title: Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758).
abstract: Amnesia is a common sequela following traumatic brain injury (TBI), for which there is no current treatment. Pleiotropic effects of statins have demonstrated faster recovery of spatial memory after TBI in animals. We conducted a double-blind randomized clinical trial add-on of patients with TBI (16-50 years of age), with Glasgow Coma Scale (GCS) scores of 9-13, and intracranial lesions as demonstrated by computed tomography (CT) scan. We excluded those patients with recent head injury or severe disability; administration of known drugs as modifiers of statin metabolism; multisystemic trauma; prior use of mannitol, barbiturate, corticosteroids, indomethacin or calcium antagonists; surgical or isolated lesion in brainstem; allergy to statins; previous hepatopathy or myopathy; previous management in another clinic; or pregnancy. Each patient received the same treatment and was randomly allocated to receive either rosuvastatin (RVS) or placebo over a period of 10 days. The primary outcome measures assessed were amnesia and disorientation times using Galveston Orientation Amnesia Test. Additionally, we evaluated plasma levels of interleukin (IL) 1beta, tumor necrosis factor (TNF) alpha, and IL-6, as well as disability at 3 months. We analyzed eight patients with RVS and 13 controls with similar basal characteristics. Using Cox regression analysis, administration of RVS showed a reduction of amnesia time with a hazard ratio of 53.76 (95% confidence interval [CI], 1.58-1824.64). This was adjusted for early intubation, basal leukocytes, basal Marshall and Fisher score, change of IL-1beta levels, and lesion side. IL-6 values at day 3 were increased in the RVS group (p = 0.04). No difference was detected in disability at 3 months. While statins may reduce amnesia time after TBI, possibly by immunomodulation, further trials are needed in order to confirm this positive association.
authors.affiliation: Clinical Epidemiology, Faculty of Medicine, Universidad Autónoma de San Luis Potosí, San Luis Potosí, SLP, México. lehwand@hotmail.com
authors.forename: J  Humberto
authors.initials: J
authors.lastname: Tapia-Perez
authors.forename: Martin
authors.initials: M
authors.lastname: Sanchez-Aguilar
authors.forename: Jaime Gerardo
authors.initials: JG
authors.lastname: Torres-Corzo
authors.forename: Antonio
authors.initials: A
authors.lastname: Gordillo-Moscoso
authors.forename: Patricia
authors.initials: P
authors.lastname: Martinez-Perez
authors.forename: Peter
authors.initials: P
authors.lastname: Madeville
authors.forename: Esperanza
authors.initials: E
authors.lastname: de la Cruz-Mendoza
authors.forename: Juan
authors.initials: J
authors.lastname: Chalita-Williams
mesh_terms: D000293:Adolescent; D000328:Adult; D000647:Amnesia / Q000209:etiology / Q000517:prevention & control*; D001930:Brain Injuries / Q000188:drug therapy* / Q000523:psychology*; D003221:Confusion / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D015599:Trauma Severity Indices
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium