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Objective: This study investigated whether a new sustained-release (SR) pregabalin formulation is noninferior to immediate-release (IR) pregabalin in alleviating peripheral neuropathic pain in Korean patients., Materials and Methods: This was a randomized, double-blind, active-controlled phase 3 study of patients with diabetic peripheral neuropathy or postherpetic neuralgia from 41 sites in South Korea in 2017-2018. Eligible patients were randomized (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150 to 600 mg/d) in a double-dummy manner for 12 weeks according to a stratified permuted block randomization scheme. The primary endpoint was the Daily Pain Rating Scale score at the end of treatment, averaged from the last 7 available scores., Results: A total of 319 of 371 (86.0%) randomized patients completed the 12-week treatment (SR pregabalin: n=154; IR pregabalin: n=165; per-protocol set: n=296). The least square mean difference between both groups for the primary endpoint was 0.06 (SE 0.19); (95% confidence interval -0.31 to 0.42), with the lower limit of the confidence interval above the pre-specified margin (-0.78; Pnoninferiority<0.0001). Drug-related treatment-emergent adverse events (TEAEs) were comparable between both groups. The incidence of drug-related TEAEs leading to treatment discontinuation was low (SR pregabalin: 2.7%; IR pregabalin: 1.1%). No serious drug-related TEAEs or deaths occurred., Discussion: The results demonstrate that the new once-daily SR pregabalin formulation is noninferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain and is well tolerated in Korean patients with diabetic peripheral neuropathy or postherpetic neuralgia after 12 weeks of treatment., Competing Interests: Supported by Yuhan Corporation (Seoul, Republic of Korea), which was involved in all aspects of study design, data collection, data analysis, data interpretation, assisted in writing the report, and approved the final version of the manuscript for publication in conjunction with the authors. S.K. and T.A. are employees of Yuhan Corporation, Seoul, Republic of Korea. The remaining authors declare no conflict of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid (GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN)., Methods: This study included 100 T2DM patients between 20 and 75 years of age who had painful DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for 12 weeks. The primary outcome measures were mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS)., Results: Of the 100 subjects who initially participated in the study, 73 completed the 12-week treatment period. Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups. The treatment difference for the VAS (95% confidence interval [CI]) between the two groups was -0.65 (-1.526 to 0.213) and the upper bound of the 95% CI did not exceed the predefined noninferiority margin (δ₁=0.51). For the TSS, the treatment difference was -0.05 (-1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority margin (δ₂=0.054). There were no serious adverse events associated with the treatments., Conclusion: GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks., Competing Interests: This study was supported by a grant from Dalin Biotech Korea Co. Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript., (Copyright © 2020 Korean Diabetes Association.)

Objectives: Patients with diabetic peripheral neuropathy (DPN) is the most common complication. However, patients are usually suffering from not only diverse sensory deficit but also neuropathy-related discomforts. The aim of this study is to identify distinct groups of patients with DPN with respect to its clinical impacts on symptom patterns and comorbidities., Methods: A hierarchical cluster analysis and factor analysis were performed to identify relevant subgroups of patients with DPN ( n = 1338) and symptom patterns., Results: Patients with DPN were divided into three clusters: asymptomatic (cluster 1, n = 448, 33.5%), moderate symptoms with disturbed sleep (cluster 2, n = 562, 42.0%), and severe symptoms with decreased quality of life (cluster 3, n = 328, 24.5%). Patients in cluster 3, compared with clusters 1 and 2, were characterized by higher levels of HbA1c and more severe pain and physical impairments. Patients in cluster 2 had moderate pain levels but disturbed sleep patterns comparable to those in cluster 3. The frequency of symptoms on each item of MNSI by "painful" symptom pattern showed a similar distribution pattern with increasing intensities along the three clusters., Conclusions: Cluster and factor analysis endorsed the use of comprehensive and symptomatic subgrouping to individualize the evaluation of patients with DPN.

