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Table 4 The relationship between supratherapeutic voriconazole drug levels during therapy and adverse drug events

From: Voriconazole therapeutic drug monitoring: retrospective cohort study of the relationship to clinical outcomes and adverse 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]†

  1. *For at least one month after initiation of therapy.
  2. †Fisher’s exact test.
  3. §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.