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PubMed | Ajou University, Korea University, Chonnam National University, LG Life science Ltd. and 17 more.
Type: Published Erratum | Journal: Korean circulation journal | Year: 2015

[This corrects the article on p. 225 in vol. 45, PMID: 26023311.].


PubMed | Ajou University, Korea University, Chonnam National University, LG Life science Ltd. and 17 more.
Type: Journal Article | Journal: Korean circulation journal | Year: 2015

We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients.Patients who met inclusion criteria were randomized to receive 1 of the following 2-month drug regimens: valsartan 160 mg plus rosuvastatin 20 mg, valsartan 160 mg plus placebo, or rosuvastatin 20 mg plus placebo. The primary efficacy variables were change in sitting diastolic blood pressure (sitDBP) and sitting systolic blood pressure (sitSBP), and percentage change in low-density lipoprotein-cholesterol (LDL-C) in the combination, valsartan, and rosuvastatin groups. Adverse events (AEs) during the study were analyzed.A total of 354 patients were screened and 123 of them were finally randomized. Changes of sitDBP by least squares mean (LSM) were -11.1, -7.2, and -3.6 mm Hg, respectively, and was greater in the combination, as compared to both valsartan (p=0.02) and rosuvastatin (p<0.001). Changes of sitSBP by LSM were -13.2, -10.8, and -4.9 mm Hg, and was greater in the combination, as compared to rosuvastatin (p=0.006) and not valsartan (p=0.42). Percentage changes of LDL-C by LSM were -52, -4, and -47% in each group, and was greater in the combination, as compared to valsartan (p<0.001), similar to rosuvastatin (p=0.16). Most AEs were mild and resolved by the end of the study.Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability, as compared to valsartan monotherapy. Its lipid lowering effect was similar to rosuvatatin monotherapy.


PubMed | Ajou University, Yonsei University, Korea University, Chonnam National University and 17 more.
Type: Clinical Trial, Phase III | Journal: Clinical therapeutics | Year: 2016

Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine 2A antagonist, is a widely used antiplatelet agent for the treatment of peripheral arterial disease (PAD). DP-R202 is a new sarpogrelate hydrochloride product with an improved dosage regimen compared with the agent in current use. The aim of this study was to compare the efficacy and safety profile of DP-R202 and Anplag() Tab in patients with PAD.This study was a 12-week, multicenter, randomized, double-blinded, active-controlled, parallel group comparative Phase III clinical trial. One hundred fifty-one volunteer patients with PAD were randomized to receive DP-R202 300 mg once daily or Anplag Table 100 mg TID for 12 weeks. The primary end point was a change in patient assessment of lower leg pain intensity with the use of a visual analog scale (VAS) after 12 weeks of treatment. Results after 4, 8, and 12 weeks of treatment were compared with baseline and between treatment groups, and all patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs.Two hundred thirty-one patients from 25 medical centers were assessed, and 151 were enrolled and randomly assigned to 1 of 2 treatment groups. Seventy-five patients received DP-R202 300 mg once daily and 76 patients received Anplag Table 100 mg TID for 12 weeks. Analysis of the change in lower leg pain intensity as determined by VAS score between baseline and week 12 (mean [SD], 20.72 [20.06] mm vs 15.55 [21.44] mm) suggested that DP-R202 was not inferior to Anplag Tab, and no significant differences were found in the secondary end points. No significant between-group differences were observed in the prevalence of drug-related clinical- or laboratory-determined AEs. For tolerability, no specific issue was found during the treatment period.The results of this study suggest that DP-R202 was not inferior to Anplag Tab for efficacy in patients with PAD and indicated a good safety profile.


