(HealthDay News) — A new drug, patiromer, decreases serum potassium levels in patients with hyperkalemia and diabetic kidney disease, according to the results of a phase 2 study published in the Journal of the American Medical Association.
George Bakris, MD, a professor of medicine at the University of Chicago, and colleagues randomly assigned 306 patients with type 2 diabetes and high potassium levels to one of three doses of patiromer twice a day for a month. Patients also took renin-angiotensin-aldosterone system (RAAS) inhibitors before and during the trial.
All doses of patiromer significantly reduced potassium levels after a month and continued to keep levels low over a year, according to the data. Additionally, for most patients, potassium levels remained low without falling below normal.
Over the course of a year, 5.6% of patients developed hypokalemia; 7.2% developed hypomagnesemia and 6.3% experienced mild to moderate constipation.
If patiromer is approved by the U.S. Food and Drug Administration, the author of an accompanying journal editorial urges the agency to consider requiring post-marketing studies.
These should assess whether the drug slows kidney disease progression, reduces the need for dialysis and improves heart failure outcomes, Wolfgang Winkelmayer, MD, ScD, chair of nephrology at Baylor College of Medicine in Houston, said in the editorial.
The current study was funded by Relypsa, the maker of patiromer.