Wilson Rosamund J, Copley J Brian
Spica Consultants, Marlborough, UK.
Shire Pharmaceuticals, Lexington, MA, USA.
Drugs Context. 2017 Jan 20;6:212302. doi: 10.7573/dic.212302. eCollection 2017.
Calcium-based and non-calcium-based phosphate binders have similar efficacy in the treatment of hyperphosphatemia; however, calcium-based binders may be associated with hypercalcemia, vascular calcification, and adynamic bone disease.
A analysis was carried out of data from a 16-week, Phase IV study of patients with end-stage renal disease (ESRD) who switched to lanthanum carbonate monotherapy from baseline calcium acetate/calcium carbonate monotherapy. Of the intent-to-treat population (N=2520), 752 patients with recorded dose data for calcium acetate (n=551)/calcium carbonate (n=201) at baseline and lanthanum carbonate at week 16 were studied. Elemental calcium intake, serum phosphate, corrected serum calcium, and serum intact parathyroid hormone levels were analyzed.
Of the 551 patients with calcium acetate dose data, 271 (49.2%) had an elemental calcium intake of at least 1.5 g/day at baseline, and 142 (25.8%) had an intake of at least 2.0 g/day. Mean (95% confidence interval [CI]) serum phosphate levels were 6.1 (5.89, 6.21) mg/dL at baseline and 6.2 (6.04, 6.38) mg/dL at 16 weeks; mean (95% CI) corrected serum calcium levels were 9.3 (9.16, 9.44) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively. Of the 201 patients with calcium carbonate dose data, 117 (58.2%) had an elemental calcium intake of at least 1.5 g/day, and 76 (37.8%) had an intake of at least 2.0 g/day. Mean (95% CI) serum phosphate levels were 5.8 (5.52, 6.06) mg/dL at baseline and 5.8 (5.53, 6.05) mg/dL at week 16; mean (95% CI) corrected serum calcium levels were 9.7 (9.15, 10.25) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively.
Calcium acetate/calcium carbonate phosphate binders, taken to control serum phosphate levels, may result in high levels of elemental calcium intake. This may lead to complications related to calcium balance.
钙基和非钙基磷酸盐结合剂在治疗高磷血症方面具有相似的疗效;然而,钙基结合剂可能与高钙血症、血管钙化和动力缺失性骨病有关。
对一项为期16周的IV期研究数据进行了分析,该研究针对的是终末期肾病(ESRD)患者,这些患者从基线的醋酸钙/碳酸钙单一疗法转换为碳酸镧单一疗法。在意向性治疗人群(N = 2520)中,研究了752例在基线时有醋酸钙(n = 551)/碳酸钙(n = 201)剂量记录数据且在第16周有碳酸镧剂量记录数据的患者。分析了元素钙摄入量、血清磷酸盐、校正血清钙和血清完整甲状旁腺激素水平。
在551例有醋酸钙剂量数据的患者中,271例(49.2%)在基线时元素钙摄入量至少为1.5克/天,142例(25.8%)摄入量至少为2.0克/天。平均(95%置信区间[CI])血清磷酸盐水平在基线时为6.1(5.89,6.21)毫克/分升,在16周时为6.2(6.04,6.38)毫克/分升;平均(95%CI)校正血清钙水平分别为9.3(9.16,9.44)毫克/分升和9.2(9.06,9.34)毫克/分升。在201例有碳酸钙剂量数据的患者中,117例(58.2%)元素钙摄入量至少为1.5克/天,76例(37.8%)摄入量至少为2.0克/天。平均(95%CI)血清磷酸盐水平在基线时为5.8(5.52,6.06)毫克/分升,在第16周时为5.8(5.53,6.05)毫克/分升;平均(95%CI)校正血清钙水平分别为9.7(9.15,10.25)毫克/分升和9.2(9.06,9.34)毫克/分升。
为控制血清磷酸盐水平而服用的醋酸钙/碳酸钙磷酸盐结合剂可能导致元素钙摄入量过高。这可能会引发与钙平衡相关的并发症。