Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical Practice (PRASFIT-Practice II)　- 1-Year Follow-up Results of a Postmarketing Observational Study.

Abstract

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, 20/3.75 mg) 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.

• Authors: Masato Nakamura, Takanari Kitazono, Ken Kozuma, Toru Sekine, Shinya Nakamura, Kazuhito Shiosakai, Tomoko Iizuka
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 84 Issue 1 Pg. 101-108 (12 25 2019) ISSN: 1347-4820 [Electronic] Japan
• PMID: 31748446 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Platelet Aggregation Inhibitors
• Prasugrel Hydrochloride
• Aspirin

Topics

• Aged
• Aged, 80 and over
• Anemia (chemically induced, epidemiology)
• Aspirin (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Incidence
• Japan
• Male
• Myocardial Ischemia (drug therapy, epidemiology)
• Peptic Ulcer (chemically induced, epidemiology)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Prasugrel Hydrochloride (administration & dosage, adverse effects)
• Product Surveillance, Postmarketing
• Prospective Studies
• Risk Factors
• Thrombolytic Therapy