Evaluation of interaction between biotechnology-based drug and chemical drug using medical information databases

• Project/Area Number: 25460239
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: National Institute of Health Sciences
• Principal Investigator: SAI KIMIE 国立医薬品食品衛生研究所, 医薬安全科学部, 室長 (20195960)
• Co-Investigator(Kenkyū-buntansha): KAWAKAMI JUN-ICHI 浜松医科大学, 医学部附属病院, 教授・薬剤部長 (50272539) ; HORI KATSUHITO 浜松医科大学, 医学部附属病院, 副薬剤部長 (20436786)
• Project Period (FY): 2013-04-01 – 2016-03-31
• Project Status: Completed (Fiscal Year 2015)
• Budget Amount: ¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000); Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2014: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2013: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
• Keywords: 医療情報データベース / 薬物間相互作用 / 免疫バイオ医薬品 / スタチン / 免疫関連バイオ医薬品

Outline of Final Research Achievements

To investigate interactions between biotechnology-based drug and chemical drug, we established an assessment method using medical information databases and applied it to evaluate a possible interaction between statin drugs and antibody drugs for IL-6 receptor and TNFα or TNF receptor drugs. Changes in any indices for statin related efficacy or adverse reactions after co-administration with these biotechnology-based drugs were almost equivalent to those after treatment with these drugs alone. This finding indicated that interactions between statins and these biotechnology-based drugs might be ignorable under the clinical setting in Japan.