Non-Selective Beta-Blockers and Risk of Sepsis in Patients with Cirrhosis and Ascites: Results from a Large Observational Study

Figures & data

Table 1 Characteristics of the 1198 Patients from the Satavaptan Trials at Inclusion Based on Use of Non-Selective Beta-Blockers (NSBB) at Inclusion

	NSBB Users	NSBB Nonusers	p-value
	N = 562	N = 636
Female, (%)	165 (29.4)	199 (31.3)	0.469
Age, median (IQR)	57 (51–64)	57 (50–64)	0.702
Follow-up (days), median (IQR)	242 (115–370)	250 (109–370)	0.644
Albumin, median (IQR)	33 (29–37)	33 (29–38)	0.041
MELD-Na score, median (IQR)	14 (11–19)	15 (11–21)	0.316
HE grade 1, (%)	38 (6.8)	39 (6.1)*	0.657
Cirrhosis etiology, (%)
Alcohol-related (alone)	314 (55.9)	378 (59.4)	0.213
Hepatitis B (alone)	23 (4.1)	30 (4.7)	0.600
Hepatitis C (alone)	79 (14.1)	82 (12.9)	0.556
Cryptogenic (alone)	32 (5.7)	42 (6.6)	0.514
Other (alone)	29 (5.2)	39 (6.1)	0.468
Multiple etiologies	85 (15.1)	65 (10.2)	0.010
Refractory ascites, (%)	261 (46.4)	334 (52.5)	0.036
History of HCC, (%)	19 (3.4)	23 (3.6)	0.825
History of cancer (excluding HCC), (%)	18 (3.2)	22 (3.5)	0.805
History of diabetes mellitus, (%)	145 (25.8)	145 (22.8)	0.226
History of SBP, (%)	90 (16.0)	87 (13.7)	0.256
History of variceal bleeding, (%)	169 (30.1)	81 (12.7)	<0.001
Antibiotics, (%)	127 (22.6)	159 (25.0)	0.330
PPI, (%)	255 (45.4)	269 (42.3)	0.284
Geographic region, (%)
Asia	3 (0.5)	31 (4.9)	<0.001
Eastern Europe	193 (34.3)	146 (23.0)	<0.001
North/Western Europe	116 (20.6)	170 (26.7)	0.014
Southern Europe	80 (14.2)	139 (21.9)	0.001
North America	69 (12.3)	71 (11.2)	0.549
South America	74 (13.2)	45 (7.1)	<0.001
Other	27 (4.8)	34 (5.3)	0.670
NSBB type, (%)**
Propranolol	468 (84.2)	–	–
Nadolol	69 (12.4)	–	–
Carvedilol	19 (3.4)	–	–
NSBB dose, (%)
Non	–	636 (100)	–
Low	368 (65.5)	–	–
Medium	133 (23.7)	–	–
High	61 (10.9)	–	–

Notes: “History of” indicates before inclusion. Antibiotics were defined as “any antibiotics except rifaximin or paromomycin”. Patients included had HE grade ≤ 1. Patient characteristics were compared using: chi-square test for dichotomous variables and Wilcoxon Mann–Whitney rank sum test for medians. *Some patients may have been screened, in regards of meeting the inclusion criteria, the day before inclusion in the study, resulting in two patients having HE grad 2 at the day of inclusion. **NSBB type was not available for six patients at inclusion (only their NSBB dose) and characteristics of NSBB type are therefore based on the remaining 556 patients. Percentages have been rounded and may hence not accumulate to 100%.

Abbreviations: N, number of patients; IQR, interquartile range (ie, 25th–75th percentile); INR, international normalized ratio; MELD-Na, model for end-stage liver disease sodium; HE, hepatic encephalopathy; HCC, hepatocellular carcinoma; SBP, spontaneous bacterial peritonitis; PPI, proton pump inhibitors; NSBB dose, (annotated as propranolol/carvedilol daily dose) low: ≤40/<12.5mg; medium: 41–80/12.5–24mg; high: >80/≥25mg.

Figure 1 Cumulative risk of sepsis based on use of non-selective beta-blocker (NSBB) at the beginning of the study while applying inverse probability of censoring weights.