Nearly 370 Hospitals Have Signed on to Implement Evidence-Based Care Practices Including LOKELMA® (sodium - zirconium cyclosilicate)
CHARLOTTE, N.C. - Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company, announced today it has reached a significant milestone in its partnership with AstraZeneca, a global, science-led biopharmaceutical company aimed at reducing hospitalizations among patients with hyperkalemia, which is characterized by higher-than-normal potassium levels. Premier Applied Sciences® has implemented evidence-based care practices with nearly 370 hospitals across the U.S. designed to prevent patients with hyperkalemia from requiring treatment in the acute-care setting.
The risk of hyperkalemia increases significantly for patients with chronic kidney disease and for those who take common medications for heart failure, such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalemia occurs in 23-47 percent of patients with chronic kidney disease and/or heart failure. Hyperkalemia can lead to hospitalization and increased resource utilization. Together, Premier Applied Sciences and AstraZeneca have developed a protocol for monitoring and treating patients with hyperkalemia. The protocol includes the potential use of LOKELMA® (sodium - zirconium cyclosilicate), a potassium binder indicated for the treatment of hyperkalemia in adults.1
“Working with AstraZeneca, we have been able to observe many challenges clinicians face when treating patients with hyperkalemia,” said Denise Juliano, Group Vice President for Premier Applied Sciences. “We have been able to identify gaps in care and create a discharge protocol to help patients better manage their hyperkalemia status and help reduce readmissions to the hospitals.”
As part of the first phase in Premier’s partnership with AstraZeneca, Premier Applied Sciences conducted a study to examine the clinical characteristics of patients with hyperkalemia and assessed hyperkalemia-related readmissions, emergency room presentations, outpatient visits and costs. For the second phase of the study, Premier will utilize a linked sample from the Premier Healthcare Database (PHD) and a large commercial claims database to further assess the association between LOKELMA® use and specific clinical outcomes such as hyperkalemia, cost, readmissions and other hospital visits among patients with hyperkalemia. The final component of this de-identified study will examine the impact of having a hyperkalemia discharge protocol on cost and healthcare resource utilization among hospitalized patients.
“AstraZeneca continues to support and encourage solutions to help patients live healthier lives,” said Tarek Rabah, Vice President, Renal, US, at AstraZeneca. “Through our work with the Premier Applied Sciences team, we are furthering our commitment to revolutionize treatment and care for the millions of patients living with hyperkalemia.”
Hospitals participating in the partnership are eligible for discounts on LOKELMA® from AstraZeneca. These evidence-based care practices allow hospitals to improve care delivery with an aim to reduce the risk for admissions and readmissions for patients with hyperkalemia.
IMPORTANT SAFETY INFORMATION FOR LOKELMA® 5 g and 10 g (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.
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.
- Non-hemodialysis Patients
For initial treatment of hyperkalemia, the recommended starting dose is 10 g administered three times a day up to 48 hours. For maintenance treatment, the recommended starting dose is 10 g once daily. Monitor serum potassium and adjust dose of LOKELMA at 1-week intervals or longer in increments of 5 g based on serum potassium and desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily. Discontinue or decrease the dose of LOKELMA if serum potassium is below the desired target range.
- Hemodialysis Patients
For patients on chronic hemodialysis, administer LOKELMA only on non‑dialysis days. The recommended starting dose is 5 g once daily on non-dialysis days. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L. Monitor serum potassium and adjust the dose of LOKELMA based on the pre‑dialysis serum potassium value after the long interdialytic interval and desired target range. During initiation and after dose adjustment, assess serum potassium after one week. Discontinue or decrease the dose of LOKELMA if serum potassium falls below the desired target range based on pre-dialysis value after the long interdialytic interval or the patient develops clinically significant hypokalemia. The recommended maintenance dose range is from 5 g to 15 g once daily, on non-dialysis days.
PLEASE READ FULL PRESCRIBING INFORMATION.
The risk of hyperkalemia increases significantly for patients with CKD and for those who take common medications for HF, such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalemia occurs in 23% to 47% of patients with CKD and/or HF, with an estimated 200 million and 38 million people, respectively, living with each condition worldwide. Hyperkalemia can lead to hospitalization and increased resource utilization.
1. LOKELMA® (sodium - zirconium cyclosilicate) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. Accessed March 25, 2020.