Results presented at late-breaking trial session of National Kidney Foundation's 2019 Spring Clinical Meetings
New York, NY–Sept. 15, 2019— The respected peer-reviewed, medical journal The Lancet will publish today the results of a study presented in May at the National Kidney Foundation's 2019 Spring Clinical Meetings as a late breaking clinical trial that may offer hope to some patients with advanced chronic kidney disease (CKD) whose hypertension is difficult to treat.
It is challenging for many patients to stay on spironolactone therapy, which is a type of diuretic, because it can increase the risk of hyperkalemia. If left untreated, hyperkalemia can cause abnormal heart rhythms and even sudden death, according to the investigators of the study "Patiromer to Enable Spironolactone in Patients with Resistant Hypertension and CKD: Primary Results of AMBER."
The study was presented by Dr. Rajiv Agarwal of Indiana University School of Medicine, Indianapolis, at the NKF Spring Clinical Meetings. Thousands of kidney healthcare professionals gathered at NKF's annual event to learn about the latest innovations in nephrology.
"There is a clear unmet need for safe and effective therapies to treat chronic kidney disease patients with resistant hypertension who need to control both blood pressure and blood potassium levels, as these patients are at particularly high-risk for cardiovascular events," said Dr. Rajiv Agarwal of Indiana University School of Medicine, Indianapolis.
"In fact, spironolactone has not previously been studied in this patient population in reasonable numbers due to the potential increased risk of developing hyperkalemia," Dr. Agarwal said. "The results of the AMBER study suggest that patients treated with patiromer may be more likely to stay on spironolactone therapy, a life-saving medicine to control blood pressure in resistant hypertension."
The team of investigators hope to present further data from this clinical trial at future congresses and in peer-reviewed publications, according to Dr. Agarwal.
In addition to Dr. Agarwal, the investigators are Patrick Rossignol of the University of Lorraine, Nancy, France; Dahlia Garza, Martha R. Mayo, Suzette Warren, Jia Ma, and Alain Romero of Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA; William B. White of the University of Connecticut School of Medicine, Farmington; and Bryan Williams of the University College London.
NKF Chief Medical Officer Joseph Vassalotti, MD, who was not involved in the study, commended Dr. Rajiv Agarwal and colleagues for presenting these important findings for the first time at the NKF Spring Clinical Meetings.
"Spironolactone was shown to be an effective drug for treating resistant hypertension in the previously published PATHWAY-2 trial, but individuals with advanced CKD were excluded," Dr. Vassalotti said. "Now, the AMBER trial results inform the treatment of resistant hypertension for people living with low levels of kidney function."
Dr. Agarwal also created a video about the study that can be viewed at https://youtu.be/gBbqEuWTGgc To read the full article in The Lancet, go to:
"The Lancet is among the top three medical journals and all specialties compete for publication in the journal," Dr. Agarwal said. "The decision by the editors to publish our manuscript is a victory for patients with advanced CKD in whom clinical trials are rare. However, our work has just started with publication of AMBER. Our positive findings should encourage further studies in this group of patients who are often excluded from clinical trials."
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Kidney Disease Facts
In the United States, 37 million adults are estimated to have chronic kidney disease—and most aren't aware of it. 1 in 3 American adults are at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).
The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.