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Table 2 Randomised studies

From: Clinical review: Statins and trauma - a systematic review

Study

Design

Participants

Intervention

Comparisons

Outcome

Results

Subgroup analyses

Remarks

Akcay et al. (2005) [33]

Clinical trial

20 patients with severe burns, treated in a single centre

Atorvastatin, 20 mg once daily, orally, for 14 days (n = 10)

Placebo (n = 10)

Plasma E-selectin

23.69 ng/ml (intervention group), 18.08 ng/ ml (control group) on enrolment; 10.86 ng/ ml and 21.69 ng/ml, respectively, after 14 days (P < 0.05)

  

Tapia-Perez et al. (2008) [31]

Double blind randomised controlled trial, designated as 'pilot'

21 patients aged between 16 and 50 years with traumatic brain injury, GCS 9-13 and intracranial lesion on CT scan

Rosuvastatin, 20 mg once daily, for 10 days (n = 8)

Placebo (n = 13)

Reduction in amnesia time (measured using Galveston Orientation and Amnesia Test)

HR 53.76 (95% CI 1.58-1,824.64)

 

Despite randomisation, due to small numbers, the groups were not homogenous with regard to neurological parameters, with possibly more severe injury in treatment group

Patil et al. (2009) [46]

Double blind, placebo-controlled, randomised controlled trial

Patients with undisplaced, extra-articular distal radial fractures

Simvastatin, 20 mg, once daily (n = 31)

Placebo (n = 31)

Mean time to fracture union

Mean percentage trabecular healing at 12 weeks post-injury

Simvastatin group, 71.7 days; control group, 71.3 days (P = 0.6481) Simvastatin group, 85%; control group, 87% (P = 0.431)

 

Low dose simvastatin used. No measures of simvastatin levels reported

  1. AIS, Abbreviated Injury Scale; CI, confidence interval; GCS, Glasgow Coma Scale; HR, hazard ratio; NSCOT, National Study on the Costs and Outcomes of Trauma; RR, relative risk.