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Purpose This study compared the efficacy and safety of controlled-release pregabalin (GLA5PR GLARS-NF1 tablets) with those of an immediate-release pregabalin capsule after 12 weeks' administration to patients with peripheral neuropathic pain. Methods In this multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III study, the primary outcome was to confirm that a single treatment with the study drug (after the evening meal) is clinically noninferior to the control drug (BID regimen) at improving the mean Daily Pain Rating Scale score for treating peripheral neuropathic pain. Secondary outcomes were the Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, Hospital Anxiety and Depression scale, and frequency of rescue medication use. The safety and tolerability of GLA5PR GLARS-NF1 tablets were also evaluated. The total daily dose of pregabalin is 150–600 mg. Findings Of the 352 randomized subjects, 261 (n = 130, study group; n = 131, control group) were analyzed. The difference in adjusted mean Daily Pain Rating Scale scores between the groups was −0.11 (95% confidence interval, −0.05 to 0.30), indicating that the study group is noninferior to the control group. There was no statistically significant difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores between the groups at treatment termination. Logistic regression analysis revealed no significant difference in the use of rescue medication between the groups (P = 0.217). The overall adverse event profile of the groups was similar, and no serious adverse drug reactions were observed. Implications GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression were improved with pain control. Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907.

Aims The aim of this study was to evaluate ethnic- and sex-specific associations between DM and hearing impairment. Methods For this cross-sectional study using National Health and Nutrition Examination Survey in the U.S. and Korea, the total number of eligible participants included was 7081 in the U.S. and 15,704 in Korea. Hearing impairment was defined as a pure tone threshold level ≥ 25 dB. Multivariate logistic regression analysis was conducted, adjusting for age, sex, race/ethnicity, socioeconomic status, body mass index, noise exposure, smoking, hypertension, and dyslipidemia. Results The association between DM and hearing impairment was found to be sex-specific. The multivariate adjusted ORs of high-frequency impairment were 0.843 (95% CI, 0.524–1.356) in American men, and 1.073 (95% CI, 0.835–1.379) in Korean men, while the ORs in women from U.S. and Korea were 1.911 (95% CI, 1.244–2.935) and 1.421 (95% CI, 1.103–1.830), respectively. A subgroup analysis of each race/ethnicity among the U.S. adults showed similar results. In contrast to high-frequency impairment, there was no significant association between low-frequency impairment and DM in both men and women. Conclusion Our results suggest that DM is associated with hearing impairment in only women, irrespective of race/ethnicity groups.

Objectives To investigate the association and influence of urinary incontinence (UI) on falls in older adults using the 2017 National Survey of Older Koreans data. Methods We retrospectively analyzed the 2017 National Survey of Older Koreans, which was conducted on 10,299 adults aged 65 and older in 2017 by the Korea Institute for Health and Social Affairs. Results This study included a total of 6,134 women aged 65–106, with a mean age of 74.8. In total, 1,152 women experienced at least 1 fall in the past 1 year and 382 experienced 2 or more recurrent falls; 281 women were diagnosed with UI. UI and falls (odds ratio, 1.329; 95 % confidence interval, 1.003−1.762) and recurrent falls (odds ratio=,1.703; 95% confidence interval=,1.145−2.534) were significantly associated. Older individuals with UI were more likely to fall at least once per year (odds ratio=,1.52; 95 % confidence interval=,1.15–2.20, odds ratio=,1.49; 95 % confidence interval=,1.09–2.04) than those without and were also linked to higher odds of recurrent falls (odds ratio=,2.16; 95 % confidence interval=,1.47–3.16, odds ratio=,2.13; 95 % confidence interval=,1.41–3.22) in those with at least 1 cognitive impairment, body functional impairment, or activity limitation. Conclusion Our findings showed a possible increased risk of falls and recurrent falls in older individuals with UI compared to those without, especially in people with cognitive and functional impairment.

Objective The use of a real time continuous glucose monitoring system (RT-CGM) was studied as a behavior modification tool and the effectiveness of a RT-CGM in glucose control for patients with type 2 diabetes was determined. Methods We conducted a prospective, open-label, randomized, controlled clinical trial in 65 patients with poorly controlled type 2 diabetes (8.0 ≤ HbA1c ≤ 10%) over a 3-month period. The intervention group was monitored monthly with a RT-CGM (three days at a time for 3 months) and the control group continued self-monitoring blood glucose (SMBG) at least four times a week for 3 months. Results The HbA1c of the RT-CGM group was significantly reduced after 12 weeks compared with the SMBG group (9.1 ± 1.0% to 8.0 ± 1.2% vs. 8.7 ± 0.7% to 8.3 ± 1.1%, respectively; P = 0.004). In the RT-CGM group, there was a significant reduction in total daily calorie intake, weight, body mass index (BMI), and postprandial glucose level, and a significant increase in total exercise time per week after 3 months. Conclusions We demonstrated that the RT-CGM was useful in modifying a patient's diet and exercise habits and could induce better glycemic control than SMBG for patients with type 2 diabetes.