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Game Changer in the Management of Diabetic Neuropathy: an Indian Perspective - Post-Marketing Surveillance of Epalrestat and Methylcobalamin
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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 12th 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.
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