Effectiveness and safety of amitriptyline, duloxetine, and pregabalin in painful diabetic neuropathy: An observational study

Abstract

Background: Studies comparing the real-world effectiveness, safety, and effect on quality of life (QoL) of drugs for painful diabetic peripheral neuropathy (DPN) are scarce. Aims and Objectives: The aim of the study was to compare effectiveness, safety and effect on QoL of amitriptyline (AMY), duloxetine (DUL) and pregabalin (PGN) in DPN. Materials and Methods: After ethics committee approval and informed consent, 75 outpatients (25 each) prescribed any one of above drugs were consecutively recruited in a prospective and observational study. Drug effectiveness was assessed by comparing difference in mean monthly visual analogue scale (VAS) score from baseline, obtained from pain diary. QoL was assessed by comparing total and domain-wise score on Nottingham health profile (NHP) questionnaire. Safety was assessed by comparing frequency of adverse drug reactions (ADRs). Qualitative and quantitative outcome measures were compared using Chi-square test and one-way analysis of variance, respectively. P < 0.05 was considered statistically significant. Results: The difference in mean monthly VAS scores at the end of 4, 8, and 12 weeks was similar between the three drugs. Patients on PGN had smaller beneficial effects in total as well as emotional, energy, and sleep domains of NHP compared to other drugs. Sedation and dizziness occurred with all drugs but PGN had least incidence of sedation. Conclusion: AMY, DUL and PGN are equally effective and safe in DPN. Although PGN did not improve QoL unlike AMY and DUL, it had lower incidence of sedation.