Kenichi Tsujita1, Seigo Sugiyama2, Hitoshi Sumida3, Hideki Shimomura4, Takuro Yamashita5, Kenshi Yamanaga6, Naohiro Komura6, Kenji Sakamoto6, Hideki Oka7, Koichi Nakao8, Sunao Nakamura9, Masaharu Ishihara10, Kunihiko Matsui11, Naritsugu Sakaino12, Natsuki Nakamura13, Nobuyasu Yamamoto14, Shunichi Koide15, Toshiyuki Matsumura16, Kazuteru Fujimoto17, Ryusuke Tsunoda18, Yasuhiro Morikami19, Koushi Matsuyama5, Shuichi Oshima3, Koichi Kaikita6, Seiji Hokimoto6, Hisao Ogawa20. 1. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. Electronic address: tsujita@kumamoto-u.ac.jp. 2. Diabetes Care Center, Cardiovascular Division, Jinnouchi Hospital, Kumamoto, Japan. 3. Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan. 4. Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center, Kasuga, Japan. 5. Division of Cardiology, Social Insurance Omuta Tenryo Hospital, Omuta, Japan. 6. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. 7. Division of Cardiology, Health Insurance Hitoyoshi General Hospital, Hitoyoshi, Japan. 8. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan. 9. Interventional Cardiology Unit, New Tokyo Hospital, Matsudo, Japan. 10. Division of Coronary Artery Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan. 11. Department of Community Medicine, Kumamoto University, Kumamoto, Japan. 12. Division of Cardiology, Amakusa Medical Center, Amakusa, Japan. 13. Division of Cardiology, Shin-Beppu Hospital, Beppu, Japan. 14. Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan. 15. Division of Cardiology, Health Insurance Kumamoto General Hospital, Yatsushiro, Japan. 16. Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital, Yatsushiro, Japan. 17. Department of Cardiology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan. 18. Division of Cardiology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan. 19. Division of Cardiology, Kumamoto City Hospital, Kumamoto, Japan. 20. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Abstract
BACKGROUND: Despite standard statin therapy, a majority of patients retain a high "residual risk" of cardiovascular events. OBJECTIVES: The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention (PCI). METHODS: This trial was a prospective, randomized, controlled, multicenter study. Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily. Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol (LDL-C) <70 mg/dl. Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients. RESULTS: The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy (63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl; p < 0.001). For the absolute change in percent atheroma volume (PAV), the mean difference between the 2 groups (-1.538%; 95% confidence interval [CI]: -3.079% to 0.003%) did not exceed the pre-defined noninferiority margin of 3%, but the absolute change in PAV did show superiority for the dual lipid-lowering strategy (-1.4%; 95% CI: -3.4% to -0.1% vs. -0.3%; 95% CI: -1.9% to 0.9% with atorvastatin alone; p = 0.001). For PAV, a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression (78% vs. 58%; p = 0.004). Both strategies had acceptable side effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events. CONCLUSIONS: Compared with standard statin monotherapy, the combination of statin plus ezetimibe showed greater coronary plaque regression, which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering. (Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [PRECISE-IVUS]; NCT01043380).
RCT Entities:
BACKGROUND: Despite standard statin therapy, a majority of patients retain a high "residual risk" of cardiovascular events. OBJECTIVES: The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention (PCI). METHODS: This trial was a prospective, randomized, controlled, multicenter study. Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily. Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol (LDL-C) <70 mg/dl. Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients. RESULTS: The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy (63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl; p < 0.001). For the absolute change in percent atheroma volume (PAV), the mean difference between the 2 groups (-1.538%; 95% confidence interval [CI]: -3.079% to 0.003%) did not exceed the pre-defined noninferiority margin of 3%, but the absolute change in PAV did show superiority for the dual lipid-lowering strategy (-1.4%; 95% CI: -3.4% to -0.1% vs. -0.3%; 95% CI: -1.9% to 0.9% with atorvastatin alone; p = 0.001). For PAV, a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression (78% vs. 58%; p = 0.004). Both strategies had acceptable side effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events. CONCLUSIONS: Compared with standard statin monotherapy, the combination of statin plus ezetimibe showed greater coronary plaque regression, which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering. (Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [PRECISE-IVUS]; NCT01043380).
Authors: Peter J H Jones; Maryam Shamloo; Dylan S MacKay; Todd C Rideout; Semone B Myrie; Jogchum Plat; Jean-Baptiste Roullet; David J Baer; Kara L Calkins; Harry R Davis; P Barton Duell; Henry Ginsberg; Helena Gylling; David Jenkins; Dieter Lütjohann; Mohammad Moghadasian; Robert A Moreau; David Mymin; Richard E Ostlund; Rouyanne T Ras; Javier Ochoa Reparaz; Elke A Trautwein; Stephen Turley; Tim Vanmierlo; Oliver Weingärtner Journal: Nutr Rev Date: 2018-10-01 Impact factor: 7.110
Authors: Udo Hoffmann; Michael T Lu; Devvora Olalere; Elizabeth C Adami; Michael T Osborne; Alex Ivanov; John Sukumar Aluru; Saeyun Lee; Nadja Arifovic; Edgar Turner Overton; Carl J Fichtenbaum; Judith A Aberg; Beverly Alston-Smith; Karin L Klingman; Myron Waclawiw; Tricia H Burdo; Kenneth C Williams; Markella V Zanni; Patrice Desvigne-Nickens; Katharine Cooper-Arnold; Kathleen V Fitch; Heather Ribaudo; Pamela S Douglas; Steven K Grinspoon Journal: Am Heart J Date: 2019-03-04 Impact factor: 4.749