Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins - ODYSSEY JAPAN Randomized Controlled Trial

被引:93
作者
Teramoto, Tamio [1 ]
Kobayashi, Masahiko [2 ]
Tasaki, Hiromi [5 ]
Yagyu, Hiroaki [6 ]
Higashikata, Toshinori [7 ]
Takagi, Yoshiharu [3 ]
Uno, Kiyoko [4 ]
Baccara-Dinet, Marie T. [8 ]
Nohara, Atsushi [9 ]
机构
[1] Teikyo Univ, Teikyo Acad Res Ctr, Tokyo, Japan
[2] Sanofi, Therapeut Strategy Unit Asia Pacific R&D, Tokyo, Japan
[3] Sanofi, Clin Sci & Operat, R&D, Tokyo, Japan
[4] Sanofi, Cardiovasc Med, Tokyo, Japan
[5] Kitakyushu Municipal Yahata Hosp, Dept Cardiovasc Med, Fukuoka, Japan
[6] Tsukuba Univ Hosp, Dept Endocrinol & Metab, Mito Med Ctr, Ibaraki, Japan
[7] Komatsu Municipal Hosp, Dept Cardiovasc Med, Komatsu, Ishikawa, Japan
[8] Sanofi, Dev & Launch Unit PCSK9, Montpellier, France
[9] Kanazawa Univ, Med Educ Res Ctr, Grad Sch Med Sci, Kanazawa, Ishikawa 9201192, Japan
关键词
Alirocumab; Coronary artery disease; Low-density lipoprotein cholesterol; Monoclonal antibody; DENSITY-LIPOPROTEIN CHOLESTEROL; ACUTE CORONARY SYNDROMES; EVOLOCUMAB AMG 145; MONOCLONAL-ANTIBODY; INHIBITOR ALIROCUMAB; PCSK9; EZETIMIBE; THERAPY; ATORVASTATIN; GUIDELINES;
D O I
10.1253/circj.CJ-16-0387
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: The ODYSSEY Japan study was designed to demonstrate the reduction in low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on to existing lipid-lowering therapy in Japanese patients with heterozygous familial hypercholesterolemia (heFH) or non-FH at high cardiovascular risk who require additional pharmacological management to achieve their LDL-C treatment goal (<2.6 or <3.1 mmol/L, depending on risk category). Methods and Results: This randomized, double-blind, parallel-group, 52-week study was conducted in Japan. Patients (n=216) with heFH, non-FH at high cardiovascular risk with coronary disease, or classified as category III were enrolled. The prespecified safety analysis was done after the last patient completed 52 weeks. Patients were randomized (2:1, alirocumab:placebo) with stratification for heFH to s.c. alirocumab (75 mg every 2 weeks [Q2 W] with increase to 150 mg if week 8 LDL-C >= 2.6/3.1 mmol/L) or placebo for 52 weeks plus stable statin therapy. At week 24, mean +/- SE change in LDL-C from baseline was -62.5 +/- 1.3% in the alirocumab group and 1.6 +/- 1.8% in the placebo group (difference, -64.1 +/- 2.2%; P<0.0001); the reduction was sustained to week 52 (alirocumab, -62.5 +/- 1.4%; placebo, -3.6 +/- 1.9%). No patterns were evident between treatment groups for adverse events at 52 weeks. Conclusions: In high-risk Japanese patients with hypercholesterolemia on stable statin therapy, alirocumab markedly reduced LDL-C vs. placebo and was well tolerated over 52 weeks.
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页码:1980 / +
页数:13
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