Why carry out this study?

Hospitalized patients with hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) have a high burden of illness and require careful management to safely normalize serum sodium levels.

This pharmacovigilance study was conducted to provide real-world safety and efficacy data on the use of tolvaptan in this population.

What was learned from the study?

In clinical practice, tolvaptan was used in the correct indication of hyponatremia secondary to SIADH, increasing patient serum sodium and reducing the frequency of hyponatremia symptoms.

Cases of overly rapid correction of hyponatremia occurred, but no osmotic demyelination syndrome was reported.

Data from real-world clinical practice support clinical trial findings that tolvaptan improves serum sodium in hyponatremia secondary to SIADH with appropriate monitoring to reduce the risks associated with overly rapid correction of hyponatremia.