1.
Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study.
Covic, AC, Sprague, SM, Rastogi, A, Ketteler, M, Walpen, S, Perrin, A, Floege, J
Nephron. 2020;(9):428-439
Abstract
INTRODUCTION Control of hyperphosphatemia in patients on dialysis remains a major challenge. OBJECTIVE This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial. METHODS Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled. RESULTS Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (-2.89 vs. -0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765-0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328-0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937-0.992) as significant predictors of uncontrolled sP. CONCLUSION This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.
2.
Concentration of 25(OH)D₃ and calcium and phosphorus metabolism in patients suffering from relapsing-remitting multiple sclerosis. A pilot study.
Kubicka, K, Pierzchała, K
Neurologia i neurochirurgia polska. 2013;(2):126-30
Abstract
BACKGROUND AND PURPOSE The aim of this study was to evaluate the concentration of 25(OH)D₃ and the indices of calcium and phosphorus metabolism at different times of relapsing-remitting multiple sclerosis (MS). The relationships between the concentrations of 25(OH)D₃ and the indices of calcium-phosphate metabolism were determined, depending on the duration of disease and vitamin and unsaturated fatty acids supplementation. MATERIAL AND METHODS Thirty patients (15 at the early stage and 15 at the advanced stage of MS) were enrolled. Each patient underwent neurological examination; neurological motor disability was defined according to the Expanded Disability Status Scale (EDSS). The results were compared to the values obtained in the control group (15 individuals) selected according to the age of subjects, their residence, ethnicity and gender. RESULTS Significantly lower serum concentrations of 25(OH)D₃ in MS patients compared to the control group were found. MS patients at the advanced stage of the disease (duration of 5-6 years) had lower 25(OH)D₃ concentrations than patients at the early stage of MS. Among patients in an advanced stage of MS, significantly lower levels of 25(OH)D₃ were found in women compared to men with a similar level of physical disability. CONCLUSIONS Lower serum concentrations of 25(OH)D₃ in MS patients compared to the control group were found. The lowest concentrations of 25(OH)D₃ were found in female patients aged 20-40 and in patients with a longer disease duration without substantial impairment of calcium-phosphate metabolism.
3.
Additional reduction in serum phosphorus levels by pulverized lanthanum carbonate chewable in hemodialysis patients.
Yamashita, T, Ogawa, T, Takahashi, M, Mitsuhashi, T, Shizuku, J, Takahashi, N, Ohba, T, Miyajima, S, Kabaya, T, Otsuka, K, et al
Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy. 2013;:54-9
Abstract
Lanthanum carbonate (LC) is one of the relatively new phosphate binders. The general LC dosage form is a chewable pharmaceutical preparation. This investigation was targeted to subjects who do not chew LC chewable preparations adequately, for the purpose of studying the clinical efficacy of changing to pulverized prescriptions, such as changes in serum phosphorus levels (P levels). The study took place at Minamisenju Hospital in October 2011, with 41 subjects on maintenance hemodialysis. We pulverized all of the LC chewable medicines of the LC insufficient mastication group (non-chewing: NC group, n = 18) using a crusher, and changed them to pulverized prescriptions. The testing period was set at 10 weeks. In the NC group, there was a significant lowering of P levels from 5.86 ± 1.31 mg/dL before pulverization of the LC chewable preparation (week 0) to 5.38 ± 1.26 mg/dL after 2 weeks of administration of the pulverized medication (P = 0.0310), 5.20 ± 1.25 mg/dL after 4 weeks (P = 0.0077), and 5.12 ± 1.34 mg/dL after 6 weeks (P = 0.0167). P levels in other patients than NC group showed no significant change. In this study, the P levels in the NC group was lowered significantly by changing the LC chewable to the pulverized prescription, and the residual LC images on the abdominal X-rays disappeared to the point where they could barely be confirmed.
4.
Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl.
Sprague, SM, Evenepoel, P, Curzi, MP, González, MT, Husserl, FE, Kopyt, N, Sterling, LR, Mix, C, Wong, G
Clinical journal of the American Society of Nephrology : CJASN. 2009;(9):1465-76
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Abstract
BACKGROUND & OBJECTIVES Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180. RESULTS Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were < or =300 pg/ml (weeks 16 through 180) and median CaxP values were < or =55 mg(2)/dl(2) (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events. CONCLUSIONS Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk.