Efficacy and Safety of Divaza for The Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Objective: To determine if Divaza was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. Study design: 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. Setting: 10 clinical centers across the Russian Federation. Interventions: Patients were randomized into two groups and instructed to take either 2 tablets of the study drug or placebo 3 times per day in conjunction with basic therapy. Outcomes: The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The laboratory indicators of oxidative stress were analyzed at baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. Results: : 124 outpatients with a mean age of 60.7±7.6 years were enrolled and randomly assigned to receive Divaza (n=65) or placebo (n=59). The Administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8±14.7 [14.8±14.7] seconds latent period versus 6.4±16.9 [6.9±16.7] seconds in the placebo group (p=0.007 [p=0.0107]). In addition, a recovery of cognitive impairment was observed in all patients of the Divaza group at the end of treatment; this was significantly better when compared with the placebo group (100 [100] % versus 89.5 [89.1] %, respectively, p=0.0272 [p=0.0128]). The treatment was safe, well-tolerated, and had a high compliance rate. Conclusions: : Divaza is a safe and effective therapeutic option for attenuating oxidative stress and recovery of cognitive impairment in patients with cerebral atherosclerosis. Trial registration: clinicaltrials.gov NCT03485495, of April 02, 2018.