Multicentric open-label study of the efficacy and tolerability of citicoline in the treatment of acute cerebral infarction

Citicoline is considered a promoter of neuronal repair. It has been shown in humans to be effective in the treatment of several cerebral pathologic conditions, including acute stroke. The aim of this open-label, uncontrolled study was to assess the efficacy and tolerability of citicoline in the treatment of patients suffering from acute cerebral infarction. Included in the trial, which lasted 10 to 14 days, were 123 patients who had an acute stroke within a maximum of 48 hours of the study. During the first 5 days, citicoline was administered intravenously (2 g per 24 hours). From day 6, it was administered intramuscularly (1 g per 24 hours). Patients were assessed using the Canadian Neurological (CAN) scale (patient alert or drowsy) and side effects were recorded at each visit. Each patient was always assessed by the same neurologist, who was aware of the treatment. The total score on the CAN scale showed a significant evolution over time. Post-hoc paired Student's t tests showed that this score had increased significantly after 3 days of citicoline administration and continued to increase to the end of treatment. An end-point analysis (value observed at the last available visit; n = 113) showed that the score decreased in 5.3% of patients and remained the same in 15.9% of patients. The score increased at least 1 point in 71.7% of patients, 3 points in 35.4% of patients, and 5 points in 12.4% of patients. Patients receiving aspirin concomitantly did not show a greater improvement in their neurologic state than patients receiving citicoline only. The frequency of patients showing side effects probably related to the medication was 7.4%. The results of this study are consistent with those already available, which show that citicoline is an effective and well-tolerated treatment for patients suffering from acute cerebral infarction.