Study Finds LOKELMA™ (sodium zirconium cyclosilicate) Reduces Elevated Potassium in Hemodialysis Patients

MedicalResearch.com Interview with:

Steven Fishbane MD Chief, Division of Kidney Disease and Hypertension Vice President, Northwell Health for Network Dialysis Services, Northwell Health Professor of Medicine Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York

Dr. Fishbane

Steven Fishbane MD
Chief, Division of Kidney Disease and Hypertension
Vice President, Northwell Health for Network Dialysis Services, Northwell Health
Professor of Medicine
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Department of Medicine, Zucker School of Medicine at Hofstra/Northwell,
Great Neck, New York 


MedicalResearch.com: What is the background for this study?

Response: Patients on hemodialysis have a great frequency of hyperkalemia. The hemodialysis treatment removes some potassium but not enough to get rid of this problem. Available medications to bind potassium have not been tested among these patients.

The purpose of the study was to see if sodium zirconium cyclosilicate could be used as a potassium binder to reduce the risk of hyperkalemia in patients on a hemodialysis.

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Many ER Patients with Elevated Potassium, End up Being Admitted After Discharge

MedicalResearch.com Interview with:
AstraZenecaJill Davis, MS
Director, Health Economics and Outcomes Research
AstraZeneca 

MedicalResearch.com: What is the background for this study? Who is most at risk for hyperkalemia post discharge?

Response: In the United States, an estimated 30 million people suffer from chronic kidney disease (CKD), about 3.7 million of which have hyperkalemia (elevated potassium level). Hyperkalemia (HK) can be chronic, so it’s important that those who have been diagnosed with hyperkalemia previously or have CKD have their potassium levels monitored by their healthcare provider. Additionally, although HK is estimated to be prevalent in more than 66,000 emergency department (ED) visits annually, there is limited knowledge about the management of patients with HK in the ED setting and post-discharge. We decided to focus our study to better understand and compare the ED management and post-discharge outcomes among patients with varying levels of hyperkalemia

To conduct this study, we analyzed the electronic medical record data from the Research Action for Health Network (2012-2018) of 6,222 adult patients with a randomly selected HK-related ED visit. We concluded that improved management of HK patients in the ED and post-discharge period is needed to reduce the recurrence of hyperkalemia.

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LOKELMA (Sodium zirconium cyclosilicate) for Elevated Potassium: Results of the HARMONIZE GLOBAL Study

MedicalResearch.com Interview with:

Rahul Agrawal MD PhD VP, Global Medicines Leader AstraZeneca

Dr. Agrawal

Rahul Agrawal MD PhD
VP, Global Medicines Leader
AstraZeneca

MedicalResearch.com: What is the background for this study?  

About the study: HARMONIZE Global is a Phase III, randomized, multicenter, double-blind, placebo-controlled trial involving 267 patients with hyperkalemia (mean potassium levels greater than 5.0 mEq/L) in 47 study locations across the Asia Pacific region, which will support registration in Japan, Taiwan, Korea and Russia.

Study design: The trial design of HARMONIZE Global is similar to HARMONIZE (NCT02088073) but evaluated two doses of LOKELMATM (sodium zirconium cyclosilicate) instead of three, as well as patients in different geographical regions. Continue reading

Lokelma Receives FDA Approval To Treat Elevated Potassium, Hyperkalemia

MedicalResearch.com Interview with:

Steven Fishbane, MD, Chief, Division of Kidney Disease and Hypertension, Northwell Health Vice President, Northwell Health for Network Dialysis Services, Northwell Health Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Lead investigator of the ZS 005 study.

Dr. Fishbane

Steven Fishbane, MD,
Chief, Division of Kidney Disease and Hypertension, Northwell Health
Vice President, Northwell Health for Network Dialysis Services, Northwell Health
Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Lead investigator of the ZS 005 study

MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by hyperkalemia?What are the dangers of an elevated potassium and how does LOKELMA differ from prior standard treatments?

 Response: Hyperkalemia is when the potassium in the blood rises to potentially harmful levels. High potassium is primarily harmful for the heart. As the potassium level rises the risk for abnormal electrical rhythms or disruption of the heart’s pumping occur. When severe, a high potassium level can cause death.

Lokelma has been demonstrated to be effective for lowering potassium levels with a great degree of consistency. It is well tolerated and has a fairly rapid onset of potassium lowering compared to other drugs for the purpose.  Continue reading

Dietary Potassium Associated With Lower Risk Of Stroke in Postmenopausal Women

Sylvia Wassertheil-Smoller, PhD Department of Epidemiology and Population Health Albert Einstein College of Medicine Bronx, NY 10461.MedicalResearch.com Interview with:
Sylvia Wassertheil-Smoller, PhD
Department of Epidemiology and Population Health
Albert Einstein College of Medicine
Bronx, NY 10461.

First author on this paper was Arjun Seth, BS, Dr. Wassertheil-Smoller’s mentee and a medical student at the Albert Einstein College of Medicine.

Medical Research: What are the main findings of the study?

Dr. Wassertheil-Smoller: We found in study of nearly 100,000 postmenopausal women in the Women’s Health Initiative that a high intake of dietary potassium was associated with a lower risk of ischemic stroke and death from all causes.
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