Objective To evaluate the short-term efficacy and safety of sevelamer hydrochloride in treating maintenance hemodialysis (MHD) patients with hyperphosphemia. Methods A multicenter, open-labeled, self-control study was performed. Phosphate binders were discontinued during a two-week washout period. Patients with more than 1.78 mmol/L serum phosphorus after two-week washout period were eligible for the trial. The dose was adjusted every two weeks as necessary to achieve serum phosphorus control. Sevelamer hydrochloride was administered to 138 MHD patients for 10 weeks and a second two-week washout period followed. Results A total of 111 from 138 patients fulfilled the whole 14-week study. Mean serum phosphorus and calcium-phosphate products starte to decline after two-week sevelamer hydrochloride treatment. By the end of 10-week sevelamer hydrochloride treatment, mean serum level of phosphorus [(1.85±0.50) vs (2.57±0.54) mmol/L, P<0.01], calcium-phosphate product [(4.16±1.72) vs (5.79±1.50) mmol2/L2, P<0.01] and low density lipoprotein [(1.64±0.76) vs (2.31±0.87) mmol/L, P<0.01] were significantly decreased, while the adjusted serum level of calcium and serum intact parathyroid hormone kept steady. Both serum phosphorus and calcium-phosphrus product increased after the second washout period, but the levels were still lower as compared to pre-treatment [(2.26±0.71) vs (2.57±0.54) mmol/L; (5.12±1.63) vs (5.79±1.50) mmol2/L2, P<0.01]. Of the 138 patients involved, 214 episodes in 106 patients and 121 episodes in 89 patients were reported as adverse events and adverse drug reaction respectively. Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.1%(94/138) patients. Conclusions Sevelamer hydrochloride can control serum phosphorus and reduce the levels of calcium-phosphorus product and cholesterol. Slight gastrointestinal symptoms like constipation are common during the treatment.
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