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。
.WARNING: RISK OF THYROID C-CELL TUMORS
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications (4), Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
1 INDICATIONS AND USAGE
Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.1 Important Limitations of UseBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators. Victoza has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza. Use with caution in patients with a history of pancreatitis.
Victoza is not a substitute for insulin. Victoza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
The concurrent use of Victoza and insulin has not been studied.
2 DOSAGE AND ADMINISTRATION Victoza can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment.
For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week. The 0.6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control.