| Goldstein et al20
|
Duloxetine 20 mg/day, 60 mg/day, 60 mg twice a day (120 mg/day) |
12-week, multicenter, double blind, randomized, placebo-controlled |
457 subjects, avge 60.1 yrs, 61.5% male, 88.4% DM2 for 11.3 yrs and neuropathy for 3.7 years, avge 24-hr pain score 5.9 |
Weekly mean 24-hr avge pain score (0–10) |
Duloxetine 20 mg/d demonstrated a nonsignificant decrease in pain severity vs placebo Duloxetine 60 mg/d and 120 mg/day showed significant improvement in 24-h avge pain vs placebo No significant difference in efficacy between duloxetine 60 mg/day and 120 mg/day No significant difference in serious adverse effects between all four groups |
Significant improvement began in first week TEAE of somnolence and constipation occurred significantly more in the duloxetine 60 mg/day group vs placebo Duloxetine 120 mg/day worked the best on pain described as shooting, stabbing, burning All three duloxetine groups used less supplemental analgesic medications |
| Raskin et al6
|
Duloxetine 60 mg/day or 60 mg twice a day |
12-week, multicenter, double-blind, randomized, placebo-controlled |
348 patients, avge 58.8 yrs, 46.6% male, 84.5% DM2 for 13.8 years and neuropathy for 4.3 yrs, avge 24-hr pain score 5.6 |
Weekly mean 24-hr avge pain score (0–10) |
Both treatment groups significantly improved 24-hr avge. pain score No significant difference between daily or twice daily dosing No significant difference in serious adverse effects No clinically relevant changes in glycemic control or cardiovascular measures |
Both treatment groups were superior to placebo in all secondary efficacy measures except for the HAMD and dynamic allodynia There were significantly more discontinuations due to adverse effects in the duloxetine twice daily group vs placebo Duloxetine twice daily group had significantly less supplemental analgesic use vs placebo |
| Wernicke15
|
Duloxetine 60 mg daily or 60 mg twice a day |
12 week, multicenter, double-blind, randomized, placebo-controlled study |
334 patients, avge age 60.7 yrs, 61.1% male, 91% DM2 for 10.2 yrs and neuropathy for 3.8 years, avge 24-hr pain score 6.1 |
Weekly mean 24-hr avge pain score (0–10) |
Both treatment groups significantly improved 24-hr avge pain score No significant difference between daily or twice daily dosing No significant difference in serious adverse effects No clinically relevant changes in glycemic control or cardiovascular measures |
Both treatment groups were superior to placebo in all secondary efficacy measures except for the HAMD and dynamic allodynia The duloxetine twice daily treatment group used significantly less supplemental analgesics than the duloxetine daily group or placebo The duloxetine daily group had a significantly higher occurrence of TEAE of dizziness and diarrhea vs placebo The duloxetine twice daily group had a significantly higher occurrence of TEAE of constipation, insomnia, decreased appetite, asthenia, erectile dysfunction and tremor as TEAE vs placebo |
