Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials.

Davalos A, Castillo J, Alvarez-Sabin J, Secades JJ, Mercadal J, 
Lopez S, Cobo E, Warach S, Sherman D, Clark WM, Lozano R.

Department of Neurology, 
Hospital Universitari Doctor Josep Trueta, 
Girona, Spain (A.D.).
Stroke 2002 Dec;33(12):2850-7

Abstract

Background and Purpose- No single neuroprotective agent has been shown to influence outcome after acute stroke. Citicoline (CDP-choline) has been studied worldwide in many clinical trials with positive findings, but only 1 trial has obtained significant results in the primary efficacy variables. Our objective was to evaluate the effects of oral citicoline in patients with acute ischemic stroke by a data pooling analysis of clinical trials. The primary efficacy end point chosen was the common evaluation of recovery, combining National Institutes of Health Stroke Scale </=1, modified Rankin Scale score </=1, and Barthel Index >/=95 at 3 months using the generalized estimating equations analysis. 

METHODS: A systematic search of all prospective, randomized, placebo-controlled, double-blind clinical trials with oral citicoline  (Medline, Cochrane, and Ferrer Group bibliographic databases) was undertaken. Individual patient data were extracted from each study and pooled in a single data file. The main inclusion criteria included compatible neuroimaging with ischemic stroke, National Institutes of Health Stroke Scale >/=8, and prior modified Rankin Scale score </=1. Four clinical trials using various doses of oral citicoline (500, 1000, and 2000 mg) were identified. 

RESULTS: Of 1652 randomized patients, 1372 fulfilled the inclusion criteria (583 received placebo, 789 received citicoline). Recovery at 3 months was 25.2% in citicoline-treated patients and 20.2% in placebo-treated patients (odds ratio [OR], 1.33; 95% CI, 1.10 to 1.62; P=0.0034). The dose showing the largest difference with placebo was 2000 mg, with 27.9% of patients achieving recovery (OR, 1.38; 95% CI, 1.10 to 1.72; P=0.0043). The overall safety of citicoline was similar to placebo. 

CONCLUSIONS: Treatment with oral citicoline (CDP-choline) within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery at 3 months.

 | Home | Order |

 1.   CDP choline  may be useful in the treatment of Alzheimer's
 2.   CDP choline  therapeutic effects in Alzheimer's
 3.   CDP choline  choline  effects on cognition in patients with Alzheimer's
 4.   CDP choline  significant improvement in Alzheimer's after 1 month  
 5.   CDP choline  improved mental performance in Alzheimer's
 6.   CDP choline  improvement in glaucoma
 7.   CDP choline  therapeutic value in the treatment of glaucoma
 8.   CDP choline  improved retinal responses in patients with glaucoma
 9.   CDP choline  in acute ischemic stroke
10.  CDP choline  randomized trial in acute ischemic stroke
11.  CDP choline  treatment after traumatic brain injury
12.  CDP choline  action and effects in ischemic brain injury