Comparative Efficacy of Pregabalin and Duloxetine in the Management of Diabetic Neuropathic Pain: A Randomized Controlled Study

Abstract

Objective: To assess and compare the efficacy, safety and patient-reported outcomes of pregabalin versus duloxetine in adults with painful diabetic peripheral neuropathy (DPN).

Methods: Prospective, Double blind, Double dummy, Parallel group, Randomized control trial was done in three tertiary care centers. Adults (30-70 years) with type 2 diabetes mellitus (T2DM) and confirmed painful DPN (Numerical Rating Scale [NRS] ≥5) were randomized 1:1 to receive either pregabalin (150-300 mg/day) or duloxetine (60 mg/day) for 12 weeks. P value of < 0.05 was considered statistically significant.

Results: Both treatments resulted in significant decrease in pain from baseline (p<0.001). At weeks 2 and 4, pregabalin had a faster onset of action than duloxetine for pain (p=0.003 and 0.012, respectively), and SF-36 mental component scores (p=0.008 and p=0.021, respectively) at 12 weeks. There was a similar responder rate (pregabalin 68.3% and duloxetine 65.7%, p=0.71). The incidence of nausea and dry mouth was increased with duloxetine compared with pregabalin (all p<0.05), while dizziness and weight gain were increased with pregabalin compared with duloxetine.

Conclusion: Both Pregabalin and Duloxetine shown to be equally effective for the relief of DPN pain for 12 weeks, but they have different onset of action, patient-reported outcomes, and adverse effect profile. Choices of treatment should be individualized, taking into account symptom dominance and comorbid conditions, as well as tolerability.