RESUMO
OBJECTIVE: The purpose of the present double-blind, placebo-controlled, randomized clinical trial was to evaluate the efficacy and safety of Cytoflavin in patients with diabetic polyneuropathy (DPN). MATERIAL AND METHODS: Investigational therapy was administered in two steps: intravenous infusions of experimental drug/placebo for 10 days followed by oral administration for 75 days. In 10 clinical centers, 216 patients aged 45-74 years with a diagnosis of type 2 diabetes mellitus, symptomatic distal sensorimotor DPN, confirmed no earlier than 1 year before screening, on stable therapy (no change of drugs and doses) by oral hypoglycemic drugs, intermediate-acting, long-acting or extra-long-acting insulin, and/or GLP-1 receptor agonists. RESULTS: By the end of treatment, the change of the Total Symptom Score (TSS) in the experimental group was -2.65 points, in the placebo group -1.73 points (p<0.001). Improvement of symptoms in the experimental group was achieved regardless of the degree of compensation for type 2 diabetes (both in those with Hb1Ac <8.0% and in those with Hb1Ac ≥8.0%), but demonstrated better results in patients with less severe baseline symptoms (TSS <7.5). Improvement in the components of the TSS scale «paresthesia¼ and «numbness¼ occurred as early as on day 11 of therapy; by the end of treatment, a significant decrease in the «burning¼ component was also demonstrated. The experimental drug had a positive safety profile. CONCLUSION: Cytoflavin, intravenous solution and enteric-coated tablets (SPTF Polysan Ltd.) is indicated for the symptomatic treatment of DPN.
