Document Detail


Begin with the Real-world Patients of Non-goal-achieved Hypercholesterolemia in Taiwan through the Ezetimibe/Simvastatin Tablet - The BRAVO Study.
MedLine Citation:
PMID:  21699369     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract Objective: To assess the efficacy, safety, and tolerability of a combination of 10 mg ezetimibe and 20 mg simvastatin in Taiwanese patients with hypercholesterolemia. Research design and methods: A prospective, open-label, multi-center, hospital-based cohort study was conducted to evaluate the efficacy, safety, and tolerability of a single tablet combination of ezetimibe/simvastatin for the treatment of hypercholesterolemia. Taiwanese adults without low-density lipoprotein cholesterol (LDL-C) goal achievement, based on the National Cholesterol Education Program Adult Treatment Panel III guidelines, were treated with ezetimibe/simvastatin once daily for 6 weeks. The primary endpoint was the percentage of patients achieving LDL-C treatment goals after 6 weeks of treatment. Secondary endpoints included percentage change from baseline of LDL-C, total cholesterol, high-density lipoprotein cholesterol, and triglyceride. Safety and tolerability were assessed via clinical and laboratory examinations. The clinicaltrial.gov identifier of this study was NCT00654628. Results: In total, 173 patients with a mean age of 57.9 ± 10.4 years were included. Of these, 57.8% were female and the average body mass index was 25.5 ± 3.4 kg/m(2). After 6 weeks of treatment, the great majority of the patients had reached their treatment goals (90.4% for LDL-C; 87% for TC; and 59% for TG). LDL-C levels were significantly reduced from 156.8 ± 30.8 mg/dL at baseline to 75.9 ± 25.4 mg/dL (51.4%, P < 0.0001) after only 6 weeks of therapy. Forty-nine adverse events (AEs), including one non-drug related serious AE, were reported. For non-serious AEs, the most common reported AEs during the entire study period were myalgia and upper respiratory infection (both n = 7). Nine patients dropped out of the study, reportedly due to AEs. Conclusions: A single tablet combination of 10 mg ezetimibe and 20 mg simvastatin in Taiwanese patients with hypercholesterolemia provided high LDL-C goal attainment rates and resulted in significant reductions in LDL-C.
Authors:
Jui-Chu Huang; Tao-Yu Lee; Miaw-Jene Liou; Chi-Min Lin; Dee Pei; Zhih-Cherng Chen; Rue-Tsuan Liu; Ching-Fai Kwok
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-6-23
Journal Detail:
Title:  Current medical research and opinion     Volume:  -     ISSN:  1473-4877     ISO Abbreviation:  -     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-6-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Division of Metabolism and Endocrinology, Department of Internal Medicine, Chang Gung Memorial Hospital , Taoyuan , Taiwan.
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