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Duloxetine May Be Effective for Treatment of Pain Associated With Diabetic Neuropathy: Presented at AAPM

By Jerry Ingram

ORLANDO, FL -- March 5, 2004 -- Duloxetine, a dual reuptake inhibitor, appears to be safe and significantly effective in the treatment of pain associated with diabetic neuropathy, researchers said here on March 5^th at the American Academy of Pain Medicine 20^th Annual Meeting.

"This study was highly successful in that it shows dramatic and significant results by 1 week and continuing throughout the 12 weeks of the study in terms of improving pain and an number of secondary measures in diabetic neuropathic pain, " said Madelaine Wohlreich, MD, research physician, Eli Lilly and Company, Indianapolis, Indiana, United States.

Previous studies have shown that duloxetine is effective and safe for treating major depression and painful physical symptoms that may accompany depression. Benefits associated with pain often have been ascribed to a secondary effect, resulting from alleviation of depression. Researchers conducted this particular study to determine the safety and effectiveness of duloxetine for treatment of pain in individuals who did not have major depressive disorder.

For this investigation Dr. Wohlreich and her colleagues enrolled 457 patients diagnosed with diabetic neuropathy and treated them for 12 weeks with duloxetine 60 mg BID, 60 mg QD, 20mg QD or placebo. They used the weekly mean score of the 24-hour Average Pain Severity on the 11-point Likert scale to determine the outcome of the study.

Patients who received duloxetine 60mg QD or BID had significant improvement compared to placebo on the 24-Hour Average pain Severity score as early as the first week after randomisation. These results continued throughout the duration of the study. On most secondary measures of efficacy duloxetine was also superior to placebo.

In addition, the researchers noted that the discontinuation rate due to adverse events was less than 20% for patients treated with duloxetine. These results illustrate that duloxetine at 60mg is safe and effective in the treatment of pain associated with diabetic neuropathy, they said.

The results also suggest that 5-HT and NE reuptake inhibition by duloxetine may be effective and safe alternative for patients with chronic pain, according to the researchers.

They concluded that changes in pain severity in depressed patients on duloxetine for major depressive disorder may not be merely a secondary effect related to relief from depression.


[Study title: Duloxetine in the Treatment of the Pain Associated with Diabetic Neuropathy. Poster 165]

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