A randomized dose-response trial of citicoline (CDP-choline) in acute ischemic stroke patients.
Citicoline Stroke Study Group.
Clark WM, Warach SJ, Pettigrew LC, Gammans RE, Sabounjian LA.
Oregon Stroke Center,
Oregon Health Sciences University, Portland, OR, 97201.
Neurology 1997 Sep;49(3):671-8
Citicoline (CDP-choline) is a key intermediary in the biosynthesis of phosphatidylcholine, an important component of the neural cell membrane. It has been shown to produce beneficial effects in both animal models and non-US clinical stroke trials. This study comprised a randomized (3 doses of CDP-choline to 1 placebo), vehicle-controlled, double-blind trial at 21 US centers. Treatment was to be started within 24 hours of stroke onset and was continued orally for 6 weeks. Final outcome assessments were at 12 weeks. Two hundred fifty-nine patients were enrolled, with approximately 65 in each of the four groups. Mean time from stroke onset to treatment was 14.5 hours, and there were no significant differences in baseline characteristics between the four groups except for patient weight. A significant difference between the groups, favoring CDP-choline treatment, was seen in terms of functional outcome as measured by the Barthel Index and Rankin scale, neurologic evaluation as measured by the National Institutes of Health (NIH) stroke scale, and cognitive function as measured by the Mini Mental Status Examination. When the baseline NIH stroke scale was used as a covariate, both the 500-mg CDP-choline group and the 2,000-mg CDP-choline group had a significant improvement in terms of the percent of patients who had a favorable outcome on the Barthel Index at 90 days. There were no drug-related serious adverse events or deaths in this study. This study suggests that oral CDP-choline can be used safely with minimal side effects in acute stroke treatment. CDP-choline appears to improve functional outcome and reduce neurologic deficit with 500 mg of
CDP-choline appearing to be the optimal dose.