SAT-595 - Comparative Efficacy and Safety of Duloxetine Versus Amitriptyline for Pain Reduction in Diabetic Neuropathy: A Systematic Review and Meta-Analysis

Background:
Painful diabetic neuropathy is a frequent and debilitating complication of diabetes mellitus, significantly impairing quality of life. Duloxetine, a serotonin–norepinephrine reuptake inhibitor, and amitriptyline, a tricyclic antidepressant, are commonly prescribed for neuropathic pain; however, their comparative efficacy and tolerability remain a subject of clinical debate. This systematic review and meta-analysis aimed to compare the efficacy of duloxetine versus amitriptyline in reducing pain frequency among patients with diabetic neuropathy, along with an assessment of key adverse effects.

Methods:
A comprehensive literature search of major electronic databases was conducted to identify comparative clinical studies evaluating duloxetine versus amitriptyline in patients with diabetic neuropathy. Outcomes analyzed included overall efficacy in pain reduction and adverse events such as constipation, dizziness, dry mouth, nausea, and somnolence. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using appropriate meta-analytic models.

Results:
Four eligible studies comprising a total of 571 patients were included, with 286 patients in the duloxetine group and 285 in the amitriptyline group. Duloxetine demonstrated significantly higher efficacy in pain reduction compared with amitriptyline (OR 2.60; 95% CI 1.75–3.85). Regarding safety, duloxetine was associated with a significantly lower risk of dry mouth (OR 0.26; 95% CI 0.10–0.68). No statistically significant differences were observed between the two treatments for constipation (OR 1.40; 95% CI 0.32–6.16), dizziness (OR 0.80; 95% CI 0.23–2.85), nausea (OR 0.57; 95% CI 0.07–4.49), or somnolence (OR 0.68; 95% CI 0.26–1.76).

Conclusion:
Duloxetine appears to be more effective than amitriptyline in reducing pain frequency in patients with diabetic neuropathy, with a favorable tolerability profile, particularly regarding anticholinergic adverse effects such as dry mouth. These findings support duloxetine as a preferable first-line pharmacologic option for painful diabetic neuropathy, although larger, high-quality randomized trials are warranted to confirm long-term efficacy and safety.

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