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1.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA).
Shim, Y, Han, HJ, Park, KW, Kim, BC, Park, KH, Park, MY, Kim, HJ, Moon, SY, Choi, SH, Park, KW, et al
Journal of Alzheimer's disease : JAD. 2022;(1):391-403
Abstract
BACKGROUND Preclinical studies in transgenic models of Alzheimer's disease (AD) suggest that DHP1401 has neuroprotective and memory-enhancing effects. OBJECTIVE To evaluate the efficacy and safety of DHP1401 in AD patients treated with donepezilMethods:Methods: In a double-blind study, patients with mild-to-moderate AD were randomized (1:1:1) to receive a twice daily total dose of 500 mg or 1000 mg DHP1401 or placebo for 24 weeks. Tolerability and safety were monitored at baseline and weeks 12 and 24. RESULTS total of 180 patients were randomized to Active 1 (500 mg: n = 62), Active 2 (1000 mg: n = 53), and control groups (n = 65) in 16 sites in Korea. There was no significant difference in the Alzheimer's Disease Assessment Scale (ADAS-cog) score, the primary efficacy endpoint, from baseline. However, in the subgroup with mild AD patients (MMSE, 20-26) who received the high dose of DHP1401 and the group that received donepezil 5 mg, the ADAS-cog scores improved. MMSE and K-TMT-e type B were significant in both active groups at week 24. The most frequently observed symptom was dizziness (2.78%), and the most commonly observed reactions were related to metabolism and nutrition disorders (5.00%). No remarkable adverse events were observed for 24 weeks. CONCLUSION Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials.
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2.
Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial.
Kang, JM, Park, KH, Ahn, S, Cho, S, Han, A, Lee, T, Jung, IM, Kim, JY, Min, SK
Scientific reports. 2019;(1):20356
Abstract
Recently non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT). However, the role of NOAC after thrombolysis of acute iliofeomral DVT (IFDVT) is not yet defined. This randomized clinical trial aimed to compare the safety and efficacy of rivaroxaban versus warfarin after catheter directed thrombolysis of an IFDVT. Patients with acute DVT of both the iliac and the femoral vein (n = 72) were recruited and randomized to either standard anticoagulation (enoxaparin and warfarin, n = 35) or rivaroxaban (n = 37) after successful thrombolysis or mechanical thrombectomy. Primary efficacy outcome was a recurrence of any venous thromboembolism (VTE) within 6 months. Secondary safety outcomes included major bleeding, clinically relevant non-major bleeding (CRNMB), other adverse event, and all-cause mortality. Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94). Major bleeding or CRNMB was less in rivaroxaban group without significance (2.9% versus 9.4%, HR, 0.31; 95% CI, 0.03-2.96; p = 0.31). Recurrence-free survival and major bleeding-free survival at 6 months were not different in both groups. After thrombolysis of acute IFDVT, rivaroxaban was as safe and effective as warfarin in preventing DVT recurrence.
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3.
Comparison of prasugrel versus clopidogrel in Korean patients with acute myocardial infarction undergoing successful revascularization.
Park, KH, Jeong, MH, Kim, HK, Ahn, TH, Seung, KB, Oh, DJ, Choi, DJ, Kim, HS, Gwon, HC, Seong, IW, et al
Journal of cardiology. 2018;(1):36-43
Abstract
BACKGROUND Although there have been several reports that prasugrel can improve clinical outcomes, the efficacy and safety of prasugrel is unknown in Korean patients with acute myocardial infarction (AMI) undergoing successful revascularization. METHODS A total of 4421 patients [637 patients were prescribed prasugrel (60/10 or 5mg, loading/maintenance dose) and 3784 patients clopidogrel (600 or 300/75mg)] with AMI undergoing successful revascularization were enrolled from the core clinical cohort of Korea Acute Myocardial Infarction Registry-National Institute of Health. RESULTS After propensity score matching (637 pairs), there were no significant differences in baseline clinical and procedural characteristics and in-hospital medications between the two groups. The primary efficacy endpoint, defined as the composite of cardiac death, MI, stroke, or target vessel revascularization at 6 months showed no significant difference between prasugrel and clopidogrel (2.4% vs. 2.9%, p=0.593). Also, no difference was observed in the composite of cardiac death, MI, or stroke during hospitalization between two groups (0.8% vs. 0.9%, p=0.762). However, the incidence of in-hospital Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding was significantly higher in prasugrel compared with clopidogrel (5.3% vs. 2.7%, p=0.015). In multivariate linear regression analysis, trans-femoral intervention, use of glycoprotein IIb/IIIa inhibitors, use of calcium channel blocker, and use of prasugrel were independent predictors of in-hospital TIMI major or minor bleeding [odds ratio (OR)=6.918; 95% confidence interval (CI)=2.453-19.510, OR=2.577; 95% CI=1.406-4.724, OR=4.016; 95% CI=1.382-11.668, OR=2.022; 95% CI=1.101-3.714]. CONCLUSIONS Our study shows that the recommended dose of prasugrel had significantly higher in-hospital bleeding complications without reducing ischemic events compared with clopidogrel. However, further large-scale, long-term, randomized clinical trials are required to accurately assess the efficacy and safety of prasgurel and to find out the optimal dose for Korean AMI patients.
