Burke Steven K, Dillon Maureen A, Hemken Douglas E, Rezabek Margit S, Balwit James M
Genzyme Corporation, 153 Second Avenue, Waltham, MA 02451, USA.
Adv Ren Replace Ther. 2003 Apr;10(2):133-45. doi: 10.1053/jarr.2003.50016.
Hyperphosphatemia and dyslipidemia are common clinically significant conditions in end-stage renal disease (ESRD). Hyperphosphatemia management is essential; however, use of calcium-based phosphate binder has been associated with elevated risk of cardiac calcification in ESRD, increasing risks for cardiovascular disease and death. An alternative to calcium-based phosphate binders is sevelamer hydrochloride, a calcium-free, metal-free, nonabsorbed polymer that binds phosphate effectively. We conducted a meta-analysis on the effects of sevelamer hydrochloride on parameters of mineral metabolism (serum phosphorous, calcium, Ca x P, and iPTH) and the lipid profile (total, LDL, HDL, and non-HDL cholesterol, and triglycerides) in dialysis patients. After application of inclusion/exclusion criteria, 17 core studies were statistically analyzed to determine the sevelamer treatment effect on the study parameters as demonstrated by simple, n-weighted, and inverse variance-weighted mean changes. Analysis of inverse variance-weighted mean changes indicated that sevelamer treatment was associated with a 2.14 mg/dL drop in serum phosphorus (P <.001), no significant overall effect on calcium (0.09 mg/dL, P =.364), significant decline in Ca x P product (15.91 mg(2)/dL(2), P <.001), 35.99 pg/mL reduction in iPTH (P =.026), significant reduction in total cholesterol (30.58 mg/dL, P <.001), 31.38 mg/dL drop in LDL cholesterol (P <.001), significant increase in HDL cholesterol (4.09 mg/dL, P =.008), and a significant reduction in triglycerides (22.04 mg/dL, P x.001). This meta-analysis suggests that sevelamer offers a dual therapeutic benefit in dialysis patients-a population at high risk for cardiovascular disease-by improving phosphorus control and the lipid profile, without altering serum calcium.
高磷血症和血脂异常是终末期肾病(ESRD)临床上常见的重要病症。高磷血症的管理至关重要;然而,使用钙基磷结合剂与ESRD患者心脏钙化风险升高相关,增加了心血管疾病和死亡风险。盐酸司维拉姆是钙基磷结合剂的替代品,它是一种无钙、无金属、不被吸收的聚合物,能有效结合磷。我们对盐酸司维拉姆对透析患者矿物质代谢参数(血清磷、钙、钙磷乘积和iPTH)及血脂谱(总胆固醇、低密度脂蛋白、高密度脂蛋白、非高密度脂蛋白胆固醇和甘油三酯)的影响进行了荟萃分析。应用纳入/排除标准后,对17项核心研究进行了统计分析,以确定盐酸司维拉姆治疗对研究参数的影响,表现为简单、n加权和逆方差加权平均变化。逆方差加权平均变化分析表明,盐酸司维拉姆治疗使血清磷下降2.14mg/dL(P<.001),对钙无显著总体影响(0.09mg/dL,P=.364),钙磷乘积显著下降(15.91mg²/dL²,P<.001),iPTH降低35.99pg/mL(P=.026),总胆固醇显著降低(30.58mg/dL,P<.001),低密度脂蛋白胆固醇下降31.38mg/dL(P<.001),高密度脂蛋白胆固醇显著升高(4.09mg/dL,P=.008),甘油三酯显著降低(22.04mg/dL,P<.001)。这项荟萃分析表明,盐酸司维拉姆在透析患者(心血管疾病高危人群)中具有双重治疗益处,即改善磷控制和血脂谱,同时不改变血清钙。