FDA Approves Potassium-Binder Patiromer (Veltassa), New Option for RAAS-Inhibitor–Treated Patients

Disclosures

October 21, 2015

BETHESDA, MD — The US Food and Drug Administration (FDA) has approved a new oral option for reversing hyperkalemia, which is a persisting concern with standard medications for heart failure, especially antialdosterone agents, ACE inhibitors, and angiotensin-receptor blockers[1].

The approval of patiromer for oral suspension (Veltassa, Relypsa) comes after the phase 2 AMETHYST-DN study showed that daily administration of the potassium-binding agent safely controlled hyperkalemia over 1 year in patients with type 2 diabetes and hypertension with or without heart failure (HF). They had entered with mild to moderate hyperkalemia secondary to treatment with renin-angiotensin-aldosterone-system (RAAS)–inhibiting drugs.

After Dr Bertram Pitt (University of Michigan, Ann Arbor) presented the trial at the American College of Cardiology 2015 Scientific Sessions, he told heartwire from Medscape that after the supposed approval of patiromer, and if another investigational potassium-binding agent, ZS-9 (ZS Pharma) is approved, "it looks like there is a new era . . . for renal disease and HF that really will change the game."

The FDA described Veltassa as "a powdered medication that patients mix with water and take by mouth" that works by binding potassium in the gastrointestinal tract and allowing it to pass through and out of the body. Its most common reported adverse effects, the agency continued, are hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.

Patiromer, according to its labeling, "should not be used as an emergency treatment for life-threatening hyperkalemia, because of its delayed onset of action."

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