Treatment of patients with diabetic peripheral neuropathic pain in China: a double-blind randomised trial of duloxetine vs. placebo.
BACKGROUND
Duloxetine has been approved in the United States, European Union and some Asian countries for the treatment of diabetic peripheral neuropathic pain (DPNP). We assessed the efficacy and safety of duloxetine (60 mg once daily) compared with placebo in Chinese patients suffering from DPNP.


METHODS
This was a phase 3, multicenter, randomised, double-blind, parallel, placebo-controlled, 12-week trial of the treatment of DPNP with duloxetine. Subjects were male and female outpatients ≥ 18 years of age with DPNP, as assessed by the Michigan Neuropathy Screening Instrument, and had a rating of ≥ 4 on the Brief Pain Inventory-Modified Short Form-Severity weekly average pain item. The primary efficacy measure was the reduction in pain severity from baseline to 12 weeks, as measured by the weekly mean of 24-h average pain ratings recorded in the patient's diary. Mean changes from baseline in efficacy measures were analysed by a restricted maximum likelihood-based, mixed-effects model repeated measures approach and by analysis of covariance.


RESULTS
Of the 405 patients randomised, 203 patients were assigned to duloxetine 60 mg once daily and 202 patients were assigned to placebo. Duloxetine-treated patients showed significantly greater pain relief on 24-h average pain ratings compared with placebo-treated patients each week of the 12-week study period [week 12: least squares (LS) mean change duloxetine: -2.40, placebo: -1.97; LS mean change difference (95% confidence interval) = -0.43 (-0.82, -0.04), p = 0.030]. Compared with placebo, patients treated with duloxetine experienced higher rates of nausea (p = 0.010), somnolence (p < 0.001) and asthenia (p = 0.002).


CONCLUSIONS
Duloxetine-treated patients showed significantly greater pain relief compared with placebo-treated patients over the 12-week study period. Duloxetine was shown in Chinese patients to have a safety profile similar to that found in previous duloxetine trials.
Peking University First Hospital, Beijing, China.
Y
Y
Gao
Peking University First Hospital, Beijing, China.
X
X
Guo
Shengjing Hospital of China Medical University, Shengyang, China.
P
P
Han
The Second Artillery General Hospital of Chinese People's Liberation Army, Beijing, China.
Q
Q
Li
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
G
G
Yang
Shanghai Tenth People's Hospital, Shanghai, China.
S
S
Qu
Lilly Suzhou Pharmaceutical Company, Ltd., Shanghai, China.
L
L
Yue
Lilly Suzhou Pharmaceutical Company, Ltd., Shanghai, China.
C-N
CN
Wang
Eli Lilly and Company, Indianapolis, IN, USA.
V
V
Skljarevski
Eli Lilly de Mexico, Mexico City, Mexico.
H
H
Dueñas
Eli Lilly Canada, Toronto, Canada.
J
J
Raskin
Lilly Suzhou Pharmaceutical Company, Ltd., Shanghai, China.
L
L
Gu
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D002681:China; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010147:Pain Measurement; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors / Q000627:therapeutic use*; D014481:United States
D000700:Analgesics; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors; D000068736:Duloxetine Hydrochloride