Fresenius Medical Care Completes Acquisition of NxStage Medical
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Real-world data analyses for PD patients (n = 258) also showed improvements in sP levels along with reductions in PB pill burden after switching to Velphoro (Figure 3).17The proportion of patients achieving sP 5.5 mg per dL increased by 72 percent from baseline to month 6 of Velphoro follow-up. Prescribed PB pills per day decreased by 57 percent from 10 at BL to 4.3 at Velphoro follow-up (p < 0.0001).
An analysis of 103 patients on HHD prescribed Velphoro for six months showed improvement in sP (Figure 4).18 Patients achieving sP 5.5 mg per dL increased by 96 percent, from 24.3 percent at baseline to 47.6 percent during Velphoro treatment. The number of PB pills per day was reduced from 8.9 to 4.3 pills per day.
Several sub-analyses were conducted to examine the effectiveness of Velphoro in specific HD patient populations. Among Hispanics/Latin Americans prescribed Velphoro, the percent of patients achieving sP < 5.5 mg per dL increased by 73 percent and the number of PB pills per day decreased by greater than 50 percent after six months.19 Black/African American patients prescribed Velphoro experienced a 58 percent increase in achieving sP < 5.5 mg per dL along with a greater than 50 percent reduction in number of PB pills per day.20 A subpopulation of patients with low serum albumin (< 3.5 g per dL) was analyzed to determine nutritional status and phosphorus control after switching to Velphoro.21 Serum albumin levels increased, while serum phosphorus levels decreased. These finding are being further investigated, as both low serum albumin and high serum phosphorus are known predictors of increased mortality risk.22,23 Sub-analyses of iron indices showed that changes were consistent with the findings reported in the phase III trial, where increases from baseline were not clinically significant and increases were mainly observed in patients receiving IV iron.24,25,26
In summary, significant increases (between 70 and 135 percent) in the number of patients achieving sP 5.5 mg per dL were observed for HD, HHD, and PD patients switched from any of the major binders (sevelamer, calcium acetate, lanthanum, and ferric citrate) to Velphoro, supporting the potency of Velphoro as a PB with a low pill burden. By reducing the PB pill number by half or more, Velphoro helps reduce the total daily pill burden and may improve adherence to medications. Ongoing and future data analyses include combination PB therapies, improved adherence, and assessing potential cost savings associated with lowering serum phosphorus (e.g., reducing hospitalization risk).27
In her seven years with Fresenius Medical Care Renal Therapies Group, Linda Ficociello has focused her research on evidence-based medicine and database studies on various topics, including bone and mineral metabolism and home dialysis therapies. She earned her bachelor’s degree at the University of New Hampshire, and her doctorate in epidemiology and master of science at Boston University School of Public Health. She completed her training as a post-doctoral fellow at Harvard Medical School.
Robert “Rob” Kossmann practiced nephrology for two decades prior to joining FMCNA in 2014. The former president of the Renal Physicians Association and founding member of its Nephrology Coverage Advocacy Program, he served as nephrology advisor to the American Medical Association’s Relative Value Scale Update and founded the New Mexico Renal Disease Collaborative Group.
Claudy Mullon received his doctorate from Washington University in St. Louis and was a postdoctoral fellow at MIT where he remained a research affiliate for 10 years. He has co-authored more than 50 articles in peer-reviewed journals and is an inventor on 20 US patents. He is a current member of the American Society of Transplantation and an elected fellow of the American Institute for Medical and Biological Engineering.
The Real-World Effectiveness of Velphoro in Patients on Chronic Dialysis
by Linda Ficociello, DSc, Robert J. Kossmann, MD, FACP, FASN &
Claudy Mullon, PhD