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).

PEDro=Physiotherapy Evidence Database rating scale score (Moseley et al., 2002).