Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-blinded Randomized Clinical Trial

Abstract

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

The neuroprotective effect of statin in traumatic brain injury: A systematic review

“…No adverse effects were reported in this research. 4 The medication was given to each individual within 10 h of the accident in both research. 4 , 11 …”

“…In clinical management, statin use should not be discontinued after TBI. Soltani et al 4 2021 Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-blinded Randomized Clinical Trial Randomized controlled trial 60 ✓ The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI. Khokhar et al 5 2018 Mortality and Associated Morbidities Following Traumatic Brain Injury in Older Medicare Statin Users Retrospective cohort study 100.515 ✓ When appropriate, atorvastatin and simvastatin can be considered to older adults with TBI in order to decrease mortality and associated morbidities.…”

“…As a result, more efficacious therapy choices for these individuals are urgently needed to promote and enhance therapeutic outcomes. 4 The Operation Brain Trauma Therapy (OBTT) consortium was founded to identify potential pharmacotherapies for TBI in both the short and long term, from animal research to clinical trials in humans. The consortium has proposed statins as a feasible medication for TBI and its sequelae due to their properties of minimizing neuroinflammation and enhancing cerebral blood flow (CBF) following a TBI.…”

Role of statins in regulating molecular pathways following traumatic brain injury: A system pharmacology study

“…In spite of the fact that several new lipid-lowering medications have been introduced in the past decade [26][27][28], statins still remain as the most widely used class of medications prescribed for atherosclerotic cardiovascular disease hyperlipidemia [29,30]. Statins have interesting pleiotropic properties [31][32][33][34][35][36][37][38][39][40], which attract the attention of researchers to use them as potential drugs for improving the recovery and reducing the severity of TBI [29,41,42]. According to Fig.…”

“…Numerous preclinical and clinical research was accomplished to survey the impact of statins on TBI. For instance, two randomized clinical trials (RCT) demonstrated that atorvastatin and simvastatin could significantly improve the Glasgow Coma Scale (GCS) and Disability Rating Scale (DRS) test after one to three months and ameliorate Glasgow Outcome Scale (GOS) in the first month of post-intervention [41]. Other research on the TBI mouse model reported that statins could effectively improve post-TBI neuroinflammation through alternative polarization of microglia/macrophages and changing peripheral leukocyte invasion [42].…”