Begin with the Real-world Patients of Non-goal-achieved Hypercholesterolemia in Taiwan through the Ezetimibe/Simvastatin Tablet –– The BRAVO Study.

AbstractObjective: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/m2. 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. [ABSTRACT FROM AUTHOR]