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Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study.
Lee, SA, Hong, SJ, Sung, JH, Kim, KS, Kim, SH, Cho, JM, Chun, SW, Lee, SR, Kim, CS, Kim, TN, et al
Medicine. 2023;(47):e36122
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Abstract
BACKGROUND We compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS At 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters. RESULTS Baseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline. CONCLUSIONS The addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.
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Deferasirox improves hematologic and hepatic function with effective reduction of serum ferritin and liver iron concentration in transfusional iron overload patients with myelodysplastic syndrome or aplastic anemia.
Cheong, JW, Kim, HJ, Lee, KH, Yoon, SS, Lee, JH, Park, HS, Kim, HY, Shim, H, Seong, CM, Kim, CS, et al
Transfusion. 2014;(6):1542-51
Abstract
BACKGROUND Transfusional iron overload and its consequences are challenges in chronically transfused patients with myelodysplastic syndromes (MDSs) or aplastic anemia (AA). STUDY DESIGN AND METHODS This was a prospective, multicenter, open-label study to investigate the efficacy of deferasirox (DFX) by serial measurement of serum ferritin (S-ferritin) level, liver iron concentration (LIC) level using relaxation rates magnetic resonance imaging, and other laboratory variables in patients with MDS or AA. RESULTS A total of 96 patients showing S-ferritin level of at least 1000 ng/mL received daily DFX for up to 1 year. At the end of the study, S-ferritin level was significantly decreased in MDS (p=0.02366) and AA (p=0.0009). LIC level was also significantly reduced by more than 6.7 mg Fe/g dry weight from baseline. Hemoglobin level and platelet counts were significantly increased from baseline (p=0.002 and p=0.025, respectively) for patients showing significant anemia or thrombocytopenia. Elevated alanine aminotransferase was also significantly decreased from baseline. CONCLUSIONS This study shows that DFX is effective in reducing S-ferritin and LIC level in transfusional iron overload patients with MDS or AA and is well tolerated. In addition, positive effects in hematologic and hepatic function can be expected with DFX. Iron chelation treatment should be considered in transfused patients with MDS and AA when transfusion-related iron overload is documented.
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Phase II study of a cremophor-free, polymeric micelle formulation of paclitaxel for patients with advanced urothelial cancer previously treated with gemcitabine and platinum.
Lee, JL, Ahn, JH, Park, SH, Lim, HY, Kwon, JH, Ahn, S, Song, C, Hong, JH, Kim, CS, Ahn, H
Investigational new drugs. 2012;(5):1984-90
Abstract
INTRODUCTION Genexol-PM is a novel Cremophor® EL (CrEL)-free polymeric micelle formulation of paclitaxel. This multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM monotherapy in patients with advanced urothelial carcinoma who developed disease progression after gemcitabine and cisplatin combination chemotherapy. PATIENTS AND METHODS Patients received Genexol-PM 240 mg/m(2) intravenously over 3 h every 3 weeks without premedication. Intra-patient dose escalation to 300 mg/m(2) was allowed during the second and subsequent cycles if pre-specified toxicities were not observed during the first cycle. The primary endpoint was response. RESULTS Thirty-seven patients were enrolled in this study. Platinum-free interval was less than 6 months in 27 (73%) patients, and 24 (64%) were categorized as having intermediate or poor prognosis according to Bajorin's criteria. Of 34 evaluable patients, there were 7 responses (21%; 95% CI, 7-34%), including one complete response (CR), with a median response duration of 6.5 months (95% CI, 3.5-9.6 months). The median time to progression was 2.7 months (95% CI, 0.9-4.6 months) with a median overall survival of 6.5 months (95% CI, 5.0-8.0 months). The most common grade 3/4 non-hematologic toxicities were peripheral neuropathy (sensory type 5.9%; motor type 8.8%) and infection (5.9%). Grade ≥3 hematologic toxicities occurred in only one patient. CONCLUSION Genexol-PM was generally well tolerated and demonstrated sufficient antitumor activity to warrant further development when used as second-line chemotherapy after gemcitabine-cisplatin failure in patients with urothelial carcinoma (NCT01426126).
