Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain (DPNP) in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain.</p><p><b>METHODS</b>This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory (BPI) 24-hour average pain severity ratings ≥ 4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator's judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol: 5 Dimensions, Athens Insomnia Scale, and safety measures.</p><p><b>RESULTS</b>Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively, completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups (P = 0.124). Duloxetine- treated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1, 2, and 4 (P = 0.004, P = 0.009, and P = 0.006, respectively), but not at weeks 8 (P = 0.125) and 12 (P = 0.107). Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo.</p><p><b>CONCLUSIONS</b>Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.</p>

Prevalence and risk factors of peripheral arterial disease in diabetic patients over 50 years old in China / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To investigate the prevalence of peripheral arterial disease (PAD) in China type 2 diabetic patients and to demonstrate the relationships between putative risk factors and PAD.</p><p><b>METHODS</b>In total 1,397 type 2 diabetic patients aged 50 years and older were enrolled and determined ankle-brachial index (ABI) and brachial-ankle pulse wave velocity (baPWV) in 15 Class III Grade A hospitals in 7 major cities of China.</p><p><b>RESULTS</b>Mean patient age was 63.7 +/- 8.2 years and mean duration of diabetes mellitus was 9.39 +/- 7.4 years. Two hundreds and seventy-two (19.47%) patients were diagnosed as PAD by ABI < 0.9, 122 (18.37%) in male and 150 (20.46%) in female. PAD patients had a significantly longer duration of diabetes mellitus, higher hemoglobin A1c, and a significantly lower mean body mass index than non-PAD ones. Aging, smoking, and systolic blood pressure were found to be positively related with the prevalence of PAD. In terms of lipid profiles, no variable was found to relate with PAD. Notably, baPWV showed as the same significant guiding index for PAD, almost matched with ABI.</p><p><b>CONCLUSIONS</b>PAD is a common complication in China type 2 diabetic patients. Therefore, PAD screening and treatment should be emphasized for diabetic patients with high risk factors.</p>

Lipids disorder, macrovascular diseases, and insulin resistance in Chinese diabetic patients / 中国医学科学院学报

<p><b>OBJECTIVE</b>To investigate the types of lipid disorder and its relationship with macrovascular diseases and insulin resistance in Chinese diabetic patients.</p><p><b>METHODS</b>2,430 diabetic patients finished the diabetes complications assessment and were surveyed on their blood lipids, insulin level and macrovascular diseases. The insulin resistance (HOMA-IR) was calculated based on HOMA model.</p><p><b>RESULTS</b>Prevalence of lipids disorder was as high as 63.8% in this group, including 23.9% with both hypercholesterolemia and hypertriglyceridemia (HY-C-T), 16.1% with hypercholesterolemia only (HY-C), 15.0% with hypertriglyceridemia only (HY-T), 5.5% with lower HDL level (L-HDL), 3.3% with hypercholesterolemia, hypertriglyceridemia and lower HDL level together. Compared with the patients with normal lipid level (control group), no duration differences existed among these groups. There were more female patients in HY-C and HY-C-T groups. BMI and WHR were higher in all groups with lipid disorder except in HY-C group. Macrovascular diseases were more common in HY-C-T patients than in control group (33.6% vs 24.0%, P < 0.001). Average blood pressure and the prevalence of hypertension were significantly higher in HY-C-T, HY-C, HY-T groups than in control group (139/79, 138/76, 134/77 vs. 132/75 mmHg; 53.2%, 50.1%, 46.2% vs. 39.2%). Fasting insulin level was significantly higher in HY-C-T and HY-C-T-L-LDL groups than in controls. Insulin resistance was more severe in all patients with lipid disorder except in L-HDL group, particularly in the HY-C-T-L-HDL group.</p><p><b>CONCLUSIONS</b>(1) BMI, WHR increased significantly with the severity of lipid disorder. (2) Nearly two thirds of Chinese diabetic patients have lipid disorder, which is the strong risk factor of macrovascular diseases and aggravates insulin resistance. (3) There was severe insulin resistance in patients with hypertriglyceridemia or with hypertriglyceridemia plus other lipid disorder.</p>