Amit Sharma

In the base-case model, FC had a net budgetary impact (savings)
Of US$213,223/year per 100 patients treated vs. standard
of care. One-way sensitivity analyses showed a net budgetary
impact of up to US$316,296/year per 100 patients
treated when higher hemoglobin levels observed with FC
translated into a 30% additional ESA dose reduction.

The efficacy of peginesatide
(administered monthly) was similar to that of darbepoetin
(administered every 2 weeks) in increasing and maintaining hemoglobin
levels. However, cardiovascular events and mortality were increased with peginesatide
in patients with chronic kidney disease who were not undergoing dialysis.
(Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers,
NCT00598273 [PEARL 1], NCT00598442 [PEARL 2], NCT00597753 [EMERALD 1],
and NCT00597584… Show more

The efficacy of peginesatide
(administered monthly) was similar to that of darbepoetin
(administered every 2 weeks) in increasing and maintaining hemoglobin
levels. However, cardiovascular events and mortality were increased with peginesatide
in patients with chronic kidney disease who were not undergoing dialysis.
(Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers,
NCT00598273 [PEARL 1], NCT00598442 [PEARL 2], NCT00597753 [EMERALD 1],
and NCT00597584 [EMERALD 2].) Show less

Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia.

Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient… Show more

Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient regiments. This nutraceutical was used in an attempt to replete vitamin D levels and decrease inflammation that dialysis patients experience. Additionally, we investigated the potential of this therapy to reduce the need for erythropoietin-stimulating agents. Results indicate MV-ONE caused: (1) increases in 25-OH vitamin D (p = 0.0058), (2) decreases in ESA dose (p = 0.0475), and (3) no change in C-reactive protein (p = 0.3290). Overall, this suggests the addition of MV-ONE does benefit the vitamin D deficiency and anemia observed in ESRD patients. Show less

The study participants are representative of a multinational cohort of patients on haemodialysis with elevated iPTH. The study results will provide valuable information on the best available treatment of SHPT in patients on haemodialysis.

The emergence of safety concerns and the subsequent changes in product labeling, reimbursement and clinical practice guidelines all appear to have influenced physician dosing practices resulting in less frequent use of ESAs, lower ESA doses and lower achieved Hb levels in CKD-NOD patients.

The two methods in estimating the DCR presented here provide payers with an empirical way of comparing ESA utilization for pharmacoeconomic evaluation. DCR results may vary according to patient characteristics; however, mean DCRs of greater than 300:1 were obtained in this analysis. Exclusion of other patient-related factors that may influence ESA dose is a possible limitation of the study.

Therapeutic strategies for SHPT therefore focus on controlling serum PTH, calcium and phosphate levels and effective treatment options include VDR activation and calcimimetic therapy. VDR activation involves the use of non-selective VDR activators (calcitriol), vitamin D prohormones (doxercalciferol and alfacalcidol), or the selective VDR activators maxacalcitol and paricalcitol. Clinical studies support the efficacy and safety of VDR activators as effective treatments for SHPT and recent… Show more

Therapeutic strategies for SHPT therefore focus on controlling serum PTH, calcium and phosphate levels and effective treatment options include VDR activation and calcimimetic therapy. VDR activation involves the use of non-selective VDR activators (calcitriol), vitamin D prohormones (doxercalciferol and alfacalcidol), or the selective VDR activators maxacalcitol and paricalcitol. Clinical studies support the efficacy and safety of VDR activators as effective treatments for SHPT and recent findings from several large observational studies have also suggested that the benefits of VDR activators may extend beyond the PTH-lowering effect, and could result in direct cardiovascular and survival benefits. Calcimimetics increase the sensitivity of the parathyroid gland to calcium through allosteric modulation of the calcium-sensing receptor, thus decreasing PTH secretion. A number of clinical studies support the use of cinacalcet, the only currently available calcimimetic, as an adjunct to VDR activator therapy in the treatment of SHPT, and a number of recent studies have investigated the role of cinacalcet with concomitant low-dose VDR activator therapy for the treatment of SHPT in dialysis patients, positioning cinacalcet as the primary therapy in the treatment regimen. Consequently, there is considerable debate surrounding the optimal approach to SHPT management and the respective roles of VDR activators and cinacalcet. Ongoing studies such as the IMPACT SHPT trial, a comparison of on-label dose titration protocols for paricalcitol and cinacalcet, should provide useful information in terms of the preferred approach for controlling SHPT in hemodialysis patients. Show less

Intravenous (IV) iron is a necessary component of the anemia management plan for the hemodialysis patient. Despite the demonstrated benefits of IV iron, questions remain as to the most effective strategies for using IV iron to maintain target hemoglobin (Hb) levels, ensure adequate iron supply, and optimize erythropoiesis-stimulating agent (ESA) therapy. Significant questions also surround the extent of the serum ferritin marker to reliably guide IV iron treatment decisions. The recent Dialysis… Show more

Intravenous (IV) iron is a necessary component of the anemia management plan for the hemodialysis patient. Despite the demonstrated benefits of IV iron, questions remain as to the most effective strategies for using IV iron to maintain target hemoglobin (Hb) levels, ensure adequate iron supply, and optimize erythropoiesis-stimulating agent (ESA) therapy. Significant questions also surround the extent of the serum ferritin marker to reliably guide IV iron treatment decisions. The recent Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) and DRIVE-II studies showed that improvements in Hb levels, iron status, and ESA responsiveness can be achieved with a repletion course of IV iron in patients with serum ferritin levels up to 1200 ng/mL. These studies also demonstrated that higher serum ferritin levels are a poor predictor of positive response to IV iron. We sought to apply the lessons learned from the DRIVE studies in our hemodialysis clinic. We designed this retrospective study to determine if regular, low-dose IV iron administered to patients with serum ferritin levels up to 1200 ng/mL could improve measures of anemia and iron status while optimizing the use of IV iron and ESAs. Show less

The hemodialysis (HD) patient is often marked by constant malnutrition, inflammation, and atherosclerosis, resulting in an increased risk of cardiovascular events and mortality. This chronic inflammatory state is often the result of increased oxidative stress. Nutritional supplementation may become an additional therapy to lower this inflammatory burden. By providing these patients with nutritional supplement and antioxidant therapies consisting of alpha-lipoic acid, cholecalciferol, ascorbic… Show more

The hemodialysis (HD) patient is often marked by constant malnutrition, inflammation, and atherosclerosis, resulting in an increased risk of cardiovascular events and mortality. This chronic inflammatory state is often the result of increased oxidative stress. Nutritional supplementation may become an additional therapy to lower this inflammatory burden. By providing these patients with nutritional supplement and antioxidant therapies consisting of alpha-lipoic acid, cholecalciferol, ascorbic acid, and Gamma-Tocopherol, providers may reduce overall inflammation and improve HD outcomes in patients with end-stage renal disease. Show less