Table 4.
Responder analysis
| Patients’ characteristics: responder vs. non-responder | ||||
|---|---|---|---|---|
| Characteristics | Total (N = 841) | Responder (N = 525) | Non-responder (N = 316) | P value |
| Age (years) | 69.3 ± 11.4 | 68.5 ± 11.2 | 70.7 ± 11.6 | 0.0088** |
| Sex, male (%) | 62.2 | 61.3 | 63.6 | 0.5570 |
| Serum albumin (g/dL), mean ± SD | 2.6 ± 0.5 | 2.6 ± 0.5 | 2.6 ± 0.5 | 0.3232 |
| Serum creatinine (mg/dL), mean ± SD | 1.0 ± 0.5 | 1.0 ± 0.5 | 1.1 ± 0.5 | 0.0013** |
| Blood urea nitrogen (mg/dL), mean ± SD | 21.3 ± 11.8 | 19.4 ± 10.2 | 24.6 ± 13.7 | < 0.0001*** |
| Dear alcoholic hepatitis (%) | 31.8 | 35.1 | 26.3 | 0.0093** |
| Hepatitis B (%) | 6.5 | 5.1 | 8.9 | 0.0432* |
| Hepatitis C (%) | 42.9 | 41.5 | 45.3 | 0.3141 |
| Hepatocellular carcinoma (%) | 42.7 | 40.4 | 46.5 | 0.0966 |
| Loop diureticsa (mg), mean ± SD | 36.9 ± 24.0 | 37.5 ± 22.5 | 35.8 ± 26.3 | 0.3471 |
| Spironolactoneb (mg), mean ± SD | 65.1 ± 88.1 | 70.7 ± 100.2 | 54.6 ± 26.3 | 0.0258* |
| Tolvaptan (mg) mean ± SD | 5.4 ± 1.9 | 5.5 ± 1.9 | 5.3 ± 1.9 | 0.2626 |
| Multiple regression model for predicting responder | |||
|---|---|---|---|
| Parameter | Odds ratio | 95% CI | P value |
| Age | 0.994 | 0.976–1.012 | 0.5051 |
| Serum creatinine | 1.586 | 0.900–2.795 | 0.1109 |
| Blood urea nitrogen | 0.954 | 0.931–0.978 | 0.0002*** |
| spironolactone | 1.002 | 0.999–1.005 | 0.1327 |
| Hepatitis B | 0.537 | 0.276–1.048 | 0.0686 |
| Alcoholic hepatitis | 1.193 | 0.772–1.845 | 0.4263 |
| Multiple regression model for predicting responder in patients with or without HCC | |||
|---|---|---|---|
| Parameter | Odds ratio | 95% CI | P value |
| Patients with HCC | |||
| Age | 0.998 | 0.965–1.033 | 0.9174 |
| Serum creatinine | 1.568 | 0.661–3.723 | 0.3078 |
| Blood urea nitrogen | 0.941 | 0.905–0.978 | 0.0023** |
| Spironolactone | 1.001 | 0.997–1.005 | 0.5354 |
| Hepatitis B | 0.348 | 0.139–0.871 | 0.0241* |
| Patients without HCC | |||
| Age | 0.985 | 0.964–1.006 | 0.1603 |
| Serum creatinine | 1.733 | 0.763–3.934 | 0.1888 |
| Blood urea nitrogen | 0.957 | 0.926–0.989 | 0.0096** |
| Spironolactone | 1.003 | 0.999–1.007 | 0.1200 |
Responders: patients who lost ≥ 1.5 kg of body weight within 1 week of tolvaptan treatment
Patients who had paracentesis by day 1–7 of tolvaptan administration were excluded
CI confidence interval, HCC hepatocellular carcinoma, SD standard deviation
*< 0.05
**< 0.01
***< 0.001
aLoop diuretics: furosemide equivalent
bSpironolactone: androgen deprivation therapy equivalent