What is the clinical evidence from this study?

Study design: Observational. Population: Acute coronary syndrome (n=732). Intervention: Prasugrel. Primary outcome: Incidence of major adverse cardiovascular events (MACE) at the end of the observation period.

February 17, 2017Cardiovascular Intervention and Therapeutics33 citationsOpen Access

Prasugrel for Japanese patients with acute coronary syndrome in short-term clinical practice (PRASFIT-Practice I): a postmarketing observational study

MNMasato Nakamura TITomoko Iizuka KSKei Sagawa

Key Result

Short-term prasugrel treatment in Japanese patients with acute coronary syndrome resulted in a 6.4% incidence of bleeding adverse events and a 3.1% incidence of major adverse cardiovascular events.

Study Design

Type

Observational (n=732)

Multicenter

Yes

Structured PICO

Is short-term prasugrel use at 20 mg/3.75 mg/day safe and effective in Japanese patients with ACS requiring PCI?

Population

732 Japanese patients with acute coronary syndrome (ACS) requiring percutaneous coronary intervention (PCI), mean age 67.0 years, 76.5% male.

Intervention

Prasugrel loading dose 20 mg, maintenance dose 3.75 mg/day oral, in combination with aspirin.

Outcome

Incidence rates of adverse drug reactions (ADRs) and bleeding adverse events (AEs), and incidence rates of cardiovascular events (including major adverse cardiovascular events [MACE]).safety

Short-term prasugrel treatment at a reduced dose of 20 mg loading/3.75 mg maintenance was safe and effective in Japanese ACS patients in real-world acute settings.

Limitations

Only patients treated with prasugrel were evaluated (no control group)
Observation and follow-up periods varied for each patient
Short-term study duration was insufficient to collect an adequate number of cardiovascular events to thoroughly evaluate safety
Only patients treated with prasugrel were evaluated
Patients were not subjected to strict exclusion criteria
Short-term study length was insufficient to collect an adequate number of cardiovascular events to thoroughly evaluate safety

Abstract

Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period. Safety outcomes included incidence rates of adverse drug reactions (ADRs) and bleeding adverse events (AEs). Efficacy outcomes were incidence rates of cardiovascular events (including major adverse cardiovascular events MACE). Case report forms were collected from 749 patients, 732 of whom were eligible for the safety and efficacy analysis sets. Approximately 95% of patients had a prasugrel loading/maintenance dose of 20 mg/3.75 mg/day. The incidences of ADRs and bleeding AEs were 8.6 and 6.4%, respectively. Twelve patients experienced major bleeding AEs; approximately 60% (seven patients) of which were gastrointestinal disorders. The incidence of bleeding AEs was significantly higher primarily in patients of female sex, aged ≥75 years, with low body weight (≤50 kg), severe cardiovascular disease, or severe renal impairment. The incidence of MACE was 1.9% during prasugrel treatment, and 3.1% at the end of the study period. This short-term study indicated that prasugrel treatment at loading/maintenance doses of 20 mg/3.75 mg/day was safe and effective in Japanese ACS patients in an acute setting. CLINICAL TRIAL REGISTRATION: This study is registered at http://www.umin.ac.jp/ctr/ under the identifier UMIN000014699.

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