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Title: Better Sleep Quality With Duloxetine Than Placebo in Patients With Diabetic Peripheral Neuropathic Pain: Presented at AAPM
URL: http://www.pslgroup.com/dg/21D7AA.htm
Doctor's Guide
February 19, 2008


By Ric Susman

KISSIMMEE, FL -- February 19, 2008 -- Patients with diabetic neuropathic pain appear to improve their sleep quality if they are taking the selective serotonin and norepinephrine reuptake inhibitor duloxetine rather than placebo.

"Results from this study suggest moderate to strong associations at baseline between daily pain, night pain, and sleep interference, as well as between changes in pain, daily and night, and changes in sleep interference," said David A Fishbain, MD, Professor of Psychiatry and Behavioural Sciences, University of Miami, Leonard M. Miller School of Medicine, Miami, Florida, United States.

"Although the prevalence of sleep problems in patients with chronic pain may be as high as 70%, relationships between pain and sleep have not been thoroughly quantified," Dr. Fishbain said. To get at the answer, he pooled data from three double-blind, randomised, placebo-controlled, 12-week trials in diabetic peripheral neuropathic pain patients without major mood disorders.

One study of 457 patients compared duloxetine 20 mg once daily, duloxetine 60 mg once daily, duloxetine 60 mg twice daily, and placebo. The second study included 334 diabetic patients with peripheral neuropathic pain and compared duloxetine 60 mg once daily, duloxetine 60 mg twice daily, and placebo. The third study enrolled 348 similar patients and also compared duloxetine 60 mg once daily, duloxetine 60 mg twice daily, and placebo.

Excluded from the study were 216 patients who reported somnolence or who were on sedating concomitant medications. The remaining patients kept diaries of average pain levels. "This was a good way to check for the efficacy measurements of the treatment, as the patients were to update their diaries day and night for pain severity," explained Dr. Fishbain in a poster presentation on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

At baseline, both daily and night pain severity were positively and significantly correlated with sleep interference. Both duloxetine doses were significantly superior to placebo in reducing daily and night pain at week 1 and at all assessment times thereafter. Both duloxetine doses were superior to placebo in reducing sleep interference at weeks 4, 8, and 12 (P < .001).

"Although causality was not established, findings suggest improvements in pain will be associated with less sleep interference," Dr. Fishbain said.

Funding for this study was provided by Eli Lilly and Company.


[Presentation title: The Relationships Between Sleep and Pain in Patients With Diabetic Peripheral Neuropathic Pain: Responses to Treatment With Duloxetine. Abstract 101]

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