Multicenter study on the long-term (3-year) efficacy of lanthanum carbonate in dialysis patients.

We previously conducted a multicenter study enrolling 101 dialysis patients with hyperphosphatemia in which lanthanum carbonate (LC) was administered for 2 years. In this study, the administration has been continued for an additional year, and we have evaluated the long-term (a total of 3 years) effects of LC. The average serum phosphorus (P) level was 6.05 mg/dL at the start and decreased to 5.84 mg/dL after 3 years, but no significant differences were observed at both points. The average serum corrected calcium (Ca) level significantly reduced after 3 years (P < 0.001). As results of evaluating the achievement rates with the management target values of serum P, Ca and intact parathyroid hormone (PTH) stated in the Japanese guideline, the achievement rates increased after 3 years. From these results, LC is considered to be a useful P binder that can be used for long-term treatment of hyperphosphatemia, without causing a Ca load.

Baseline characteristics and prevalence of cardiovascular disease in newly visiting or referred chronic kidney disease patients to nephrology centers in Japan: a prospective cohort study.

BACKGROUND: About 39,000 patients were newly prescribed renal replacement therapy in Japan in 2011, resulting in a total of more than 300,000 patients being treated with dialysis. This high prevalence of treated end stage kidney disease (ESKD) patients is an emergent problem that requires immediate attention. We launched a prospective cohort study to evaluate population specific characteristics of the progression of chronic kidney disease (CKD). In this report, we describe the baseline characteristics and risk factors for cardiovascular disease (CVD) prevalence among this cohort. METHODS: New patients from 16 nephrology centers who were older than 20 years of age and who visited or were referred for the treatment of CKD stage 2-5, but were not on dialysis therapy, were recruited in this study. At enrollment, medical history, lifestyle behaviors, functional status and current medications were recorded, and blood and urine samples were collected. Estimated glomerular filtration rate (eGFR) was calculated by a modified three-variable equation. RESULTS: We enrolled 1138 patients, 69.6% of whom were male, with a mean age of 68 years. Compared with Western cohorts, patients in this study had a lower body mass index (BMI) and higher proteinuria. The prevalence of CVD was 26.8%, which was lower than that in Western cohorts but higher than that in the general Japanese population. Multivariate analysis demonstrated the following association with CVD prevalence: hypertension (adjusted odds ratio (aOR) 3.57; 95% confidence interval (CI) 1.82-7.02); diabetes (aOR 2.45; 95% CI 1.86-3.23); hemoglobin level less than 11 g/dl (aOR 1.61; 95% CI 1.21-2.15); receiving anti-hypertensive agents (aOR 3.54; 95% CI 2.27-5.53); and statin therapy (aOR 2.73; 95% CI 2.04-3.66). The combination of decreased eGFR and increased proteinuria was also associated with a higher prevalence of CVD. CONCLUSIONS: The participants in this cohort had a lower BMI, higher proteinuria and lower prevalence of CVD compared with Western cohorts. Lower eGFR and high proteinuria were associated with CVD prevalence. Prospective follow up of these study patients will contribute to establishment of individual population-based treatment of CKD.

Multicenter study of long-term (two-year) efficacy of lanthanum carbonate.

Long-term efficacy of lanthanum carbonate on hyperphosphatemia was examined in multicenter dialysis patients. Outcome and efficacy after 2 years was investigated in 101 patients who had undergone lanthanum carbonate administration. Thirty-three cases dropped out by the 2-year point; patients undergoing at least 2 years of administration totaled 68. Reasons for dropping out were as follows: improvement of hyperphosphatemia, nine cases; changing hospitals, seven cases; medical complications, five cases; digestive symptoms, four cases; poor compliance, four cases; parathyroidectomy, two cases; death, two cases. The mean dosage was increased from initial daily dosage of 744 mg to 1266 mg after 1 year, and to 1246 mg after 2 years. Serum phosphate concentration decreased significantly from the initial 6.15 mg to 5.57 mg/dL after 1 year, and to 5.45 mg/dL after 2 years. Although a lowering trend was observed in corrected calcium levels, the difference was not significant. Parathyroid hormone was unchanged. Achievement rate of Japanese Society for Dialysis Therapy (JSDT) management target values for both phosphorus and calcium improved from 32.7% to 50.0% after 1 year, and to 56.5% after 2 years. Lanthanum carbonate is useful as a therapeutic tool for hyperphosphatemia over long durations.

