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Patiromer safe, effective for hyperkalemia, regardless of HF status
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LAS VEGAS — Patiromer, a nonabsorbed, metal-free polymer, was associated with significant, persistent reductions in serum potassium in patients with hyperkalemia and chronic kidney disease, regardless of HF status, according to data presented at the Heart Failure Society of America Annual Scientific Meeting.
Bertram Pitt, MD, and colleagues performed a subgroup analysis of an international study of patiromer (Relypsa Inc.) in patients with hyperkalemia and chronic kidney disease (CKD) who were receiving treatment with one or more renin-angiotensin-aldosterone system (RAAS) inhibitors. The cohort included 102 patients with HF and 141 without HF.
In the initial treatment phase of the analysis, patients with mild hyperkalemia (5.1 to <5.5 mEq/L of serum potassium; n=92) received 4.2 g patiromer twice daily and patients with moderate-to-severe hyperkalemia (5.5 to <6.5 mEq/L; n=151) received 8.4 g twice daily. During a subsequent randomized withdrawal phase, 107 patients in the moderate-to-severe group with serum potassium levels of 3.8 mEq/L to <5.1 mEq/L upon completion of the treatment phase continued therapy with patiromer (n=55) or placebo (n=52), besides a RAAS inhibitor, for another 8 weeks.
Bertram Pitt
During the treatment phase, patients with and without HF experienced similar significant decreases in mean serum potassium from baseline (HF, –1.06 mEq/L vs. no HF, –0.98 mEq/L; P=.22). These changes occurred rapidly and persisted throughout the 4-week period. During the withdrawal phase, patients who received placebo experienced a marked increase in serum potassium compared with those who remained on patiromer treatment, regardless of the presence of HF (P=.5).
The researchers also noted a significant increase in the recurrence of hyperkalemia among placebo vs. patiromer recipients during the second phase, with or without HF (P=.96). Placebo recipients required discontinuation of RAAS inhibitor therapy more frequently than patiromer recipients, regardless of HF status.
Patiromer was well-tolerated within the cohort, with no significant differences in safety profile according to HF status. The most commonly observed adverse events were mild gastrointestinal issues, including diarrhea and nausea.
Pitt told Cardiology Today that patiromer is a “well-tolerated, effective way of treating hyperkalemia compared to what we had before. It is going to lead to a big change in practice."
While the new results indicate the ability of patiromer to control hyperkalemia, further assessment of the polymer through larger studies remains necessary to confirm a potential life-saving benefit, according to Pitt.
“I would like to see outcome studies [showing] that [this therapy] really makes a difference in hospitalization and mortality,” said Pitt, professor of medicine emeritus at University of Michigan School of Medicine. “This would open up not just the treatment of hyperkalemia, but, eventually, once we become more comfortable, the prevention of hyperkalemia.” – by Adam Taliercio
For more information:
Pitt B. Late-Breaking Clinical Trials. Presented at: the Heart Failure Society of America Annual Scientific Meeting; Sept. 14-17, 2014; Las Vegas.
Disclosure: Pitt reports receiving honoraria from Novartis, ownership interest in Relypsa and serving on consultant and advisory boards for Bayer, DaVinci Therapeutics, Eli Lilly, Johnson and Johnson, Juventis, Pfizer, Relypsa, Sarfez, scPharmaceuticals, Stealth Peptides and Takeda.