Table 3.
Hepatotoxicity report from published articles of second-generation antipsychotic drugs in human subjects. Our study was conducted in patients who were actively drinking and had a heavy drinking profile
| Study | Drug and dose | Treatment population (baseline liver status) |
New hepatotoxicity incidence % |
Level of Liver injury reported (ALT IU/l) |
Patients actively drinking (yes/ no) |
|---|---|---|---|---|---|
| Kurz et al. [45] | Clozapine (193.7 mg/d) | 167 Patient (normal liver tests) |
W1–6: (18/59) 30.5%; W13–18: (7/59) 11.9%; |
W1–6: 69.5 ± 28.1 W13–18: 62.35 ± 20.6 (only with liver injury) |
No |
| Atasoy et al. [43] | Olanzapine (14.8 mg/d) | 33 Patients (normal liver tests) |
4 W: (4/33) 12.1% | 4 W: 27.8 ± 14.4 24 W: 24.5 ± 14.3 (adjusted overall mean) |
No |
| Atasoy et al. [43] | Risperidone (2.9 mg/d) | 29 Patients (normal liver tests) |
4 W: (3/29) 10.3% | 4 W: 20.6 ± 13.9 24 W: 26.7 ± 14.0 (adjusted overall mean) |
No |
| Atasoy et al. [43] | Quetiapine (244 mg/d) | 48 Patients (normal liver tests) |
4 W: (4/48) 8.3% | 4 W: 23.2 ± 14.0 24 W: 26.1 ± 13.9 (adjusted overall mean) |
No |
| Wang et al. [21] | Quetiapine XR (50–300 mg/d titrated) |
157 Patients (normal liver tests) |
None reported | None reported | No |
| Present Study (CSP-1027) |
Quetiapine XR (50–400 mg/d titrated) |
78 Patients (normal liver tests) |
4 W: 7/ 76 (9%); 8 W: 10/ 71 (14%); 13 W: 9/ 63 (14%). |
4 W: 66.0 ± 10.2; 8 W: 50.8 ± 3.0; 13 W: 82.7 ± 28.1 (Only with liver injury) |
Yes |
| Present Study (CSP-1027) |
Quetiapine XR (50–400 mg/d titrated) |
29 Patients (confirmed liver injury) |
4 W: 19/ 28 (68%); 8 W: 9/ 27 (33%); 13 W: 12/ 24 (50%). |
4 W: 57.1 ± 3.6; 8 W: 70.0 ± 6.9; 13 W: 62.2 ± 5.3 (Only with liver injury) |
Yes |
mg milligram, d day, W weeks, CSP Clinical Study Protocol