Duloxetine versus Routine Care in the Long-Term Management of Diabetic Peripheral Neuropathic Pain

Abstract

Introduction: Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. In the present open-label study, the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks was evaluated and compared to routine care in the therapy of patients diagnosed with diabetic peripheral neuropathic pain (DPNP).Methods: Patients who completed a 13-week, double-blind, duloxetine and placebo acute therapy period were rerandomly assigned in a 2:1 ratio to therapy with duloxetine 60 mg BID (N ‫؍‬ 161) or routine care (N ‫؍‬ 76) for an additional 52 weeks. Routine care consisted primarily of gabapentin, amitriptyline, and venlafaxine. The study included male or female outpatients 18 years of age or older with a diagnosis of DPNP caused by type 1 or type 2 diabetes.Results: A higher percentage of routine care-treated patients experienced 1 or more serious adverse events. No statistically significant therapy-group difference was observed in the overall incidence of treatment-emergent adverse events (TEAEs). The TEAEs reported by 10% or more of duloxetine 60 mg BID-treated patients were nausea, and by the routine care-treated patients were peripheral edema, pain in the extremity, somnolence, and dizziness. Duloxetine did not appear to adversely affect glycemic control, lipid profiles, nerve function, or the course of DPNP. There were no statistically significant therapy-group differences observed in the 36-item Short-Form Health Survey subscales or in the EuroQol 5-Dimension Questionnaire.Conclusions: In this study, duloxetine was safe and well tolerated compared to routine care in the long-term management of patients with DPNP.

Recommendations for the Pharmacological Management of Neuropathic Pain: An Overview and Literature Update

“…Duloxetine has shown consistent efficacy in painful DPN, 12 with effectiveness sustained for 1 year in an open-label trial. 23 Unfortunately, duloxetine has not been studied in other types of NP, and so its efficacy in such conditions is unknown. Duloxetine has shown efficacy in the treatment of major depression and generalized anxiety disorder, and its dosing is simple, with 60 mg once daily appearing to be as effective as 60 mg twice daily.…”

Clinical practice guidelines for management of neuropathic pain: Expert panel recommendations for South Africa

“…28,30,34,71 Venlafaxine has shown efficacy in painful polyneuropathies of different origins. 31,72 Both duloxetine and venlafaxine are approved for the treatment of major depression disorder (MDD) and generalised anxiety disorder (GAD) 73,74 and hence are the treatment of choice in NeuP patients with these co-morbid conditions.…”

Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?

“…Duloxetine has demonstrated efficacy in several large clinical trials of DPNP (11)(12)(13) and is one of only two drugs to have received regulatory approval for the treatment of this condition. As a selective reuptake inhibitor of both norepinephrine and serotonin, it shares some features with secondary amine TCAs such as nortriptyline.…”