Table 1.
Coumarin safety and tolerability in clinical trials.
| Number of Patients | Disease | Coumarin Dose | Cotreatment with Other Drugs | Hepatotoxic Effects (Number of Patients) | References |
|---|---|---|---|---|---|
| 7 | Melanoma | 100 mg/day | No | No | Zanker et al. (1984) [101] |
| 17 | Cancer | 100 mg/day | Cimetidine 1 g/day |
No | Nolte et al. (1987) [116] |
| 13 | Melanoma | 50 mg/day | No | No | Thornes et al. (1989) [102] |
| 42 | Lymphoedema secondary to filiriasis | 400 mg/day | Carbamazine 6 mg/Kg per day |
No | Jamal et al. (1989) [100] |
| 39 | Lymphoedema secondary to filariasis | No | Carbamazine 6 mg/Kg per day |
No | |
| 47 | Lymphoedema secondary to filariasis | 400 mg/day | No | No | |
| 50 | Cancer | 100 mg/day | Cimetidine 1.2 g/day |
No | Dexeus et al. (1990) [104] |
| 38 | Renal cell carcinoma | 100 mg/day | Cimetidine 400 mg/day |
No | Kokron et al. (1991) [117] |
| 48 | Prostate cancer | 3 g/day | No | Asymptomatic transaminase elevation (3) | Mohler et al. (1992) [112] |
| 31 | Lymphoedema secondary to breast cancer | 400 mg/day | No | No | Casley-Smith et al. (1993a) [113] |
| 45 | Chronic lymphatic filariosis |
400 mg/day | No | No | Casley-Smith et al. (1993) [114] |
| 91 | Cancer | 100 mg/day | Cimetidine 300 mg/day |
No | Marshall et al. (1994) [37] |
| 1106 | Lymphoedema | 400 mg/day | No | Mild hepatotoxicity regressed after ceased treatment (1) | Casley-Smith et al. (1995) [79] |
| 1 (Case report) | Lymphoedema | 400 mg/day | No | Severe hepatotoxicity (1) | Morrison and Welsby (1995) [80] |
| 30 | Chronic lymphoedema | 400 mg/day | No | No | Chang et al. (1996) [123] |
| 2 | Lymphoedema | 90 mg/day | No | Hepatitis with favourable outcome (2) | Koch et al. (1997) [82] |
| 2173 | Cancer/chronic infections | 100–300 mg/day | No | Serum transaminase elevation at 1 to 15 g of total dose (8) | Cox et al. (1989) [103] |
| 38 | Lymphoedema secondary to breast cancer | 90 mg/day | No | SGPT elevation (1) | Burgos et al. (1999) [115] |
| 39 | Lymphoedema secondary to breast cancer | 135 mg/day | No | SGPT elevation (1) | Burgos et al. (1999) [115] |
| 48 | Cancer | 90 mg/day | Troxerutin 540 mg/day |
No | Grötz et al. (2001) [118] |
| 114 | Chronic venous insufficiency | 90 mg/day | No | Mild changes in liver function parameters (4.9%) compared to controls (2.1%) | Vanscheidt et al. (2002) [119]; Schmeck-Lindenau et al. (2003) [120] |
| 60 | Lymphatic oedema of lower limbs | 10 mg/day | No | No statistical differences compared to controls | Lessiani et al. (2015) [121] |