MD Consult：Invokana获准用于2型糖尿病

圣路易斯(MD Consult)——2013年3月29日，美国食品药品管理局(FDA)与杨森制药宣布，Invokana(canagliflozin)已获准用于治疗成人2型糖尿病。Invokana将会联合饮食与运动治疗，以改善血糖控制。
Invokana是一类名为钠葡萄糖协同转运子2抑制剂的新型药物中的一种。该药通过阻断肾脏葡萄糖重吸收、增加葡萄糖排泄而发挥降低血糖的作用。
Invokana的安全性和有效性在9项临床试验、超过10,285例2型糖尿病患者中得到了评估。这些试验中的患者显示出糖化血红蛋白A1c水平和空腹血糖水平的改善。Invokana单独治疗和联合其他2型糖尿病治疗(包括二甲双胍、磺酰脲类、吡格列酮和胰岛素)的方案均已得到了研究。
来自3期研究的结果显示，Invokana通常耐受性良好。接受Invokana治疗的患者中最常见的不良事件为生殖器霉菌(真菌)感染、尿路感染和排尿增多。这些特定的不良事件通常为轻至中度，很少导致停药。女性使用Invokana与外阴阴道念珠菌病风险增加有关。
由于Invokana有利尿作用，使用该药可导致血管内容量下降，进而引起直立性或体位性低血压。后者可能导致头晕或昏厥，而且在治疗的头3个月内最常见。不得使用Invokana治疗1型糖尿病，也不得用于合并糖尿病酮症酸中毒的患者、正在接受透析的患者，以及患有严重肾功能损害或终末期肾病的患者。
FDA正在要求开展5项关于Invokana的上市后研究：1项心血管结局试验，1项用于监测恶性肿瘤、严重胰腺炎、严重超敏反应、光敏反应、肝功能异常和不良妊娠结局的强化药物警戒计划，1项骨骼安全性研究，以及2项儿科研究(包括1项药代学与药效学研究和1项安全性与有效性研究)。
推荐的初始剂量为100 mg每日1次，第一餐前服用。之后可将剂量增加至300 mg/d。
与糖尿病相关的拓展阅读：

• Diabetes Care：NT-proBNP为老年糖尿病患者短期死亡强预测因子
• Invokana获准用于2型糖尿病
• 抑郁与1型糖尿病血糖控制不佳相关
• 抑郁与1型糖尿病血糖控制不佳相关
• Eur J Med Res：糖尿病患者需要口腔健康教育
• Diabetes Care：青少年期肥胖增高糖尿病风险
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原文阅读：U.S. FDA Approves INVOKANA™ (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes
INVOKANA™ is the first in a new class of type 2 diabetes medications available in the United States
In Phase 3 studies, INVOKANA™ improved blood glucose control and was associated with reductions in body weight and systolic blood pressure
Janssen will partner with other Johnson & Johnson companies focused on diabetes to bring INVOKANA™ to healthcare professionals
RARITAN, N.J., March 29, 2013 – Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes. INVOKANA™ is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials.
“Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life-threatening complications,” said Richard Aguilar*, M.D., Medical Director, Diabetes Nation, LLC and Diabetes Care Foundation, a non-profit organization committed to improving diabetes care. "INVOKANA™ is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a ‘glucuretic,’ increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes – glucose in the urine – may also reflect the efficacy of a new and unique approach to treatment.”....