Won K.-B.,Myongji Hospital Cardiovascular Center | Kim B.-K.,Yonsei University | Chang H.-J.,Yonsei University | Shin D.-H.,Yonsei University | And 6 more authors.
Catheterization and Cardiovascular Interventions | Year: 2014

Objective This study aimed to evaluate long-term survival according to the presence of metabolic syndrome (MS) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Background Despite the significance of coronary reperfusion in AMI, the prognostic impact of MS has been investigated under inconsistent reperfusion therapy in AMI patients. Methods and Results Three-year clinical outcomes, including all-cause death and the composite of cardiac death or myocardial infarction, were evaluated according to MS status for 963 patients with AMI treated with successful PCI with DES. This study included 494 subjects with MS (51%) and 469 subjects without MS (49%) the incidence of multivessel disease and the mean number of implanted stents were significantly higher in patients with MS than in patients with non-MS the occurrence of all-cause death (5.9% vs. 6.4%, P = 0.789) and the composite outcomes (5.1% vs. 6.2%, P = 0.485) did not differ significantly between patients with and without MS. Cox regression models revealed that MS had no significant impact on all-cause death (hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.55-1.52; P = 0.726) or the composite outcomes (HR 0.81; 95% CI 0.48-1.39; P = 0.448). Obesity was associated with a decreased risk of all-cause death and the composite outcomes among all MS components. Conclusions No difference was observed in long-term survival according to the presence of MS in patients with AMI after successful PCI with DES. This suggests that reperfusion therapy using PCI with DES is equally beneficial in patients AMI with and without MS. © 2013 Wiley Periodicals, Inc. Copyright © 2013 Wiley Periodicals, Inc.


Won K.-B.,Myongji Hospital Cardiovascular Center | Chang H.-J.,Yonsei University | Hong S.-J.,Yonsei University | Ko Y.-G.,Yonsei University | And 4 more authors.
Yonsei Medical Journal | Year: 2014

Purpose: Metabolic syndrome (MS) is a clinical condition that shares many common characteristics with diabetes. However, unlike diabetes, the usefulness of MS as a prognostic entity in peripheral arterial disease is uncertain. This study evaluated the prognostic usefulness of MS in critical lower limb ischemia (CLI) patients. Materials and Methods: We compared the 2-year clinical outcomes in 101 consecutive CLI patients (66±14 years; 78% men) with 118 affected limbs treated with percutaneous transluminal angioplasty (PTA) according to the presence of MS and diabetes. Results: The number of MS patients was 53 (52%), of which 45 (85%) had diabetes. During a 2-year follow-up, the incidence of clinical outcomes, including reintervention, major amputation, minor amputation, and survival, was not significantly different between MS and non-MS patients; however, the incidence of minor amputation was significantly higher in diabetic than in non-diabetic patients (42% vs. 17%; p=0.011). Cox regression analysis for the 2-year primary patency demonstrated no association between MS and 2-year primary patency [hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.45-2.30; p=0.961], whereas there was a significant association between diabetes and 2-year primary patency (HR, 2.81; 95% CI, 1.02-7.72; p=0.046). Kaplan-Meier analysis revealed no significant difference in the 2-year primary patency between MS and non-MS patients; however, the 2-year primary patency was lower in diabetic than in non-diabetic patients (p=0.038). Conclusion: As a prognostic concept, MS might conceal the adverse impact of diabetes on the prognosis of CLI patients treated with PTA. © Yonsei University College of Medicine 2014.


PubMed | Myongji Hospital Cardiovascular Center
Type: Journal Article | Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions | Year: 2014

This study aimed to evaluate long-term survival according to the presence of metabolic syndrome (MS) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI) with drug-eluting stents (DES).Despite the significance of coronary reperfusion in AMI, the prognostic impact of MS has been investigated under inconsistent reperfusion therapy in AMI patients.Three-year clinical outcomes, including all-cause death and the composite of cardiac death or myocardial infarction, were evaluated according to MS status for 963 patients with AMI treated with successful PCI with DES. This study included 494 subjects with MS (51%) and 469 subjects without MS (49%). The incidence of multivessel disease and the mean number of implanted stents were significantly higher in patients with MS than in patients with non-MS. The occurrence of all-cause death (5.9% vs. 6.4%, P = 0.789) and the composite outcomes (5.1% vs. 6.2%, P = 0.485) did not differ significantly between patients with and without MS. Cox regression models revealed that MS had no significant impact on all-cause death (hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.55-1.52; P = 0.726) or the composite outcomes (HR 0.81; 95% CI 0.48-1.39; P = 0.448). Obesity was associated with a decreased risk of all-cause death and the composite outcomes among all MS components.No difference was observed in long-term survival according to the presence of MS in patients with AMI after successful PCI with DES. This suggests that reperfusion therapy using PCI with DES is equally beneficial in patients AMI with and without MS.

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