A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF AMITRIPTYLINE AND PREGABALIN IN DIABETIC NEUROPATHY

Abstract

Objective: To compare amitriptyline and pregabalin in terms of efficacy and safety in diabetic peripheral neuropathy patients. Methods: This prospective, open-label, non-randomised, comparative study conducted in Department of Neurology, KIMS Hospital, Hubballi, Karnataka, India from January 2018 to December 2018. 110 patients were alternately allocated to receive amitriptyline 10 mg once daily or pregabalin 75 mg once daily for 12 weeks. Pain intensity after taking medication was assessed by Visual Analogue Scale (VAS), while sleep interference score was used as a secondary efficacy parameter. Patients were assessed at baseline and at 4 weeks, 8 weeks, and 12 weeks and adverse drug reactions were monitored. Chi-square test, independent t-test and paired t- test were used as appropriate. Results: Amitriptyline and pregabalin treatment groups showed significant reduction in VAS scores from baseline to 12 weeks (p < 0.001), with no significant difference between the groups. Sleep interference scores also improved significantly in both groups at all visits, but statistically significant superiority of either treatment was not seen. Drowsiness was the common adverse effect observed in both groups at early follow-up. Dry mouth and constipation were frequently reported with amitriptyline, whereas dizziness was common with pregabalin group. In the pregabalin group three patients discontinued treatment because of adverse effects. Conclusion: Both groups showed significant reduction in pain intensity and sleep disturbance over 12 weeks with no statistically significant difference observed between the groups in the measured efficacy outcomes.