Division of Clinical Pharmacology and Division of Diabetes, Nutrition and Metabolic Disorders, Department of Medicine, CHU Sart Tilman, University of Liège, Liège, Belgium.
Clin Pharmacokinet. 2010 Sep;49(9):573-88. doi: 10.2165/11532980-000000000-00000.
Patients with type 2 diabetes mellitus (T2DM) are generally treated with many pharmacological compounds and are exposed to a high risk of drug-drug interactions. Indeed, blood glucose control usually requires a combination of various glucose-lowering agents, and the recommended global approach to reduce overall cardiovascular risk generally implies administration of several protective compounds, including HMG-CoA reductase inhibitors (statins), antihypertensive compounds and antiplatelet agents. New compounds have been developed to improve glucose-induced beta-cell secretion and glucose control, without inducing hypoglycaemia or weight gain, in patients with T2DM. Dipeptidylpeptidase-4 (DPP-4) inhibitors are novel oral glucose-lowering agents, which may be used as monotherapy or in combination with other antidiabetic compounds, metformin, thiazolidinediones or even sulfonylureas. Sitagliptin, vildagliptin and saxagliptin are already on the market, either as single agents or in fixed-dose combined formulations with metformin. Other compounds, such as alogliptin and linagliptin, are in a late phase of development. This review summarizes the available data on drug-drug interactions reported in the literature for these five DDP-4 inhibitors: sitagliptin, vildagliptin, saxagliptin, alogliptin and linagliptin. Possible pharmacokinetic interferences have been investigated between each of these compounds and various pharmacological agents, which were selected because there are other glucose-lowering agents (metformin, glibenclamide [glyburide], pioglitazone/rosiglitazone) that may be prescribed in combination with DPP-4 inhibitors, other drugs that are currently used in patients with T2DM (statins, antihypertensive agents), compounds that are known to interfere with the cytochrome P450 (CYP) system (ketoconazole, diltiazem, rifampicin [rifampin]) or with P-glycoprotein transport (ciclosporin), or agents with a narrow therapeutic safety window (warfarin, digoxin). Generally speaking, almost no drug-drug interactions or only minor drug-drug interactions have been reported between DPP-4 inhibitors and any of these drugs. The gliptins do not significantly modify the pharmacokinetic profile and exposure of the other tested drugs, and the other drugs do not significantly alter the pharmacokinetic profile of the gliptins or exposure to these. The only exception concerns saxagliptin, which is metabolized to an active metabolite by CYP3A4/5. Therefore, exposure to saxagliptin and its primary metabolite may be significantly modified when saxagliptin is coadministered with specific strong inhibitors (ketoconazole, diltiazem) or inducers (rifampicin) of CYP3A4/5 isoforms. The absence of significant drug-drug interactions could be explained by the favourable pharmacokinetic characteristics of DPP-4 inhibitors, which are not inducers or inhibitors of CYP isoforms and are not bound to plasma proteins to a great extent. Therefore, according to these pharmacokinetic findings, which were generally obtained in healthy young male subjects, no dosage adjustment is recommended when gliptins are combined with other pharmacological agents in patients with T2DM, with the exception of a reduction in the daily dosage of saxagliptin when this drug is used in association with a strong inhibitor of CYP3A4/A5. It is worth noting, however, that a reduction in the dose of sulfonylureas is usually recommended when a DPP-4 inhibitor is added, because of a pharmacodynamic interaction (rather than a pharmacokinetic interaction) between the sulfonylurea and the DPP-4 inhibitor, which may result in a higher risk of hypoglycaemia. Otherwise, any gliptin may be combined with metformin or a thiazolidinedione (pioglitazone, rosiglitazone), leading to a significant improvement in glycaemic control without an increased risk of hypoglycaemia or any other adverse event in patients with T2DM. Finally, the absence of drug-drug interactions in clinical trials in healthy subjects requires further evidence from large-scale studies, including typical subjects with T2DM - in particular, multimorbid and geriatric patients receiving polypharmacy.
患有 2 型糖尿病(T2DM)的患者通常需要使用多种药理化合物,并且面临着很高的药物相互作用风险。事实上,血糖控制通常需要各种降糖药物的组合,而降低整体心血管风险的推荐全球方法通常意味着需要使用几种保护化合物,包括 HMG-CoA 还原酶抑制剂(他汀类药物)、抗高血压药物和抗血小板药物。已经开发出一些新的化合物来改善葡萄糖诱导的β细胞分泌和血糖控制,而不会引起低血糖或体重增加,用于 T2DM 患者。二肽基肽酶-4(DPP-4)抑制剂是新型口服降糖药物,可单独使用或与其他抗糖尿病化合物(二甲双胍、噻唑烷二酮甚至磺酰脲类药物)联合使用。西格列汀、维格列汀和沙格列汀已经上市,无论是作为单一药物还是与二甲双胍的固定剂量联合制剂。其他化合物,如阿格列汀和利格列汀,处于后期开发阶段。本文综述了文献中报道的这五种 DPP-4 抑制剂(西格列汀、维格列汀、沙格列汀、阿格列汀和利格列汀)的药物相互作用数据。已经研究了每种化合物与各种药理药物之间可能存在的药代动力学相互干扰,这些药物是根据其他可能与 DPP-4 抑制剂联合使用的降糖药物(二甲双胍、格列本脲[格列吡嗪]、吡格列酮/罗格列酮)、目前用于 T2DM 患者的其他药物(他汀类药物、抗高血压药物)、已知会干扰细胞色素 P450(CYP)系统(酮康唑、地尔硫卓、利福平[利福喷汀])或 P-糖蛋白转运(环孢素)的化合物,或治疗安全窗口狭窄的药物(华法林、地高辛)选择的。一般来说,DPP-4 抑制剂与这些药物中的任何一种药物之间几乎没有或只有轻微的药物相互作用。gliptins 不会显著改变其他测试药物的药代动力学特征和暴露量,其他药物也不会显著改变 gliptins 的药代动力学特征或暴露量。唯一的例外是沙格列汀,它被 CYP3A4/5 代谢为活性代谢物。因此,当沙格列汀与特定的强抑制剂(酮康唑、地尔硫卓)或诱导剂(利福平)合用时,沙格列汀及其主要代谢物的暴露量可能会显著改变 CYP3A4/5 同工酶。没有明显的药物相互作用可能是由于 DPP-4 抑制剂的良好药代动力学特征,它们不是 CYP 同工酶的诱导剂或抑制剂,也不会与血浆蛋白结合。因此,根据这些药代动力学发现,这些发现通常是在健康年轻男性受试者中获得的,当 gliptins 与 T2DM 患者的其他药理药物联合使用时,不建议调整剂量,除了当该药与 CYP3A4/A5 的强抑制剂联合使用时,需要减少沙格列汀的每日剂量。然而,值得注意的是,当添加 DPP-4 抑制剂时,通常建议减少磺酰脲类药物的剂量,因为磺酰脲类药物和 DPP-4 抑制剂之间存在药效学相互作用(而不是药代动力学相互作用),这可能会导致低血糖风险增加。否则,任何 gliptin 都可以与二甲双胍或噻唑烷二酮(吡格列酮、罗格列酮)联合使用,在 T2DM 患者中显著改善血糖控制,而不会增加低血糖或任何其他不良事件的风险。最后,在健康受试者的临床试验中没有药物相互作用需要进一步的证据,包括典型的 T2DM 患者-特别是多系统疾病和老年患者接受多种药物治疗。