ST LOUIS (MD Consult) - On May 14, 2009, Takeda Pharmaceutical Company Limited announced that the US Food and Drug Administration (FDA) approved extended-release combination medication Actoplus Met XR (pioglitazone and metformin) as an adjunct to diet and exercise for the treatment of type 2 diabetes mellitus. Actoplus Met XR is indicated for the treatment of adults with type 2 diabetes who have already been treated with Actos (pioglitazone) and metformin or who have experienced inadequate glycemic control on Actos or metformin alone.

One component of Actoplus Met XR, Actos, directly targets insulin resistance. The second component, metformin, acts by reducing the amount of glucose produced by the liver.

Treatment with Actoplus Met XR can cause or worsen congestive heart failure. Patients should be instructed to contact their physician if they experience rapid weight gain, fluid retention, or shortness of breath. In addition, a small number of persons who have taken metformin have been diagnosed with lactic acidosis, a condition that can be fatal in about half the cases. Because lactic acidosis occurs most frequently in persons with renal problems, Actoplus Met XR should not be prescribed for persons with kidney disease or for persons aged 80 years and older with kidney dysfunction. Furthermore, Actoplus Met XR should not be taken by persons with metabolic acidosis or by persons who consume excessive amounts of alcohol. Actoplus met XR should be discontinued in patients with severe infection and in patients undergoing radiologic studies using intravenous contrast dye.

Patients prescribed Actoplus Met XR should undergo laboratory testing of liver function before treatment is initiated and periodically thereafter. Actoplus Met XR is contraindicated in persons with active liver disease. Patients should be instructed to contact their physician if they experience nausea, vomiting, abdominal pain, fatigue, or loss of appetite or if they observe skin yellowing or a darkening of urine color.

Takeda expects Actopuls Met XR to be available before the end of 2009.

圣路易斯(MD Consult)——2009年5月14日，武田制药公司(Takeda Pharmaceutical Company Limited)宣布，美国食品药品管理局(FDA)已批准复方缓释药Actoplus Met XR(匹格列酮和二甲双胍)用于治疗2型糖尿病。该药可辅助饮食和运动，共同治疗2型糖尿病。Actoplus Met XR适用于治疗曾接受过Actos (匹格列酮)和二甲双胍治疗的2型糖尿病成人患者或经Actos单药治疗或二甲双胍单药治疗后血糖控制不佳的2型糖尿病成人患者。

Actoplus Met XR中的Actos可直接针对胰岛素抵抗起作用。第2个成分——二甲双胍，可通过减少肝脏生成的葡萄糖量而发挥作用。

Actoplus Met XR治疗可引起或加重充血性心力衰竭。患者如果出现体重迅速增加、液体潴留或气短，则应与经治医生联系。此外，少数服用二甲双胍的患者会出现乳酸酸中毒。在约半数情况下，乳酸酸中毒具有致命性。由于乳酸酸中毒最常发生于有肾脏疾病的患者，因此不应为肾病患者或年龄≥80岁的肾功能损害患者开具Actoplus Met XR处方。另外，代谢性酸中毒患者或酗酒患者也不应服用Actoplus Met XR。严重感染患者和采用静脉注射造影剂进行放射学检查的患者不应停用Actoplus met XR。

患者应在接受Actoplus Met XR治疗前进行肝功能实验室检查，并在此后定期进行此类检查。Actoplus Met XR禁用于患有活动性肝病的患者。患者如果出现恶心、呕吐、腹痛、疲劳、食欲不振、皮肤发黄或尿色变暗，则应与经治医生联系。

武田制药公司预期Actopuls Met XR可在2009年底前上市。

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