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继日本中央社会保险医疗委员会批准了Victoza®(利拉鲁肽)的定价之后,诺和诺德制药公司计划将尽快在当地市场推出这种产品。诺和诺德表示,Victoza®是首个在日本获准上市的GLP-1类药物,既可以单独用药,也可以作为辅助药物与磺脲类降糖药(SU)联用。
2型糖尿病患者使用新一代GLP-1制剂Liraglutide的研究
诺和诺德公司研发的长效GLP-1制剂Liraglutide(利拉鲁肽)正在接受相关机构审查。作为新一代天然GLP-1的类似物的代表之一,它与蛋白非共价性结合,增加了代谢的稳定性,延长其半衰期长达12~14小时,仅需每日皮下注射1次。
长达一年的临床试验结果表明,Liraglutide能够改善胰腺B细胞功能,对空腹和餐后血糖控制均有良好疗效。无论是单用还是与其他口服药物合用,对HbA1c的降幅达1.5%;Liraglutide还能减轻体重、降低血压(收缩压为主)。
【Abstract】Liraglutide is a long-acting analog of GLP-1, being developed by Novo Nordisk and currently undergoing regulatory review for the treatment of type 2 diabetes. Upon injection, liraglutide binds non-covalently to albumin, giving it a pharmacokinetic profile suitable for once-daily administration. In clinical trials of up to 1 year duration, liraglutide has been demonstrated to have beneficial effects on islet cell function, leading to improvements in glycemic control. Both fasting and postprandial glucose concentrations are lowered, and are associated with lasting reductions in HbA1c levels. Liraglutide is effective as monotherapy and in combination therapy with oral antidiabetic drugs, and reduces HbA1c by up to approximately 1.5% from baseline (8.2%-8.4%). Because of the glucose-dependency of its action, there is a low incidence of hypoglycemia. Liraglutide is associated with body weight loss, and reductions in systolic blood pressure have been observed throughout the clinical trials. The most common adverse events reported with liraglutide are gastrointestinal (nausea, vomiting and diarrhea). These tend to be most pronounced during the initial period of therapy and decline with time. Further clinical experience with liraglutide will reveal its long-term durability, safety and efficacy.
编辑: helen