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

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/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.

Key words::

• Cholesterol
• Dual-inhibition action therapy
• Ezetimibe
• Hypercholesterolemia
• Safety
• Simvastatin

Transparency

Declaration of funding

This study and its reporting, including the preparation of this manuscript, were supported by Merck Sharp & Dohme (I.A.) Corporation, Taiwan Branch.

Declaration of financial/other relationships

The authors declare no conflicts of interest.

Acknowledgements

This study was supported by Merck Sharp & Dohme (I.A.) Corporation, Taiwan Branch. The authors thank Vivien Chien (MSD-Taiwan) for coordinating the study and the preparation of this manuscript. The authors also thank Ya-Chuan Wang (MSD-Taiwan) for statistical support. The authors appreciate the contribution of all investigators at each study site, including Dr Min-Ji Charng (Taipei Veterans General Hospital), Dr Yu-Yao Huang and Dr Hung-Yu Chang (Chang Gung Memorial Hospital-Lin Kao branch), Dr Ching-Chieh Su and Dr Te-Lin Hsia (Cardinal Tien Hospital), Dr Hsin-Jung Ke (Keelung Hospital, Department of Health Executive Yuan), and Dr Rue-Tsuan Liu, Dr Pei-Wen Wang, Dr Chih-Yin Chen, Dr Ching-Jung Hsieh, Dr Chih-Ching Wang, Dr Shih-Chen Tung, and Dr Ming-Chun Kuo (Chang Gung Memorial Hospital-Kaoshiung branch).