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 ―

Masato Nakamura, Ken Kozuma, Takanari Kitazono, Tomoko Iizuka, Toru Sekine, Kazuhito Shiosakai, Isao Usui, Seiji Kogure

研究成果: ジャーナルへの寄稿記事

1 引用 (Scopus)

抄録

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.

元の言語英語
ページ(範囲)637-646
ページ数10
ジャーナルCirculation Journal
83
発行部数3
DOI
出版物ステータス出版済み - 2 25 2019

Fingerprint

Observational Studies
Myocardial Ischemia
Hemorrhage
Incidence
Myocardial Infarction
Safety
Percutaneous Coronary Intervention
varespladib methyl
Stents
Prasugrel Hydrochloride
Thrombosis
Therapeutics
Arteries

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

これを引用

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 ―. / Nakamura, Masato; Kozuma, Ken; Kitazono, Takanari; Iizuka, Tomoko; Sekine, Toru; Shiosakai, Kazuhito; Usui, Isao; Kogure, Seiji.

:: Circulation Journal, 巻 83, 番号 3, 25.02.2019, p. 637-646.

研究成果: ジャーナルへの寄稿記事

Nakamura, Masato ; Kozuma, Ken ; Kitazono, Takanari ; Iizuka, Tomoko ; Sekine, Toru ; Shiosakai, Kazuhito ; Usui, Isao ; Kogure, Seiji. / 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 ―. :: Circulation Journal. 2019 ; 巻 83, 番号 3. pp. 637-646.
@article{7cf3a87be29d4a00b2c75080b6d3c125,
title = "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 ―",
abstract = "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.",
author = "Masato Nakamura and Ken Kozuma and Takanari Kitazono and Tomoko Iizuka and Toru Sekine and Kazuhito Shiosakai and Isao Usui and Seiji Kogure",
year = "2019",
month = "2",
day = "25",
doi = "10.1253/circj.CJ-18-0956",
language = "English",
volume = "83",
pages = "637--646",
journal = "Circulation Journal",
issn = "1346-9843",
publisher = "Japanese Circulation Society",
number = "3",

}

TY - JOUR

T1 - Prasugrel for Japanese patients with ischemic heart disease in long-term clinical practice (PRASFIT-Practice II)

T2 - ― A 3-month interim analysis of a postmarketing observational study ―

AU - Nakamura, Masato

AU - Kozuma, Ken

AU - Kitazono, Takanari

AU - Iizuka, Tomoko

AU - Sekine, Toru

AU - Shiosakai, Kazuhito

AU - Usui, Isao

AU - Kogure, Seiji

PY - 2019/2/25

Y1 - 2019/2/25

N2 - 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.

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.

UR - http://www.scopus.com/inward/record.url?scp=85062098174&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85062098174&partnerID=8YFLogxK

U2 - 10.1253/circj.CJ-18-0956

DO - 10.1253/circj.CJ-18-0956

M3 - Article

VL - 83

SP - 637

EP - 646

JO - Circulation Journal

JF - Circulation Journal

SN - 1346-9843

IS - 3

ER -