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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