An open clinical study of arbekacin 200mg q.d. in patients infected with methicillin-resistant Staphylococcus aureus (MRSA)-A clinical pharmacology study-

DOI 7 Citations 30 References
  • Aikawa Naoki
    Department of Emergency and Critical Care Medicine, School of Medicine, Keio University
  • Kohno Shigeru
    Division of Molecular and Clinical Microbiology, Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences
  • Kaku Mitsuo
    Department of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
  • Watanabe Akira
    Division for Development of Antiinfective Agents, Institute of Development, Aging, and Cancer, Tohoku University
  • Yamaguchi Keizo
    Department of Microbiology and Infectious Diseases, Toho University School of Medicine
  • Tanigawara Yusuke
    Department of Pharmacy, School of Medicine, Keio University

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  • ＭＲＳＡ感染症患者に対するａｒｂｅｋａｃｉｎ　２００ｍｇ　１日１回投与の治療効果―臨床薬理試験―
  • A clinical pharmacology study
  • 臨床薬理試験

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Abstract

A multi-center collaborative open clinical study was conducted in patients infected with methicillinresistant Staphylococcus aureus (MRSA) to determine the efficacy and safety of arbekacin (ABK) administered at a dosage regimen of 200mg q. d. and the relationship between efficacy/safety and blood ABK concentration (PIVPD).<BR>Effectiveness (clinical efficacy) against MRSA-caused pneumonia was 71.4% and eradication/decrease (bacteriological efficacy) was 46.2%, showing favorable results. We thus confirmed that the 200 mg q.d.regimen of ABK would be effective against MRSA-caused pneumonia. Evaluating pharmacokinetic parameters, mean Cmax and Ctrough values were 16.2μg/mL and 1.1μg/mL, respectively, and the elimination half-life was prolonged in patients with moderate to severe renal dysfunction. As a result of PK/PD analysis, it was estimated that the expected clinical effect could be obtained when the ratio of Cmax/MIC exceeded 7 or 8, but it was difficult to clarify the target value due to the small sample size.In safety evaluation, the incidence of adverse drug reactions related to subjective/objective findings was 15.8% and the incidence of adverse reactions related to abnormal laboratory findings was 36.8%, and no unknown adverse drug reactions were observed. As a serious adverse event, shock was noted in one patient, but the causal relationship to ABK was ruled out. When patients were categorized with Cmax by whether or not reaching 12μg/mL, regarded as a safety benchmark, the incidence of adverse drug reactions was not higher in patients with a Cmax of≥12μg/mL than in those with a Cmax of<12μg/mL. This was also the case when the trough concentration of 2μg/mL, was used as another safety benchmark.<BR>As mentioned above, high Cmax and excellent efficacy of ABK were achieved by the 200mg q. d. regimen, and the trough concentration was controlled at<2μg/mL., in many patients. The incidence of adverse drug reactions did not increase with this regimen.The usefulness of ABK 200mg q. d. was thus confirmed.

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