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FDA Approves Potassium Absorption Blocker Veltassa
The potassium binder patiromer (Veltassa, Relypsa) has received FDA approval for the treatment of hyperkalemia. The medication is a powder for oral suspension that is meant to be mixed with water. The approval of patiromer was based on patients who typically experience high blood potassium levels, including those with chronic kidney disease (CKD), heart failure, diabetes, and hypertension.
Relypsa says the pivotal phase III OPAL-HK study showed patiromer significantly decreased potassium levels in hyperkalemic CKD patients taking renin-angiotensin-aldosterone system (RAAS) inhibitors (mean decrease of –1.01 ± 0.03 mEq/L from baseline; P < 0.001). At four weeks, 76% of patients had potassium levels in the target range (3.8 to < 5.1 mEq/L). During the second part of the trial, patients taking patiromer had no change in median potassium from baseline (0.00 mEq/L), whereas potassium levels significantly increased in the placebo group (0.72 mEq/L; P < 0.001).
In the clinical trials, most adverse reactions were mild to moderate. The most common adverse reactions in all trials included constipation (7.2%: 5.4% mild and 1.8% moderate), hypomagnesemia (5.3%), diarrhea (4.8%), nausea (2.3%), abdominal discomfort (2.0%), and flatulence (2.0%).
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia (elevated blood potassium levels). Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience recurrent spikes in potassium levels and be at risk for these cardiac events.
Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors such as angiotensin receptor blockers, aldosterone antagonists, and angiotensin-converting enzyme inhibitors.
Veltassa is expected to be available to patients in the United States by the first week of January 2016.
Source: Relypsa, October 21, 2015.