PMID- 25912697
OWN - NLM
STAT- MEDLINE
DCOM- 20160301
LR  - 20221207
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 79
IP  - 6
DP  - 2015
TI  - Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase II Study of 
      Serelaxin in Japanese Patients With Acute Heart Failure.
PG  - 1237-47
LID - 10.1253/circj.CJ-15-0227 [doi]
AB  - 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 microg.kg(-1).day(-1)continuous 
      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 microg.kg(-1).day(-1)vs. 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 microg.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 microg.kg(-1).day(-1)in this patient population.
FAU - Sato, Naoki
AU  - Sato N
AD  - Cardiology and Intensive Care Unit, Nippon Medical School Musashi-Kosugi 
      Hospital.
FAU - Takahashi, Wataru
AU  - Takahashi W
FAU - Hirayama, Atsushi
AU  - Hirayama A
FAU - Ajioka, Masayoshi
AU  - Ajioka M
FAU - Takahashi, Naoto
AU  - Takahashi N
FAU - Okishige, Kaoru
AU  - Okishige K
FAU - Wang, XingLi
AU  - Wang X
FAU - Maki, Akio
AU  - Maki A
FAU - Maruyama, Hideki
AU  - Maruyama H
FAU - Ebinger, Ursula
AU  - Ebinger U
FAU - Yamaguchi, Masayuki
AU  - Yamaguchi M
FAU - Pang, Yinuo
AU  - Pang Y
FAU - Matsumoto, Hiroki
AU  - Matsumoto H
FAU - Kawana, Masatoshi
AU  - Kawana M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150424
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
RN  - 0 (Biomarkers)
RN  - 0 (Cardiovascular Agents)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 0 (serelaxin protein, human)
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
RN  - 9002-69-1 (Relaxin)
SB  - IM
MH  - Acute Disease
MH  - Aged
MH  - Aged, 80 and over
MH  - *Asian People
MH  - Biomarkers
MH  - Blood Pressure/drug effects
MH  - Cardiovascular Agents/therapeutic use
MH  - Comorbidity
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Dyspnea/etiology/prevention & control
MH  - Female
MH  - Heart Failure/complications/*drug therapy
MH  - Humans
MH  - Infusions, Intravenous
MH  - Japan
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Middle Aged
MH  - Natriuretic Peptide, Brain/blood
MH  - Peptide Fragments/blood
MH  - Recombinant Proteins/adverse effects/blood/pharmacokinetics/therapeutic use
MH  - Relaxin/adverse effects/blood/pharmacokinetics/*therapeutic use
MH  - Treatment Outcome
EDAT- 2015/04/29 06:00
MHDA- 2016/03/02 06:00
CRDT- 2015/04/28 06:00
PHST- 2015/04/28 06:00 [entrez]
PHST- 2015/04/29 06:00 [pubmed]
PHST- 2016/03/02 06:00 [medline]
AID - 10.1253/circj.CJ-15-0227 [doi]
PST - ppublish
SO  - Circ J. 2015;79(6):1237-47. doi: 10.1253/circj.CJ-15-0227. Epub 2015 Apr 24.