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Cardiovascular Intervention and Therapeutics

, Volume 31, Issue 2, pp 101–113 | Cite as

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)

  • Junya Ako
  • Yoshihiro Morino
  • Kaoru OkuizumiEmail author
  • Makiko Usami
  • Masato Nakamura
Original Article

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.

Keywords

Clopidogrel Postmarketing surveillance SA/OMI STEMI 

Notes

Acknowledgments

The authors are grateful to all the physicians who participated in this study for their cooperation and provision of valuable data.

Author contributions

The study was conducted by Sanofi K.K. Statistical analysis was conducted by CMIC Co., Ltd. Editorial support was provided by Clinical study support, Inc., under a contract with Sanofi K.K. All the authors reviewed and revised the analysis and interpretation of the data and manuscript.

Compliance with ethical standards

Conflict of interest

JA, YM, and MN received consultant fees and remuneration (lectures) from Sanofi K.K. MN received manuscript fees from Sanofi K.K. YM received research funding from Sanofi K.K. KO and MU are employees of Sanofi K.K.

Ethical approval

All procedures performed in this post-marketing surveillance were in accordance with GPSP, as authorized by the Japanese Health Authority.

Informed consent

Informed consent was not mandatory, as this study was in accordance with GPSP. However, data were collected anonymously to protect personal information. There was no access to personal medical records by the sponsor.

Supplementary material

12928_2015_355_MOESM1_ESM.doc (1019 kb)
Supplementary material 1 (DOC 1019 kb)

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Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2015

Authors and Affiliations

  • Junya Ako
    • 1
  • Yoshihiro Morino
    • 2
  • Kaoru Okuizumi
    • 3
    Email author
  • Makiko Usami
    • 3
  • Masato Nakamura
    • 4
  1. 1.Department of Cardiovascular MedicineKitasato UniversityKanagawaJapan
  2. 2.Division of Cardiology, Department of Internal MedicineIwate Medical UniversityMoriokaJapan
  3. 3.Medical Affiars, Sanofi K.K.TokyoJapan
  4. 4.Division of Cardiovascular MedicineToho University Ohashi Medical CenterTokyoJapan

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