March 2017: News Briefs

Real-Time Models Predict Risk of AKI

In a study conducted recently among acute kidney injury (AKI) patients at the University of Pennsylvania Hospital in Philadelphia, researchers found that measuring and accounting for risk factors in real-time worked well for predicting dialysis, death, and length of stay. The strategy worked well whether using a traditional logistic regression model or machine-learning techniques.

In an article in Medpage Today, F. Perry Wilson, MD, of Yale University in New Haven, said, “In the end, both approaches worked quite well, though the machine-learning approach was more parsimonious. Either approach can be used to create real-time, time-updated predictive models––imagine a real-time risk score that changes with every data point—that physicians in the hospital can use to direct care to the right patient at the right time.”

Study results were reported in PLOS One.

FDA Approval for Parsabiv™ for HPT

In early February, the FDA approved Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adults with chronic kidney disease on dialysis. Parsabiv is the first therapy to be FDA-approved for this indication in 12 years. It is the only calcimimetic that can be administered intravenously by dialysis healthcare providers three times a week at the end of the hemodialysis session.

In a February 7 press release from Amgen, Sean E. Harper, MD, executive vice president of research and development, said, “We are excited about today’s approval of Parsabiv in the US and the opportunity to provide patients and healthcare providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis. Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the healthcare professional.”

Geoffrey A. Block, MD, a nephrologist at Denver Nephrologists, PC, in Colorado, said, “As a physician who cares for patients with advanced chronic kidney disease, I understand the importance of achieving and maintaining simultaneous reductions in a number of complex lab values in the treatment of secondary HPT. The ability to provide my patients with an intravenous calcimimetic and help ensure they receive the therapy they need is a tremendous milestone in the management of this frequently undertreated chronic progressive disease.”

Veltassa® Drug-Drug Interaction Studies

Relypsa, Inc. has announced results of phase 1 drug-drug interaction studies that demonstrated minimal risk for drug-drug interactions with Veltassa® when other oral drugs are administered 3 hours apart. Study results were published in the Journal of Cardiovascular Pharmacology and Therapeutics by Lawrence J. Lesko, PhD, lead author. The data were the basis for the updates to Veltassa’s prescribing information announced in 2016 that included removing the Boxed Warning and shortening of the dosing separation to 3 hours.

In a press release from Relypsa, Dr. Lesko said, “These phase 1 studies in healthy volunteers were rigorously designed to maximize the probability of identifying drug-drug interactions with Veltassa if they were to occur. We believe these clinical results confirm minimal risk of drug-drug interactions with Veltassa and the majority of the drugs tested. Furthermore, where an interaction was observed, separating Veltassa from the other oral medications by at least 3 hours removed the potential for an interaction. These findings significantly add to our understanding of Veltassa and how to avoid drug-drug interactions with coadministered oral medications.”

Lance Berman, MD, chief medical officer of Relypsa, added, “With the change to a 3-hour dose separation between Veltassa and other medications, physicians now have increased flexibility in selecting Veltassa for patients with hyperkalemia and adding it to their daily treatment regimen. We are pleased by these study results and by the updated Veltassa label and are working to provide this information to physicians who treat patients with hyperkalemia.”

Organ Transplants Reach Record High in 2016

According to a press release from the Organ Procurement and Transplantation Network (OPTN), for the fourth consecutive year, organ transplants in 2016 in the United States reached a record high. The announcement was based on preliminary data from the United Network for Organ Sharing (UNOS). For the year 2016, there were a reported 33,606 transplants, a 8.5% increase over the number in 2015 and an increase of 19.8% since 2012.

Stuart Sweet, MD, PhD, president of the OPTN/UNOS board of directors, said, “Thousands more men, women, and children are receiving a life-saving transplant opportunity each year. We are deeply grateful to all who have chosen to help others through the life-saving act of organ donation. We are also very conscious that many more people are still anxiously awaiting a transplant, so we must continue to work with our partners in the donation and transplant community to meet the needs of those who continue to wait.”

The increase in overall transplants was driven in part by an increase of 9.2% in the number of deceased donors from 2015 to 2016, continuing a 6-year trend of annual increases. Approximately 82% of the transplants performed in 2016 involved organs from deceased donors.

An increasing number of deceased donors in 2016 had medical characteristics or a medical history that in the past may have been considered less often by clinicians. These include people who donated after circulatory death as opposed to brain death, as well as donors who died of drug intoxication or those identified as having some increased risk for blood-borne disease, the press release noted.

Renal Dysfunction Indicator of Mortality Risk in Stroke Patients

In a study at Wake Forest Baptist Medical Center, a nephrologist-led team found that patients with renal dysfunction on admission, indicated by estimated glomerular filtration rate calculated from a blood creatinine test and basic demographic information (age, race, sex), were significantly more likely to die while hospitalized and less likely to be discharged home. The study was reported in the February issue of Stroke.

In a press release from the Wake Forest Baptist Medical Center, Nasa El Husseini, MD, lead investigator, said, “Kidney disease is frequently a comorbidity in patients with acute ischemic stroke. This one test done on admission to measure kidney function can be used to better inform patients with ischemic stroke and their families about what to expect.”

The study results found that in-hospital mortality was most common among stroke patients with eGFR ≤15 mL/min/1.73 m2 without dialysis and least common among stroke patients with eGFR ≥60 mL/min/1.73 m2. The data also showed that discharge home was most common among stroke patients with eGFR ≥60 mL/min/1.73 m2 and least common among those with scores ≤15 mL/min/1.73 m2 without dialysis.

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases.

Pediatric Asthma Patients Risk of Kidney Stones

One in three children with kidney stones (<12 years of age) has asthma. In a Cleveland Clinic study reported in PLOS One, researchers found that kidney stones are four times more likely to occur in children with asthma than in children without asthma, and that asthma is four times more likely to occur in children with kidney stones.

“These results clearly demonstrate a link between the conditions in a large pediatric population. A better understanding of the link between the diseases might uncover new genetic or biochemical pathways and could lead to better interventions to prevent painful stones from developing in pediatric asthma patients,” according to Serpil Erzurum, MD, coauthor of the study.

In a press release from the Cleveland Clinic, coauthor Manoj Monga, MD, said, “While obesity is thought to predispose children to kidney stones, the association between asthma and kidney stones in this study was not related to body mass index.”

CMS Awards Fresenius 18 ESCOs

In January, the Centers for Medicare & Medicaid Services awarded Fresenius Medical Care North America one of 18 new End Stage Renal Disease Seamless Care Organization (ESCO) designations. An ESCO is the nation’s first disease-specific shared savings program. The program is designed to identify, test, and evaluate new ways to improve care for people with end-stage renal disease (ESRD). Under each ESCO, local nephrologists and dialysis providers partner to develop an innovative care model based on highly coordinated, patient-centered care.

According to a press release from Fresenius Medical Care, the company now operates 24 ESCO’s nationwide, approximately two thirds of the ESCOs in the country. The 24 ESCOs represent the largest ESCO presence of any kidney care provider.

Bill Valle, chief executive officer of Fresenius Medical Care North American, said, “We are excited for the opportunity to work with CMS on this important initiative and we are proud to have been awarded 18 ESCOs in markets across the country…By working closely with our physician partners, our network of providers and care coordinators have demonstrated the ability to improve our patients’ health outcomes and reduce costs for the system.”