OBJECTIVE

The aim of this study was to evaluate the efficacy of infusion therapy with the drug Cytoflavin (Inosine+Nicotinamide+ Riboflavin+Succinic Acid) in patients with ischemic stroke (IS) who did not receive reperfusion therapy.

MATERIAL AND METHODS

A prospective, multicenter, observational study was conducted. Patients (n=281, 50% of the planned enrollment) with IS that developed within no more than 36 hours before study inclusion received intravenous Cytoflavin for at least 10 days as part of routine clinical practice (main group). The control group consisted of patients who received any other neurometabolic drugs or did not receive therapy from this category. Assessments were performed using the NIHSS, Modified Rankin Scale (mRS), Rivermead Index, and SS-QoL at time points up to 90 days. Logistic regression, adjusted for potentially significant clinical factors, was used for the analysis.

RESULTS

The proportion of patients with a good functional outcome (mRS 0—1) in the main group was statistically significantly higher compared to the control group: 23.8% vs. 12.0% at discharge (p=0.0078), and 40.1% vs. 27.3% at Day 90 (p=0.016). The proportion of patients with a favorable outcome (mRS 0—2) was higher in the Cytoflavin group: 51.0% vs. 42.9% and 76.9% vs. 68.2% at discharge and Day 90, respectively, although statistical significance was not achieved. Logistic regression revealed a significant influence of Cytoflavin therapy on the likelihood of a favorable outcome by Day 90 OR 1.51, 95% CI 0.88; 2.61, p=0.0316).

CONCLUSION

Thus, the interim analysis demonstrates, across several criteria, a positive effect of Cytoflavin therapy on the functional recovery of patients with ischemic stroke without reperfusion therapy, confirming the promise of the drug in clinical practice. Final conclusions will be drawn after the completion of the study.