Background and Purpose-Citicoline (cytidine-5Ј-diphosphocholine; CDP-choline) may reduce central nervous system ischemic injury by stabilizing cell membranes and reducing free radical generation. A previous dose-comparison trial in patients with acute stroke found that 500 mg of citicoline appeared to improve neurological outcome with minimal side effects. Methods-The current trial was a 33-center, randomized, double-blind, efficacy trial in 394 patients comparing placebo (nϭ127) with citicoline (nϭ267) (500 mg po daily) for 6 weeks, with a 6-week posttreatment follow-up period. Patients with acute (24 hours) ischemic strokes clinically assessed to be in the middle cerebral artery territory with National Institutes of Health Stroke Scale (NIHSS) Ն5 were enrolled. Results-Mean time to treatment was 12 hours, and mean age was 71 for placebo and 70 for citicoline. Although mean baseline NIHSS were similar for both groups, there was a higher percentage of placebo patients with NIHSS Ͻ8 (34% vs 22%; PϽ0.01). The incidence and type of side effects were similar between the groups. The planned primary analysis (logistic regression: 5 categories Barthel) failed the proportional odds assumption and was rendered unreliable. There were no between-group differences seen on the planned secondary assessment analyses at 90 days, including the Barthel Index Ն95 at 12 weeks (last observation carried forward: placebo 40%; citicoline 40%) or mortality rate (placebo 18%; citicoline 17%). However, post hoc analyses in a subgroup of patients with baseline NIHSS Ն8 found that citicoline-treated patients were more likely to have a full recovery (Barthel Ն95): placebo 21%; citicoline 33%; Pϭ0.05; whereas no difference was seen in patients with baseline NIHSSϽ8 (placebo 77%; citicoline 69%; PϾ0.1. Conclusions-The results of this study indicate that citicoline was safe but ineffective in improving the outcome of patients with acute ischemic stroke who were enrolled in this trial. Post hoc analyses indicate that there may be a subgroup of patients with moderate to severe strokes who would benefit. (Stroke. 1999;30:2592-2597.)
Intensive education of migraine patients by trained lay instructors may convey significant benefit to those patients and reduce their utilization of healthcare resources.
on behalf of the SPARCL InvestigatorsBackground and Purpose-Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces strokes in subjects with recent stroke or transient ischemic attack (nϭ4731). We analyzed SPARCL trial data to determine whether treatment favorably shifts the distribution of severities of ischemic cerebrovascular outcomes. Methods-Severity was assessed with the National Institutes of Health Stroke Scale, Barthel Index, and modified Rankin Scale score at enrollment (1 to 6 months after the index event) and 90 days poststroke in subjects having a stroke during the trial. Results-Over 4.9 years, strokes occurred in 576 subjects. There were reductions in fatal, severe (modified Rankin Scale score 5 or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (PϽ0.001 unadjusted and adjusted). Results were similar for all outcome events (ischemic and hemorrhagic, PϽ0.001 unadjusted and adjusted) with no effect on outcome hemorrhagic stroke severity (Pϭ0.174 unadjusted, Pϭ0.218 adjusted). If the analysis is restricted to those having an outcome ischemic stroke (ie, excluding those having a transient ischemic attack or no event), there was only a trend toward lesser severity with treatment based on the modified Rankin Scale score (Pϭ0.0647) with no difference based on the National Institutes of Health Stroke Scale or Barthel Index. Conclusion-The
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