Aims: To determine the prevalence and risk factors for painful diabetic peripheral neuropathy (PDPN) and evaluate sleep impairment and quality of life in patients with PDPN., Methods: Data from the Korean Diabetes Association Neuropathy Study Group were used to evaluate 3999 patients with type 2 diabetes. PDPN was diagnosed using visual analogue scales (VAS) and medical history. The patients were asked to answer the Brief Pain Inventory-Short Form (BPI-SF), Medical Outcomes Study Sleep (MOS-Sleep) Scale, EuroQol (EQ-5D), and VAS., Results: Among the patients with diabetic peripheral neuropathy (n=1338), 577 (43.1%) were diagnosed with PDPN (14.4% of all patients with type 2 diabetes). PDPN was independently associated with age, female gender, fasting plasma glucose, hypertension, and previous cerebrovascular events. All pain severity and interference measures were higher in patients with PDPN than in non-PDPN patients, and patients with PDPN reported more impaired sleep and lower EQ-5D and VAS scores., Conclusions: The prevalence of PDPN in Koreans was comparable to that in Western populations. PDPN may impair sleep and quality of life compared with non-PDPN, and physicians should carefully consider pain symptoms in patients with diabetic peripheral neuropathy., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objective: Patients with type 2 diabetes mellitus are at greater risk of bone fractures than nondiabetics. However, the risk factors for fractures in patients with diabetes have not been fully evaluated. This study was designed to evaluate the relative frequency of fractures at different sites and the diabetes-associated factors that affect nontraumatic bone fracture in patients with type 2 diabetes., Patients and Design: This retrospective case-control study recruited 144 patients with type 2 diabetes, who presented with nontraumatic fractures between March 2004 and March 2009 and 150 age-, gender-, body mass index (BMI)- and duration of diabetes-matched control subjects. Nontraumatic fractures were confirmed using patients' medical records and radiological findings. All subjects were examined for their diabetes status and associated factors for fracture, including bone mineral density (BMD)., Results: Of 150 reported bone fractures, the hip was the most frequent fracture site (32·7%), followed by the upper extremity (19·3%). Nontraumatic fractures were associated with diabetic retinopathy, diabetic peripheral neuropathy, stroke history, previous fracture and insulin treatment (P < 0·05). In multivariate analyses, independently associated factors for bone fracture were diabetic peripheral neuropathy [odds ratio (OR) = 37·3, 95% confidence interval (CI) = 1·46-652·57] and previous fracture (OR = 9·54, 95% CI = 1·18-77·37; P < 0·05)., Conclusions: The hip was the most frequent site of nontraumatic fracture, and diabetic peripheral neuropathy was significantly associated with an increased risk of nontraumatic fractures in patients with type 2 diabetes., (© 2012 Blackwell Publishing Ltd.)

Objective: We investigated whether cardiovascular autonomic dysfunction was associated with glycemic control status over time in patients with type 2 diabetes., Research Design and Methods: From 1999 to 2000, cardiovascular autonomic nerve function testing (AFT) was performed on patients with type 2 diabetes (n = 1,021) and was followed-up in 2006 and February 2008. Tests for cardiovascular autonomic functions measured heart rate variability parameters (expiration-to-inspiration [E/I] ratio, responses to the Valsalva maneuver, and standing). AFT scores were determined from the results of the each test as follows: 0 for normal and 1 for abnormal. We began with those who had a score of 0 and assessed the changes in total score along with biannual A1C levels., Results: At follow-up, the development of cardiovascular autonomic dysfunction was 34.5% (E/I ratio 21.9%, Valsalva maneuver 77.8%, and posture 58.9%; n = 783). The development of cardiovascular autonomic dysfunction was higher in older patients (P < 0.001); in those with longer duration of diabetes (P < 0.001); of hypertension (P = 0.005), and of diabetic retinopathy (P < 0.001); and in those who had higher levels of microalbuminuria (P = 0.002). Logistic regression analysis revealed that the development of cardiovascular autonomic dysfunction was strongly associated with the mean A1C level during the follow-up period (mean A1C >9.0% vs.

