Table 3:
Summary of cases of liver injury associated with phosphodiesterase type 5 inhibitors
| Patient characteristics | Type of PDI | Age | Gender | Ethnicity | Time to onset (days) | Peak bilirubin (mg/dL) | Peak alkaline phosphatase (U/L) | Peak ALT (U/L) | Peak AST (U/L) | Presentation to peak bilirubin (weeks) | Presentation to peak alkaline phosphatase (weeks) | Presentation to peak ALT (weeks) | Peak INR | R factor Pattern of injury | Time from peak to resolution (weeks) | Rechallenge | Alcohol Intake | How long been taking | Histology | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ref [Essaid | Tadalafil | 38 | Male | Not available | 5 | 2.5 × ULN | 4 × ULN | 4 x ULN | 3 × ULN | 1.0 Cholestatic | 8 | No | None | 5 days | No | |||||
| Ref [Nissan] | Sildenafil | 65 | Male | Caucasian | 17 | 2.06 | 326 | 984 | 1342 | 1 | 1 | 1 | 1.37 | >5 Hepatocellular | 30 | No | One ounce/month | 2.5 weeks | No | |
| Ref [Maroy] | Sildenafil | 65 | Male | Not available | 1 | Not reported | 5 × ULN | 113 × ULN | 114 × ULN | 1 | 1 | >5 Hepatocellular | 4 | Yes | None | > 1year | No | |||
| Ref [Balian] | Sildenafil | 56 | Male | Not available | 21 | 6.5 x ULN | 2.5 × ULN | 8 × ULN | 3.5 × ULN | 1 | 1 | 1 | 3.2 Mixed Cholestatic | 4 | No | <10 g/day | Yes Cholestasis | |||
| Ref [Enomoto] | Sildenafil | 58 | Male | Not available | 30 | 8.5 | 476 | 64 | 42 | 0.5 Cholestatic | 16 | No | No excessive alcohol intake | 1 month | Yes Cholestasis Minimal portal inflammation | |||||
| Ref [Wolfhagen] | Sildenafil | 59 | Male | Not available | 7 | 19 | 225 | 1,665 | 1,077 | 10 | 9 | 1 | > 5 Hepatocellular | 13 | No | 1 unit/week | 3 months | Yes Cholestasis Minor infiltrate with predominant eosinophils | ||
| Ref [Daghfous] | Sildenafil | 49 | Male | Not available | 28 | 0.62 | Normal | 1.2 × ULN | 7.4 × ULN | 1 | 4 | > 5 Hepatocellular | 3 | Yes | Information not provided | 1 month | No | |||
| Patient in this case report | Vardenafil Tadalafil | 72 | Male | Caucasian | 5 | 31.2 | 391 | 214 | 111 | 2 | 2 | 1 | 1.2 | 1.9 Cholestatic | 12 | Yes | 2 units, 3 times/week | Vardenafil individually >2 years Tadalafil individually 3 months | Cholestasis |