Evaluation of Efficacy and Safety of Epalrestat (150 mg) Compared to Epalrestat (50 mg) in Patients Suffering from Diabetic Peripheral Neuropathy

Shende, SD; Baig, MS; Doifode, SM

Shende, SD (reprint author), Alkern Labs Ltd, Dept Med Affair, Bombay, Maharashtra, India.



Introduction: Epalrestat is currently the only Aldose Reductase Inhibitor (ARI) approved to treat symptoms of Diabetic Peripheral Neuropathy (DPN). The efficacy and safety of Epalrestat 50 mg TDS have been established in clinical practice, however compliance is challenging. Aim: To evaluate efficacy and safety of Epalrestat Sustained Release (SR) (150 mg) compared to Epalrestat Immediate Release (IR) (50 mg) in patients suffering from DPN. Materials and Methods: A total of 100 patients with DPN were enrolled in the study after fulfilling the inclusion and exclusion criteria into two groups of fifty each. Each patient received tablet Epalrestat SR 150 mg once daily or Epalrestat IR 50 mg thrice daily orally for 12 weeks were follow-up at the end of 4, 8, and 12 weeks for evaluation. Primary outcome measure was percent change in Modified Neuropathy Disability Score (MNDS) in both groups from baseline. Secondary outcomes were mean change in pain intensity, numbness in Upper Limb (UL); Lower Limb (LL), cramping and dizziness on VAS score in both groups from baseline. Statistical analysis was done using Student's paired and unpaired t-test, Fisher's-exact-test, and repeated measures ANOVA test. Results: Epalrestat SR treatment showed clinically significant improvements in MNDS Score and symptoms of neuropathy when compared with Epalrestat IR tablet. Mean MNDS in Epalrestat SR group was reduced to 6.38, 4.28, 1.86 after 4, 8 and 12 weeks of treatment respectively (p<0.001). At the end of 12 weeks mean pain severity was reduced to 1.68 in Epalrestat SR group and 2.68 in Epalrestat IR group respectively on VAS (p<0.0001). UL numbness was reduced to 0.54 in Epalrestat SR group and to 1.14 in Epalrestat IR group after 12 weeks of treatment which was statistically significant. Similar statistically significant decline was observed in numbness of LL at the end of 12 weeks of treatment (Epalrestat SR: 1.46 and Epalrestat IR: 2.12). Cramping and dizziness also showed improvement in both Epalrestat groups (p>0.05). The most common reported adverse events were headache, diarrhoea and vomiting. Conclusion: Epalrestat SR is a better alternative to Epalrestat IR in the treatment of DPN.

Download PDF

Full Text Link