New Treatment Options for Hyperkalemia in Development

Two new oral medications currently under development could help maintain and prevent the onset of hyperkalemia, according to 2 recent studies.

In the first study—a double-blinded phase 3 trial—researchers assigned 753 hyperkalemia patients to receive a zirconium cyclosilicate (ZS-9) dose of 1.25 g, 2.5 g, 5 g, or 10 g or a placebo, which participants took 3 times a day for 48 hours.¹

According to researchers, patients showed a significant decrease in potassium levels at 48 hours. Further, they noticed that patients normalized at higher doses of serum potassium.
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On days 3 to 14, participants with normokalemia (a serum potassium level of 3.5 to 4.9 mmol per liter) were assigned at random to receive the placebo or ZS-9 once per day.¹

For the second study, researchers monitored 240 patients with chronic kidney disease on renin-angiotensin inhibiting drugs with elevated potassium levels. The participants were treated with patiromer (a nonabsorbed, potassium-binding polymer).

Researchers reduced potassium by 1 mmol/L after 4 weeks and 76% of the participants reached their target levels.²

After randomizing 100 of those patients to patiromer or placebo for an 8-week period, researchers found that hyperkalemia was more prevalent in patients receiving the placebo than the patiromer group: 60% vs. 15%, respectively.²

“The 2 relatively short-term studies by Weir et al. and Packham et al. excluded patients with serum potassium levels greater than 6.5 mmol per liter or electrocardiographic changes, hospitalized patients, and patients undergoing dialysis³,” said Julie R. Infelfinger, MD, in an accompanying editorial.

“Thus, the durability and side-effect profile of these agents over time remain unclear. Certainly, whether either or both of these agents will permit long-term administration of renoprotective and cardioprotective agents that block the RAAS will require more investigation³,” she said.

The complete studies are published in the November issue of the New England Journal of Medicine.

-Michelle Canales

References:

1. Packham DK, Rasmussen HS, Lavin PT, et al. Sodium Zirconium Cyclosilicate in Hyperkalemia. NJEM. 2014 November [epub ahead of print] doi: 10.1056/NEJMoa1411487.

2. Weir MR, Bakris GL, Bushinsk D A, et al. Patriomer in patients with kidney disease and hyperkalemia receiving RAAS Inhibitors. NJEM. 2014 November [epub ahead of print] doi: 10.1056/NEJMoa1410853

3. Ingelfinger JR. A new era for the treatment of hyperkalemia? NJEM. 2014 November [epub ahead of print] doi: 10.1056/NEJMe1414112.