Efficacy and safety of ipidacrine (Neuromidin) in patients with diabetic polyneuropathy: results of an open-label comparative study

Objective. To assess the efficacy and safety of two ipidacrine (Neuromidin) treatment regimens-a stepwise regimen (intramuscular administration followed by oral therapy) and an oral-only regimen-in patients with type 1 or type 2 diabetes mellitus (DM) and confirmed diabetic polyneuropathy (DPN). Material and methods. In an open-label comparative study, the efficacy and safety of ipidacrine (Neuromidin) were evaluated in 90 patients with DPN receiving conventional antidiabetic therapy. Patients were assigned to three groups of 30 each: 1st — stepwise ipidacrine therapy (initial intramuscular administration followed by oral therapy); 2nd — oral ipidacrine therapy only; 3rd — control group (conventional antidiabetic therapy without ipidacrine). The treatment duration was 60 days. DPN was assessed using the Neuropathy Symptom Score (NSS), Neuropathy Disability Score (NDS), and Total Symptom Score (TSS). The intensity of neuropathic pain was evaluated using the Numeric Rating Scale (NRS). In addition, glycated hemoglobin (HbA1c), cognitive status (Mini-Mental State Examination, MMSE), and electroneuromyography of the peroneal nerve were assessed. Results. Both treatment groups demonstrated a significant improvement in DPN parameters (p