Clinical Question Is citicoline effective in improving the recovery of acute ischemic stroke versus placebo?
Evidence-Based Answer Six randomized, placebo-controlled trials have been conducted evaluating the efficacy of citicoline in improving the recovery in patients with acute ischemic stroke. The first study revealed citicoline to be more effective than placebo in patients with moderate to mild ischemic stroke. The following three trials by Clark et al focused on finding an effective dose and specific stroke severity scores to show the possible efficacy of citicoline. Citicoline showed very little to no benefit in these trials. The ICTUS trial confirmed those finding from the Clark trials stating no significant difference in citicoline …show more content…
The primary outcome was to compare the efficacy of recovery of 500mg oral citicoline with placebo for a 6 week treatment period with a 6 week follow up. 394 patients were randomized in a 2:1 ratio to 500mg/day citicoline (n=267) and placebo (n= 127). Baseline characteristics were similar except there were more patients in the placebo group who had a NIHSS score <8 vs citicoline (p= 0.01, 34% vs 22%, respectively). Outcome measures were similar to the previous trial which includes differences in BI, MRs, MMSE, and NIHSS. In the overall population of this trial, there was no treatment benefit observed in any of the outcome measures. Post hoc analyses revealed significant results in patients with NIHSS ≥8. Overall, there was a treatment benefit seen with citicoline vs placebo (p= 0.04, OR 1.9). There was also larger improvement in NIHSS scores (≥ 7 point improvement) at week 12 with citicoline vs placebo (p= 0.01, 42% vs 30%, respectively). It was determined that the benefit cannot be seen with citicoline in mild strokes because there is a high recovery rate in …show more content…
The primary outcome was to determine the efficacy on stroke recovery of 2000mg oral citicoline vs placebo following similar protocol to the previous trials but with narrowed inclusion and exclusion criteria. 899 patients were randomized into this trial, citicoline (n=453) and placebo (n= 446). NO significant differences were seen between both groups. Primary outcome was comparing the % of improvement of NIHSS score of ≥ 7 points at week 12. Secondary outcomes included % of patients returning to prestroke BI, improvement by 1 or 2 points on Clinician’s Global Impressions (CGI) scale, MRs and Global test. The primary outcome NIHSS ≥ 7 improvement in citicoline vs placebo was found to be non-significant (52% vs 51%, respectively.) All secondary outcomes were found to be non-significant when comparing the treatment effect of citicoline with placebo. Citicoline was found to have modest treatment benefit vs placebo only when “excellent recovery” endpoints were used in post hoc
Evidence-Based Answer Six randomized, placebo-controlled trials have been conducted evaluating the efficacy of citicoline in improving the recovery in patients with acute ischemic stroke. The first study revealed citicoline to be more effective than placebo in patients with moderate to mild ischemic stroke. The following three trials by Clark et al focused on finding an effective dose and specific stroke severity scores to show the possible efficacy of citicoline. Citicoline showed very little to no benefit in these trials. The ICTUS trial confirmed those finding from the Clark trials stating no significant difference in citicoline …show more content…
The primary outcome was to compare the efficacy of recovery of 500mg oral citicoline with placebo for a 6 week treatment period with a 6 week follow up. 394 patients were randomized in a 2:1 ratio to 500mg/day citicoline (n=267) and placebo (n= 127). Baseline characteristics were similar except there were more patients in the placebo group who had a NIHSS score <8 vs citicoline (p= 0.01, 34% vs 22%, respectively). Outcome measures were similar to the previous trial which includes differences in BI, MRs, MMSE, and NIHSS. In the overall population of this trial, there was no treatment benefit observed in any of the outcome measures. Post hoc analyses revealed significant results in patients with NIHSS ≥8. Overall, there was a treatment benefit seen with citicoline vs placebo (p= 0.04, OR 1.9). There was also larger improvement in NIHSS scores (≥ 7 point improvement) at week 12 with citicoline vs placebo (p= 0.01, 42% vs 30%, respectively). It was determined that the benefit cannot be seen with citicoline in mild strokes because there is a high recovery rate in …show more content…
The primary outcome was to determine the efficacy on stroke recovery of 2000mg oral citicoline vs placebo following similar protocol to the previous trials but with narrowed inclusion and exclusion criteria. 899 patients were randomized into this trial, citicoline (n=453) and placebo (n= 446). NO significant differences were seen between both groups. Primary outcome was comparing the % of improvement of NIHSS score of ≥ 7 points at week 12. Secondary outcomes included % of patients returning to prestroke BI, improvement by 1 or 2 points on Clinician’s Global Impressions (CGI) scale, MRs and Global test. The primary outcome NIHSS ≥ 7 improvement in citicoline vs placebo was found to be non-significant (52% vs 51%, respectively.) All secondary outcomes were found to be non-significant when comparing the treatment effect of citicoline with placebo. Citicoline was found to have modest treatment benefit vs placebo only when “excellent recovery” endpoints were used in post hoc