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LOKELMA®在美国获得快速通道认证，以改善慢性血液透析伴高钾血症患者的心血管结局
Hyperkalemia is characterized by excessive potassium levels in the blood, generally defined as greater than 5.0 meq/L. Many patients with chronic kidney disease (CKD) remain hyperkalemic despite hemodialysis and often experience fluctuations in potassium levels. Despite adequate hemodialysis, up to 25% of patients have serum potassium >5.5 meq/L. Patients who experience large changes in potassium levels during dialysis are at high risk for developing cardiac arrhythmias, which may lead to cardiac arrest.
On November 17, 2021, AstraZeneca's LOKELMA (sodium zirconium cyclosilicate, sodium zirconium cyclosilicate) received fast track certification in the United States for reducing arrhythmia-related cardiovascular outcomes in chronic hemodialysis patients with recurrent hyperkalemia (HK). The designation is based on LOKELMA's potential to reduce serious adverse cardiovascular outcomes in this patient population and addresses a serious unmet medical need. This is being investigated in the ongoing Phase 3 DIALIZE-Outcomes trial.
HK is prevalent in patients with chronic kidney disease (CKD) and heart failure (HF), affecting 24% to 48% of patients with moderate to advanced (stage 3-4) CKD and/or HF, and remains a burden once patients undergo chronic hemodialysis. In patients with end-stage renal disease (ESRD) receiving chronic hemodialysis, HK is associated with an increased risk of all-cause and cardiovascular death and hospitalization.
Mene Pangalos, executive vice president, Biopharmaceuticals R&D, AstraZeneca, said: "The DIALIZE-Outcomes trial is the first-ever cardiovascular outcomes trial using a potassium binder in hemodialysis and has the potential to change the standard of care for these patients. The FDA's decision demonstrates the importance of this trial, which will provide important information on the ability of LOKELMA to reduce potentially fatal cardiovascular complications associated with hyperkalemia in chronic hemodialysis patients."
The DIALIZE-Outcomes trial is part of the CRYSTALIZE evidence project, which consists of more than 50 clinical and real-world evidence studies investigating the potential benefit of LOKELMA in treating HK across the cardiorenal spectrum. The DIALIZE-Outcomes trial is currently ongoing, with results expected in 2024.
LOKELMA is a highly selective oral potassium remover that has been approved for the treatment of HK in the United States, the European Union, Canada, China, Hong Kong, Russia, Japan and other countries and regions. In 2020, the FDA and the European Commission (EC) approved label updates in the United States and the European Union, respectively, to include a dosing regimen specifically for the treatment of HK in patients with chronic hemodialysis ESRD.
The most common adverse reaction in non-dialysis patients treated with LOKELMA is mild to moderate edema. In placebo-controlled trials of up to 28 days, edema occurred in 4.4%, 5.9% and 16.1% of non-dialysis patients taking 5 g, 10 g and 15 g of LOKELMA once daily, respectively, compared with 2.4% in the placebo group.
References:
https://www.businesswire.com/news/home/20211117006015/en/LOKELMA%C2%AE-Granted-Fast-Track-Designation-in-the-US-to-Reduce-Cardiovascular-Outcomes-in-Patients-on-Chronic-Hemodialysis-With-Hyperkalemia
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