TITLE

Safety and Tolerability of Duloxetine in the Acute Management of Diabetic Peripheral Neuropathic Pain: Analysis of Pooled Data from Three Placebo-Controlled Clinical Trials

AUTHOR(S)
Hall, Jerry; Fujun Wang; Robinson, Michael; Oakes, Tina Myers; Jamal, Hassan; Acharya, Nayan
PUB. DATE
June 2007
SOURCE
Diabetes;Jun2007 Supplement 1, Vol. 56, pA574
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The purpose of this study is to summarize the safety and tolerability of duloxetine in treating diabetic peripheral neuropathic pain (DPNP) using data pooled from 3 double-blind, randomized, placebo-controlled, 12-13 week acute phase therapy studies of duloxetine. Placebo (n=339), duloxetine 20 mg once daily (QD, n=115), 60 mg QD (n=344), and 60 mg twice daily (BID, n=341) was compared. Demographics: Mean age=60 (±10.6) years, 84% Caucasian, and 57% male. Concomitant medications in ≥20% of patients were acetylsalicylic acid (33%) and metformin (21%). Study completion rate was 77%. The most common treatment-emergent adverse events (TEAEs) were nausea (9%, 24%), somnolence (5%, 16%), and dizziness (6%, 11%) for placebo and duloxetine (across all doses studied), respectively. In mean change from baseline to endpoint laboratory values for alkaline phosphatase, there was an increase with duloxetine treatment, and a decrease in the placebo arms. Compared to placebo, there was a greater increase in heart rate, and greater decrease in ECG intervals (RR, QT and QTcF) in the duloxetine arms. These studies were not long enough to detect medically significant effects on glycemic control. Discontinuations due to adverse events were (6% placebo; duloxetine: 4% 20mg QD, 11% 60 mg QD, and 17% 60mg BID). The most common TEAEs associated with duloxetine treatment were nausea, somnolence and dizziness. Discontinuations due to adverse events were dose-related (p<.001 for test of trend), although this may have been due to initial dosing. Small mean changes in vital signs and liver enzymes were observed with treatment. These analyses suggest that duloxetine treatment for DPNP in the population studied was safe and well-tolerated.
ACCESSION #
25822543

 

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