Improvement of MBD parameters in dialysis patients by a switch to, and combined use of lanthanum carbonate: Josai Dialysis Forum collaborative study.

The effects of lanthanum carbonate on MBD parameters were investigated in 59 hemodialysis patients who were taking calcium carbonate. Lanthanum carbonate (initial dosage: 750 mg/day), as a replacement for or in combination with calcium carbonate and/or sevelamer hydrochloride, was administered for 12 months with increase/decrease of dosages. Lanthanum carbonate replaced calcium carbonate for 21 cases and was co-administered in 38 cases. It replaced sevelamer hydrochloride in 20 cases and was co-administered in 10 cases. Both the number of cases to which calcium carbonate was administered and their dosages decreased to about 70-80% 12 months after the initiation, and cases administered sevelamer decreased to about 30%. In the cases for which lanthanum carbonate was co-administered, the dosages of calcium carbonate and sevelamer slightly decreased. A significant decrease in serum calcium level was observed. In the serum phosphorus levels (P levels), significant decrease compared with the initial level was observed only at six and nine months. Intact parathyroid hormone (iPTH) level remained stable at around 230 pg/mL without significant change. The dosage of vitamin D and cinacalcet remained without significant change. The results of this trial suggest that, if dosages of vitamin D and cinacalcet are adequately controlled, a switch to lanthanum carbonate and its concomitant use are effective to control the Ca and P levels without changing iPTH levels.

The influence of dialysate calcium on the therapeutic effects of sevelamer hydrochloride in hemodialysis patients with secondary hyperparathyroidism under treatment of intravenous vitamin d metabolites.

The management of hyperphosphatemia is essential to treat secondary hyperparathyroidism and to prevent ectopic calcification. Sevelamer hydrochloride (sevelamer), a new phosphate binder that contains neither aluminum nor calcium, which could be theoretically beneficial for the management of hyperphosphatemia in dialysis patients with secondary hyperparathyroidism who are receiving intravenous vitamin D metabolites (maxacalcitol or calcitriol). To reduce calcium loads, a dialysate calcium concentration of 2.5 mEq/L is recommended by Kidney Disease Outcome Quality Initiative (K/DOQI) guidelines. In Japan, a dialysate calcium concentration of 3.0 mEq/L prevails. We investigated the influence of dialysate calcium on the therapeutic effect of sevelamer in 40 hemodialysis patients who are under treatment of intravenous vitamin D metabolites for secondary hyperparathyroidism (VD(+)) and compared the results with those of 41 patients who had not received vitamin D metabolites (VD(-)). Serum phosphorus and calcium-phosphorus products showed no significant change by sevelamer in either the VD(+) subgroup of patients receiving hemodialysis with dialysate calcium of 2.5 mEq/L (DCa2.5) or those receiving hemodialysis with dialysate calcium of 3.0 mEq/L (DCa3.0), while serum phosphorus and calcium-phosphorus products decreased in both the VD(-) subgroups. Serum calcium decreased in the DCa2.5 subgroup and did not change in the DCa3.0 subgroup in both the VD(+) and the VD(-) subjects. Parathyroid hormone and alkaline phosphatase increased in the DCa2.5 subgroup and did not change in the Ca 3.0 subgroup in the VD(+) subjects. Serum calcium decreased in both subgroups in the VD(-) subjects. Parathyroid hormone obtained after sevelamer administration in the VD(-) group was within the target range of the K/DOQI guidelines. In conclusion, the concomitant use of sevelamer as a phosphate binder and the dialysate of calcium concentration of 2.5 mEq/L have possibilities for worsening secondary hyperparathyroidism in patients receiving intravenous vitamin D.