著者
Naoki Sato Wataru Takahashi Atsushi Hirayama Masayoshi Ajioka Naoto Takahashi Kaoru Okishige XingLi Wang Akio Maki Hideki Maruyama Ursula Ebinger Masayuki Yamaguchi Yinuo Pang Hiroki Matsumoto Masatoshi Kawana
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-15-0227, (Released:2015-04-24)
参考文献数
27
被引用文献数
4 15

Background:Serelaxin, a recombinant form of human relaxin-2, is in development for treating acute heart failure (AHF) and a Phase II study in Japanese AHF patients was conducted.Methods and Results:A randomized, double-blind, placebo-controlled study of serelaxin at 10 and 30 µg·kg–1·day–1continuous intravenous infusion for up to 48 h, added to standard care for Japanese AHF patients. Primary endpoints were adverse events (AEs) through Day 5, serious AEs (SAEs) through Day 14, and serelaxin pharmacokinetics. Secondary endpoints included changes in systolic blood pressure (SBP) and cardiorenal biomarkers. A total of 46 patients received the study drug and were followed for 60 days. The observed AE profile was comparable between the groups, with no AEs of concern. Dose-dependent increase in the serum concentration of serelaxin was observed across the 2 dose rates of serelaxin. A greater reduction in SBP was observed with serelaxin 30 µg·kg–1·day–1vs. placebo (–7.7 [–16.4, 1.0] mmHg). A greater reduction in NT-proBNP was noted with serelaxin (–50.8% and –54.9% for 10 and 30 µg·kg–1·day–1, respectively at Day 2).Conclusions:Serelaxin was well tolerated in this study with Japanese AHF patients, with no AEs of concern and favorable beneficial trends on efficacy. These findings support further evaluation of serelaxin 30 µg·kg–1·day–1in this patient population.

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【SBP>125mmHgで軽・中等度腎機能低下の日本人急性心不全に対し,ヒトリラキシン2製剤 "Serelaxin" は安全。5日間非重篤・14日間重篤有害事象はプラセボと差なし:46例ランダム化二重盲検 第II相試験】 Circ J http://t.co/JaVACbUg8C

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