Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1 Kajigaya Takatsu-ku, Kawasaki, Kanagawa Prefecture, Japan.
Department of Nephrology, Saitama Medical University, Saitama, Japan.
J Nephrol. 2018 Dec;31(6):961-966. doi: 10.1007/s40620-018-0545-8. Epub 2018 Oct 24.
A recent study demonstrated that tolvaptan slowed estimated glomerular filtration rate (eGFR) decline in later-stage autosomal dominant polycystic kidney disease (ADPKD) patients. However, Japanese patients were not included in that trial, therefore tolvaptan's efficacy in Japanese patients with advanced chronic kidney disease (CKD) has remained unknown.
In this prospective cohort study, 54 patients with ADPKD who had eGFR ≥ 15 ml/min/1.73 m and total kidney volume (TKV) ≥ 750 ml were treated with tolvaptan. The primary endpoint was the change in height-adjusted total kidney volume (htTKV) and eGFR after 1-year treatment with tolvaptan. Then, we compared the primary endpoint between later CKD stage (baseline eGFR < 45 ml/min/1.73 m) and earlier CKD stage (baseline eGFR ≥ 45 ml/min/1.73 m).
The rate of kidney growth during the 1-year treatment did not differ significantly between earlier and later CKD stages. The median and interquartile range of relative change in htTKV in later CKD stage was 8.2%/year [4.4, 26.6], as compared with 5.7%/year [1.6, 16.4] in earlier CKD stage (p = 0.17). Nor did the rate of eGFR decline between earlier and later CKD stages. The relative annual change in eGFR in later CKD stage was - 9.7%/year [- 15.9, - 2.1], as compared with - 6.8%/year [- 11.1, 0.1] in earlier CKD stage (p = 0.18).
This analysis indicates that the efficacy of tolvaptan for Japanese patients with later stage ADPKD was not significantly different from that of Japanese patients with earlier stage ADPKD.
最近的一项研究表明,托伐普坦可减缓常染色体显性多囊肾病(ADPKD)晚期患者的估算肾小球滤过率(eGFR)下降。然而,该试验未纳入日本患者,因此托伐普坦在晚期慢性肾脏病(CKD)日本患者中的疗效仍不清楚。
在这项前瞻性队列研究中,54 名 ADKP 患者的 eGFR≥15ml/min/1.73m 且总肾体积(TKV)≥750ml,接受托伐普坦治疗。主要终点是托伐普坦治疗 1 年后身高校正总肾体积(htTKV)和 eGFR 的变化。然后,我们比较了晚期 CKD 期(基线 eGFR<45ml/min/1.73m)和早期 CKD 期(基线 eGFR≥45ml/min/1.73m)的主要终点。
1 年治疗期间肾脏生长速度在晚期和早期 CKD 期之间无显著差异。晚期 CKD 期 htTKV 的相对变化中位数和四分位距为 8.2%/年[4.4, 26.6],而早期 CKD 期为 5.7%/年[1.6, 16.4](p=0.17)。晚期和早期 CKD 期之间的 eGFR 下降速度也没有差异。晚期 CKD 期 eGFR 的相对年变化率为-9.7%/年[-15.9, -2.1],而早期 CKD 期为-6.8%/年[-11.1, 0.1](p=0.18)。
这项分析表明,托伐普坦对日本晚期 ADPKD 患者的疗效与日本早期 ADPKD 患者无显著差异。