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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。
Liraglutide(利拉鲁肽)安全性、有效性3期临床研究LEAD的6个随机对照研究介绍
Liraglutide Added to Glimepiride (LEAD-1)
Liraglutide added to a sulfonylurea was more effective than a sulfonylurea alone or a sulfonylurea combined with rosiglitazone in the randomized, double-blind, 26-week LEAD-1 study. The efficacy and safety of 3 doses of liraglutide (0.6 mg, 1.2 mg, and 1.8 mg) in combination with glimepiride were compared with glimepiride monotherapy and glimepiride + rosiglitazone combination therapy in 1041 patients with type 2 diabetes. All 3 doses of liraglutide administered in combination with glimepiride resulted in superior glycemic control compared with glimepiride monotherapy (P < 0.0001), and the 1.2- and 1.8-mg liraglutide doses resulted in superior glycemic control compared with the combination of glimepiride and rosiglitazone (P < 0.0001) (Table 2). The percentage of patients reaching HbA1c < 7% was significantly higher in the 1.2- and 1.8-mg liraglutide groups compared with the glimepiride monotherapy group (P < 0.0001) and the glimepiride + rosiglitazone group (P ≤ 0.0003). The greatest increase in body weight was seen in the glimepiride + rosiglitazone group, while a decrease was seen in the liraglutide 1.8-mg group (P < 0.0001). β-cell function, assessed by proinsulin-to-insulin ratio and HOMA-β, significantly increased in the liraglutide 1.2-mg and 1.8-mg groups compared with the glimepiride + rosiglitazone group, and significantly increased in the liraglutide 1.2-mg group compared with the glimepiride monotherapy group. Changes in BP did not significantly differ between groups (Table 2). One major hypoglycemic episode occurred in a patient in the 1.8-mg liraglutide group; the episode was thought to be related to glimepiride. The majority of adverse events were gastrointestinal, and most were mild or moderate.
编辑: helen