Hyperkalemia Treatment, Veltassa, Seen to Work With or Without Food in Phase 4 Study

Hyperkalemia Treatment, Veltassa, Seen to Work With or Without Food in Phase 4 Study

Phase 4 clinical trial results show that Relypsa‘s Veltassa (patiromer), a drug used to treat hyperkalemia (excessive levels of potassium in the blood) — a condition that affects many patients with chronic kidney disease (CKD) — can reduce blood potassium levels whether taken with or without food, meeting the study’s primary endpoint.

CKD patients have impaired kidney function, which leads to the inefficient excretion of potassium, causing abnormally high levels of potassium to accumulate in the blood. This may lead to heart failure and sudden death.

The trial (TOURMALINE, NCT02694744) followed 114 patients with hyperkalemia (with blood potassium levels ranging from above 5.1 to less than 6.5 mEq/L), who were given Veltassa in a daily dose (8.4 g/day), taking it with or without food.  After four weeks of treatment, the patients were followed for two additional weeks to compare whether the treatment was able to bring blood potassium levels down to a normal range (3.8 – 5.0 mEq/L) by week three or four in patients in both groups.

Results showed no difference between the groups, demonstrating that Veltassa was able to reduce blood potassium levels when taken with or without food. Also, the adverse side effects in either group were consistent with those observed in previous trials for this drug. The most common side effects include constipation, hypomagnesemia (high levels of magnesium), diarrhea, nausea, abdominal discomfort, and flatulence.

Relypsa will now submit the results obtained in the trial to an upcoming medical meeting and share them with the U.S. Food and Drug Administration (FDA). The medication was approved by the FDA to treat hyperkalemia in October 2015.

“In clinical studies supporting its approval, Veltassa was administered with food and its prescribing information requires Veltassa be taken with food,” Lance Berman, MD, chief medical officer of Relypsa, said in a news release. “We’re pleased that this study showed a similar efficacy and safety profile whether Veltassa was taken with or without food and will discuss these results with the FDA.”

Veltassa is taken mixed with water and acts directly in the gastrointestinal tract, where it binds to potassium and helps the organism to excrete it. Because it acts primarily in the colon, Veltassa has a delayed onset of action and should not be used as an emergency treatment for hyperkalemia. It also binds to other oral medications, which may reduce their action and effectiveness. For this reason, Relypsa recommends that other oral medications be taken with an interval of 6 hours before or after Veltassa.

Patients with bowel obstruction, major gastrointestinal surgery conditions, or gastrointestinal or swallowing disorders should avoid this treatment, as it can be ineffective or even worsen these conditions.

 

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Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology.

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