Impact of sevelamer hydrochloride and the K/DOQI guidelines

Sevelamer hydrochloride (SH) was registered as a new drug under the Japanese national health insurance scheme in 2003, and the Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for the treatment of renal osteodystrophy were released the same year. At that time, treatment objectives for hemodialysis outpatients at the Kojinkai Ishimaki Clinic were settled established and the outcomes reviewed 18 months later. The relationship between the type and dosage of phosphate binder (PB), and the concentrations of adjusted calcium (Ca), phosphorus (P), intact parathyroid hormone (PTH), and bone alkaline phosphatase (BAP) was examined. Patients receiving calcitriol or maxacalcitol intravenous pulse therapy, or who had undergone simultaneous pancreas-kidney transplant, were excluded from this analysis. The PB was CaCO3 in 60% of cases, SH in 33.3%, and a combination of both in 21.9%; no PB was used in 6.7% of cases. The dosage of CaCO3 was 2.8+/-1.0 g/day, and 1alpha-hydroxy activated vitamin D3 (VD) was 0.46+/-0.24 microg/day; the respective concentrations of adjusted Ca, P, intact PTH, and BAP were 9.4+/-0.7 mg/dL, 5.6+/-1.7 mg/dL, 104+/-83.9 pg/mL, and 22.7+/-10.9 IU/L. In the SH monotherapy group, the dosage of SH was 3.9+/-0.725 g/day, and VD 0.62+/-0.21 microg/day, and the concentrations for adjusted Ca, P, intact PTH, and BAP were 9.6+/-0.4 mg/dL, 6.2+/-1.5 mg/dL, 150+/-42.9 pg/mL, and 38.5+/-14.2 IU/L, respectively. In the combined therapy group, the dosage of CaCO3 was 2.9+/-0.9 g/day, SH was 3.3+/-1.1 g/day, VD was 0.53+/-0.27 microg/day, and the respective concentrations were 9.2+/-1.0 mg/dL, 5.7+/-1.4 mg/dL, 160+/-107.8 pg/mL, and 31.3+/-42.0 IU/L. One-third of all subjects were administered SH, either as monotherapy or in combination with CaCO3, and in these patients the dosage of VD was able to increase.