Efficacy and safety of rosuvastatin versus atorvastatin in high-risk Chinese patients with hypercholesterolemia: a randomized, double-blind, active-controlled study

Abstract

Objective: To evaluate and compare the efficacy and safety of rosuvastatin versus atorvastatin in a high-risk Chinese population with hypercholesterolemia.

Research design and methods: This 6 week, prospective, multicenter, double-blind, three-arm, parallel-group, active-controlled study randomized adult Chinese patients (low-density lipoprotein cholesterol [LDL-C] ≥ 130–<250 mg/dL statin-naive and ≥100–<160 mg/dL in statin treated) to receive rosuvastatin (5 mg or 10 mg) or atorvastatin 10 mg. Patients not achieving National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III LDL-C targets in the randomized phase were administered rosuvastatin 10 mg and 20 mg in the open-label phase.

Results: In total 414 patients (mean age: 59.5 ± 9.51 years, 59.4% females, mean LDL-C: 4.242 ± 0.676 mmol/L (rosuvastatin 5 mg), 4.13 ± 0.682 mmol/L (rosuvastatin 10 mg) and 4.213 ± 0.662 mmol/L (atorvastatin 10 mg) were analyzed. Compared with atorvastatin 10 mg, rosuvastatin 5 mg (−41.70% vs. −38.67%, p = .132) and rosuvastatin 10 mg showed greater LDL-C reduction (−46.28% vs. −38.67%, p = .0002). LDL-C target achievement rates with rosuvastatin 5 mg, rosuvastatin 10 mg and atorvastatin 10 mg were 61.0%, 79.1% and 58.3% in the randomized phase. In the open-label phase, LDL-C target achievement occurred in >40% with both doses of rosuvastatin. The rate of ≥1 adverse event was similar with rosuvastatin 5 mg (12.4%), 10 mg (11.7%) and atorvastatin 10 mg (8.9%).

Conclusion: Rosuvastatin 5 mg demonstrated non-inferiority and rosuvastatin 10 mg demonstrated superiority to atorvastatin 10 mg for lowering LDL-C in high-risk Chinese patients with dyslipidemia, which was maintained through the open-label phase.

Clinical trial registration: NCT00683618.

Keywords:

• Atorvastatin
• coronary heart disease
• hypercholesterolemia
• low-density lipoprotein cholesterol
• rosuvastatin

Transparency

Declaration of funding

This study was funded by AstraZeneca Pharmaceutical Company Ltd.

Declaration of financial/other relationships

S.Z. and D.P. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors acknowledge Mr. Karan Sharma (MPharm) and Dr Amit Bhat (PhD) (Indegene, Bangalore, India) for providing medical writing support. We would like to acknowledge the contribution of the study group on efficacy of rosuvastatin in China at each participating centre: Zhao Shuiping, The Second Xiangya Hospital of Central South University; Ye Ping, The General Hospital of the People’s Liberation Army; Sun Ningling, Peking University People’s Hospital; Ke Yuanan, China–Japan Friendship Hospital, Ministry of Health, Hua Qi, Xuanwu Hospital Capital Medical University; Li Hongwei, Beijing Friendship Hospital, Capital Medical University; Dai Qiuyan, Shanghai First People’s Hospital; Wei Meng, The Sixth People’s Hospital of Shanghai Jiaotong University; Liao Yuhua, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Wang Daowen, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Li Zhanquan, The People’s Hospital of Liaoning Province; Sun Yingxian, Shengjing Hospital of China Medical University; Wang Huaizhen, Tianjin Third Central Hospital.