HK is a prevalent condition 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 it remains a burden once patients are on chronic hemodialysis. In patients with end-stage renal disease (ESRD) receiving chronic hemodialysis, HK has been associated with an increased risk of all-cause and CV mortality, and hospitalizations.
The
The DIALIZE-Outcomes trial is part of the CRYSTALIZE evidence program, which is comprised of over 50 clinical and real-world evidence studies researching the potential benefit of LOKELMA in the management of HK across the cardiorenal spectrum. The DIALIZE-Outcomes trial is currently underway with results expected in 2024.
LOKELMA is a highly selective, oral potassium-removing agent currently approved in the US, EU,
IMPORTANT SAFETY INFORMATION FOR LOKELMA (sodium zirconium cyclosilicate)
WARNINGS AND PRECAUTIONS:
Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid LOKELMA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders. LOKELMA has not been studied in patients with these conditions and it may be ineffective and may worsen gastrointestinal conditions
Edema: Each 5-g dose of LOKELMA contains approximately 400 mg of sodium, but the extent of absorption by the patient is unknown. In clinical trials of LOKELMA in patients who were not on dialysis, edema was observed and was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily. Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure or renal disease). Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed
In a clinical trial of LOKELMA in patients on chronic hemodialysis in which most patients were treated with doses of 5 g to 10 g once daily on non-dialysis days, there was no difference in the mean change from baseline in interdialytic weight gain (a measure of fluid retention) between the LOKELMA and placebo groups
Hypokalemia in Patients on Hemodialysis: Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia on LOKELMA (eg, illnesses associated with decreased oral intake, diarrhea). Consider adjusting LOKELMA dose based on potassium levels in these settings
Diagnostic Tests: LOKELMA has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures
ADVERSE REACTIONS: The most common adverse reaction in non-dialysis patients with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of non-dialysis patients treated with 5 g, 10 g, and 15 g of LOKELMA once daily, respectively vs 2.4% of non-dialysis patients receiving placebo.
DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.
INDICATION AND LIMITATION OF USE
LOKELMA is indicated for the treatment of hyperkalemia in adults.
LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Hyperkalemia
Hyperkalemia is characterized by high levels of potassium in the blood, generally defined as greater than 5.0 meq/
DIALIZE-Outcomes
DIALIZE-Outcomes is a Phase III randomized, double-blind, placebo-controlled, multicenter study evaluating the effect of LOKELMA on arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia. The study consists of a 4-week dose-titration period followed by patient visits every 3 months over an average of 2 years. This is an international study involving approximately 300 sites across the US,
LOKELMA
LOKELMA (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odorless, tasteless and stable at room temperature. LOKELMA is indicated for the treatment of hyperkalemia in adults including patients on chronic hemodialysis.
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of
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