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4.
Z-score discordance and contributing factors in healthy premenopausal women with low bone mineral density: the Korean National Health and Nutrition Examination Survey 2008-9.
Park, KH, Lim, JS, Kim, KM, Rhee, Y, Lim, SK
Journal of bone and mineral metabolism. 2016;(6):668-677
Abstract
The premenopausal period is important for bone health and prevention of future fractures, but measuring bone mineral density (BMD) at only one site may not be sufficient to determine therapeutic strategies for low BMD in premenopausal women due to the presence of Z-score discordance. In this study, we investigated Z-score discordance in addition to contributing factors of idiopathic low BMD in healthy premenopausal Korean women. We studied 3003 premenopausal women aged 18-50 years, without secondary causes for low BMD and history of fragility fracture, who had participated in the Fourth Korean National Health and Nutrition Examination Surveys (2008-2009). Low body mass index (BMI), low vitamin D level, and low body muscle mass were associated with low BMD even in premenopausal women. Risk factors differed depending on the anatomic site. Low BMI and low vitamin D level were risk factors for low femoral neck BMD (FN-BMD), but not for low lumbar spine BMD (LS-BMD). Only total muscle mass had a slight effect on low LS-BMD. Z-score discordance was much higher than expected, in 75 and 73.8 % of the low LS-BMD and low FN-BMD groups, respectively. Our findings suggest the need to consider BMD discordance in premenopausal women and also to provide information on correctable factors affecting low BMD in younger populations. Long-term follow-up is needed to evaluate the possible effect of Z-score discordance on the prognosis of osteoporosis and subsequent fracture risk.
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5.
Prevalence, risk factors and comorbidities of allergic rhinitis in South Korea: The Fifth Korea National Health and Nutrition Examination Survey.
Rhee, CS, Wee, JH, Ahn, JC, Lee, WH, Tan, KL, Ahn, S, Lee, JH, Lee, CH, Cho, YS, Park, KH, et al
American journal of rhinology & allergy. 2014;(2):e107-14
Abstract
BACKGROUND There has been no nationwide epidemiological investigation of allergic rhinitis (AR) that was diagnosed by both questionnaires and laboratory tests in Korea. This study investigated the prevalence, risk factors, and comorbidities of AR in South Korea. METHODS The Korean National Health and Nutritional Examination Survey examined a representative sample of the Korean population. A total of 2305 participants underwent immunoradiometric assay for specific IgE antibodies against common indoor allergens. Healthy, atopy only, and AR groups were defined according to the results of allergen test. The weighted prevalence for each group was calculated. Risk factors including food and comorbidities were identified using univariate or multivariate analyses. The patients were also categorized into four subgroups according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification and associated comorbidities were analyzed. RESULTS The prevalence of atopy only and AR was 30.0 ± 1.2% and 16.2 ± 1.0%, respectively. The multivariate analysis showed that the prevalence was influenced by sex (p < 0.01) for atopy only and sex (p = 0.09), age (p = 0.02), marital status (p = 0.24), and stress level (p = 0.30) for AR. Compared with the healthy group, asthma (odds ratio [OR] = 4.77), nasal polyp (NP; OR = 3.44), chronic rhinosinusitis (OR = 13.93), and olfactory dysfunction (OR = 4.88) were more prevalent in the AR group. Based on the ARIA guideline, intermittent mild rhinitis was most common (58.1%). Asthma was correlated to severity and atopic dermatitis and NPs was associated with persistency. Daily intake of less mackerel and more carrots, bread, and bean curd were associated with the increased risk of AR. CONCLUSION Prevalence, risk factors, and comorbidities of AR were evaluated in the general Korean population, which will contribute to prevention and treatment of AR and its comorbidities in Koreans.
