Review Article
Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials
Table 3
Outcome of studies indicating hepatotoxicity in this systematic review.
| Number | Study | Intervention (dose/day) | Number of patients included | Hepatotoxic outcome Number of events (percentage of events) | AST > 3 ULN | ALT > 3 ULN | ALT, AST, or both > 3 ULN | ALP > 2 ULN | Hy’s cases | Liver-related discontinuation | Liver-related hospitalization |
| 1 | Buxton et al. 1978 [16] | Fenbufen 600 mg | 20 | 2 (10.0) | | | 3 (15.0) | | | |
| 5 | Kennedy et al. 1994 [20] | Diclofenac 150 mg | 121 | | | 14 (12.0) 5 (4.1) | | | | |
| 8 | McKenna et al. 2001 [23] | Diclofenac 150 mg | 199 | 2 (1.0) | 5 (2.5) | | | | | |
| 10 | Tugwell et al. 2004 [25] | Diclofenac 150 mg | 311 | 4 (1.4) | 13 (4.7) | | | | | | Topical diclofenac 1.5% w/w 1.55 ml | 311 | 1 (0.4) | 3 (1.1) | | | | | |
| 12 | Laine et al. 2009 [27] | Diclofenac 150 mg | 17289 | 246 (1.4) 104 (0.6) 31 (0.2) | 511 (3.0) 228 (1.3) 83 (0.5) | | | 2 (0.012) | 461 (2.7) | 4 (0.023) | Etoricoxib 60 mg or 90 mg | 17412 | | | 116 (0.7 ) 38 (0.2) 8 (0.05) | | 1 (0.006) | 57 (0.3) | |
| 13 | Dahlberg et al. 2009 [28] | Diclofenac 100 mg | 462 | | | | | | 8 (1.7) | | Celecoxib 200 mg | 463 | | | | | | 1 (0.2) | |
| 16 | Chopra et al. 2013 [31] | Celecoxib 200 mg | 110 | | 2 (1.9) | | | | | | SGCG & SCG | 220 | | 10 (4.5) | | | | 7 (3.2) | |
| 17 | Altman et al. 2015 [32] | Low dose SoluMatrix diclofenac 75–105 mg | 601 | 8 (1.4) | 24 (4.1) | | 16 (2.7) | 1 (0.2) | 23 (3.8) | |
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Remark. Hy’s cases: ALT > 3 ULN, and bilirubin ≥ 2 ULN; more than 3–6 ULN; more than 5 ULN; more than 8 ULN; more than 10 ULN; more than 1.5 ULN.
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