病的一线药物，也不能用于治疗已患甲状腺髓样癌的患者。 为确保该产品的安全性和有效性，FDA要求生产企业制定包括用药指南与交流计划在内的风险评估与降低计划（EMS），以助患者和医生了解该产品安全性方面的相关信息。
FDA Approves New Treatment for Type 2 DiabetesThe U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults. Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone. Insulin is a hormone that helps prevent sugar (glucose) from building up in the blood. People with type 2 diabetes have difficulty making and using insulin. Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal. "Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels." In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis. The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives. Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product. In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years. In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive. It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2. To ensure the safe and effective use of this product, Victoza was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer. Victoza is manufactured by Novo Nordisk of Bagsvaerd, Denmark. 2010年1月25日美国FDA批准利拉鲁肽(liraglutide)，一种胰高血糖素-样肽-1(GLP-1)受体激动剂在2型糖尿病成年中，可每天用1次改善血糖控制。在仔细权衡几种复杂安全性-相关担忧和获益考虑的基础上批准。 |
