治疗2型糖尿病的一种新型二甲双胍(Glucophage XR)获美国食品和药物管理局批准。
这种被命名为Glucophage XR的新药是盐酸二甲双胍缓释胶囊,只需一天一次服用,它被获准做为饮食控制和运动失败后治疗2型糖尿病的首选药物,也可与磺脲类药物和胰岛素合并使用。Bristol-Myers施贵宝公司周一称,他们治疗2型糖尿病的一种新型二甲双胍(Glucophage XR)获美国食品和药物管理局批准。公司称,1200例病人的临床试验结果显示,在降低病人血糖水平方面,新型二甲双胍与普通二甲双胍效果相当。
Bristol-Myers施贵宝公司周一称,他们治疗2型糖尿病的一种新型二甲双胍(Glucophage XR)获美国食品和药物管理局批准。公司估计60%接受口服降糖治疗的2型糖尿病病人每天要服多种药物,该公司世界医药部负责人Lane说:“这种新型二甲双胍为2型糖尿病病人提供了一种每天一次的简单用药方法。”该公司发言人Shapero告诉路透社医学新闻,他们计划在11月份早些时候推出这种新型二甲双胍。
FDA最近还批准了Bristol-Myers公司的一种复方降糖药Glucovance,它是格列本脲(glyburide)和盐酸二甲双胍的复方制剂,这两种降糖药共同作用以增进2型糖尿病病人血糖的控制。Shapero说,Glucophage XR与普通二甲双胍有相同的安全性。二甲双胍的副作用有不规则的心慌、严重的胃部不适和低血糖(如与其它降糖药合用)。
Bristol-Myers公司指出,在极少的情况下,Glucophage XR、Glucovance和普通二甲双胍可能会引起乳酸性酸中毒,并有可能会致命,主要发生于肾功能较差的病人。接受心脏药物治疗、肾脏有问题、有肝脏疾病或80岁以上的病人建议不使用这种降糖药。
国外的研究人员近期进行了一项为期24周的双盲研究,评估了新型缓释二甲双胍治疗2型糖尿病的有效性和安全性。 将新诊断的、单纯饮食控制和运动干预及既往只服用口服降糖药的2型糖尿病患者随机分为三种缓释二甲双胍剂量组(1500mg qd组、1500mg bid组、2000mg qd组)及短效二甲双胍组(1500mg bid)。结果显示,治疗12周时,所有治疗组患者的平均HbA1c均有显著下降(P < 0.001)。与治疗基线相比,缓释二甲双胍1500mg qd组、1500mg bid组和短效二甲双胍组患者的A1C分别下降了0.73%、0.74%和0.70%,不具有统计学意义;而缓释二甲双胍2000mg组患者的A1C平均下降了1.06%,与短效二甲双胍组相比具有统计学差异。治疗1~8周时,患者血糖的下降最为明显,并持续至研究结束。 各治疗组的副反应相似,但缓释二甲双胍治疗组中患者因为恶心而自行停药的比例要低于短效二甲双胍组。研究人员指出,每日1次或2次应用缓释二甲双胍与每日2次服用短效二甲双胍一样安全、有效,且能满意控制血糖达24周.
----------------------------------------------------------------------------- 【原产地英文商品名】GLUCOPHAGE XR 750MG/tablet 100Tabs/box 【原产地英文药品名】METFORMIN HYDROCHLORIDE 【中文参考商品译名】 注:以下产品不同的规格和不同的价格,购买时请以电话咨询为准 ·格华止缓释片 750毫克/片 100片/盒 ·格华止缓释片 500毫克/片 100片/盒 【生产厂家中文参考译名】百时美施贵宝美国制药 【生产厂家英文名】Bristol-Myers Squibb ------------------------------------------------------------------- 【原产地英文商品名】GLUCOPHAGE 850MG/tablet 100Tabs/box 【原产地英文药品名】METFORMIN HYDROCHLORIDE 【中文参考商品译名】 注:以下产品不同的规格和不同的价格,购买时请以电话咨询为准 ·格华止 850毫克/片 100片/盒 ·格华止 500毫克/片 100片/盒 ·格华止 1000毫克/片 100片/盒 【生产厂家中文参考译名】百时美施贵宝美国制药 【生产厂家英文名】Bristol-Myers Squibb ----------------------------------------------------------------------------- 【原产地英文商品名】Generic ACTOPLUS MET pioglitazone HCl15 MG/metformin HCl 500 MG TAB /180Tablets 【原产地英文药品名:盐酸吡格列酮 (pioglitazone HCl) /盐酸二甲双胍 (metformin HCl)) 【中文参考商品译名】 ·Generic ACTOPLUS MET 盐酸吡格列酮 (pioglitazone HCl)15毫克 /盐酸二甲双胍 (metformin HCl))500毫克 【中文参考药品译名】盐酸吡格列酮 (pioglitazone HCl) /盐酸二甲双胍 (metformin HCl)) -----------------------------------------------------------------------------
Glucophage XR Extended-Release Tablets is used for:
Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Glucophage XR Extended-Release Tablets is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.
Do NOT use Glucophage XR Extended-Release Tablets if: you are allergic to any ingredient in Glucophage XR Extended-Release Tablets you have congestive heart failure that is treated by medicine you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or severe dehydration you have had a stroke or a recent heart attack, or you are in shock you are 80 years old or older and have not had a kidney function test you will be having surgery or certain lab procedures Contact your doctor or health care provider right away if any of these apply to you.
Before using Glucophage XR Extended-Release Tablets: Some medical conditions may interact with Glucophage XR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems (eg, heart failure), lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, or lactic acidosis if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia, or if you are dehydrated if you have an infection, fever, recent injury, or moderate to severe burns if you drink alcohol or have a history of alcohol abuse if you will be having surgery or certain lab procedures if you are taking a beta-blocker (eg, propranolol) Some MEDICINES MAY INTERACT with Glucophage XR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Glucophage XR Extended-Release Tablets's side effects This may not be a complete list of all interactions that may occur. Ask your health care provider if Glucophage XR Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. |