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

doi:10.1111/j.1526-4637.2007.00276.x

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Wiley InterScience

Pain Medicine

Volume 8 Issue 5, Pages 410 - 418

Published Online: 11 Jul 2007

Erratum:

Pain Medicine, 2007, 8 (8), 690-690

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

David G. Armstrong, DPM, PhD,* Amy S. Chappell, MD, ^† Trong K. Le, MPH, ^† Daniel K. Kajdasz, PhD, ^† Miroslav Backonja, MD, ^‡ Deborah N. D'Souza, PhD, MBA, ^† and James M. Russell, MD ^†

*Scholl's Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA; ^† Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA; ^‡ University of Wisconsin Medical School, Madison, Wisconsin, USA

Correspondence to Amy S. Chappell, MD, Eli Lilly and Company, Indianapolis, IN 46285, USA. Tel: 317-277-3846; Fax: 317-276-6026; E-mail: aschappell@lilly.com

KEYWORDS

Diabetic Neuropathy • Antidepressants

ABSTRACT

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 ≤ 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.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1526-4637.2007.00276.x About DOI