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dapagliflozin:A hypoglycaemic drug causing disproportionate harm, especially to kidneys

机译：达格列净：一种降血糖药，引起特别是对肾脏的不成比例的伤害

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Type 2 diabetes is a common disease with potentially serious complications. It usually occurs in overweight patients over 40 years of age. In late 2013, metformin and glibenclamide are the only oral hypoglycaemic agents for which there is reasonable evidence of a preventive effect on certain clinical complications of type 2 diabetes and, in the case of metformin, mortality.? Dapagliflozin was authorised in the European Union, for first-line mono-therapy when metformin is poorly tolerated, or in combination with insulin or another oral hypoglycaemic drug as second-line therapy.? Dapagliflozin increases urinary glucose elimination and thereby lowers blood sugar concentration.? Dapagliflozin has not been tested in trials with morbidity or mortality end-points.? Clinical evaluation of dapagliflozin, at a dose of 10 mg per day, is mainly based on a non-inferiority trial versus glipizide (a hypoglycaemic sulphony-lurea) and on five double-blind randomised placebo-controlled trials, one of dapagliflozin monotherapy and fourof dapagliflozin in combination with other hypoglycaemic agents.? After 24 weeks, dapagliflozin reduced the average HbA1c concentration by about 0.6% more than placebo. In one trial, however, dapagliflozin had no impact on the HbA1c level in patients with renal impairment.? Patients receiving dapagliflozin combination therapy lost about 1 to 2 kg, due to both fat and water loss.? The mechanism of action of dapagliflozin explains some of its adverse effects, including urogenital infections, arterial hypotension, dehydration, and aggravation of renal impairment. Other data point to a possibility of excess mortality, hepatitis, bone fractures, renal failure, and bladder, breast and prostate cancer.? Renal impairment reduces the hypoglycaemic effect of dapagliflozin and increases the frequency of certain adverse effects, including renal failure. Dapagliflozin is metabolised by UDP glucuronosyltransferase (UGT1A9) and by cytochrome P450 isoenzymes, creating a risk of multiple pharmacokinet-ic interactions and additive adverse effects when dapagliflozin is co-administered with nephrotoxic or anti-hypertensive drugs, among others.? In practice, given the lack of any proven impact on the complications of diabetes, dapagliflozin exposes patients to a disproportionate risk of adverse effects. It is best to avoid prescribing dapagliflozin to patients with type 2 diabetes.
机译：2型糖尿病是一种常见的疾病，可能会引起严重的并发症。它通常发生在40岁以上的超重患者中。在2013年末，二甲双胍和格列本脲是仅有的口服降血糖药，有合理的证据表明该药可预防某些2型糖尿病的临床并发症，对于二甲双胍则可降低死亡率。达格列净在欧盟已获准用于二甲双胍耐受性差的一线单药治疗，或与胰岛素或另一种口服降血糖药联合作为二线治疗。达格列净增加尿中葡萄糖的清除，从而降低血糖浓度。达格列净尚未在具有发病率或死亡率终点的试验中进行过测试。达格列净的剂量为每天10 mg，其临床评估主要基于一项非劣效性试验与格列吡嗪（一种降血糖的磺脲类药物）以及五项双盲随机安慰剂对照试验中的一项，达格列净单药治疗和四项达格列净与其他降血糖药合用。 24周后，达格列净降低了HbA1c的平均浓度，比安慰剂降低了约0.6％。然而，在一项试验中，达格列净对肾功能不全患者的HbA1c水平没有影响。由于脂肪和水分的流失，接受达格列净治疗的患者体重减轻了约1至2公斤。达格列净的作用机理解释了它的一些不良反应，包括泌尿生殖系统感染，动脉低血压，脱水和肾功能不全加重。其他数据表明，有可能导致过度死亡，肝炎，骨折，肾功能衰竭以及膀胱癌，乳腺癌和前列腺癌。肾功能不全会降低达格列净的降血糖作用，并增加某些不良反应（包括肾衰竭）的发生频率。 Dapagliflozin由UDP葡萄糖醛酸糖基转移酶（UGT1A9）和细胞色素P450同工酶代谢，当dapagliflozin与肾毒性或降压药共同使用时，会产生多种药代动力学相互作用和附加不良作用。在实践中，由于对糖尿病并发症缺乏任何已证明的影响，因此达格列净使患者暴露于不成比例的不良反应风险中。最好避免给2型糖尿病患者开处方dapagliflozin。

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    《Prescrire international》 |2014年第147期|共1页
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  • 中图分类 药学;
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