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 ―
| Autor: | Takanari Kitazono, Tomoko Iizuka, Ken Kozuma, Masato Nakamura, Isao Usui, Seiji Kogure, Kazuhito Shiosakai, Toru Sekine |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Prasugrel Heart Diseases medicine.medical_treatment Myocardial Ischemia Hemorrhage 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Japan Internal medicine Product Surveillance Postmarketing medicine Humans Cumulative incidence cardiovascular diseases 030212 general & internal medicine Myocardial infarction Aged business.industry Percutaneous coronary intervention General Medicine Thrombolysis Middle Aged Interim analysis medicine.disease Treatment Outcome Drug Evaluation Female Cardiology and Cardiovascular Medicine business Prasugrel Hydrochloride TIMI Mace medicine.drug |
| Zdroj: | Circulation Journal. 83:637-646 |
| ISSN: | 1347-4820 1346-9843 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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