Jalal Diana, McFadden Molly, Dwyer Jamie P, Umanath Kausik, Aguilar Erwin, Yagil Yoram, Greco Barbara, Sika Mohammed, Lewis Julia B, Greene Tom, Goral Simin
University of Colorado, Aurora, Colorado, USA.
University of Utah, Salt Lake, Utah, USA.
Hemodial Int. 2017 Apr;21(2):243-249. doi: 10.1111/hdi.12487. Epub 2016 Sep 12.
Oral phosphate binders are the main stay of treatment of hyperphosphatemia. Adherence rates to ferric citrate, a recently approved phosphate binder, are unknown.
We conducted a post-hoc analysis to evaluate whether adherence rates were different for ferric citrate vs. active control in 412 subjects with end stage kidney disease (ESKD) who were randomized to ferric citrate vs. active control (sevelamer carbonate and/or calcium acetate). Adherence was defined as percent of actual number of pills taken to total number of pills prescribed.
There were no significant differences in baseline characteristics including gender, race/ethnicity, and age between the ferric citrate and active control groups. Baseline phosphorus, calcium, and parathyroid hormone levels were similar. Mean (SD) adherence was 81.4% (17.4) and 81.7% (15.9) in the ferric citrate and active control groups, respectively (P = 0.88). Adherence remained similar between both groups after adjusting for gender, race/ethnicity, age, cardiovascular disease (CVD), and diabetic nephropathy (mean [95% CI]: 81.4% [78.2, 84.6] and 81.5% [77.7, 85.2] for ferric citrate and active control, respectively). Gender, race/ethnicity, age, and diagnosis of diabetic nephropathy did not influence adherence to the prescribed phosphate binder. Subjects with CVD had lower adherence rates to phosphate binder; this was significant only in the active control group.
Adherence rates to the phosphate binder, ferric citrate, were similar to adherence rates to active control. Similar adherence rates to ferric citrate are notable since tolerance to active control was an entry criteria and the study was open label. Gender, race/ethnicity, nor age influenced adherence.
口服磷结合剂是治疗高磷血症的主要手段。对于最近获批的磷结合剂柠檬酸铁，其依从率尚不清楚。
我们进行了一项事后分析，以评估在412例终末期肾病（ESKD）患者中，随机分配接受柠檬酸铁与活性对照（碳酸司维拉姆和/或醋酸钙）治疗时，柠檬酸铁与活性对照的依从率是否存在差异。依从性定义为实际服用药丸数量占处方药丸总数的百分比。
柠檬酸铁组和活性对照组在包括性别、种族/民族和年龄在内的基线特征方面没有显著差异。基线磷、钙和甲状旁腺激素水平相似。柠檬酸铁组和活性对照组的平均（标准差）依从率分别为81.4%（17.4）和81.7%（15.9）（P = 0.88）。在对性别、种族/民族、年龄、心血管疾病（CVD）和糖尿病肾病进行调整后，两组之间的依从性仍然相似（柠檬酸铁组和活性对照组的平均值[95%置信区间]分别为81.4%[78.2, 84.6]和81.5%[77.7, 85.2]）。性别、种族/民族、年龄和糖尿病肾病的诊断不影响对处方磷结合剂的依从性。患有CVD的受试者对磷结合剂的依从率较低；这仅在活性对照组中具有统计学意义。
磷结合剂柠檬酸铁的依从率与活性对照的依从率相似。鉴于对活性对照的耐受性是纳入标准且该研究为开放标签，柠檬酸铁相似的依从率值得关注。性别、种族/民族和年龄均不影响依从性。
