Efficacy, safety, and tolerability of Epalrestat compared to Methylcobalamine in patients with diabetic neuropathy.
OBJECTIVE
To compare the efficacy, safety, and tolerability of Epalrestat with Methylcobalamine in patients with diabetic neuropathy.


METHODS
This prospective, open-labeled, comparative, and multicentric study was conducted on an outpatient basis by qualified investigators at four different centers. A total of 242 patients with diabetic neuropathy were enrolled in the study. The enrollment of patients was as per inclusion/exclusion criteria. After obtaining their informed consent, they were individually interviewed, examined, investigated, and treated as per the study protocol. Each patient was administered with one tablet containing Epalrestat 50 mg thrice daily or Methylcobalamine 500 microg thrice daily for 12 weeks. They were followed up at the end of weeks 4, 8, and 12 for their examination. Therapeutic success was assessed in terms of clinical symptoms, physical examinations, and electrophysiological assessments.


RESULTS
A significant improvement in all the efficacy parameters was observed with Epalrestat treatment compared to Methylcobalamin treatment. The efficacy parameters assessed were loss of sensation, burning sensation, numbness, muscle cramps, spontaneous pain, weakness, mean score of isometric muscle strength, tendon reflexes, and sensation. Epalrestat treatment is associated with very few adverse events. The tolerability to Epalrestat treatment was also reported to be excellent in the majority of the study population compared to tolerability to Methylcobalamine. Patients as well as physicians reported that the Epalrestat treatment is superior in efficacy and safety parameters compared to Methylcobalamin.


CONCLUSIONS
The present study concludes that Epalrestat has better efficacy and safety profile than Methylcobalamine in the treatment of diabetic neuropathy.
Maladkar
Manish
M
Aristo Pharmaceuticals P Ltd Mumbai-53, India.
Rajadhyaksha
Girish
G
Venkataswamy
N
N
Hariharan
R S
RS
Lohati
Sathis R
SR