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.
| Original language | English |
|---|---|
| Pages (from-to) | 637-646 |
| Number of pages | 10 |
| Journal | Circulation Journal |
| Volume | 83 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Feb 25 2019 |
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All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
Cite this
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.
In: Circulation Journal, Vol. 83, No. 3, 25.02.2019, p. 637-646.Research output: Contribution to journal › Article
}
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
C2 - 30674776
AN - SCOPUS:85062098174
VL - 83
SP - 637
EP - 646
JO - Circulation Journal
JF - Circulation Journal
SN - 1346-9843
IS - 3
ER -