Copyright
©The Author(s) 2015.
World J Hepatol. Jun 28, 2015; 7(12): 1685-1693
Published online Jun 28, 2015. doi: 10.4254/wjh.v7.i12.1685
Published online Jun 28, 2015. doi: 10.4254/wjh.v7.i12.1685
Table 1 Baseline characteristics of the patients treated with tolvaptan and controls
| Characteristic | TLV group (n = 60) | Controls (n = 60) | P |
| Age (yr) | 67.1 ± 11.2 | 69.5 ± 9.0 | 0.21 |
| Male | 46 (76.7%) | 46 (76.7%) | 1.00 |
| Bodyweight (kg) | 61 (54-69) | 64 (55-73) | 0.58 |
| HCV antibody positive | 36 (60.0%) | 35 (58.3%) | 1.00 |
| Child-Pugh class C | 27 (45.0%) | 24 (40.0%) | 0.71 |
| Refractory ascites | 56 (93.3%) | 60 (100%) | 0.12 |
| Hepatic hydrothorax | 32 (53.3%) | 29 (48.3%) | 0.72 |
| Liver neoplasms stage 3, 4a, or 4b | 26 (43.3%) | 25 (41.7%) | 1.00 |
| Serum albumin (g/dL) | 2.8 (2.5-3.1) | 2.8 (2.5-3.1) | 0.98 |
| Total bilirubin (mg/dL) | 2.7 (0.7-3.1) | 2.8 (1.1-3.6) | 0.81 |
| ALT (IU/L) | 42 (20-44) | 36 (20-53) | 0.27 |
| Serum creatinine (mg/dL) | 1.40 (0.90-1.61) | 1.45 (0.78-1.59) | 0.30 |
| eGFR (mL/min per 1.73 m2) | 43.1 (31.0-62.7) | 49.8 (33.5-67.8) | 0.95 |
| Serum sodium (mEq/L) | 133 (130-136) | 136 (132-139) | 0.02 |
| Platelet count (× 103/μL) | 114 (58-147) | 95 (69-139) | 0.80 |
| Prothrombin activity (%) | 58.7 (45.0-70.0) | 57.3 (42.3-70.2) | 0.71 |
Table 2 Changes in the urine volume and osmolality after administration of tolvaptan
| TLV group (n = 60) | |
| 24 h urine volume (mL) | 1844 (1200-2400) |
| 24 h water intake (mL) | 1231 (894-1463) |
| Pre-urine osmolality (OSM) | 417 (366-487) |
| Time to achieve the minimum urine osmolality (d) | 7 (2-6) |
| The minimum urine osmolality (OSM) | 274 (230-311) |
| Pre-post-urine osmolality rate (%) | 66 (55-79) |
Table 3 Comparison of baseline characteristics (effective vs ineffective with tolvaptan)
| Characteristic | Effective (n = 38) | Ineffective (n = 22) | P |
| Dosing period (d) | 73 (12-109) | 22 (7-36) | 0.02 |
| TLV (mg/d) | 7.5 (7.5-7.5) | 7.5 (7.5-7.5) | 0.36 |
| Age (yr) | 66.7 ± 11.1 | 67.0 ± 11.4 | 0.95 |
| Male | 33 (86.8%) | 13 (59.1%) | 0.02 |
| Bodyweight (kg) | 62 (54-68) | 60 (48-71) | 0.58 |
| 1Bodyweight (kg) | 3.6 (2.1-4.7) | 0.2 (0.1-0.8) | < 0.01 |
| HCV antibody positive | 27 (71.1%) | 9 (40.9%) | 0.03 |
| Child-Pugh class C | 11 (28.9%) | 16 (72.7%) | < 0.01 |
| Refractory ascites | 35 (92.1%) | 32 (95.5%) | 1.00 |
| Hepatic hydrothorax | 21 (55.3%) | 11 (50.0%) | 0.79 |
| Liver neoplasms stage 3, 4a, or 4b | 11 (28.9%) | 15 (68.2%) | < 0.01 |
