FDA Approves Hyperkalemia Drug
Patiromer for oral suspension lowers potassium levels in hyperkalemic patients with chronic kidney disease.
The FDA has approved patiromer for oral suspension (Veltassa) to treat hyperkalemia.
The product, which is a powdered medication that patients mix with water and take orally, binds to potassium within the gastrointestinal tract, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
In clinical trials, patiromer lowered potassium levels in hyperkalemic patients with chronic kidney disease (CKD) who were taking at least 1 drug that inhibits the renin-angiotensin-aldosterone system (RAAS).
The most common patient-reported adverse reactions included constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.
The drug is made by Relypsa Inc., of Redwood City, Calif.
In a study of 27 hyperkalemic CKD patients taking at least 1 RAAS inhibitor published online recently in Kidney International, researchers demonstrated that patiromer induced a rapid and sustained lowering of potassium levels. In the study, David A. Bushinsky, MD, of the University of Rochester Medical Center in Rochester, N.Y., and colleagues found that patiromer treatment resulted in a significant 0.21 mEq/L decrease in mean serum potassium level by 7 hours after the first dose. At 48 hours (14 hours after the final dose), the investigators observed a significant mean reduction of 0.75 mEq/L in serum potassium levels. These levels did not increase before the next dose or for 24 hours after the last dose.