FDA approves pioglitazone for diabetes.
FDA approves pioglitazone for diabetes.
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DOI：
10.1093/ajhp/56.17.1698
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发表时间：
1999-09
期刊：
影响因子：
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通讯作者：
J. Miller
中科院分区：
文献类型：
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作者：
J. Miller
FDA已批准盐酸吡格列酮（Actos; Takeda，由礼来公司上市）用于治疗2型糖尿病。当磺脲类药物、二甲双胍或胰岛素被证明不足时，吡格列酮可作为单一疗法或与这些药物联合使用。吡格列酮是今年获批的第二种噻唑烷二酮类降糖药。罗格列酮（文迪雅，SmithKline Beecham）于5月获批。这两种药物均与曲格列酮引起的特异性肝毒性无关。然而，由于这三种药物具有结构相关性，服用吡格列酮或罗格列酮的患者应监测肝脏异常。肝酶水平应在治疗开始前测定，第一年每两个月测定一次，之后定期测定。与噻唑烷二酮类其他药物一样，吡格列酮主要通过降低胰岛素抵抗来改善血糖控制。在临床试验中，吡格列酮治疗与较低的血糖水平、血浆胰岛素水平和较低的HbA1c值相关。吡格列酮被广泛代谢。母体化合物的尿排泄可以忽略不计。吡格列酮单独使用或与其他抗糖尿病药物联合使用的推荐起始剂量为15或30毫克，每日一次。最大推荐剂量为45毫克/天。
The FDA has approved marketing of pioglitazone hydrochloride (Actos; Takeda, comarketed by Lilly) for the treatment of type 2 diabetes mellitus. Pioglitazone is indicated for use as monotherapy or in combination with sulfonylureas, metformin, or insulin when these agents prove inadequate. Pioglitazone is the second drug in the thiazolidinedione class of antidiabetic agents to be approved this year. Rosiglitazone (Avandia, SmithKline Beecham) was approved in May. Neither of these agents has been associated with the idiosyncratic hepatotoxicity attributed to troglitazone. However, because the three drugs are structurally related, patients who take either pioglitazone or rosiglitazone should be monitored for hepatic abnormalities. Liver enzyme levels should be measured before treatment is started, every two months for the first year, and periodically thereafter.Like other drugs in the thiazolidinedione class, pioglitazone improves glycemic control primarily by reducing insulin resistance. In clinical trials, pioglitazone treatment was associated with lower blood glucose levels, lower plasma insulin levels, and lower HbA1c values. Pioglitazone is extensively metabolized. Urinary excretion of the parent compound is negligible. The recommended starting dosage of pioglitazone used alone or added to other antidiabetic agents is 15 or 30 mg once daily. The maximum recommended dosage is 45 mg/day.