Woohyeun Kim1, Yeonyee E Yoon2, Sung-Hee Shin3, Jang-Whan Bae4, Bum-Kee Hong5, Soon Jun Hong6, Ki Chul Sung7, Seung Hwan Han8, Weon Kim9, Moo-Yong Rhee10, Sang-Hyun Kim11, Sang Eun Lee12, Min Su Hyon13, Gyo-Seung Hwang14, Jang Won Son15, Jang-Young Kim16, Min Kyu Kim17, Sang Wook Kim18, Jae-Hyeong Park19, Jin Ho Shin20, Chang Gyu Park21. 1. Department of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea. 2. Department of Cardiology, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. 3. Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea. 4. Division of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. 5. Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 6. Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea. 7. Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 8. Division of Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea. 9. Division of Cardiology, Department of Internal Medicine, Kyung Hee University, Kyung Hee University Hospital, Seoul, Republic of Korea. 10. Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea. 11. Division of Cardiology, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Republic of Korea. 12. Division of Cardiology, Asan Medical Center, Seoul, Republic of Korea. 13. Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea. 14. Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea. 15. Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea. 16. Department of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. 17. Division of Cardiology, Department of Internal Medicine, Hallym University Dontan Sacred Heart Hospital, Hwaseong, Republic of Korea. 18. Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea. 19. Division of Cardiology, Department of Internal Medicine, Chungnam National University College of Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea. 20. Division of Cardiology, Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea. 21. Department of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea. Electronic address: parkcg@kumc.or.kr.
Abstract
PURPOSE: The aim of this study was to evaluate the safety and efficacy of combination treatment of rosuvastatin with ezetimibe in patients with primary hypercholesterolemia. METHODS: This multicenter, randomized, double-blind study comprised a main study and an extension study. In the main study, the efficacy and safety of a combination of rosuvastatin (5, 10, and 20 mg) with ezetimibe (10 mg) were compared with those of rosuvastatin (5, 10, and 20 mg) alone. The subjects who achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the main study and agreed to a further study were enrolled for the extension study. In the extension study, ezetimibe 10 mg was also administered to subjects who had received rosuvastatin (5, 10, and 20 mg) alone in the main study, and the same treatment was continued for subjects who had received a combination of rosuvastatin with ezetimibe in the main study. FINDINGS: At the end of the main study (week 8), LDL-C levels were significantly lower in subjects receiving combination therapy than in those receiving rosuvastatin monotherapy. Other lipid profiles also significantly improved in the combination therapy group. These improvements continued in the extension study. The combination therapy of rosuvastatin and ezetimibe was generally well tolerated. At the end of the main study, more subjects achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the combination therapy group than in the monotherapy group. The increased dosage of rosuvastatin was also well tolerated in the combination treatment. IMPLICATIONS: Combination therapy of ezetimibe 10 mg with varying doses of rosuvastatin that are commonly used in the clinical field improved the lipid profile and allowed more subjects to reach the LDL-C goal in primary hypercholesterolemia compared with rosuvastatin monotherapy. In addition, the efficacy of the combination therapy was maintained for the extended period. Additional beneficial changes were also achieved with combination therapy even in patients who responded well to rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT03288038.
RCT Entities:
PURPOSE: The aim of this study was to evaluate the safety and efficacy of combination treatment of rosuvastatin with ezetimibe in patients with primary hypercholesterolemia. METHODS: This multicenter, randomized, double-blind study comprised a main study and an extension study. In the main study, the efficacy and safety of a combination of rosuvastatin (5, 10, and 20 mg) with ezetimibe (10 mg) were compared with those of rosuvastatin (5, 10, and 20 mg) alone. The subjects who achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the main study and agreed to a further study were enrolled for the extension study. In the extension study, ezetimibe 10 mg was also administered to subjects who had received rosuvastatin (5, 10, and 20 mg) alone in the main study, and the same treatment was continued for subjects who had received a combination of rosuvastatin with ezetimibe in the main study. FINDINGS: At the end of the main study (week 8), LDL-C levels were significantly lower in subjects receiving combination therapy than in those receiving rosuvastatin monotherapy. Other lipid profiles also significantly improved in the combination therapy group. These improvements continued in the extension study. The combination therapy of rosuvastatin and ezetimibe was generally well tolerated. At the end of the main study, more subjects achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the combination therapy group than in the monotherapy group. The increased dosage of rosuvastatin was also well tolerated in the combination treatment. IMPLICATIONS: Combination therapy of ezetimibe 10 mg with varying doses of rosuvastatin that are commonly used in the clinical field improved the lipid profile and allowed more subjects to reach the LDL-C goal in primary hypercholesterolemia compared with rosuvastatin monotherapy. In addition, the efficacy of the combination therapy was maintained for the extended period. Additional beneficial changes were also achieved with combination therapy even in patients who responded well to rosuvastatin monotherapy. ClinicalTrials.gov identifier: NCT03288038.
Authors: Gabriella di Mauro; Alessia Zinzi; Cristina Scavone; Francesco Rossi; Annalisa Capuano; Annamaria Mascolo; Mario Gaio; Liberata Sportiello; Carmen Ferrajolo; Concetta Rafaniello Journal: Drug Saf Date: 2020-12-22 Impact factor: 5.606