Game Changer in the Management of Diabetic Neuropathy: an Indian Perspective - Post-Marketing Surveillance of Epalrestat and Methylcobalamin

Background: Diabetic Neuropathy is one amongst the most common long - term complication of diabetes. It is prevalent in more than 50% of people suffering from diabetes mellitus. Management of diabetic neuropathy is aimed at targeting the pathogenetic factors that leads to neuropathy. Epalrestat helps to prevent neuronal degeneration by reducing the accumulation of toxic sorbitol and decreasing the oxidative stress while methylcobalamin helps to recover neuronal injury.The purpose of this study was to evaluate safety and efficacy of fixed dose combination of Epalrestat+ Methylcobalamin in patients with diabetic neuropathy.

Method: A prospective, open-label, non-comparative study was conducted in different regions of India. A pool of 150 patients was involved in the study and the duration of study was 12 weeks. A fixed dose combination of Epalrestat 50 mg + Methylcobalamin 500 mcg three times a day was administered.

Results: At the end of the study, a significant difference was observed in various parameters from baseline. A significant reduction in neuropathic symptoms was observed at the end of the treatment (58% reduction at 4th week and 94% reduction at 12^th week). The mean pain intensity score reduced to 89.4% from baseline. A positive effect was also observed in muscle strength that increased to 36% in patients. As per investigator's assessment about efficacy and tolerability, 82.7% of patients reported excellent efficacy and 86.7% of patients reported excellent tolerability. The therapy was well tolerated with few adverse events (AEs).

Conclusion: The results of this study confirm that this combination of Epalrestat+ Methylcobalamin is well tolerated and it showed significant improvement in the symptoms of diabetic neuropathy at the end of treatment.