TABLE 3

Stratified analysis on the daily dose and lipophilicity for the association of DILI with drugs being P450 substrates, inhibitors, or inducers

The analysis is based on data shown in Supplemental Table 1. The high daily dose and high lipophilicity were previously defined (Chen et al., 2013a).

ClassificationDILI-PositiveDILI-NegativeOR (95%CI)P Value
High daily dose (≥100 mg)
 P450 substrate
  Yes10154.83 (1.59–14.7)0.0029
  No4611
 P450 inhibitor
  Yes6826.03 (1.32–27.5)0.0098
  No7914
 P450 inducer
  Yes 3131.16 (0.31–4.32)0.8275
  No11613
 Total147164.98 (2.55–9.76)0.0001
Low daily dose (<100 mg)
 P450 substrate
  Yes48145.61 (2.15–14.6)0.0003
  No1118
 P450 inhibitor
  Yes25140.95 (0.40–2.25)0.8997
  No3418
 P450 inducer
  Yes 1241.79 (0.53–6.08)0.3509
  No4728
 Total5932
High lipophilicity (logP ≥3.0)
 P450 substrate
  Yes7393.60 (1.22–10.6)0.0274
  No188
 P450 inhibitor
  Yes4781.20 (0.43–3.39)0.7954
  No449
 P450 inducer
  Yes2114.80 (0.60–38.4)0.1863
  No7016
 Total91171.44 (0.75–2.77)0.3312
Low lipophilicity (logP <3.0)
 P450 substrate
  Yes76104.09 (1.76–9.54)0.0009
  No3921
 P450 inhibitor
  Yes4681.92 (0.79–4.65)0.2081
  No6923
 P450 inducer
  Yes2116.70 (0.86–51.9)0.0459
  No9430
 Total11531