Efficacy and safety evaluation of new anti-diabetic drug by analyzing the claim database

2020 Fiscal Year Final Research Report

• Project/Area Number: 18K06789
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Nagoya City University
• Principal Investigator: TOHKIN Masahiro 名古屋市立大学, 医薬学総合研究院(薬学), 教授 (00270629)
• Project Period (FY): 2018-04-01 – 2021-03-31
• Keywords: レセプトデータベース / スタチン / 経皮的冠動脈形成術 / 虚血性心疾患

Outline of Final Research Achievements

Percutaneous coronary intervention (PCI) may cause ischemic heart disease (IHD). It is suggested that statin administration during PCI may prevent IHD. However, this has not been validated by a large-scale clinical study. We aimed to evaluate the relationship between statin administration during PCI and cardiovascular events by analyzing the national claims database. We analyzed patients who underwent PCI and had been continuously administered statin. We assigned patients who were administered statins for 7 days before the procedure to the exposure group and those who were not to the non-exposure group. We compared the incidence of IHD and mortality after the procedure. The results indicated lower incident risks of IHD after the procedure in angina patients in the exposure group and lower mortality after the procedure in myocardial infarction patients in the exposure group. These results suggest that perioperative treatment with statin during PCI could improve PCI prognosis.

Free Research Field

レギュラトリーサイエンス

Academic Significance and Societal Importance of the Research Achievements

本研究では，日本の保険診療情報を網羅したNDBを用いて，PCI施行患者における術前スタチン投与の有用性を評価した．スタチン曝露群において，狭心症患者では術後のIHD及び心房細動の発症リスクの低下が認められ，心筋梗塞患者では死亡率の低下が認められたことから，PCI施行前のスタチン投与は患者の予後の向上に有益であると考えられる．