Lilly's Cymbalta for diabetic nerve pain found to be safe, well-tolerated

By Lisa Kerner

Erie, Pa., Feb. 14 - Eli Lilly said a long-term study of more than 200 patients found that Cymbalta (duloxetine HCl) is as safe and well-tolerated as current routine care that uses one or more medications for the management of pain caused by diabetic nerve damage.

According to a company news release, study findings also show that Cymbalta did not adversely affect the progression of diabetes or many of the complications associated with the illness, such as damage to the nerves, kidneys and eyes.

Cymbalta is believed to modulate both serotonin and norepinephrine in the brain and the spinal cord, impacting nerve signaling, officials said.

The 52-week study compared Cymbalta to routine care such as anticonvulsants and antidepressants. The most commonly used prescription pain medications for routine care included Neurontin (gabapentin), Elavil (amitriptyline) and Effexor-XR (venlafaxine extended release), the company said.

In this trial, 237 patients 18 years and older, with an average age of 60 years, diagnosed with diabetic nerve pain completed a 13-week acute therapy stage. They were randomly assigned in a 2:1 ratio to therapy with 161 patients receiving Cymbalta 60 mg twice daily and 76 patients receiving routine care, consisting primarily of gabapentin, amitriptyline and venlafaxine.

Safety was measured by discontinuation rates, TEAEs, laboratory assessments, weight and electrocardiograms.

Health outcome measures were collected by patient-report using the 36-item Short Form Health Survey (SF-36) and the EuroQoL Questionnaire-Version 5-D (EQ-5D).

Progression of neuropathy was measured by the MNSI. Progression of retinopathy was measured using ophthalmology assessments and visual acuity. Progression of nephropathy was measured by the microalbumin/creatinine ratio.

The data found no significant differences in the overall incidence of either adverse events resulting from treatment or quality of life measures in patients taking Cymbalta compared to those receiving routine care, the release stated.

This study met its primary endpoints, which were to evaluate the safety of Cymbalta over a 52-week open-label extension period, to evaluate the safety of Cymbalta for up to 65 weeks with regard to the progression of diabetic complications, and to assess the impact of Cymbalta treatment and routine care on patient-reported health outcomes, Lilly said.

The findings were published in the current issue of the Journal of Palliative Medicine.

Cymbalta is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults.

Based in Indianapolis, Eli Lilly is developing a growing portfolio pharmaceutical products by applying research from its own worldwide laboratories and from collaborations with scientific organizations.

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