Abstract | IMPORTANCE: OBJECTIVE: EVIDENCE REVIEW: Studies of patiromer were obtained via a literature search of PubMed database and Google Scholar (2000 to the present) using ' patiromer', ' RLY5016', and ' hyperkalemia management' as keywords. Additional references were identified from fda.gov, clinicaltrials.gov, and the pharmaceutical manufacturer, Relypsa Inc. FINDINGS: Three published clinical trials, ten posters, one clinical trial commentary, three editorials and one oral presentation were obtained. The materials discussed three main clinical trials (PEARL-HF, OPAL-HK and AMETHYST-DN) and examined the safety and efficacy of patiromer in patients with hyperkalemia or at risk for hyperkalemia who have chronic kidney disease (CKD), type 2 diabetes mellitus (T2DM), hypertension and/or heart failure (HF) while receiving renin-angiotensin-aldosterone system inhibitors (RAASis). All three studies achieved their primary endpoints and reduced serum potassium. The PEARL-HF study increased the proportion of patients able to titrate their spironolactone dose from 25 mg/day to 50 mg/day in patients with normokalemia who had a history of hyperkalemia or an estimated glomerular filtration rate of <60 mL/min. The OPAL-HK study allowed patients receiving patiromer to remain on their RAASi therapy. The AMETHYST-DN study demonstrated that patiromer reduced and maintained mean serum potassium ≤5.0 mEq/L for up to 1 year, with a low rate of hypokalemia. Adverse events (AEs) were similar between studies. The most commonly reported adverse event was constipation. CONCLUSIONS AND RELEVANCE:
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Authors | Ann G Montaperto, Mona A Gandhi, Lauren Z Gashlin, Melanie R Symoniak |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 32
Issue 1
Pg. 155-64
( 2016)
ISSN: 1473-4877 [Electronic] England |
PMID | 26456884
(Publication Type: Journal Article, Review)
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Chemical References |
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Topics |
- Aged
- Clinical Trials as Topic
- Female
- Heart Failure
(complications)
- Humans
- Hyperkalemia
(drug therapy)
- Male
- Polymers
(adverse effects, therapeutic use)
- Renal Insufficiency, Chronic
(complications)
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