title: Meta-analysis of the effect of sevelamer on phosphorus, calcium, PTH, and serum lipids in dialysis patients.
abstract: 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.
authors.affiliation: Genzyme Corporation, 153 Second Avenue, Waltham, MA 02451, USA. steven.burke@genzyme.com
authors.forename: Steven K
authors.initials: SK
authors.lastname: Burke
authors.forename: Maureen A
authors.initials: MA
authors.lastname: Dillon
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Hemken
authors.forename: Margit S
authors.initials: MS
authors.lastname: Rezabek
authors.forename: James M
authors.initials: JM
authors.lastname: Balwit
mesh_terms: D002118:Calcium / Q000097:blood*; D004852:Epoxy Compounds / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000628:therapy; D008055:Lipids / Q000097:blood*; D010281:Parathyroid Hormone / Q000097:blood*; D010758:Phosphorus / Q000097:blood*; D011073:Polyamines; D011095:Polyethylenes / Q000627:therapeutic use*; D006435:Renal Dialysis; D000069603:Sevelamer
chemical_list: D004852:Epoxy Compounds; D008055:Lipids; D010281:Parathyroid Hormone; D011073:Polyamines; D011095:Polyethylenes; D010758:Phosphorus; D000069603:Sevelamer; D002118:Calcium