Hemodialysis.com Interview with: Albert Q. Lam, MD Harvard Medical School, Boston, MA More »
Hemodialysis.com Interview with: Dr. Der-Cherng Tarng and Dr. Chih-Cheng Hsu. More »
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication – Strengthened Kidney Warnings
ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
BACKGROUND: Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see Drug Safety Communication for the Data Summary). This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.
UnitedHealthcare Will Reimburse Kidney Donors’ Travel Expenses, Expanding Life-Saving Access to Kidney Transplants
BOSTON (June 13, 2016) – UnitedHealthcare will pay travel expenses for kidney transplant donors, addressing one of the major barriers to living organ donation.
The announcement was made yesterday at the 2016 American Transplant Congress in Boston by Jon Friedman, M.D., chief medical officer for Optum’s Complex Medical Conditions programs. Optum is the health services company that manages transplant services for UnitedHealthcare. Both companies are collaborating with the American Society of Transplantation (AST) and American Society of Transplant Surgeons (ASTS), which hosted the congress, to improve outcomes, reduce costs and enhance the experience of donors and recipients.
UnitedHealthcare will be the largest payer to directly reimburse living donors, from the start of their evaluation process, through follow-up visits two years post-donation. The donor does not need to be enrolled in a UnitedHealthcare plan to qualify for reimbursement.
“Many healthy people are eligible to donate a kidney, yet only one-third of kidney transplants come from living donors,” said Friedman, who has clinical oversight and responsibility for transplantation and chronic and end-stage kidney disease for Optum. “This initiative will make it easier for living kidney donors to provide a life-saving gift to patients and their families.”
According to the AST, 96 percent of kidney donors experience donation-related financial consequences.
Starting in 2017, UnitedHealthcare will reimburse up to $5,000 toward lodging and travel expenses for living kidney donors. The travel reimbursement will be offered on top of existing coverage of medical expenses associated with a kidney transplant for both the recipient and the living donor.
While the need for kidney transplants continues to increase, the number of donor kidneys falls far short of demand. In 2015, only about one in five people on the kidney transplant waiting list received a transplant, according to the Organ Procurement and Transplantation Network (OPTN). Living donors are the best source to increase the pool of kidneys available for transplantation.
“The American Society of Transplant Surgeons applauds UnitedHealthcare and Optum for taking this significant step toward reducing the financial barriers to living organ donation, and we look forward to working with them and other partners to make it possible for everyone who wants to donate an organ to do so,” said Charlie Miller, M.D., president of ASTS.
James Allan, M.D., president of the American Society of Transplantation, added: “UnitedHealthcare and Optum’s efforts to address the issue of late-stage kidney disease are significant. We hope this is only the first step as our health care system works to remove financial and other barriers to organ donation.”
UnitedHealthcare plans will reimburse lodging and travel expenses for the kidney donor and a companion, starting with the donor’s initial evaluation to determine suitability, through follow-up evaluations up to two years after donor surgery. The travel reimbursement, up to $5,000, will be available for all donors whose intended transplant recipients are enrolled in UnitedHealthcare fully insured plans as of the new policy year, Jan. 1, 2017.
Philadelphia, PA — February 17, 2016 – Philadelphia-based MC has been selected as the recipient of the National Kidney Foundation (NKF)’s Patient Advocacy Award. Freeway will be honored on World Kidney Day, Thursday, March 10, 2016 at the NKF Honors Awards Reception in Philadelphia. During September 2015, without warning, the 37-year-old State Property MC and North Philadelphia native was diagnosed with kidney failure.
Currently undergoing dialysis three times a week, Freeway is committed to raising awareness of kidney disease and ensuring Philadelphians stay on top of their kidney health. In October, Freeway hosted and helped kick off the Kidney Walk in Philadelphia at the Philadelphia Museum of Art. The event drew over 4,000 walkers who helped raise awareness and funds to support the fight against kidney disease. “It is a pleasure to be presenting Freeway with the Patient Advocacy Award at March’s NKF Honors Award Ceremony,” said Christin Naab, Executive Director of the National Kidney Foundation in Philadelphia. “Freeway remains committed to sharing his story on local and national platforms, encouraging the public to learn kidney disease risk factors and to get their kidneys checked.”
Alongside Freeway, NKF will honor Joseph Cosgrove, President and CEO of Pentec Health with the Leadership in Business Award, nephrologist Dr. Robert Benz, of Lankenau Medical Center with the Excellence in Care Award and Mrs. Tina Wilson, of Team Wilson/Wilmington University with the Community Leadership Award.
NKF Press Release:
Wynnewood, PA– February 17, 2016 –Dr. Robert Benz, nephrologist of Lankenau Medical Center, has been selected as the recipient of the National Kidney Foundation (NKF)’s Excellence in Care Award.
Dr. Benz will be honored on World Kidney Day, Thursday, March 10, 2016 at the NKF Honors Awards Reception in Philadelphia. Dr. Robert Benz is the Chief of the Division of Nephrology at Main Line Health and Lankenau and has been caring for Philadelphia area kidney patients for over 30 years. He is also currently Director of the Nephrology Fellowship Program and has trained numerous residents and fellows with teaching being a major part of career and mission, utilizing the knowledge and education that he gained during his years at Penn.
He currently sits on the NKF’s Medical Advisory Board along with many other leadership roles in the field. “It is a pleasure to be presenting Dr. Benz with the Excellence in Care Award at March’s NKF Honors Award Ceremony,” said Christin Naab, Executive Director of the National Kidney Foundation in Philadelphia. “Dr. Benz and Lankenau Medical Center are committed to improving the health and quality of life for kidney patients and help to provide top quality care right here in the Delaware Valley.”
