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- Title
Review of Efficacy and Safety of Duloxetine 40 to 60mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain.
- Authors
Skljarevski, Vladimir; Frakes, Elijah P.; Sagman, Doron; Lipsius, Sarah; Heinloth, Alexandra N.; Dueñas Tentori, Héctor J.
- Abstract
We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P<.01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P<.05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P<.01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P<.01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.
- Subjects
DULOXETINE; DRUG efficacy; MEDICATION safety; DRUG dosage; PEOPLE with diabetes; TREATMENT of peripheral neuropathy
- Publication
Pain Research & Treatment, 2012, p1
- ISSN
2090-1542
- Publication type
Article
- DOI
10.1155/2012/898347