| Serum albumin (g/dL) | 2.9 (2.6-3.2) | 2.7 (2.3-3.0) | 0.20 |
| Total bilirubin (mg/dL) | 1.7 (0.7-1.9) | 4.5 (1.5-6.3) | < 0.01 |
| ALT (IU/L) | 37 (20-41) | 50 (25-77) | 0.18 |
| Serum creatinine (mg/dL) | 1.53 (0.89-2.09) | 1.17 (0.95-1.40) | 0.11 |
| eGFR (mL/min per 1.73 m2) | 49.8 (26.7-62.7) | 51.7 (34.6-62.5) | 0.80 |
| Serum sodium (mEq/L) | 134 (132-138) | 131 (128-136) | 0.03 |
| Platelet count (× 103/μL) | 107 (58-144) | 127 (65-190) | 0.27 |
| Prothrombin activity (%) | 61.5 (46.3-73.2) | 53.8 (41.2-64.2) | 0.10 |
Table 4 Comparison of the changes after administration of tolvaptan (effective vs ineffective with tolvaptan)
| Effective (n = 38) | Ineffective (n = 22) | P | |
| 1Bodyweight | 3.6 (2.1-4.7) | 0.2 (0.1-0.8) | < 0.01 |
| 24 h urine volume (mL) | 2154 (1448-2516) | 1352 (871-1675) | < 0.01 |
| 24 h water intake (mL) | 1238 (800-1429) | 1235 (1000-1463) | 0.96 |
| Pre-urine osmolality (OSM) | 445 (411-485) | 417 (335-495) | 0.42 |
| Time to achieve the minimum urine osmolality (d) | 7 (3-9) | 4 (1-6) | 0.02 |
| The minimum urine osmolality (OSM) | 251 (213-288) | 313 (256-359) | < 0.01 |
| Pre-post-urine osmolality rate (%) | 58 (51-69) | 78 (66-90) | < 0.01 |
Table 5 Multivariate regression analysis assessing the effectiveness of tolvaptan
| Variables | HR (95%CI) | P |
| Reduction of urine osmolality over 25% | 20.7 (3.26-132) | < 0.01 |
| Age (yr) | 1.00 (0.93-1.08) | 0.91 |
| HCV antibody positive | 5.93 (1.01-34.8) | 0.05 |
| Uncontrollable liver neoplasms | 0.68 (0.03-1.20) | 0.21 |
| Total bilirubin (per 1.0 mg/dL) | 0.57 (0.35-0.93) | 0.02 |
| Na (per 1.0 mEq/mL) | 0.99 (0.84-1.17) | 0.93 |
Table 6 Cox’s proportional hazard multivariate regression analysis assessing the factors contributing to the incidence of refractory ascites
| Variables | HR (95%CI) | P |
| Use of TLV | 0.58 (0.39-0.87) | < 0.01 |
| Age (yr) | 1.01 (0.99-1.03) | 0.19 |
| Uncontrollable liver neoplasms | 1.92 (1.23-2.94) | < 0.01 |
| ALT (IU/L) | 1.00 (0.98-1.01) | 0.11 |
| Total bilirubin (mg/dL) | 1.10 (1.03-1.18) | < 0.01 |
| Na (mEq/mL) | 0.94 (0.91-0.98) | < 0.01 |
- Citation: Ohki T, Sato K, Yamada T, Yamagami M, Ito D, Kawanishi K, Kojima K, Seki M, Toda N, Tagawa K. Efficacy of tolvaptan in patients with refractory ascites in a clinical setting. World J Hepatol 2015; 7(12): 1685-1693
- URL: https://www.wjgnet.com/1948-5182/full/v7/i12/1685.htm
- DOI: https://dx.doi.org/10.4254/wjh.v7.i12.1685