Alongside Dr. Benz, NKF will honor Joseph Cosgrove, President and CEO of Pentec Health with the Leadership in Business Award, Tina Wilson, of Team Wilson/Wilmington University with the Community Leadership Award and Philadelphia native and MC Freeway, with the Patient Advocacy Award. NKF Honors is the NKF’s annual affair that honors those in the communities who have made a difference in the lives of kidney patients and have advanced the mission of the National Kidney Foundation. The Kidney Ball is one of NKF’s largest annual fundraisers and is anticipated to raise over $300,000 for the organization’s awareness, prevention, and treatment programs. Those interested in attending or sponsoring can find more information online at www.nkfdv.org
Peritoneal Dialysis: Skin Autofluorescence Correlates With Increased Heart Disease and Mortality Risk
Emília Mácsai MD. PhD. nephrologist, diabetologist
Hemodialysis.com: What are the main finding of the study? Were any of the findings unexpected?
Response: Advanced glycation end-products are well-known markers of cardiovascular mortality in hemodialysed patients, they represent subgroup of uremic toxins and molecular mediators of diabetic complications. Their tissue accumulation is measurable with a special AGE Reader device. Skin autofluorescence evaluating with this simple non-invasive method signs in our study the previous cumulative glucose burden (higher rates in case of diabetes), correlates with presence of cardiovascular disease and in 3 years term predicts mortality in patients on peritoneal dialysis. Peritoneal glucose exposure and elapsed time in peritoneal dialysis also connected with skin autofluorescence, which indicate additional dialysis-associated glycemic effect.
Hemodialysis.com: What should clinicians and patients take away from this study?
Response: This method seems to be suitable to evaluate the extent of long-term damage in connective tissues caused by diabetes and decreased renal elimination of advanced glycation end-products, and signifies patients with high cardiovascular risk in this vulnerable population. Helps us to recognize patients who mostly need for non-glucose based peritoneal solution and multidisciplinary intervention.
Hemodialysis.com: What recommendations do you have for future research as a result of your study?
Response: More biocompatible low glucose peritoneal dialysis solutions should be introduced more extensively, further result could prove their advantageous effect on skin autofluorescence and simultaneous changes in mortality and cardiovascular events.
Background Skin autofluorescence (SAF) is a proven prognostic factor of mortality in hemodialysis patients. Traditional and non-traditional risk components are similar in peritoneal dialysis (PD), and as well cardiovascular disease (CVD) is the leading cause of death. Moreover peritoneal glucose absorption accelerates degenerative processes of the connective tissues, like in diabetes. In our study we examined the predictive value of SAF for mortality in PD population.
Methods Data were taken from 198 prevalent adult Caucasian PD patients, 126 of them (mean age 66.2 year; male 73; diabetes ratio 75/126) had anamnestic CVD (coronary heart disease, cerebrovascular disease, peripheral arterial disease). Initially we evaluated the factors affecting SAF and CVD by multivariate linear regression. Registering the clinical and demographic data associations with mortality during the next 36 months survival were estimated using Kaplan-Meier method, analysis were stratified on presence of CVD and SAF level above or below the upper tercils 3.61.
Results SAF was influenced by CVD (p<0.01; CI 0.1-0.5) and white blood cell count (p<0.001; CI 0.031-0.117). According Spearman correlation it connected with peritoneal cumulative glucose exposure (p=0.02) and elapsed time in PD (p=0.008). CVD related with age (p<0.001; CI 1.24-1.65) and diabetes (p<0.001; CI 2.58-10.66). More death were observed in the high SAF group, than in the low SAF group (34/68 v. 44/130; p=0.04). Comparing the CVD(-) low SAF group survival (mean 33.9 month; SE 1.39) to CVD(+) low SAF (mean 30.5 month; SE 1.37; p=0.03) and to CVD(+) high SAF group (mean 27.1; month; SE 1.83; p=0.001) the difference was significant.
Conclusions Among patients on PD the SAF value over 3.61 seems to be predictor of mortality. Relationship with glucose-exposure, CVD and diabetes suggests its suitability to characterize systemic cumulative glucose load.
Hemodialysis.com Interview with:
Hemodialysis.com: What are the main findings of the study?
Response: We followed over 5900 elderly patients, hospitalized with acute coronary syndrome for development of acute kidney injury (AKI) after coronary angiography. We found that those who developed stage 1 and stage 2-3 AKI had 35% and 66% low odds of use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers after hospital discharge. The odds of use of statins and beta-blockers after discharge were also lower in those who developed stage 2-3 AKI by 56% and 54%, respectively. The lower use of these medications after discharge was seen across a number of subgroups, including those with diabetes, heart failure, chronic kidney disease, and proteinuria.
Hemodialysis.com: What are the main findings of this study?
Dr. Robinson-Cohen: The primary findings of the study show that a simple measure of self-rated health, a CKD patient’s answer to the question “In general, would you say your health is excellent, very good, good, fair, or poor?”, predicts mortality and kidney disease progression at least as well as traditional risk models and a panel of novel biomarkers.
The assessment of general self-rated health could be incorporated into patient evaluation to provide a quick and easy tool for identifying patients who might benefit from closer surveillance or more intensive risk factor management.
Further research is needed to determine the best way to incorporate this assessment into clinical practice, as well as to investigate whether interventions targeting self-reported health translate into improved outcomes for patients.
Self-Rated Health and Adverse Events in CKD
Cassianne Robinson-Cohen, Yoshio N. Hall, Ronit Katz, Matthew B. Rivara, Ian H. de Boer, Bryan R. Kestenbaum, and Jonathan Himmelfarb
CJASN CJN.03140314; published ahead of print October 9, 2014, doi:10.2215/CJN.03140314