title: Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain.
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.
authors.affiliation: Department of Neuroscience, Eli Lilly and Company, Indianapolis, IN 46285, USA.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Skljarevski
authors.forename: Elijah P
authors.initials: EP
authors.lastname: Frakes
authors.forename: Doron
authors.initials: D
authors.lastname: Sagman
authors.forename: Sarah
authors.initials: S
authors.lastname: Lipsius
authors.forename: Alexandra N
authors.initials: AN
authors.lastname: Heinloth
authors.forename: Héctor J
authors.initials: HJ
authors.lastname: Dueñas Tentori