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Drug Safety Evaluation

The tolerability and safety profile of patiromer: a novel polymer-based potassium binder for the treatment of hyperkalemia

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Pages 525-535 | Received 06 Feb 2018, Accepted 04 Apr 2018, Published online: 22 Apr 2018
 

ABSTRACT

Introduction: Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions.

Areas covered: We review pooled data from two clinical trials of patiromer in patients with CKD and HK, safety of patiromer in special populations, drug–drug interaction (DDI) studies, and other studies in healthy volunteers.

Expert opinion: Potassium must be maintained within a narrow range to avoid increased risk of mortality. Patients with CKD and HF and those receiving RAASI require careful monitoring of potassium levels. Patiromer effectively reduces serum potassium, and gastrointestinal adverse events (AEs) are the most common patiromer-associated AEs. Effective management of HK with patiromer may allow use of RAASI at optimal doses as recommended by treatment guidelines. Future research should examine the potential for potassium binders, including patiromer, to extend use of RAASI in appropriate patient populations.

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Corrigendum

Box 1. Drug summary.

Acknowledgments

Medical writing and editorial support were provided by Impact Communication Partners, Inc. and funded by Relypsa, Inc.

Declaration of interests

Dr. Bertram Pitt reports personal fees for consulting with Sanofi, Relypsa, Merck, Bayer, AstraZeneca, scPharmaceuticals, Tricida, KBP Biosciences, Stealth Peptides, Sarfez, and AuraSense. He has stock options with scPharmaceuticals, Tricida, KBP Biosciences, Sarfez, and AuraSense. He serves on a data safety monitoring committee for and receives personal fees from Johnson & Johnson. In addition, he has a pending patent EFS ID 14916043, application number 61762661/UM-33001/US-1PRO for the site-specific delivery of eplerenone to the myocardium.

Dr. Garza reports employment with Relypsa, Inc., a Vifor Pharma Group Company.

Additional information

Funding

The studies reported in this manuscript were funded by Relypsa, Inc., a Vifor Pharma Group Company. Medical writing assistance and editorial support was funded by Relypsa, Inc.

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