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6.
Comparison of drug-eluting stents in acute myocardial infarction patients with chronic kidney disease.
Hachinohe, D, Jeong, MH, Saito, S, Kim, MC, Cho, KH, Ahmed, K, Hwang, SH, Lee, MG, Sim, DS, Park, KH, et al
The Korean journal of internal medicine. 2012;(4):397-406
Abstract
BACKGROUND/AIMS: To determine which drug-eluting stents are more effective in acute myocardial infarction (MI) patients with chronic kidney disease (CKD). METHODS This study included a total of 3,566 acute MI survivors with CKD from the Korea Acute Myocardial Infarction Registry who were treated with stenting and followed up for 12 months: 1,845 patients who received sirolimus-eluting stents (SES), 1,356 who received paclitaxel-eluting stents (PES), and 365 who received zotarolimus-eluting stents (ZES). CKD was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m(2) calculated by the modification of diet in renal disease method. RESULTS At the 12-month follow-up, patients receiving ZES demonstrated a higher incidence (14.8%) of major adverse cardiac events (MACEs) compared to those receiving SES (10.1%) and PES (12%, p = 0.019). The ZES patients also had a higher incidence (3.9%) of target lesion revascularization (TLR) compared to those receiving SES (1.5%) and PES (2.4%, p = 0.011). After adjusting for confounding factors, ZES was associated with a higher incidence of MACE and TLR than SES (adjusted hazard ratio [HR], 0.623; 95% confidence interval [CI], 0.442 to 0.879; p = 0.007; adjusted HR, 0.350; 95% CI, 0.165 to 0.743; p = 0.006, respectively), and with a higher rate of TLR than PES (adjusted HR, 0.471; 95% CI, 0.223 to 0.997; p = 0.049). CONCLUSIONS Our findings suggest that ZES is less effective than SES and PES in terms of 12-month TLR, and has a higher incidence of MACE due to a higher TLR rate compared with SES, in acute MI patients with CKD.
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7.
Black cohosh and St. John's wort (GYNO-Plus) for climacteric symptoms.
Chung, DJ, Kim, HY, Park, KH, Jeong, KA, Lee, SK, Lee, YI, Hur, SE, Cho, MS, Lee, BS, Bai, SW, et al
Yonsei medical journal. 2007;(2):289-94
Abstract
PURPOSE This study was conducted to investigate the efficacy of black cohosh (Cimicifuga racemosa) and St. John's wort (Hypericum perforatum) in women with climacteric symptoms, and to assess their effects on vaginal atrophy, hormone levels, and lipid profiles. MATERIALS AND METHODS In this double-blind randomized, placebo-controlled, multicenter study, 89 peri- or postmenopausal women experiencing climacteric symptoms were treated with St. John's wort and black cohosh extract (Gynoplus), Jin-Yang Pharm., Seoul, Korea) or a matched placebo for 12 weeks. Climacteric complaints were evaluated by the Kupperman Index (KI) initially and at 4 and 12 weeks following treatment. Vaginal maturation indices, serum estradiol, FSH, LH, total cholesterol, HDL- cholesterol, LDL-cholesterol, and triglyceride levels were measured before and after treatment. From the initial 89 participants, 77 completed the trial (42 in the Gynoplus group, 35 in the placebo group). RESULTS Baseline characteristics were not significantly different between the two groups. Mean KI scores and hot flushes after 4 and 12 weeks were significantly lower in the Gynoplus group. Differences in superficial cell proportion were not statistically significant. HDL levels decreased in the control group from 60.20 +/- 16.37 to 56.63 +/- 12.67, and increased in the Gynoplus group from 58.32 +/- 11.64 to 59.74 +/- 10.54; this was statistically significant (p=0.04). CONCLUSION Black cohosh and St. John's wort combination was found to be effective in alleviating climacteric symptoms and might provide benefits to lipid metabolism.