Efficacy of Tolvaptan in elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia / 中华老年医学杂志

ABSTRACT

Objective:To evaluate the efficacy and safety of conventional diuretic therapy versus Tolvaptan in elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia, in order to provide clinical evidence for the treatment of heart failure in the elderly.Methods:This was a randomized control trial.A total of 88 elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia were randomly divided into the control group(n=46)and the experimental group(n=42). Once enrolled both groups stopped taking oral loop diuretics.In addition to routine treatment, the control group was treated with furosemide 40 mg once a day, while the experimental group was treated with Tolvaptan 15 mg once a day.The rate of effectiveness in relieving heart failure, the diuretic effects and improvement in heart and kidney function were monitored, and changes in serum potassium and sodium levels and the incidences of thirst and other adverse events were compared between the two groups.Results:The effectiveness rate on heart failure was higher in the experimental group than in the control group(85.7% or 36/42 vs.65.2% or 30/46, χ2=17.855, P<0.001). After treatment, greater changes in average 24-hour urine volume from baseline(787.4±219.6 ml vs.388.6±179.6 ml, t=322.588, P<0.001), more weight loss(-2.4±2.1 kg vs.-1.7±1.6 kg, t=6.942, P=0.009), smaller changes in N-terminal pro-B-type natriuretic peptide(NT-proBNP)from baseline(-897.6±432.1 ng/L vs.-578.4±476.9 ng/L, t=539.400, P<0.001), greater changes in left ventricular ejection fraction(LVEF)from baseline(6.5±5.6 % vs.1.5±5.7 %, t=3.966, P=0.048), smaller changes in serum creatinine from baseline(-8.6±12.4 μmol/L vs.9.6±11.3 μmol/L, t=87.161, P<0.001), and greater changes in estimated glomerular filtration rate(eGFR)from baseline(1.4±1.8 ml·min -1·1.73m -2vs.-4.1±5.6 ml·min -1·1.73m -2, t=63.856, P<0.001)and in serum sodium from baseline(6.2±2.1 mmol/L vs.1.4±1.9 mmol/L, t=234.065, P<0.001)were observed in the experimental group than in the control group.There was no significant difference in the incidences of thirst, dry mouth and other adverse events between the two groups(16.7% or 7/42 vs.10.9% or 5/46, χ2=0.626, P=0.429). Conclusions:Tolvaptan can effectively improve the clinical symptoms and cardiac function and correct hyponatremia in elderly chronic heart failure patients combined with mild to moderate renal insufficiency, with a good safety profile.