TY - JOUR
T1 - Prasugrel for Japanese patients with ischemic heart disease in long-term clinical practice (PRASFIT-PRACTICE II)
AU - Nakamura, Masato
AU - Kitazono, Takanari
AU - Kozuma, Ken
AU - Sekine, Toru
AU - Nakamura, Shinya
AU - Shiosakai, Kazuhito
AU - Iizuka, Tomoko
N1 - Funding Information:
The authors thank all the investigators, staff, and patients who contributed to this postmarketing observational study. The authors also thank Kokoro Koyama, PhD, of in Science Communications, Springer Healthcare, for providing medical writing assistance, which was funded by Daiichi Sankyo Co., Ltd. (Tokyo, Japan).
Publisher Copyright:
© 2019 Japanese Circulation Society. All rights reserved.
PY - 2019
Y1 - 2019
N2 - Background: Although the effectiveness and safety of prasugrel for the prevention of cardiovascular events in patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) have been demonstrated, long-term real-world data of Japanese unique doses are insufficient. Therefore, we report the results of an analysis of 1-year follow-up data from a postmarketing observational study (PRASFIT-Practice II). Methods and Results: The safety and effectiveness analysis sets included 4,155 IHD patients receiving prasugrel (loading dose/ maintenance dose, 20/3.75mg) as dual antiplatelet therapy (DAPT) with aspirin. At 360 days (after treatment start), 62.2% continued DAPT. Cumulative incidences of major adverse cardiovascular events and stent thrombosis were 1.6% and 0.2%, respectively. Cumulative incidences of Thrombolysis In Myocardial Infarction (TIMI) major bleeding and TIMI major or minor bleeding were 1.0% and 2.0%, respectively. Risk factors for TIMI major or minor bleeding in the first 30 days of treatment were age ≥80 years, anemia, female sex, and liver disease, and from day 31 to the end of month 12, hypertension and peptic ulcer. Conclusions: The 1-year follow-up results showed long-term effectiveness and safety of prasugrel at dosages approved in Japan for the treatment of IHD patients undergoing PCI.
AB - Background: Although the effectiveness and safety of prasugrel for the prevention of cardiovascular events in patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) have been demonstrated, long-term real-world data of Japanese unique doses are insufficient. Therefore, we report the results of an analysis of 1-year follow-up data from a postmarketing observational study (PRASFIT-Practice II). Methods and Results: The safety and effectiveness analysis sets included 4,155 IHD patients receiving prasugrel (loading dose/ maintenance dose, 20/3.75mg) as dual antiplatelet therapy (DAPT) with aspirin. At 360 days (after treatment start), 62.2% continued DAPT. Cumulative incidences of major adverse cardiovascular events and stent thrombosis were 1.6% and 0.2%, respectively. Cumulative incidences of Thrombolysis In Myocardial Infarction (TIMI) major bleeding and TIMI major or minor bleeding were 1.0% and 2.0%, respectively. Risk factors for TIMI major or minor bleeding in the first 30 days of treatment were age ≥80 years, anemia, female sex, and liver disease, and from day 31 to the end of month 12, hypertension and peptic ulcer. Conclusions: The 1-year follow-up results showed long-term effectiveness and safety of prasugrel at dosages approved in Japan for the treatment of IHD patients undergoing PCI.
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U2 - 10.1253/circj.CJ-19-0645
DO - 10.1253/circj.CJ-19-0645
M3 - Article
C2 - 31748446
AN - SCOPUS:85077222381
SN - 1346-9843
VL - 84
SP - 101
EP - 108
JO - Circulation Journal
JF - Circulation Journal
IS - 1
ER -