Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand.
J Nephrol. 2012 May-Jun;25(3):354-62. doi: 10.5301/jn.5000011.
Hyperphosphatemia is commonly found in dialysis patients, which can lead to fatal cardiovascular diseases. The objective of this study was to evaluate the effectiveness and safety of extended-release nicotinic acid for reducing serum phosphorus in hemodialysis patients.
A randomized placebo-controlled trial was conducted, and 28 hemodialysis patients with hyperphosphatemia after 4 weeks of diet control were randomized to receive extended-release nicotinic acid (treatment group) once daily for 12 weeks. The initial daily dose was 375 mg, which was then titrated once weekly to 500, 750 and 1,000 mg, as tolerated. The control group received placebo. All patients in each group still received their phosphate-binding medication as standard treatment.
At the 12th week, mean serum phosphorus of the treatment group significantly decreased from 7.13 ± 1.09 mg/dL to 5.65 ± 1.22 mg/dL (p<0.001). However, there was no statistically significant difference between the control and treatment groups. Nine out of the 14 patients (64.29%) in the treatment group achieved the K/DOQI serum phosphorus goal. Serum high-density lipoprotein cholesterol of patients in the treatment group increased by 30.22% from baseline (p=0.037). There were no significant changes in serum calcium or parathyroid hormone level in any of the patients. Hot flushes were observed in all patients of the treatment group. There were no significant changes in the fasting blood glucose level, uric acid or liver function enzymes in any of the patients.
Extended-release nicotinic acid is effective and safe in reducing serum phosphorus as an add-on standard therapy in hemodialysis patients.
高磷血症在透析患者中很常见,可导致致命的心血管疾病。本研究旨在评估烟酸缓释剂降低血液透析患者血清磷的有效性和安全性。
采用随机、安慰剂对照试验,28 例经过 4 周饮食控制后仍存在高磷血症的血液透析患者,随机分为接受烟酸缓释剂(治疗组)治疗 12 周,每天一次。初始日剂量为 375mg,每周递增一次,最高耐受剂量为 500mg、750mg 和 1000mg。对照组给予安慰剂。两组患者均接受标准的磷结合药物治疗。
第 12 周时,治疗组患者的平均血清磷从 7.13±1.09mg/dL 显著下降至 5.65±1.22mg/dL(p<0.001),但与对照组相比,差异无统计学意义。治疗组 14 例患者中有 9 例(64.29%)达到 K/DOQI 血清磷目标。治疗组患者的血清高密度脂蛋白胆固醇从基线水平增加了 30.22%(p=0.037)。所有患者的血清钙或甲状旁腺激素水平均无明显变化。治疗组所有患者均出现热潮红。所有患者的空腹血糖水平、尿酸或肝功能酶均无明显变化。
烟酸缓释剂作为血液透析患者标准治疗的附加治疗,可有效降低血清磷,且安全。