Clinical efficacy of tolvaptan for treatment of refractory ascites in liver cirrhosis patients

Table 1 Definitions for grades representing the measures of improvement for the urine excretion volume, ascites and edema

	Measure of improvement
	Significant improvement	Improvement	No improvement
Grade	A	B	C
Volume of urine excretion	Increased by > 1000 mL/24 h	Increased by 500-1000 mL/24 h	Increased by < 500 mL/24 h
Abdominal circumference	Decreased by > 2 cm	Decreased by 0-2 cm	No change
Edema (lower extremities)	A lack of visible pitting	Presence of visible pitting	Distinctly visible pitting

Table 2 Baseline characteristics of the cirrhotic patients with refractory ascites included in the study n (%)

Baseline characteristics		Value
Total number of patients		39
Age (yr)		55.0 ± 12.4
Sex	Male	32 (82.0)
	Female	7 (17.9)
Underlying liver disease	Cirrhosis	20 (51.3)
	Cirrhosis with hepatocellular carcinoma	19 (48.7)
Liver disease etiology	HBV infection	27 (69.2)
	HCV infection	3 (7.69)
	Alcoholic cirrhosis	9 (23.1)
Coexisting hepatorenal syndrome	Type 1	2 (5.13)
	Type 2	7 (17.9)
Coexisting hepatic encephalopathy		13 (33.3)
Child-Pugh score	Class C	39 (11.8 ± 1.5)
MELD score		39 (37.5 ± 5.6)
Coexisting diabetes		9 (23.1)
Hyponatremia	Yes	21 (53.8)
	No	18 (46.2)

Data are expressed as absolute numbers (percentage) or mean ± SD. HBV: Hepatitis B virus; HCV: Hepatitis C virus; MELD: Model for end-stage liver disease.

Table 3 Summary of the improvement in the urine excretion, ascites and edema after tolvaptan treatment, according to grading criteria, and in the overall improvement n (%)

	n	Significant improvement	Improvement	No improvement
Urine excretion	39	26 (66.7)	9 (23.1)	4 (10.3)
Abdominal circumference	39	19 (48.7)	13 (33.3)	7 (17.9)
Edema (lower extremities)	24	17 (70.8)	5 (20.8)	2 (8.3)
Overall improvement for all patients1	39	18 (46.2)	17 (43.6)	4 (10.2)
Overall improvement in patients with coexisting hepatocellular carcinoma1	19	9 (47.4)	7 (36.8)	3 (15.8)
Overall improvement in patients with coexisting hepatorenal syndrome (Type 1)1	2	0 (0)	0 (0)	2 (100.0)
Overall improvement in patients with coexisting hepatorenal syndrome (Type 2)1	7	2 (28.6)	5 (71.4)	0 (0)

¹Overall improvement definitions: Significant improvement = grade of A for urine excretion, ascites and edema; Improvement = grade of B for urine excretion and a grade of improvement for ascites or edema; No improvement = grade of C for urine excretion.