BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSIONS:Extended-release nicotinic acid is effective and safe in reducing serum phosphorus as an add-on standard therapy in hemodialysis patients.
RCT Entities:
BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Extended-release nicotinic acid is effective and safe in reducing serum phosphorus as an add-on standard therapy in hemodialysis patients.