Doripenem versus meropenem as first-line empiric therapy of febrile neutropenia in patients with acute leukemia: a prospective, randomized study View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-03-01

AUTHORS

Tatsuo Oyake, Yuka Takemasa-Fujisawa, Norifumi Sugawara, Takahiro Mine, Yasuhiko Tsukushi, Ichiro Hanamura, Yukiteru Fujishima, Yusei Aoki, Shugo Kowata, Shigeki Ito, Yoji Ishida

ABSTRACT

Febrile neutropenia is often observed in patients with hematologic malignancies, especially in those with acute leukemia. Meropenem has potent and broad antibacterial activity against gram-positive and gram-negative bacteria, and is recommended as first-line empiric therapy for febrile neutropenia. In contrast, the safety and efficacy of doripenem in patients with febrile neutropenia and hematologic malignancies is limited. In this randomized, prospective, cooperative, open-label trial, we compared doripenem (1.0 g every 8 h) to meropenem (1.0 g every 8 h) as first-line empiric antibacterial treatment of febrile neutropenia. To evaluate efficacy and safety, 133 hospitalized patients with acute leukemia or high-risk myelodysplastic syndrome, who developed febrile neutropenia during or after chemotherapy, were randomized to each drug. Resolution of fever within 3 to 5 days without treatment modification (i.e., the primary endpoint) did not significantly differ between the doripenem and meropenem groups (60.0% vs. 45.6%, respectively; P = 0.136). However, resolution of fever within 7 days of treatment was significantly higher in the doripenem group than in the meropenem group (78.4% vs. 60.2%, respectively; P = 0.037). Similar rates of adverse events (grades 1-2) were observed in both groups. Thus, we conclude that both drugs are safe and well-tolerated for the treatment of febrile neutropenia in patients with acute leukemia or high-risk myelodysplastic syndrome, and that the clinical efficacy of doripenem is noninferior to that of meropenem. UMIN Clinical Trial Registry number: 000006124. More... »

PAGES

1-8

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00277-019-03634-w

DOI

http://dx.doi.org/10.1007/s00277-019-03634-w

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112466610

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30824955


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