PMID- 21699369 OWN - NLM STAT- MEDLINE DCOM- 20111115 LR - 20151119 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 27 IP - 8 DP - 2011 Aug TI - Begin with the real-world patients of non-goal-achieved hypercholesterolemia in taiwan through the ezetimibe/simvastatin tablet - The BRAVO Study. PG - 1645-51 LID - 10.1185/03007995.2011.594425 [doi] AB - 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. FAU - Huang, Jui-Chu AU - Huang JC AD - Division of Metabolism and Endocrinology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan. FAU - Lee, Tao-Yu AU - Lee TY FAU - Liou, Miaw-Jene AU - Liou MJ FAU - Lin, Chi-Min AU - Lin CM FAU - Pei, Dee AU - Pei D FAU - Chen, Zhih-Cherng AU - Chen ZC FAU - Liu, Rue-Tsuan AU - Liu RT FAU - Kwok, Ching-Fai AU - Kwok CF LA - eng SI - ClinicalTrials.gov/NCT00654628 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20110623 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Anticholesteremic Agents) RN - 0 (Azetidines) RN - 0 (Cholesterol, HDL) RN - 0 (Cholesterol, LDL) RN - 0 (Drug Combinations) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Triglycerides) RN - AGG2FN16EV (Simvastatin) RN - EOR26LQQ24 (Ezetimibe) SB - IM MH - Adult MH - Aged MH - Anticholesteremic Agents/*administration & dosage/adverse effects MH - Azetidines/*administration & dosage/adverse effects MH - Cholesterol, HDL/*blood MH - Cholesterol, LDL/*blood MH - Drug Combinations MH - Ezetimibe MH - Female MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage/adverse effects MH - *Hypercholesterolemia/blood/drug therapy MH - Male MH - Middle Aged MH - Simvastatin/*administration & dosage/adverse effects MH - Taiwan MH - Time Factors MH - Triglycerides/*blood EDAT- 2011/06/28 06:00 MHDA- 2011/11/16 06:00 CRDT- 2011/06/25 06:00 PHST- 2011/06/25 06:00 [entrez] PHST- 2011/06/28 06:00 [pubmed] PHST- 2011/11/16 06:00 [medline] AID - 10.1185/03007995.2011.594425 [doi] PST - ppublish SO - Curr Med Res Opin. 2011 Aug;27(8):1645-51. doi: 10.1185/03007995.2011.594425. Epub 2011 Jun 23.