Ji Bak Kim1, Woo Hyuk Song2, Jong Sung Park3, Tae-Jin Youn4, Yong Hyun Park5, Shin-Jae Kim6, Sung Gyun Ahn7, Joon-Hyung Doh8, Yun-Hyeong Cho9, Jin Won Kim10. 1. Department of Medicine, Korea University Graduate School, Seoul, Korea. 2. Division of Cardiology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea. 3. Department of Cardiology, Dong-A University Hospital, Busan, Korea. 4. Division of Cardiology, Department of Internal Medicine, College of Medicine, Seoul National University and Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea. 5. Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Pusan National University Yangsan Hospital, Yangsan, Korea. 6. Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. 7. Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea. 8. Department of Cardiology, Inje University Ilsan Paik Hospital, Goyang, Korea. 9. Department of Internal Medicine, Myongji Hospital, Goyang, Korea. 10. Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.
Abstract
BACKGROUND: Although accumulating evidence suggests a more extensive reduction of low-density lipoprotein cholesterol (LDL-C), it is unclear whether a higher statin dose is more effective and cost-effective in the Asian population. This study compared the efficacy, safety, and cost-effectiveness of atorvastatin 20 and 10 mg in high-risk Asian patients with hypercholesterolemia. METHODS: A 12-week, open-label, parallel, multicenter, Phase IV randomized controlled trial was conducted at ten hospitals in the Republic of Korea between October 2017 and May 2019. High-risk patients with hypercholesterolemia, defined according to 2015 Korean guidelines for dyslipidemia management, were eligible to participate. We randomly assigned 250 patients at risk of atherosclerotic cardiovascular disease to receive 20 mg (n = 124) or 10 mg (n = 126) ofatorvastatin. The primary endpoint was the difference in the mean percentage change in LDL-C levels from baseline after 12 weeks. Cost-effectiveness was measured as an exploratory endpoint. RESULTS:LDL-C levels were reduced more significantly by atorvastatin 20 mg than by 10 mg after 12 weeks (42.4% vs. 33.5%, p < 0.0001). Significantly more patients achieved target LDL-C levels (<100 mg/dL for high-risk patients, <70 mg/dL for very high-risk patients) with atorvastatin 20 mg than with 10 mg (40.3% vs. 25.6%, p < 0.05). Apolipoprotein B decreased significantly with atorvastatin 20mg versus 10 mg (-36.2% vs. -29.9%, p < 0.05). Lipid ratios also showed greater improvement with atorvastatin 20 mg than with 10 mg (total cholesterol/high-density lipoprotein cholesterol ratio, -33.3% vs. -29.4%, p < 0.05; apolipoprotein B/apolipoprotein A1 ratio, -36.7% vs. -31.4%, p < 0.05). Atorvastatin 20 mg was more cost-effective than atorvastatin 10 mg in terms of both the average and incremental cost-effectiveness ratios. Safety and tolerability of atorvastatin 20 mg were comparable to those of atorvastatin 10 mg. CONCLUSION: In high-risk Asian patients with hypercholesterolemia, atorvastatin 20 mg was both efficacious in reducing LDL-C and cost-effective compared with atorvastatin 10 mg.
RCT Entities:
BACKGROUND: Although accumulating evidence suggests a more extensive reduction of low-density lipoprotein cholesterol (LDL-C), it is unclear whether a higher statin dose is more effective and cost-effective in the Asian population. This study compared the efficacy, safety, and cost-effectiveness of atorvastatin 20 and 10 mg in high-risk Asian patients with hypercholesterolemia. METHODS: A 12-week, open-label, parallel, multicenter, Phase IV randomized controlled trial was conducted at ten hospitals in the Republic of Korea between October 2017 and May 2019. High-risk patients with hypercholesterolemia, defined according to 2015 Korean guidelines for dyslipidemia management, were eligible to participate. We randomly assigned 250 patients at risk of atherosclerotic cardiovascular disease to receive 20 mg (n = 124) or 10 mg (n = 126) of atorvastatin. The primary endpoint was the difference in the mean percentage change in LDL-C levels from baseline after 12 weeks. Cost-effectiveness was measured as an exploratory endpoint. RESULTS:LDL-C levels were reduced more significantly by atorvastatin 20 mg than by 10 mg after 12 weeks (42.4% vs. 33.5%, p < 0.0001). Significantly more patients achieved target LDL-C levels (<100 mg/dL for high-risk patients, <70 mg/dL for very high-risk patients) with atorvastatin 20 mg than with 10 mg (40.3% vs. 25.6%, p < 0.05). Apolipoprotein B decreased significantly with atorvastatin 20mg versus 10 mg (-36.2% vs. -29.9%, p < 0.05). Lipid ratios also showed greater improvement with atorvastatin 20 mg than with 10 mg (total cholesterol/high-density lipoprotein cholesterol ratio, -33.3% vs. -29.4%, p < 0.05; apolipoprotein B/apolipoprotein A1 ratio, -36.7% vs. -31.4%, p < 0.05). Atorvastatin 20 mg was more cost-effective than atorvastatin 10 mg in terms of both the average and incremental cost-effectiveness ratios. Safety and tolerability of atorvastatin 20 mg were comparable to those of atorvastatin 10 mg. CONCLUSION: In high-risk Asian patients with hypercholesterolemia, atorvastatin 20 mg was both efficacious in reducing LDL-C and cost-effective compared with atorvastatin 10 mg.
Authors: Jeffrey J Ellis; Steven R Erickson; James G Stevenson; Steven J Bernstein; Renee A Stiles; A Mark Fendrick Journal: J Gen Intern Med Date: 2004-06 Impact factor: 5.128
Authors: Andrei C Sposito; Luiz Sergio F Carvalho; Filipe A Moura; Alessandra M Campos-Staffico; Riobaldo M R Cintra; Wilson Nadruz; Osorio R Almeida; Jose C Quinaglia E Silva Journal: Sci Rep Date: 2019-11-08 Impact factor: 4.379