Suzuki Naoki, Takeda Yuuki, Kabuto Akie, Konishi Takao, Konishi Takahiro, Sumino Fumi, Iwata Hayanari, Iwagami Mone, Kouchi Yusuke, Hitomi Yasumasa, Takatani Toru, Nishimura Masato, Sato Nodoka
Division of Data science, Tojinkai Hospital, Kyoto, Japan.
Division of Clinical Engineering, Tojinkai Hospital, Kyoto, Japan.
PLoS One. 2025 Jun 17;20(6):e0319319. doi: 10.1371/journal.pone.0319319. eCollection 2025.
Tenapanor is a minimally absorbed, small-molecule inhibitor of sodium/hydrogen exchanger 3 and thus suppresses sodium absorption in the gastrointestinal tract. It is approved by the FDA for the treatment of hyperphosphatemia in dialysis patients. This randomized controlled trial evaluated its efficacy in the treatment of hyperphosphatemia and constipation in hemodialysis patients.
Ninety hemodialysis patients were randomized 1:1 to receive either tenapanor or standard care. Randomization was performed using a computer-generated sequence stratified by baseline serum phosphorus levels. The tenapanor group began treatment with a dosage of 10 mg/day, which was adjusted based on serum phosphorus levels. Primary outcomes were changes in serum phosphorus levels in the tenapanor and control groups and changes in stool consistency, assessed weekly using the Bristol Stool Form Scale (BSFS) in the tenapanor group. Secondary outcomes included laxative use and phosphate binder prescription patterns. Serum phosphorus levels, serum calcium, albumin, and related biochemical parameters were monitored every two weeks. Data were analyzed using intention-to-treat principles. This study was not blinded.
Of the 90 randomized participants, 69 completed the 23-week study. Tenapanor significantly improved stool consistency and resolved constipation (BSFS types 1-2) by week 5. A transient increase in loose stools (BSFS types 6-7) occurred early, with 10 participants discontinuing due to diarrhea. Laxative use decreased significantly in the tenapanor group, from 58.2% at baseline to 35.6% at week 23 (p < 0.01). Serum phosphorus levels were decreased in both groups, with comparable control. Lanthanum carbonate prescriptions decreased significantly in the tenapanor group and were largely replaced by low-dose tenapanor.
Tenapanor improves stool consistency, reduces laxative use, and provides effective phosphorus control in hemodialysis patients and represents a promising alternative to conventional phosphate binders.
替那帕诺是一种吸收极少的小分子钠/氢交换体3抑制剂，因此可抑制胃肠道中的钠吸收。它已获美国食品药品监督管理局批准用于治疗透析患者的高磷血症。这项随机对照试验评估了其治疗血液透析患者高磷血症和便秘的疗效。
90名血液透析患者按1:1随机分组，分别接受替那帕诺或标准治疗。使用根据基线血清磷水平分层的计算机生成序列进行随机分组。替那帕诺组开始以10毫克/天的剂量治疗，并根据血清磷水平进行调整。主要结局是替那帕诺组和对照组血清磷水平的变化，以及替那帕诺组使用布里斯托大便分类法（BSFS）每周评估的大便稠度变化。次要结局包括泻药使用情况和磷结合剂处方模式。每两周监测血清磷水平、血清钙、白蛋白及相关生化参数。采用意向性分析原则进行数据分析。本研究未设盲。
90名随机参与者中，69人完成了为期23周的研究。替那帕诺在第5周时显著改善了大便稠度并缓解了便秘（BSFS 1 - 2型）。早期出现了稀便（BSFS 6 - 7型）的短暂增加，有10名参与者因腹泻而停药。替那帕诺组的泻药使用显著减少，从基线时的58.2%降至第23周时的35.6%（p < 0.01）。两组的血清磷水平均下降，控制情况相当。替那帕诺组的碳酸镧处方显著减少，大部分被低剂量替那帕诺取代。
替那帕诺可改善血液透析患者的大便稠度，减少泻药使用，并有效控制磷水平，是传统磷结合剂的一种有前景的替代药物。