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Pemetrexed and cisplatin in patients with advanced gastric cancer: a Korean cancer study group multicenter phase II study.
Kim, YH, Chung, HC, Kang, WK, Park, SR, Kim, CS, Kim, TY, Shin, SW, Park, BJ, Cha, SJ, Bang, YJ
Cancer chemotherapy and pharmacology. 2008;(2):263-70
Abstract
BACKGROUND Pemetrexed is a multitargeted antifolate enzyme inhibitor, which has activity against a variety of tumors, including advanced gastric cancer (AGC). The aim of this study was to assess efficacy and safety of pemetrexed plus cisplatin (PemCis) combination in the treatment of AGC in Korean patients. PATIENTS AND METHODS This was a multicenter, single arm, open label study. Patients with no prior palliative chemotherapy received pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) day 1, every 3 weeks plus folic acid and vitamin B(12) supplementation. Response rate was assessed according to response evaluation criteria in solid tumors (RECIST) criteria. RESULTS Of the 50 patients evaluable for efficacy, 13 had partial response for an overall response rate of 26% (95% CI, 14.6-40.3%) and 15 (30%) had stable disease. Median time to progression was 2.8 months (95%CI, 2.2-4.4 months), and median overall survival was 6.6 months (95% CI, 4.8-10.4 months). Of the 51 patients evaluable for safety, the most frequent NCI-CTC grade 3/4 toxicities were neutropenia in 49% of patients (25% of cycles) and anorexia in 10% of patients (4% of cycles). CONCLUSION PemCis has a modest activity and acceptable toxicity profile in patients with AGC. Clinical trials with different combinations and dose regimens are, therefore, warranted.
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Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer.
Lee, KS, Chung, HC, Im, SA, Park, YH, Kim, CS, Kim, SB, Rha, SY, Lee, MY, Ro, J
Breast cancer research and treatment. 2008;(2):241-50
Abstract
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM in patients with histologically confirmed metastatic breast cancer (MBC). Forty-one women received Genexol-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks without premedication until disease progression or intolerability. A total of 331 chemotherapy cycles were administered, with a median of 8 cycles per patient (range, 1-16). Overall response rate was 58.5% (95% CI: 43.5-72.3) with 5 complete responses and 19 partial responses. Thirty-seven patients who received Genexol-PM as a first-line therapy for their metastatic disease showed a response rate of 59.5% (95% CI: 43.5-73.7), and two responses were reported in four patients treated in the second-line setting for their metastatic disease. The median time to progression (TTP) for all patients was 9.0 months (range, 1.0-17.0+ months). Grade 3 non-hematologic toxicities included sensory peripheral neuropathy (51.2%), and myalgia (2.4%). Eight patients (19.5%) experienced hypersensitivity reactions, with grade 3 in two patients. Hematologic toxicities were grade 3 and 4 neutropenia (51.2 and 17.1%, respectively), and grade 1 and 2 thrombocytopenia (22.0%). Notably, no febrile neutropenia was observed. Genexol-PM appears a promising new paclitaxel in view of significant efficacies. Further trials with different dosing schedules, durations of delivery, or in combination with other drugs are warranted.
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The hemostatic effect of endoscopic sodium hyaluronate injection in peptic ulcer bleeding.
