Efficacy of combination therapy with natriuretic and aquaretic drugs in cirrhotic ascites patients: A randomized study

Table 1 Baseline patient characteristics n (%)

	Combination diuretic (n = 28)	Conventional diuretic (n = 28)	P value
Age, yr	69.3 ± 11.8	69.4 ± 12.6	0.9739
Gender: Male	17 (60.7)	15 (53.6)	0.7875
Weight, kg	61.7 ± 13.8	58.0 ± 13.5	0.3082
Body mass index, kg/m2	24.2 ± 4.74	22.4 ± 3.48	0.1044
Etiology: HBV/HCV/alcoholic/other	2/12/9/5	2/10/9/7	0.9341
Child-Pugh score	10.4 ± 1.2	10.3 ± 1.4	0.7653
Child-Pugh stage: A/B/C	0/16/12	0/15/13	0.7881
Liver cancern	7 (25.0)	8 (28.6)	1.0000
Varicose veins	23 (82.1)	25 (89.3)	0.7049
Liver encephalopathy: Grade 0/I	24/4	24/4	1.0000
Concomitant medication:
Spironolactone, mg/d	50.9 ± 29.3	50.0 ± 22.6	0.8987
Furosemide, mg/d	38.6 ± 18.4	37.7 ± 20.3	0.8639
BCAA	21 (75.0)	19 (67.8)	0.7674
Non-absorbable disaccharides	8 (28.5)	10 (35.7)	0.7748
ARB or ACE inhibitor	3 (10.7)	4 (14.3)	1.0000
Duration of diuretics therapy, d	25.9 ± 28.3	22.8 ± 20.1	0.6318
Pretreatment urine volume, mL/d	1356 ± 651	1517 ± 939	0.4213
Ascites volume, mL	2204 ± 1384	2104 ± 1084	0.6400
Grade of ascites: Mild/moderate/severe	5/15/8	6/13/9	0.8901
Amount of water drunk, mL/d	1032 ± 491.2	1071 ± 870.0	0.9710
Pulse rate, /min	78 ± 10.1	78 ± 11.2	0.8514
Systolic blood pressure, mmHg	121 ± 21.6	116 ± 12.9	0.3130
Diastolic blood pressure, mmHg	65 ± 13.5	72 ± 21.5	0.2115

Data are expressed as median, n (%) or mean ± SD. BCAA: Branched chain amino acids; ARB: Angiotensin receptor blocker; ACE: Angiotensin-converting enzyme.

Table 2 Baseline patient characteristics

	Combination diuretic (n = 28)	Conventional diuretic (n = 28)	P value
Hemoglobin, g/dL	9.43 ± 1.30	10.3 ± 1.62	0.0481
Platelets, × 103/μL	10.1 ± 7.96	12.3 ± 6.04	0.0598
Prothrombin time, s	12.5 ± 1.5	12.3 ± 1.1	0.4672
Serum albumin, g/dL	2.38 ± 0.49	2.36 ± 0.55	0.9934
BUN, g/dL	24.7 ± 14.6	27.1 ± 24.7	0.8058
Serum creatinine, mg/dL	1.14 ± 0.52	1.03 ± 0.42	0.4031
ALT, IU/L	31.3 ± 29.6	25.5 ± 12.2	0.7306
Total bilirubin, g/dL	3.20 ± 3.78	2.86 ± 2.96	0.7121
BNP, pg/mL	164 ± 310	97.1 ± 76.6	0.8957
HANP, pg/mL	79.5 ± 80.4	60.2 ± 33.6	0.8831
Ammonia, μg/dL	82.4 ± 48.5	75.6 ± 45.1	0.6314
Plasma-aldosterone, pg/mL	163 ± 178	185 ± 267	0.5221
Plasma-renin, pg/mL	9.04 ± 10.6	8.45 ± 14.3	0.8377
Plasma AVP, pg/mL	2.42 ± 1.52	2.35 ± 1.70	0.5007
Serum sodium, mEq/L	135 ± 5.4	135 ± 4.2	0.5869
Serum potassium, mEq/L	3.83 ± 0.52	3.99 ± 0.53	0.2301
Urinary OSM, mOSM/L	426 ± 163	413 ± 172	0.7742
Urinary sodium, mEq/d	88.8 ± 63.3	93.4 ± 65.3	0.5869
Urinary potassium, mEq/d	25.3 ± 13.8	26.8 ± 13.4	0.5497
24-h CCr, mL/min	57.3 ± 27.9	62.6 ± 38.4	0.9217

Data are expressed as median, n (%) or mean ± SD. BUN: Blood urea nitrogen; AVP: Arginine vasopressin; BNP: Brain natriuretic peptide; HANP: Human atrial natriuretic peptide; OSM: Osmolality; 24-h CCr: 24-hour creatinine clearance.

Table 3 Adverse events

	Combination diuretic: (n = 13) (%)		Conventional diuretic: (n = 16) (%)
	Any grade	≥ Grade 3	Any grade	≥ Grade 3
Encephalopathy	1 (3.5)		3 (10.7)	1 (3.5)
Abdominal infection				1 (3.5)
Dry mouth	6 (21.4)		2 (7.1)
Urinary frequency	4 (14.3)		2 (7.1)
Hypopotassemia	0		3 (10.7)
Acute kidney injury	2 (7.1)		4 (14.3)