( mnolence (2 percent) dizziness (2 perc...)Data Suggest Cymbalta Reduced Severity of Night Pain in Patients,with Diabetic Nerve Pain,Health

Methods:

Data were pooled from three double-blind, randomized, placebo-controlled, 12-week studies, to investigate associations between pain and sleep. In the first study, patients were treated with Cymbalta 20 mg once daily, 60 mg once daily, 60 mg twice daily and sugar pill. The second and third studies compared Cymbalta 60 mg once daily and 60 mg twice daily with sugar pill. A subset of nonsomnolent patients was created by removing patients reporting treatment-emergent somnolence or who were on sedating concomitant medications (No patients in any of the trials reported baseline somnolence.).

In the pooled data, the primary efficacy measure was the reduction in the weekly mean of the 24-hour average pain scores, calculated from daily patient diary entries and measured by an 11-point Likert scale. Secondary measures included average daily night pain severity measured by an 11-point Likert scale and the BPI sleep interference item.

Patients with diabetic nerve pain who also had major depressive disorder (MDD) were excluded from this study, since depression could have had an effect on sleep interference, and improvements in depression could have improved sleep interference in these patients.(1,2,3)

Data on treatment-emergent adverse events, including reports of somnolence, were collected by spontaneous report, and while spontaneous reporting is the standard practice for evaluating treatments, solicited scales specifically designed for particular adverse events would have been preferable for the investigation.

About Diabetic Peripheral Neuropathy

According to the National Institute of Diabetes & Digestive & Kidney Diseases, approximately half of those with diabetes have some form of nerve damage, or neuropathy, but not all will develop symptoms. While nerve problems can occur at any time, the highest rates are among those
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