Cho, YK, Kim, CS, Kim, SY, Park, JH, Kim, HJ, Park, DI, Sohn, CH, Jeon, WK, Kim, BI, Shin, JH, et al
Hepato-gastroenterology. 2007;(76):1276-9
Abstract
BACKGROUND/AIMS: Endoscopic injection therapy is a well-established method of controlling peptic ulcer bleeding but it is not clear which agent would be the best choice for injection material. In this study, we evaluated the effect of Sodium Hyaluronate for control of ulcer bleeding. METHODOLOGY The subjects consisted of 26 patients with major peptic ulcer hemorrhage from June 2000 to August 2001. There were 17 gastric ulcers, 7 duodenal ulcers and 2 ulcers at anastomosis site. According to modified Forrest classifications, there were 7 active bleeding (spurting, 3; oozing, 4) and 19 stigmata of recent hemorrhage (visible vessel, 14; fresh blood clots, 5). Sodium Hyaluronate-saline solution was injected to control the bleeding. The initial and permanent hemostatic rate, rebleeding rate, and other complications were retrospectively evaluated. RESULTS The initial hemostatic rate was 25/26 (96.2%) and re-bleeding rate 3/26 (11.5%). The success rate of the second trial of Sodium Hyaluronate injection was 3/3 (100%). Overall, the permanent hemostatic rate was 25/26 (96.2%) and there were no complications related to Sodium Hyaluronate injection. CONCLUSIONS Sodium Hyaluronate is an excellent candidate agent for endoscopic injection therapy because of its convenience and safety. Further prospective randomized trials with other hemostatic methods are needed.
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Three-dimensional dynamic liver MR imaging using sensitivity encoding for detection of hepatocellular carcinomas: comparison with superparamagnetic iron oxide-enhanced mr imaging.
Kim, YK, Kim, CS, Kwak, HS, Lee, JM
Journal of magnetic resonance imaging : JMRI. 2004;(5):826-37
Abstract
PURPOSE To assess the diagnostic performance of three-dimensional dynamic liver imaging with sensitivity encoding (SENSE), including double arterial phase images and increased resolution, by comparing it to superparamagnetic iron oxide (SPIO)-enhanced magnetic resonance (MR) imaging for the detection of hypervascular hepatocellular carcinoma (HCC). MATERIALS AND METHODS Twenty-seven consecutive patients with 50 HCCs underwent Gd-BOPTA-enhanced dynamic imaging using SENSE and SPIO-enhanced MR imaging with at least a 24-hour interval between examinations. Using a three-dimensional gradient-echo technique applying SENSE, dynamic imaging consisting of double arterial phase-, portal phase- and delayed phase-images, was obtained. Using T2-weighted turbo spin-echo and T2*-weighted fast imaging with steady-state precession sequence, SPIO-enhanced MR imaging was obtained. For qualitative analysis, the diagnostic accuracy of both MR examinations for detecting the 50 HCCs was evaluated using the alternative free-response receiver operating characteristic method. Sensitivity and positive predictive value were also evaluated. RESULTS The mean sensitivity and positive predictive value of three-dimensional dynamic imaging with SENSE were 91.3% and 89.2%, respectively, and those of SPIO-enhanced imaging were 77.3% and 92.6 %, respectively. There was a significant difference in sensitivity between the two images (P <0.05). The mean Az value of three-dimensional dynamic imaging with SENSE (0.97 +/- 0.01) was significantly higher than that of SPIO-enhanced imaging (0.90 +/- 0.02) (P=0.00). CONCLUSION Three-dimensional dynamic liver MR imaging using SENSE for acquiring double arterial phase images is more efficient than SPIO-enhanced MR imaging for detecting HCCs.
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Effects of viscoelastic material on the corneal endothelial cells in trabeculectomy with adjunctive mitomycin-C.
Shin, DB, Lee, SB, Kim, CS
Korean journal of ophthalmology : KJO. 2003;(2):83-90
Abstract
We evaluated the change of corneal endothelium after trabeculectomy with mitomycin-C soaking (0.2 mg/ml, 2.4 +/- 1.2 minutes) and the effect of viscoelastic material in reducing this change. In randomly selected cases, 0.05 ml of sodium hyaluronate(Healon) was injected into anterior chamber (Healon group, n = 20), and same amount of balanced salt solution was injected in the other eyes (Control, n = 18) at the beginning of surgery. There were no differences in clinical variables and specular microscopy result between 2 groups before surgery. After surgery, the change of endothelial cells were significantly reduced in Healon group (cell density; -2.5 +/- 1.6%, variability of cell area; 5.8 +/- 2.5%, and percentage of hexagonal cell; -2.2 +/- 0.7%) compared to control group (-7.7 +/- 6.0%, 8.9 +/- 4.4%, and -4.8 +/- 3.5% respectively, p < 0.01). In trabeculectomy with mitomycin-C, the damage to the corneal endothelium was reduced significantly by injecting the viscoelastic material without significant complication.
