An Open Label, One Arm Study To Evaluate The Efficacy And Safety of Cerebrolysin In Patients With Acute Severe Ischemic Stroke In Mexico

Abstract

We aim to evaluate the efficacy and safety of cerebrolysin in Mexican patients with acute severe ischemic stroke (ASIS) and to describe their demographic and clinical characteristics along with their comorbidities and adverse events. Open label, one arm, and dose decreasing exploratory study in 30 consecutive patients from “Unidad Hospitalaria Cruz Verde Dr. Delgadillo Araujo” with ASIS starting within 48 hours from the onset of stroke; they received 50 ml of intravenous cerebrolysin daily for 10 days followed by 10 days of 30 ml. All patients underwent CT scan and were examined using the National Institutes of Health Stroke Scale (NIHSS) score and Modified Rankin Scale (≥ to 12 and ≥ 3, respectively) score at baseline as well as on day 15 after hospital discharged. Difference between measures was evaluated with paired Student’s t statistic. The patients mean age was 60.26 ± 11.2 years, 16 (53%) were male and a majority were between 50-70 years (60%). 19 patients reported at least one physical comorbidity (63.3%), the most frequently reported comorbidities were hypertension, diabetes mellitus and atrial fibrillation (n=10, 33%; n=9, 30%; n=1, 3% respectively). Pretreatment mean score on the NIHSS scale was 20.4, SD 3.9, 95 CI [18.9 - 21.82]; mean Modified Rankin Scale (mRs) was 3.8 , SD 0.8, 95 CI [3.4 - 4.1 ]. At day 15 follow-up NIHSS, was 11; SD 4.5; 95 CI [9.3 - 12.8 ]; mean mRs score was 1.9, SD 0.7, 95 CI [1.7 - 2.2 ], (p = 0.000 and 0.000 respectively).Only one patient report nightmares as adverse event. The current study demonstrate that cerebrolysin treatment improves functional outcome safely in Mexican patients with ASIS. Future double-blind studies with larger sample sizes will further help to explore causal benefits of this drug in stroke outcome.