Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Division of Diabetes and Endocrinology, Department of Medicine, NTT Sapporo Medical Center, Sapporo, Japan.
Diabetes Metab J. 2024 May;48(3):473-481. doi: 10.4093/dmj.2023.0370. Epub 2024 Feb 29.
Fibrates have renal toxicity limiting their use in subjects with chronic kidney disease (CKD). However, pemafibrate has fewer toxic effects on renal function. In the present analysis, we evaluated the effects of pemafibrate on the renal function of diabetic subjects with or without CKD in a real-world clinical setting.
We performed a sub-analysis of data collected during a multi-center, prospective, observational study of the effects of pemafibrate on lipid metabolism in subjects with type 2 diabetes mellitus complicated by hypertriglyceridemia (the PARM-T2D study). The participants were allocated to add pemafibrate to their existing regimen (ADD-ON), switch from their existing fibrate to pemafibrate (SWITCH), or continue conventional therapy (CTRL). The changes in estimated glomerular filtration rate (eGFR) over 52 weeks were compared among these groups as well as among subgroups created according to CKD status.
Data for 520 participants (ADD-ON, n=166; SWITCH, n=96; CTRL, n=258) were analyzed. Of them, 56.7% had CKD. The eGFR increased only in the SWITCH group, and this trend was also present in the CKD subgroup (P<0.001). On the other hand, eGFR was not affected by switching in participants with severe renal dysfunction (G3b or G4) and/or macroalbuminuria. Multivariate analysis showed that being older and a switch from fenofibrate were associated with elevation in eGFR (both P<0.05).
A switch to pemafibrate may be associated with an elevation in eGFR, but to a lesser extent in patients with poor renal function.
贝特类药物具有肾毒性，限制了其在慢性肾脏病（CKD）患者中的应用。然而，帕马溴的肾功能毒性较小。在本分析中，我们在一项多中心、前瞻性、观察性研究中评估了帕马溴对伴有或不伴有 CKD 的 2 型糖尿病患者肾功能的影响，该研究评估了帕马溴对伴有高甘油三酯血症的 2 型糖尿病患者脂代谢的影响（PARM-T2D 研究）。
我们对该研究的数据进行了亚组分析。该研究纳入了伴有高甘油三酯血症的 2 型糖尿病患者，将患者随机分为加用帕马溴组（ADD-ON）、由现有贝特类药物换用为帕马溴组（SWITCH）和继续接受常规治疗组（CTRL）。比较了各组和根据 CKD 状态分组的亚组在 52 周时估算肾小球滤过率（eGFR）的变化。
共纳入了 520 名患者（ADD-ON 组 166 名，SWITCH 组 96 名，CTRL 组 258 名），其中 56.7%的患者有 CKD。只有 SWITCH 组的 eGFR 增加，这一趋势在 CKD 亚组中也存在（P<0.001）。另一方面，在严重肾功能障碍（G3b 或 G4）和/或大量蛋白尿的患者中，换药不会影响 eGFR。多变量分析显示，年龄较大和由非诺贝特换用为帕马溴与 eGFR 升高相关（均 P<0.05）。
换用帕马溴可能与 eGFR 升高相关，但在肾功能较差的患者中程度较小。
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