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Phase II trial of epirubicin, cisplatin, oral uracil and tegafur, and leucovorin in patients with advanced gastric carcinoma.
Jeen, YT, Yoon, SY, Shin, SW, Kim, BS, Mok, YJ, Kim, CS, Hyun, JH, Kim, JS, Kim, YH
Cancer. 2001;(12):2288-93
Abstract
BACKGROUND The results of chemotherapy for patients with gastric carcinoma generally have been modest, although regimens developed more recently have produced higher response rates. One such regimen is epirubicin, cisplatin, and protracted infusion of 5-fluorouracil (ECF). The advantage of a long-term oral administration of uracil and tegafur (UFT) is that this treatment may be used to mimic the protracted infusion of 5-fluorouracil (5-FU). In addition, UFT treatment combined with leucovorin had a favorable activity and tolerable toxicity in patients with advanced gastric carcinoma. Instead of the inconvenience of an infusion pump and intravenous catheter for the protracted infusion of 5-FU, the authors administered UFT plus leucovorin in an ECF regimen for the treatment of patients with advanced gastric carcinoma. METHODS Fifty-two patients with advanced gastric carcinoma received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m(2) and cisplatin 60 mg/m(2) were administered on Day 1 by intravenous injection. Tegafur and uracil 360 mg/m(2)/day orally was administered in conjunction with leucovorin administered at a fixed dose of 45 mg/day orally in divided daily doses for 21 days followed by a 7-day rest period. These courses were repeated every 4 weeks. The median age of the patients was 59 years with a median World Health Organization performance status of 1. Patients received a median of five courses of treatment (range, 1-10). RESULTS Among the 47 patients evaluated, three patients achieved complete response, and 24 patients had partial responses, for an overall response rate of 57.5% (95% confidence interval, 71.5-43.3%). Stable disease was reported in 11 patients (23.4%), and another 9 patients (19.1%) showed disease progression. The median duration of survival was 15 months (range, 2-33+). The main toxicity was nausea/vomiting and neutropenia. Significant toxicity (modified National Cancer Institute common toxicity Grade 3 or 4) included neutropenia in 22 patients (42%), nausea in 14(27%), vomiting in 9 (18%), oral mucositis in 3 (6%), and diarrhea in 3 (6%) patients. CONCLUSIONS The authors conclude that epirubicin, cisplatin, and oral UFT plus leucovorin, a convenient regimen, has a significant activity and tolerable toxicities in patients with gastric carcinoma.
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Palliation of postoperative gastrointestinal anastomotic malignant strictures with flexible covered metallic stents: preliminary results.
Lee, JM, Han, YM, Lee, SY, Kim, CS, Yang, DH, Lee, SO
Cardiovascular and interventional radiology. 2001;(1):25-30
Abstract
PURPOSE To evaluate the efficacy of the placement of covered metallic stents for palliation of gastrointestinal anastomotic strictures secondary to recurrent gastric cancer. METHODS Under fluoroscopic guidance, placement of one or two self-expandable covered metallic stents was attempted perorally in 11 patents (aged 48-76 years) with anastomotic stenoses due to recurrent gastric malignancies. The strictures involved both the afferent and efferent loops in three patients. All patients had poor peroral food intake with severe nausea and vomiting after ingestion. The technical and clinical success was evaluated. RESULTS Placement of the covered stent was technically successful in 13 of 15 (87%) attempts in ten patients. After the procedure, 9 of 11 (82%) patients overall were able to ingest at least a liquid diet and had markedly decreased incidence of vomiting. During the follow-up of 2-31 weeks (mean 8.5 weeks) there were no major complications. CONCLUSION These preliminary results suggest that flexible, covered stents may provide effective palliation of malignant anastomotic stricture secondary to recurrent gastric cancer.