Table 5.
Comparative studies highlighting clinical benefits of performing therapeutic drug monitoring for gentamicin, voriconazole and ribavirin
| Study/country/population | Patients | Study design | Clinical outcomesa | TDM | Non-TDM |
|---|---|---|---|---|---|
| Van Lent-Evers (1999) | Total: 232 | Multi-centre, non-randomised, before-and-after trial | Dose changes (%)* | 48.6 | 80.4 |
| Netherlands | TDM: 105 | TDM: Bayesian-guided dosing | Duration of therapy (days)* | 5.9 ± 2.9 | 8.0 ± 4.9 |
| Gentamicin | Non-TDM: 127 | Non-TDM: standard or nomogram | Length of stay (days)* | 20.0 ± 13.7 | 26.3 ± 31.5 |
| Gram-negative sepsis |
Mortality (%) Nephrotoxicity (%)* Total costs (in DFL)* |
9 (8.6%) 3 (2.8) 13,125 ± 9,267 |
18 (14.2) 17 (13.4) 16,862 ± 17,721 |
||
| Park (2012) | Total: 110 | Single-centre, assessor-blinded, randomised controlled trial | Adverse events (%) | 23 (42) | 22 (42)b |
| South Korea | TDM: 55 | TDM: concentration-controlledc | Drug discontinuation (%)* | 2 (4) | 9 (17)b |
| Voriconazole | Non-TDM: 55 | Non-TDM: standard therapy | Treatment response (%)*,d | 30 (81)e | 20 (59)f |
| Invasive fungal infections | |||||
| Stickel (2013)g | Total: 16 | Multi-centre, open-labelled, randomised controlled trial | Sustained virological response (%)h | 10 (62.5) | 6 (37.3) |
| Switzerland | TDM: 16 | TDM: concentration-controlledi | Mean haemoglobin (g/L)* | 99.6 | 106.3 |
| Ribavirin | Non-TDM: 16 | Non-TDM: weight-based dosing | |||
| Chronic hepatitis C |
DFL = Dutch florin, i.e. the currency of Netherlands up to 2002; TDM = therapeutic drug monitoring
aAn asterisk indicates a significant difference between TDM and non-TDM groups
bOnly 53 patients were included
cTarget trough concentration of 1.0–5.5 mg/L
dIncluded either complete or partial response
eOnly 37 patients were included
fOnly 34 patients were included
gReported in a research letter
hCumulative ribavirin exposure above 224.3 mg/L was significantly associated with sustained virological response
iTarget concentration of 3.7 mg/L