title: Japanese postmarketing surveillance of clopidogrel in patients with non-ST-segment elevation acute coronary syndrome, stable angina, old myocardial infarction, and ST-segment elevation myocardial infarction after percutaneous coronary intervention in a real-life setting: the final report (J-PLACE Final).
abstract: The present postmarketing surveillance investigated the safety and efficacy of clopidogrel for prevention of cardiovascular events following percutaneous coronary intervention (PCI) in a real-life setting with a large patient population. This study included patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who had unstable angina, and patients with non-ST-segment elevation myocardial infarction, stable angina, and old myocardial infarction (SA/OMI), or ST-segment elevation myocardial infarction (STEMI). For safety assessment in 4049 patients, the incidence of adverse drug reactions (ADR) and bleeding adverse events (AE), and for efficacy assessment in 3900 patients, that of major adverse cardiovascular events (MACE) and MACE and cerebrovascular events (MACCE), was calculated in the primary diagnosis groups (NSTE-ACS, SA/OMI, or STEMI). ADR incidence did not significantly differ by group (10.1, 11.6, and 12.2 % in the NSTE-ACS, SA/OMI, and STEMI groups, respectively). Cumulative ADR incidence was highest in the STEMI for 52 weeks. Both total and cumulative bleeding AE incidences were higher in the SA/OMI group (5.9 and 6.8 %, respectively) than in the other groups (3.5 and 3.8 % in the NSTE-ACS, 3.6 and 4.5 % in the STEMI). The MACCE and MACE incidence rates were higher in the STEMI groups than in the other groups. In conclusion, we did not find additional concerns regarding safety and efficacy of clopidogrel in patients who have undergone PCI, regardless of their diagnoses.
authors.affiliation: Department of Cardiovascular Medicine, Kitasato University, Kanagawa, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.affiliation: Medical Affiars, Sanofi K.K., 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, 163-1488, Japan. Kaoru.Okuizumi@sanofi.com.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Okuizumi
authors.affiliation: Medical Affiars, Sanofi K.K., 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, 163-1488, Japan.
authors.forename: Makiko
authors.initials: M
authors.lastname: Usami
authors.affiliation: Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D060050:Angina, Stable / Q000188:drug therapy* / Q000601:surgery; D044466:Asian People; D000077144:Clopidogrel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine
keywords: Clopidogrel; Postmarketing surveillance; SA/OMI; STEMI