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Data Suggest Cymbalta Reduced Severity of Night Pain in Patients,with Diabetic Nerve Pain

New Analysis Examines Impact of Pain on Sleep Interference

INDIANAPOLIS, May 03, 2007 /PRNewswire-FirstCall/ -- Data from a pooled analysis of three studies suggest that in patients with pain caused by diabetic nerve damage, or diabetic peripheral neuropathy, who are treated with Cymbalta (duloxetine HCl), improvements in both average daily pain and night pain severity were associated with less pain-related sleep interference than in those patients taking sugar pill. Results from the analysis of more than 1,000 patients were presented today at the annual meeting of the American Pain Society in Washington D.C.

The average daily night pain severity and sleep interference correlation assessments were secondary analyses of data from trials in which the primary efficacy endpoint was to measure the reduction in average weekly pain. For these assessments, a subset of nonsomnolent patients was created by removing those who experienced treatment-related somnolence (such as daytime sleepiness, drowsiness, grogginess or difficulty awakening) or who were on other sedating medications. At the end of the 12-week analysis, this subset of patients treated with 60 mg of Cymbalta once- and twice-daily experienced significantly more improvement in 24-hour average pain scores than those taking sugar pill (47 percent, 50 percent and 29 percent respectively), as measured by reduction of scores on the self-reported, 11-point Likert scale.

In analyses of the effect of Cymbalta on night pain and pain-related sleep interference, nonsomnolent/nonsedating drug patients treated with 60 mg of Cymbalta once- and twice-daily experienced significantly more improvement in nighttime pain than those taking sugar pill after one week of treatment (22 percent, 21 percent and 10 percent, respectively) and at the end of the 12 weeks (47 percent, 51 percent compared with 34 percent). Both doses of Cymbalta reduced pain-related sleep inter
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