Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial

被引:5
作者
Arai, Hidenori [1 ]
Yamashita, Shizuya [2 ]
Araki, Eiichi [3 ,4 ]
Yokote, Koutaro [5 ]
Tanigawa, Ryohei [6 ]
Saito, Ayumi [6 ]
Yamasaki, Sayumi [7 ]
Suganami, Hideki [8 ]
Ishibashi, Shun [9 ]
机构
[1] Natl Ctr Geriatr & Gerontol, 7-430 Morioka Cho, Obu, Aichi, Japan
[2] Rinku Gen Med Ctr, Osaka, Japan
[3] Kikuchi Med Assoc Hosp, Kumamoto, Japan
[4] Kumamoto Hlth Sci Univ, Res Ctr Hlth & Sports Sci, Kumamoto, Japan
[5] Chiba Univ, Grad Sch Med, Dept Endocrinol Hematol & Gerontol, Chiba, Japan
[6] Kowa Co Ltd, Global Clin Dev Dept, Tokyo, Japan
[7] Kowa Co Ltd, Med Affairs Dept, Tokyo, Japan
[8] Kowa Co Ltd, Data Sci Ctr, Tokyo, Japan
[9] Jichi Med Univ, Sch Med, Dept Internal Med, Div Endocrinol & Metab, Shimotsuke, Tochigi, Japan
关键词
Extended release; Pemafibrate; Remnants; Selective PPAR alpha modulator; Triglycerides; RECEPTOR-ALPHA MODULATOR; SPPARM-ALPHA; DYSLIPIDEMIC PATIENTS; K-877; METABOLISM; IMPACT;
D O I
10.5551/jat.64677
中图分类号
R6 [外科学];
学科分类号
1002 ; 100210 ;
摘要
Aims: Pemafibrate, a selective peroxisome proliferator-activated receptor alpha modulator that lowers serum triglyceride levels and increases high-density lipoprotein cholesterol levels, is approved for treating dyslipidemia as twice-daily immediate-release (IR) tablets. A once-daily extended-release (XR) tablet has also been developed. We aimed to confirm the non-inferiority of XR (0.2 or 0.4 mg/day; once daily) to IR (0.2 mg/day; twice daily) in lowering triglyceride levels in patients with hypertriglyceridemia. Methods: This phase 3, multicenter, randomized, double-blind study included patients with fasting triglycerides >= 200 mg/dL who received IR (0.2 mg/day) or XR (0.2 or 0.4 mg/day). The primary efficacy endpoint was the percentage change in fasting triglyceride levels from baseline to 4, 8, and 12 weeks. Common treatment effects at weeks 4 through 12 were compared between groups using repeated analysis of covariance. Results: In 356 randomized patients, fasting triglyceride levels decreased by 48.0%, 43.8%, and 48.0% with IR 0.2, XR 0.2, and XR 0.4 mg/day, respectively, confirming the non-inferiority of both XR regimens to IR. The proportion of patients who achieved fasting triglycerides < 150 mg/dL was 45.7%, 37.4%, and 51.7%, while the percentage change of triglycerides in the subgroup with baseline triglycerides >= 500 mg/dL was -59.3%, -52.2%, and -66.3% with IR 0.2, XR 0.2, and XR 0.4 mg/day, respectively. Conclusions: XR (0.2 and 0.4 mg/day) was non-inferior to IR (0.2 mg/day). XR 0.4 mg/day demonstrated a more potent triglyceride-lowering effect than XR 0.2 mg/day and should be considered for patients with high triglyceride levels.
引用
收藏
页码:1517 / 1538
页数:22
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