Fewer Pills, More Control with Velphoro: A Q&A with Dr. Robert Kossmann

Fewer Pills, More Control with Velphoro | FMCNA

A discussion about phosphate binders with Dr. Robert Kossmann, Chief Medical Officer for Fresenius Medical Care North America (FMCNA), including new research being presented at the 2019 National Kidney Foundation (NKF) Spring Clinical Meetings in Boston.

Q: Why is controlling phosphorus so important in patients with kidney failure?

RK: Too much phosphorus can increase the risk of cardiovascular complications such as heart attack or stroke, as well as contribute to mineral bone disease.1,2  The use of dialysis combined with the right diet can only go so far to replace the body’s normal ability to control phosphorous by excreting excess in the urine. Many patients will need a phosphate binder to help keep their levels low.

Q: Velphoro, or Sucroferric Oxyhydroxide (SO), was first offered to U.S. dialysis patients in 2014. What makes this a good binder for patients?

RK: With Velphoro, patients are provided with the most potent non-calcium phosphate binder currently available. The global organization Kidney Disease: Improving Global Outcomes (KDIGO) recommends calcium-based binders should be restricted because high calcium intake has been shown to add to the cardiovascular calcification burden. Because of its potency, Velphoro reduces the pill burden significantly.

Other options on the market typically require patients to take 9 or 10 tablets a day. The starting dose with Velphoro is one tablet with meals, and most patients settle in around 3 to 5 pills a day. This reduction in pill burden, while providing improvement in phosphate control, has really made a difference for patients.

Q: Why is reducing the pill burden so important?

RK: There is good research that suggests pill burden impacts patient adherence to the prescribed therapy.3If patients are not taking the drug, it can’t do its job. A phosphate binder will a lower pill burden can help improve patient adherence, and in turn, improve its effectiveness, with the goal of improving patient outcomes.

Q: Since Velphoro was introduced, there is an increasing body of research demonstrating its effectiveness. What is most exciting about the abstracts you are presenting at the NKF Spring Clinical Meetings this year?

RK: We have been able to consistently document what is happening in real patients, in real life, and finding evidence that patients who switch to Velphoro have sustained improvement.4 That’s really exciting.

In one of our abstracts, we document how patients with very high serum phosphorus levels, who were taking more than 12 pills a day of another non-calcium binder, were able to reduce their pill burden by 60 percent after switching to Velphoro. At the same time, it effectively lowered and helped to control their serum phosphorous levels.

In another abstract, we did a retrospective analysis and found a reduction in hospital admissions for patients who stayed with Velphoro for two years compared to patients who switched to another binder. We found a reduction of 35 hospital visits per 100 patients. That’s not only better for patient’s health but can reduce costs to the healthcare system.

This type of research, combined with our study recently published in the Journal of Renal Nutrition, is building on the evidence for why Velphoro is so effective.

Q: Have you seen nephrologists more willing and interested in prescribing Velphoro?

RK: Absolutely. This ongoing research gives nephrologists more confidence by showing how it can help patients, especially those who are struggling with the high pill burden of other options. Doctors are seeing convincing data that you can get better phosphate control with fewer pills.5

About Robert J. Kossmann, MD, FACP, FASN

Dr. Robert “Rob” Kossmann is Chief Medical Officer at Fresenius Medical Care North America and previously served as Chief Medical Officer for the company’s Renal Therapies Group. He 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.

Additional Resources:

Insight: The Real-World Effectiveness of Velphoro in Patients on Chronic Dialysis by Linda Ficociello, Dr. Robert Kossmann and Claudy Miller

Press Release:  Velphoro® Doubles Percentage of Patients Reaching Target Serum Phosphorous Levels in New Study Published in Journal of Renal Nutrition

Press Release: Abstracts on Velphoro® Accepted for Presentation at the American Society of Nephrology Kidney Week

INDICATION

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

IMPORTANT SAFETY INFORMATION

• Velphoro chewable tablets must be administered with meals. Velphoro should be chewed or crushed.  Do not swallow whole.
• Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.
• In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).
• Velphoro can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin. For oral medications where a reduction of bioavailability would be clinically significant consider separating of the timing of administration.  Consider monitoring clinical responses or blood levels of the concomitant medications.

For additional important safety information, please see the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is intended for use by US healthcare professionals only.

Velphoro is distributed by Fresenius Medical Care Renal Therapies Group, LLC.

1. Yamada S, Tsuruya K, Taniguchi M, et al. Association between serum phosphate levels and stroke risk in patients undergoing hemodialysis: the Q-Cohort Study. Stroke. 2016;47(9):2198-2196.
2. Kendrick J, Kestenbaum B, Chonchol M, et al. Phosphate and cardiovascular disease. Adv Chron Kidney Dis. 2011;18(2):113-119.
3. Chiu YW, Teitelbaum I, Mirsa M, et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6):1089-1096.
4. Kendrick J, Parameswaran V, Ficociello LH, et al. One-year historical cohort study of the phosphate binder sucroferric oxyhydroxide in patients on maintenance hemodialysis. J Ren Nutr. 2019 Jan 21. pii: S1051-2276(18)30254-1.
5. Gray K, Ficociello LH, Hunt AE, et al. Phosphate binder pill burden, adherence, and serum phosphorus control among hemodialysis patients converting to sucroferric oxyhydroxide. Int J Nephrol Renovasc Dis. 2019;12:1-8.