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Duloxetine Reduces Diabetic Neuropathic Pain, Even Without Comorbid Depression: Presented at AAPM

By Paula Moyer

PALM SPRINGS, FL -- February 28, 2005 -- The serotonin-norepinephrine reuptake inhibitor duloxetine (Cymbalta) reduces pain severity in diabetic patients with neuropathic pain, according to investigators speaking here on February 24^th at the 21^st annual meeting of the American Academy of Pain Medicine.

"Duloxetine was superior to placebo in reducing pain severity … and night pain," reported principal investigator Joachim F. Wernicke, MD, PhD, Senior Research Physician, Eli Lilly and Company, Indianapolis, Indiana, United States. "It did not adversely affect glycemic control, lipid profiles, or electrophysiology assessments."

He and his co-investigators were interested in duloxetine's potential to neuropathic pain in diabetics because serotonin and norepinephrine are both involved in pain modulation through descending inhibitory pathways in the brain and spinal cord.

Therefore, they recruited 334 diabetic patients with neuropathic pain who were free from comorbid depression to participate in a 12-week study. The investigators randomized the patients to one of three treatment arms -- 60 mg of duloxetine once daily, 60 mg of duloxetine twice daily, or placebo.

The researchers assessed response to treatment by weekly average score of 24-hour average pain severity on the 11-point Likert scale. The other assessments included pain severity at night and worst pain severity over a 24-hour period, as well as the Brief Pain Inventory (BPI), Clinical Global Impression of Severity (CGI-Severity), Patient Global Impression of Improvement (PGI-Improvement), the short-form McGill Pain Questionnaire, dynamic allodynia, and patients' average daily use of acetaminophen.

Both doses of duloxetine resulted in significantly less pain than placebo by week 2, with continued divergence from placebo through the 12 weeks of the study (P <.001), Dr. Wernicke said. Separation from placebo was measurable by week 1 on the 24-hour average pain severity score.

With the exception of allodynia, the investigators were also able to detect measurable changes in all other study outcomes for both doses of duloxetine that were better than those in the placebo arm, with no significant differences between the doses.

Patients' 24-hour average pain severity was reduced as the direct result of the treatment effect, reported Dr. Wernicke (P <.001). The CGI and PGI evaluations also showed superior results with duloxetine, he added (P <.05 and P <.001, respectively).

Duloxetine's efficacy was related to no detectable compromise of diabetic control as measured by hemoglobin A_1c levels and significant hypoglycemic episodes per week. Lipid values were also unchanged after treatment, as assessed by low-density lipid cholesterol, high-density lipid cholesterol, and triglycerides.

The researchers noted no difference among the three treatment groups regarding electrophysiology measures, reported Dr. Wernicke.

Eli Lilly and Company manufactures the study drug and funded the study


[Presentation title: Duloxetine at doses of 60 mg QD and 60 mg BID is effective treatment of diabetic neuropathic pain. Abstract 131]

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