on October 24, 2002
Published online before print October 24, 2002, doi: 10.1161/01.STR.0000038691.03334.71
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Submitted on June 19, 2002
From the Department of Neurology, Hospital Universitari Doctor Josep Trueta, Girona, Spain (A.D.); Department of Neurology, Hospital Clínico Universitario, Santiago de Compostela, Spain (J.C.); Department of Neurology, Hospitals de la Vall d'Hebrón, Barcelona, Spain (J.A.-S.); Medical Department, Grupo Ferrer SA, Barcelona, Spain (J.J.S., J.M., S.L., R.L.); Department of Statistics and Operative Research, Universitat Politècnica de Catalunya, Barcelona, Spain (E.C.); National Institutes of Health, NINDS, Bethesda, Md (S.W.); Department of Medicine (Neurology), University of Texas Health Science Center, San Antonio (D.S.); and Oregon Stroke Center, Oregon Health Sciences University, Portland (W.M.C.). * To whom correspondence should be addressed. E-mail: min.adavalos{at}htrueta.scs.es.
Background and Purpose—No single neuroprotective agent has been shown to influence outcome after acute stroke. Citicoline 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 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 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 within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery at 3 months.
Accepted on July 4, 2002
Oral Citicoline in Acute Ischemic Stroke. An Individual Patient Data Pooling Analysis of Clinical Trials
Antoni Dávalos MD, PhD*;
1, modified Rankin Scale score 1, and Barthel Index 
95 at 3 months using the generalized estimating equations analysis.8, and prior modified Rankin Scale score 1. Four clinical trials using various doses of oral citicoline (500, 1000, and 2000 mg) were identified.
Key words: cytidine diphosphate choline • neuroprotection • stroke, acute • stroke, ischemic
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