新的2型糖尿病治疗的Victoza进入市场
预计后几个月,Victoza的,诺和诺德每日一次的GLP-1类似物(类似的Byetta),被批准于2010年1月25日,在美国销售。FDA okayed药物两个用作附加治疗二甲双胍,磺脲类(如格列美脲),噻唑烷二酮和(艾可拓和迪雅),以及为那些谁不能够容忍磺脲类或二甲双胍单药。第一个“下一代” GLP-1类似物(下在线艾塞那肽每周一次或EQW是弥补本月晚些时候批准),Victoza的在集体讲一个有前途的模式 - 降低糖化血红蛋白约1%,除on average, it prompts weight loss of 5-7 pounds (unlike the weight gain seen with sulfonylureas, thiazolidinediones, and insulin), isn’t associated with hypoglycemia, requires a very thin needle gauge, is dosed only once-a-day, and can be taken at any time of day. While studies show less nausea than for Byetta, still about 43% of patients taking the drug did experience some nausea - that said, you can see clever ways around this, such as卡罗尔国王尖端的服用睡觉前右,避免感觉。
However, while approval spells safe to use, the product will carry a “black-box” warning, FDA’s method for cautioning against potentially serious side effects – in Victoza’s case, medullary thyroid carcinoma, or MTC (a very rare cancer of specific cells within the thyroid gland called C-cells). While signals for MTC still have never been seen in humans, the drug will not be recommended in those with a personal or family history of MTC or multiple endocrine neoplasia syndrome type 2, a rare genetic disorder that predisposes individuals to MTC. Due to the warning, various post-approval studies will be required of Novo Nordisk, including a 15-year cancer registry, a long term risk-evaluation study, and further preclinical studies - this is in addition to a cardiovascular safety study. And that may be a good thing, as it means Victoza could have lots of supportive safety data in the long run. Overall, we found the FDA’s response very positive – in its approval, the agency stressed the importance of getting drugs on the market that reduced the long-term complications associated with diabetes, and we definitely see Victoza as a step in the right direction (leaders of the FDA said as much in a recent article in the prestigious新英格兰医学杂志).目前,全美90%的药店都能买到这种药物——关于个人使用Victoza的经验,请参见试驾在这个问题上倾居,如果你的当前治疗不适合您,想询问您的医生约GLP-1。--LR