Citicoline is an essential precursor in the synthesis of
phosphatidylcholine, a key cell membrane
phospholipid, and is known to have
neuroprotective effects in
acute ischemic stroke. The aim of this study was to determine the efficacy and safety of oral
citicoline in Korean patients with
acute ischemic stroke. A
drug surveillance study was carried out in 4,191 patients with a diagnosis of
acute ischemic stroke. Oral
citicoline (500-4000 mg/day) was administered within less than 24 h after
acute ischemic stroke in 3,736 patients (early group) and later than 24 h after
acute ischemic stroke in 455 patients (late group) for at least 6 weeks. For efficacy assessment, primary outcomes were patients' scores obtained with a short form of the National Institutes of Health
Stroke Scale (s-NIHSS), a short form of the Barthel Index of
activities of daily living (s-BI) and a modified Rankin Scale (mRS) at enrollment, after 6 weeks and at the end of
therapy for those patients with extended treatment. All adverse reactions were monitored during the study period for safety assessment. All measured outcomes, including s-NIHSS, s-BI and mRS, were improved after 6 weeks of
therapy (P < 0.05). Further improvement was observed in 125 patients who continued
citicoline therapy for more than 12 weeks when compared with those who ended
therapy at week 6. Improvements were more significant in the higher dose group (> or = 2000 mg/day) (P < 0.001). s-BI scores showed no differences between the early and late groups at the end of
therapy.
Citicoline safety was excellent; 37 side effects were observed in 31 patients (0.73%). The most frequent findings were nervous system-related symptoms (8 of 37, 21.62%), followed by gastrointestinal symptoms (5 of 37, 13.5%). Oral
citicoline improved neurological, functional and global outcomes in patients with
acute ischemic stroke without significant safety concerns.