title: Clinical efficacy, safety and anti-inflammatory activity of two sevelamer tablet forms in patients on low-flux hemodialysis.
abstract: Sevelamer hydrochloride is an ionic exchange resin with high affinity for phosphate. This phosphate-binding agent has few serious adverse reactions with the advantage of reducing total and low density lipoprotein (LDL) cholesterol levels. However, it is controversial as to whether sevelamer hydrochloride can modulate the inflammatory response via endotoxin reduction. Therefore, a single-center, open-label, prospective and randomized study was performed to compare the clinical efficacy, safety and anti-inflammatory activity of two sevelamer hydrochloride tablet forms a branded tablet form, Renagel (Genzyme manufacturer) and its generic equivalent (EMS manufacturer). Twenty-eight chronic kidney disease volunteer patients at stage 5 (CDK 5D), on chronic low-flux hemodialysis carried out in 4-hour sessions, three times a week, were studied. The serum phosphorus, ionic calcium, total cholesterol and fractions, bicarbonate, blood pH, interleukin (IL)-6, IL-10, IL-1 beta and tumor necrosis factor-alpha (TNF-alpha) levels were collected prior to dialysis at mid-week. The incidence of gastrointestinal adverse effects were determined at the end of the phosphate-binder washout period as well as at the end of the fourth and eighth weeks of use of both tablet forms. The same magnitude of reduction in serum phosphorus was observed with both sevelamer tablet forms. Only the Renagel group showed lower total cholesterol and lower LDL cholesterol levels at the fourth and eighth week versus baseline. No significant differences in serum cytokine levels were identified in either drug group. However, the incidence of intestinal obstipation was higher among patients who used the generic equivalent form. In conclusion, Renagel and its EMS generic equivalent tablet forms have a similar clinical efficacy in reducing phosphorus in CKD 5D patients on low-flux hemodialysis and a similar safety profile.
authors.affiliation: Home Dialysis Center (HDC), Center of Study for Social and Health Humaniztion (CEHUS), São Paulo, Brazil.
authors.forename: C
authors.initials: C
authors.lastname: Tzanno-Martins
authors.affiliation: Home Dialysis Center (HDC), Center of Study for Social and Health Humaniztion (CEHUS), São Paulo, Brazil.
authors.forename: B M M
authors.initials: BM
authors.lastname: Biavo
authors.affiliation: Home Dialysis Center (HDC), Center of Study for Social and Health Humaniztion (CEHUS), São Paulo, Brazil.
authors.forename: O
authors.initials: O
authors.lastname: Ferreira-Filho
authors.affiliation: Home Dialysis Center (HDC), Center of Study for Social and Health Humaniztion (CEHUS), São Paulo, Brazil.
authors.forename: E
authors.initials: E
authors.lastname: Ribeiro-Junior
authors.affiliation: Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil.
authors.forename: M V S
authors.initials: MV
authors.lastname: João-Luiz
authors.affiliation: Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil.
authors.forename: S
authors.initials: S
authors.lastname: Degaspari
authors.affiliation: Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil.
authors.forename: C
authors.initials: C
authors.lastname: Scavone
authors.affiliation: Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil.
authors.forename: E
authors.initials: E
authors.lastname: Kawamoto
mesh_terms: D002097:C-Reactive Protein / Q000032:analysis / Q000276:immunology; D002614:Chelating Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D002784:Cholesterol / Q000097:blood; D016207:Cytokines / Q000097:blood / Q000276:immunology; D016568:Drugs, Generic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood*; D011073:Polyamines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects* / Q000379:methods; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000188:drug therapy / Q000276:immunology; D000069603:Sevelamer; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood / Q000276:immunology
chemical_list: D002614:Chelating Agents; D016207:Cytokines; D016568:Drugs, Generic; D011073:Polyamines; D014409:Tumor Necrosis Factor-alpha; D010758:Phosphorus; D002097:C-Reactive Protein; D002784:Cholesterol; D000069603:Sevelamer