Oral citicoline in acute ischemic stroke

An individual patient data pooling analysis of clinical trials

Antoni Dávalos, José Castillo, José Álvarez-Sabín, Julio J. Secades, Joan Mercadal, Sonia López, Erik Cobo, Steven Warach, David Sherman, Wayne Clark, Rafael Lozano

Research output: Contribution to journalArticle

174 Citations (Scopus)

Abstract

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 I 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 within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery at 3 months.

Original languageEnglish (US)
Pages (from-to)2850-2857
Number of pages8
JournalStroke
Volume33
Issue number12
DOIs
StatePublished - Dec 1 2002

Fingerprint

Cytidine Diphosphate Choline
Meta-Analysis
Stroke
Clinical Trials
Placebos
National Institutes of Health (U.S.)
Odds Ratio
Bibliographic Databases
Information Storage and Retrieval
Neuroprotective Agents
Neuroimaging
MEDLINE
Safety

Keywords

  • Cytidine diphosphate choline
  • Neuroprotection
  • Stroke, acute
  • Stroke, ischemic

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Dávalos, A., Castillo, J., Álvarez-Sabín, J., Secades, J. J., Mercadal, J., López, S., ... Lozano, R. (2002). Oral citicoline in acute ischemic stroke: An individual patient data pooling analysis of clinical trials. Stroke, 33(12), 2850-2857. https://doi.org/10.1161/01.STR.0000038691.03334.71

Oral citicoline in acute ischemic stroke : An individual patient data pooling analysis of clinical trials. / Dávalos, Antoni; Castillo, José; Álvarez-Sabín, José; Secades, Julio J.; Mercadal, Joan; López, Sonia; Cobo, Erik; Warach, Steven; Sherman, David; Clark, Wayne; Lozano, Rafael.

In: Stroke, Vol. 33, No. 12, 01.12.2002, p. 2850-2857.

Research output: Contribution to journalArticle

Dávalos, A, Castillo, J, Álvarez-Sabín, J, Secades, JJ, Mercadal, J, López, S, Cobo, E, Warach, S, Sherman, D, Clark, W & Lozano, R 2002, 'Oral citicoline in acute ischemic stroke: An individual patient data pooling analysis of clinical trials', Stroke, vol. 33, no. 12, pp. 2850-2857. https://doi.org/10.1161/01.STR.0000038691.03334.71
Dávalos A, Castillo J, Álvarez-Sabín J, Secades JJ, Mercadal J, López S et al. Oral citicoline in acute ischemic stroke: An individual patient data pooling analysis of clinical trials. Stroke. 2002 Dec 1;33(12):2850-2857. https://doi.org/10.1161/01.STR.0000038691.03334.71
Dávalos, Antoni ; Castillo, José ; Álvarez-Sabín, José ; Secades, Julio J. ; Mercadal, Joan ; López, Sonia ; Cobo, Erik ; Warach, Steven ; Sherman, David ; Clark, Wayne ; Lozano, Rafael. / Oral citicoline in acute ischemic stroke : An individual patient data pooling analysis of clinical trials. In: Stroke. 2002 ; Vol. 33, No. 12. pp. 2850-2857.
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