Table 16.56 Miscellaneous Outcomes – Bradykinin Antagonists for Acute Management Post ABI
by Camila | Dec 13, 2018
Table 16.56 Miscellaneous Outcomes – Bradykinin Antagonists for Acute Management Post ABI
Author/Year/ Country/ Study Design/N |
Methods |
Outcomes |
Shakur et al.
(2009)
UK
RCT
PEDro=9
N=228 |
Population: TBI; Mean Age=36 yr; Gender: Male=203, Female=25; Mean Time Post Injury=6 hr; Mean GCS=8.
Intervention: Patients were randomized to receive placebo (n=57), high-dose Anantibant (n=57; 15mg/dY), medium-dose Anantibant (n=56; 10 mg/day) or low-dose Anantibant (n=58; 5 mg/day). Maintenance doses were administered for 4 days. Outcomes were assessed at 2 wk post injury.
Outcome Measure: Glasgow Coma Scale (GCS), Disability Rating Scale (DRS), Modified Oxford Handicap Scale (HIREOS), Serious Adverse Event (SAE), Mortality. |
- The trial was ended early due to concerns with patient safety.
- Mortality was slightly higher in patients treated with Anatibant than those with placebo (19.0% versus 15.8%), but the risk was not significant (RR=1.20, p=0.38).
- There was a greater proportion of SAEs in patients treated with Anatibant than those with placebo (26.4% versus 19.3%), but the risk was not significant (RR=1.37, p=0.19).
- Mean GCS was higher in the Anatibant group than the placebo group, but the difference was not significant (12.48 versus 9.73, δ=-0.55, p>0.05).
- Mean DRS was higher in the Anatibant group than the placebo group, but the difference was not significant (11.18 versus 9.73, δ=1.61, p>0.05).
- Mean HIREOS was slightly higher in the Anatibant group than the placebo group, but the difference was not significant (3.94 versus 3.54, δ=0.42, p>0.05).
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PEDro=Physiotherapy Evidence Database rating scale score (Moseley et al., 2002).