Renal Associates, P.A., San Antonio, TX, USA.
Am J Nephrol. 2017;46(4):323-332. doi: 10.1159/000481270. Epub 2017 Oct 11.
Patiromer is a sodium-free, nonabsorbed, potassium binder approved for treatment of hyperkalemia. This open-label study compares the efficacy and safety of patiromer administered without food versus with food.
Adults with hyperkalemia (potassium ≥5.0 mEq/L) were randomized (1:1) to receive patiromer once daily without food or with food for 4 weeks. The dosage was adjusted (maximum: 25.2 g/day) using a prespecified titration schedule to achieve and maintain potassium within a target range (3.8-5.0 mEq/L). The primary efficacy endpoint was the proportion of patients with serum potassium in the target range at either week 3 or week 4. Safety was assessed by adverse events (AEs) and laboratory testing.
Efficacy was evaluated in 112 patients; 65.2% were ≥65 years of age, 75.9% had chronic kidney disease, and 82.1% had diabetes. Baseline mean serum potassium was similar in the without-food (5.44 mEq/L) and with-food (5.34 mEq/L) groups. The primary endpoint was achieved by 87.3% (95% CI 75.5-94.7) and 82.5% (95% CI 70.1-91.3) of patients in the with-food and without-food groups, respectively; least squares mean changes in serum potassium from baseline to week 4 were -0.65 and -0.62 mEq/L, respectively (p < 0.0001). The most common AEs were diarrhea and constipation. Serum K+ remained ≥3.5 mEq/L in all patients; 5 patients developed serum magnesium <1.4 mg/dL, including 4 whose baseline magnesium was below the lower limit of normal.
Patiromer is equally effective and well tolerated when taken without food or with food, thereby offering the potential for dosing flexibility.
帕替络尔是一种不含钠、不可吸收的钾结合剂，已被批准用于治疗高钾血症。这项开放标签研究比较了空腹和进食时给予帕替络尔的疗效和安全性。
高钾血症（血钾≥5.0 mEq/L）成人患者按 1:1 比例随机分为两组，分别接受空腹或进食时每日一次帕替络尔治疗，持续 4 周。根据预设的滴定方案调整剂量（最大剂量：25.2 g/天），以实现并维持钾在目标范围内（3.8-5.0 mEq/L）。主要疗效终点为第 3 周或第 4 周时血钾处于目标范围内的患者比例。通过不良事件（AE）和实验室检查评估安全性。
共 112 例患者接受了疗效评估；65.2%患者年龄≥65 岁，75.9%患者患有慢性肾脏病，82.1%患者患有糖尿病。无食物组（5.44 mEq/L）和有食物组（5.34 mEq/L）患者的基线平均血清钾相似。主要终点在有食物组和无食物组中的达成率分别为 87.3%（95%置信区间：75.5-94.7）和 82.5%（95%置信区间：70.1-91.3）；从基线到第 4 周血清钾的最小二乘均值变化分别为-0.65 和-0.62 mEq/L（p<0.0001）。最常见的 AE 是腹泻和便秘。所有患者的血清 K+均保持≥3.5 mEq/L；5 例患者出现血清镁<1.4 mg/dL，其中 4 例患者的基线镁低于正常值下限。
无论空腹还是进食时给予帕替络尔，其疗效相当，且均具有良好的耐受性，从而为剂量调整提供了更大的灵活性。
