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In both the FIDELITY analysis and FINEARTS-HF, potassium management strategies, such as pausing treatment when serum potassium levels exceeded 5.5 mmol/L and resuming therapy once levels dropped below 5.0 mmol/L, were effective in preventing hyperkalemia-related adverse events

The stricter oversight introduced by the 2026 regulations aims to mitigate these risks, even if it means restricting access to certain therapies in the short term

Sabina M, Alsamman MM

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