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.
Highlights
Worldwide, the number of people with diabetes mellitus (DM) has more than doubled over the last 3 decades [1]
Patients treated with duloxetine 60 mg once daily (QD) reported significantly greater improvements on Brief Pain Inventory (BPI)-Interference ratings (P < .001) and on the EuroQol 5D Health Questionnaire (EQ-5D) Index (P = .004) compared with patients receiving placebo [22]
In studies 1 to 4, patients treated with duloxetine 60 mg QD reported statistically significantly greater reductions in pain severity ratings from baseline to 12 weeks compared with patients receiving placebo treatment (Table 3) [13,14,15, 18]
Summary
The number of people with diabetes mellitus (DM) has more than doubled over the last 3 decades [1]. In 2008, the prevalence of DM in adults was 9.8% in men and 9.2% in women, globally [2]. Asian countries report a rapidly increasing prevalence of DM [3]. Symmetrical, sensorimotor diabetic peripheral neuropathy (DPN) is a common complication of DM. A significant number of patients with DPN suffer from diabetic peripheral neuropathic pain (DPNP) Among adults with DM, the estimates of prevalence of DPN range from 26% to 47% [4]. In a recent literature review, Sadosky and colleagues estimated the overall prevalence of DPNP in the population of patients with DM to be 15% [5]
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