Comparative study of the effectiveness of tolvaptan versus urea in patients with hyponatremia caused by SIADH.

Background and objectives: Hyponatraemia is common in elderly and hospitalised patients, often caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). This study evaluates the efficacy and safety of tolvaptan and urea in patients with hyponatraemia and SIADH.

Materials and methods: An observational cohort study was conducted on 198 patients with SIADH and hyponatraemia (Na+ <135 mmol/L) at the Complejo Hospitalario Universitario de Pontevedra from January 2015 to May 2022. Of these, 86 were treated with tolvaptan (average dose of 7.5 mg) and 112 with urea (average dose of 15 g). The primary outcome was the normalization of sodium levels (Na ≥ 135 mmol/L).

Results: The tolvaptan group showed higher sodium concentrations at the end of therapy compared to the urea group (ME = 136, IQR = 135-137 vs. ME = 134, IQR = 132-137; p < 0.001). The time to normalise sodium was shorter with tolvaptan (4 ± 3.4 days) compared to urea (6 ± 3.6 days; p = 0.03). A higher percentage of patients achieved sodium normalization with tolvaptan (83.72% vs. 59.82%; p = 0.005). Tolvaptan had more adverse effects, such as dry mouth, thirst, and sodium overcorrection, while urea caused dysgeusia, abdominal pain, and diarrhea. There were no significant differences in mortality between the groups.

Conclusions: Tolvaptan was more effective and quicker than urea in normalising sodium levels, though it showed a higher percentage of adverse effects, which did not require discontinuation of the drug.