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Duloxetine Relieves Pain Associated With Diabetic Neuropathy: Presented at IDF

By Ed Susman

PARIS, FRANCE -- August 26, 2003 -- Patients suffering from diabetic neuropathy can achieve pain relief by taking the anti-depressant duloxetine, researchers reported here Monday at the 18^th International Diabetes Foundation Congress.

Michael Detke, MD, clinical research physician, Eli Lilly Research Laboratories, Indianapolis, Indiana, U.S.A. and staff member, Indiana University School of Medicine, Indianapolis, said in his poster presentation that a series of animal and clinical studies appear to show that the drug, a serotonin and norepinephrine reuptake inhibitor, eases the pain seen by large numbers of diabetic patients.

"Duloxetine may well be suited to treat both persistent pain conditions associated with diabetic neuropathy as well as painful physical symptoms associated with depression," said Dr. Detke, who is also a research associate in psychiatry for Harvard Medical School, Boston, Massachusetts.

Dr. Detke enrolled 457 patients with diabetic neuropathy to receive placebo or three different doses of duloxetine in a 12-week, multicentre, double-blind study. The 60-mg dose and the 120-mg dose of duloxetine were significantly more effective in easing the 24-hour pain severity of the patients (P<0.001). A 20-mg dose of duloxetine was numerically superior to placebo, but the difference in pain reduction failed to reach statistical significance.

In the study, 115 patients were randomised to receive placebo; 115 received 20 mg of duloxetine once a day; 114 received duloxetine 60 mg once a day; 113 received duloxetine 60 mg twice a day. The average age of the patients was 60, and the duration of diabetes and diabetic neuropathy was 11.3 and 3.7 years respectively.

Patients taking 120 mg daily demonstrated an incidence of adverse effects -- particularly nausea, somnolence, dizziness, and decreased appetite – greater than that seen in placebo patients and most of the patients on the 60-mg dose.

The adverse-event profiles of duloxetine 60 mg and placebo were similar, although duloxetine patients reported more constipation and nausea than did placebo patients.

Dr. Detke said that duloxetine therapy was investigated for diabetic neuropathy because pre-clinical studies demonstrated that the drug was useful in reversing mechanical allydonia in nerve-injury models of neuropathic pain.

"These pre-clinical and clinical data are consistent with the proposed role of serotonin and norepinephrine as being key mediators of descending pain modulatory systems," Dr. Detke concluded. "Importantly, the clinical results provide definitive evidence that duloxetine at 60 mg once a day and 60 mg twice a day is safe and effective in the treatment of pain associated with diabetic neuropathy."


[Study title: Efficacy of duloxetine in the treatment of the pain associated with diabetic neuropathy. Abstract 912]

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