[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<0.001). The stepwise regimen resulted in a more pronounced improvement in NSS (p=0.048). The intensity of neuropathic pain on the NRS significantly decreased in both treatment groups (p<0.001). A significant improvement in glycemic control parameters was observed in the active treatment groups. A mild but statistically significant improvement in cognitive function as assessed by MMSE was also noted (p≤0.04). Electroneuromyography showed positive dynamics in sensory fiber parameters. The safety profile was favorable in both treatment groups.

CONCLUSION

Both ipidacrine regimens demonstrated high efficacy as part of combination therapy for DPN. The stepwise regimen likely provided a faster onset of clinical effect. The safety profile was favorable, and no serious adverse events were observed.