Table 4.
The relationship between supratherapeutic voriconazole drug levels during therapy and adverse drug events
| Variable | Voriconazole level ≤ 5.5 mg/L (n = 92) | Voriconazole level > 5.5 mg/L (n = 16) | OR [95% CI] |
|---|---|---|---|
|
Any adverse drug event* |
36 (39.1%) |
9 (56.3%) |
2.00 [0.60-6.89]† |
|
Adverse drug event by subtype* |
|
|
|
| Encephalopathy |
15 (16.3%) |
6 (37.5%) |
3.08 [0.79-11.0]† |
| LFT abnormalities (AST/ALT > 5x ULN, Alk phos/bili >3x ULN) |
11 (12.0%) |
4 (25.0%) |
2.45 [0.49-10.1]† |
| Acute renal failure (creatinine rise ≥ 0.3 mg/L in 48 hours)§ |
4 (4.3%) |
4 (25.0%) |
7.33 [1.17-43.8]† |
| Visual changes |
5 (5.4%) |
0 (0%) |
-- |
| Drug rash | 6 (6.5%) | 1 (6.3%) | 0.96 [0.02-8.81]† |
*For at least one month after initiation of therapy.
†Fisher’s exact test.
§Baseline creatinine 1.1 in 4 subjects with therapeutic levels, and 1.3 in 4 subjects with supratherapeutic levels, all with eventual acute renal failure.