Kidney disease is serious enough.
And hyperkalemia, a frequent and dangerous complication of both acute and chronic kidney disease (CKD), can cause life-threatening cardiac arrhythmia and sudden death.
Now, it appears an investigational drug called patiromer can help prevent this serious condition, according to a study published today in the Journal of the American Medical Association.
Hyperkalemia occurs when blood-potassium levels reach above 5 millimoles per liter. It’s a common side effect of drugs essential in the treatment of chronic diabetic kidney disease.
The yearlong study found that patiromer given at one of four doses based on disease severity returned blood potassium levels to normal when measured at four weeks. It also kept the level under control for one year.
More than 300 people in five European countries participated in the study. They included people who had hyperkalemia, hypertension, type 2 diabetes, and CKD, and who were taking renin-angiotensin-aldosterone system (RAAS) inhibitors, which slow the progression of kidney disease, prior to and during the treatments.
Previous research demonstrated the short-term benefits of patiromer, but this is the first study to follow patients beyond four weeks.
How the Drug Works
When patiromer was taken orally by people with mild or moderate hyperkalemia, the drug decreased serum potassium levels within 48 hours.
For most of those people, potassium levels remained within the target range at every scheduled visit for the next year.
When the medication was stopped, potassium levels in the blood began to increase within three days and hyperkalemia recurred within eight weeks.
With almost 1 million people in the United States living with stage 4 or 5 CKD, Dr. George Bakris, professor of medicine and director of the Comprehensive Hypertension Center at the University of Chicago Medicine, says this advancement could make a huge impact.
The only alternative is a 50-year-old drug that is “difficult to take, poorly tolerated, and unpredictable,” Bakris said. “Most patients won’t take it.”
Patiromer is made of small, smooth spherical beads that are the size of a typical dust particle.
When mixed with a few tablespoons of water and swallowed, the particles attach themselves to potassium ions in the lower part of the colon. The potassium-packed beads are then excreted.
Who Will Benefit the Most?
People who are most at risk of developing hyperkalemia are those with CKD combined with diabetes and hypertension or heart failure.
About 10 percent of people who take RAAS inhibitors develop hyperkalemia within a year.
The combination of CKD, type 2 diabetes, high blood pressure, hyperkalemia and, in about one-third of cases, heart failure, can be deadly.
“An effective treatment for hyperkalemia lets us reconsider clinical trials in more advanced kidney disease that were stopped, or never started, due to risk of hyperkalemia,” Bakris said.
He added the study allows for further evaluation of the role of RAAS blockers on progression of CKD, as well as aldosterone blockade in people with heart failure.
Researchers note that during the study, 69 percent of the people enrolled had at least one adverse event. Only 20 percent of those were thought to be related to patiromer. These adverse events involved low magnesium, mild to moderate constipation, and diarrhea.
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