Effect on renal function as measured by serum creatinine and BUN1*†
†All hyponatremic patients from placebo-controlled, multiple-dose hyponatremia and CHF trials; tolvaptan doses 15 mg to 60 mg. Serum creatinine and BUN were measured from baseline to end of study. Serum creatinine and BUN were analyzed as part of the overall safety assessment in hyponatremic patients from placebo-controlled hyponatremia and CHF trials. Effect on renal function in placebo-controlled patients, serum creatinine (baseline 1.31 mg/dL [±0.6], end of study 1.3 mg/dL [±0.3]) and BUN (baseline: 32.3 mg/dL [±20.4], end of study 31.9 mg/dL [±11.6]).
SAMSCA is not recommended in patients with creatinine clearance <10 mL/min because drug effects on serum sodium levels are likely lost at very low levels of renal function.
No clinically significant impact on blood pressure with SAMSCA was seen in clinical trials.