PMID- 30674776
OWN - NLM
STAT- MEDLINE
DCOM- 20200330
LR  - 20200330
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 83
IP  - 3
DP  - 2019 Feb 25
TI  - Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical 
      Practice (PRASFIT-Practice II)　- A 3-Month Interim Analysis of a Postmarketing 
      Observational Study.
PG  - 637-646
LID - 10.1253/circj.CJ-18-0956 [doi]
AB  - BACKGROUND: A unique dose of prasugrel has been approved exclusively for Japanese 
      patients, but real-world data for prasugrel at that dose in patients with 
      ischemic heart disease (IHD) are limited. Therefore, large-scale, real-world data 
      are needed. Methods and Results: A 2-year observational study of Japanese 
      patients with IHD undergoing percutaneous coronary intervention and being treated 
      with prasugrel to evaluate safety and effectiveness. This report is an interim 
      analysis of data from case report forms (CRFs) after 3 months. CRFs were 
      collected from 4,270 patients, 4,157 of whom were eligible for the safety and 
      effectiveness analysis sets (mean age, 68.3 years; male, 76.5%). The median 
      treatment period was 112 days, and 92.3% of patients continued treatment with 
      prasugrel. The incidence of non-coronary artery bypass grafting-related bleeding 
      adverse events (AEs) was 3.1%, of which Thrombolysis in Myocardial Infarction 
      (TIMI) major and minor bleeding accounted for 0.5% and 0.6%, respectively. The 
      most common bleeding AEs were gastrointestinal disorders, which accounted for 
      43.2% of the sum of "TIMI major and minor bleeding AEs". The incidence of major 
      adverse cardiovascular events (MACE) was 1.0%, and the cumulative incidence of 
      MACE was 1.4%. The incidence of stent thrombosis was 0.2%. CONCLUSIONS: Interim 
      study results indicated that prasugrel was safe and effective during the early 
      phase of treatment in Japanese patients with IHD in real-world clinical settings.
FAU - Nakamura, Masato
AU  - Nakamura M
AD  - Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.
FAU - Kozuma, Ken
AU  - Kozuma K
AD  - Division of Cardiology, Department of Internal Medicine, Teikyo University.
FAU - Kitazono, Takanari
AU  - Kitazono T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Kyushu University.
FAU - Iizuka, Tomoko
AU  - Iizuka T
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd.
FAU - Sekine, Toru
AU  - Sekine T
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd.
FAU - Shiosakai, Kazuhito
AU  - Shiosakai K
AD  - Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd.
FAU - Usui, Isao
AU  - Usui I
AD  - Safety and Risk Management Department, Daiichi Sankyo Co., Ltd.
FAU - Kogure, Seiji
AU  - Kogure S
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Observational Study
DEP - 20190124
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
RN  - G89JQ59I13 (Prasugrel Hydrochloride)
SB  - IM
MH  - Aged
MH  - Drug Evaluation
MH  - Female
MH  - Heart Diseases/drug therapy
MH  - Hemorrhage/chemically induced
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Myocardial Ischemia/*drug therapy
MH  - Prasugrel Hydrochloride/adverse effects/*therapeutic use
MH  - *Product Surveillance, Postmarketing
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bleeding adverse events
OT  - Ischemic heart disease
OT  - Major adverse cardiovascular events
OT  - Percutaneous coronary intervention
OT  - Prasugrel
EDAT- 2019/01/25 06:00
MHDA- 2020/03/31 06:00
CRDT- 2019/01/25 06:00
PHST- 2019/01/25 06:00 [pubmed]
PHST- 2020/03/31 06:00 [medline]
PHST- 2019/01/25 06:00 [entrez]
AID - 10.1253/circj.CJ-18-0956 [doi]
PST - ppublish
SO  - Circ J. 2019 Feb 25;83(3):637-646. doi: 10.1253/circj.CJ-18-0956. Epub 2019 Jan 
      24.