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Tolvaptan corrected hyponatremia in hospitalized patients with cancer
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Tolvaptan effectively and safely treated hyponatremia in hospitalized patients with cancer, according to results of a double-blind, adaptive, randomized trial.
Hyponatremia — an electrolyte abnormality common in hospitalized patients — occurs more frequently in those with cancer than those without, according to the study background information.
Researchers at The University of Texas MD Anderson Cancer Center sought to assess tolvaptan (Samsca, Otsuka America Pharmaceutical) for the treatment of nonhypovolemic hyponatremia — defined as 125 mmol/L to 130 mmol/L serum sodium — in 30 hospitalized adults with cancer.
Researchers randomly assigned 17 patients to tolvaptan and 13 to placebo. All patients received standard care, which included fluid restriction, salt tablets or diuretics.
The primary endpoint of hyponatremia correction was met in significantly more patients assigned to tolvaptan than placebo (94% vs. 8%; P˂.001).
Researchers reported no significant differences in mean length of hospital stay (21 days for tolvaptan vs. 26 days for placebo) or mean change in Mini-Mental State Examination score (–0.35 for tolvaptan vs. 0.31 for placebo).
Researchers did not observe overcorrection of serum sodium — defined as ˃12 mmol/L per day — with treatment.
The most common adverse events associated with tolvaptan were polydipsia (46%), dry mouth (21%) and polyuria (13%).
Thirteen percent of patients withdrew from the study due to adverse events.
“In patients who have cancer with nonhypovolemic hyponatremia of moderate severity and do not respond to stand-of-care treatment for hyponatremia, tolvaptan can be an effective treatment for correcting hyponatremia,” the researchers concluded.
Disclosure: The study was funded by Otsuka America Pharmaceuticals Inc.
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