Aims/Introduction Sleep disturbances caused by painful diabetic neuropathy ( PDN) might have substantial impacts on the multifaceted aspects of PDN, including quality of life. There are no convincing data on the validation or reliability of sleep problem measurements in patients with PDN in Korea. This large population-based cross-sectional study examined psychometric properties of the Medical Outcomes Study ( MOS) Sleep Scale in patients with PDN in Korea. Materials and Methods Measurements of patient-reported outcomes ( Brief Pain Inventory-short form, MOS Sleep Scale and Euro Qo L Health [ EQ-5D]) were documented. PDN was diagnosed if the average daily pain intensity was ≥4 based on the visual analog scale or if patients were taking medication for their current pain. Results There were 577 patients with PDN (41.6% with diabetic peripheral neuropathy). The internal consistency of reliability for the MOS Sleep Scale was 0.80 as measured by Cronbach's alpha. The extent to which multiple items in a dimension were intercorrelated and formed a dimension measuring the same underlying concept ( Pearson's correlation coefficient) ranged from 0.24 to 0.71 (all P < 0.001). Each item of the MOS Sleep Scale was significantly correlated with the average pain score and the pain interference score ( Pearson's correlation coefficients ranged from 0.20 to 0.28 and from 0.29 to 0.40, respectively; all P < 0.001). The correlations between the EQ-5 D index and the MOS Sleep Scale ranged from −0.27 to −0.31 (all P < 0.001). Conclusions The MOS Sleep Scale showed good reliability in the evaluation of PDN in Korean type 2 diabetic patients. [ABSTRACT FROM AUTHOR]

Diabetic autonomic neuropathy has a significantly negative impact on survival and quality of life in type 2 diabetic patients. Especially, cardiovascular autonomic neuropathy (CAN) is clinically important, because of its association with cardiovascular death. We investigated whether the progression of CAN is related to the cardiovascular events in type 2 diabetic patients. Total 683 type 2 diabetic patients, 244 males and 439 females, visited Diabetes Clinic. Autonomic function test at baseline was conducted from January 2000 to December 2000, and was followed from January 2006 to December 2006. Standard tests for CAN were composed of heart rate variability (E/I ratio, response to the Valsalva maneuver and standing). CAN score was determined by the results of each test as following: 0=normal, 1 =abnormal (total score 3). Progress was defined when the total score at follow was higher than the baseline score. Total 425 patients were evaluated after six years. Mean age and duration of diabetes were 58.1 ± 10.3, and 8.3 ± 7.0 years, respectively. Among the total number of patients, 106 patients (24.9%) were the group in progress. 53 patients (12.5%) developed cerebral infarction (CVA), and 46 patients (10.8%) experienced ischemic heart attack (CAD; angina, myocardial infarction) during the observation period. There were no differences in body mass index, postprandial hyperglycemia, and HbA1c level between two groups. Compared to group in non-progress, both CAD and CVA were developed more frequently in 'progress' group (21.7 vs. 14.7%, P<0.05). The incidence of vascular events were higher in patients with older age (P=0.008), longer diabetic duration (P=0.003), hypertension (P<0.001), and diabetic retinopathy (p=0.0013). Patients with CVA or CHD had lower HDL cholesterol level (39.1 ± 10.7 vs. 42.1 ± 10.8 mg/dl, p < 0.05), and higher fasting insulin (14.0 ± 14.2 vs. 9.6 ± 10.1 µIU/ml, p < 0.05) than patients without CVA or CHD. Logistic regression analysis revealed the progress of CAN score to be deeply related to the development of vascular event (OR 2.487, CI 1.134-5.458, P=0.023). These results suggest that cardiovascular autonomic function could predict the development of CVA or CAD, therefore, it could be a good screening method for the cardiovascular events in type 2 diabetic patients. [ABSTRACT FROM AUTHOR]