Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain: Evaluation of Functional Outcomes

OBJECTIVE: To assess the effectiveness of duloxetine, compared with placebo, on patient-reported health outcomes over a 12-week period, in the management of diabetic peripheral neuropathic pain (DPNP). METHODS: The results were pooled from three 12-week multicenter, double-blind studies. In study 1 (N = 457), patients with DPNP were randomly assigned to treatment with duloxetine 20 mg once daily (QD), 60 mg QD, 60 mg twice daily (BID), or placebo. In studies 2 (N = 334) and 3 (N = 348), patients with DPNP were randomly assigned to treatment with duloxetine 60 mg QD, 60 mg BID, or placebo. Patient-reported functional outcomes were measured by the Short Form 36 (SF-36), the interference portion of the Brief Pain Inventory (BPI), and EuroQol 5D Health Questionnaire (EQ-5D). Results for all functional outcomes from the intent-to-treat and completer populations are discussed. RESULTS: In the SF-36 health survey and the BPI interference, duloxetine 60 mg QD and 60 mg BID were significantly superior to placebo in all the domains (P <or= 0.03). In the analysis of the EQ-5D, duloxetine 60 mg QD (P = 0.004) and 60 mg BID (P < 0.001) were significantly better than placebo on all items. CONCLUSIONS: Acute treatment with duloxetine was associated with significant improvement in functional outcomes in persons with DPNP.