Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Ullmann, AJ; Lipton, JH; Vesole, DH; Chandrasekar, P; Langston, A; Tarantolo, SR; Greinix, H; Morais de Azevedo, W; Reddy, V; Boparai, N; Pedicone, L; Patino, H; Durrant, S.
Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease.
N Engl J Med. 2007; 356(4): 335-347.
Doi: 10.1056/NEJMoa061098
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Greinix Hildegard
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- Abstract:
- Invasive fungal infections are an important cause of morbidity and mortality after allogeneic hematopoietic stem-cell transplantation. In an international, randomized, double-blind trial, we compared oral posaconazole with oral fluconazole for prophylaxis against invasive fungal infections in patients with graft-versus-host disease (GVHD) who were receiving immunosuppressive therapy. The primary end point was the incidence of proven or probable invasive fungal infections from randomization to day 112 of the fixed treatment period of the study. Of a total of 600 patients, 301 were assigned to posaconazole and 299 to fluconazole. At the end of the fixed 112-day treatment period, posaconazole was found to be as effective as fluconazole in preventing all invasive fungal infections (incidence, 5.3% and 9.0%, respectively; odds ratio, 0.56; 95 percent confidence interval [CI], 0.30 to 1.07; P=0.07) and was superior to fluconazole in preventing proven or probable invasive aspergillosis (2.3% vs. 7.0%; odds ratio, 0.31; 95% CI, 0.13 to 0.75; P=0.006). While patients were receiving study medications (exposure period), in the posaconazole group, as compared with the fluconazole group, there were fewer breakthrough invasive fungal infections (2.4% vs. 7.6%, P=0.004), particularly invasive aspergillosis (1.0% vs. 5.9%, P=0.001). Overall mortality was similar in the two groups, but the number of deaths from invasive fungal infections was lower in the posaconazole group (1%, vs. 4% in the fluconazole group; P=0.046). The incidence of treatment-related adverse events was similar in the two groups (36% in the posaconazole group and 38% in the fluconazole group), and the rates of treatment-related serious adverse events were 13% and 10%, respectively. Posaconazole was similar to fluconazole for prophylaxis against fungal infections among patients with GVHD. It was superior in preventing invasive aspergillosis and reducing the rate of deaths related to fungal infections. (ClinicalTrials.gov number, NCT00034645 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Antifungal Agents - adverse effects Antifungal Agents - therapeutic use
- Aspergillosis - prevention & control
- Double-Blind Method -
- Female -
- Fluconazole - adverse effects Fluconazole - therapeutic use
- Graft vs Host Disease - complications Graft vs Host Disease - drug therapy
- Hematopoietic Stem Cell Transplantation - adverse effects
- Humans -
- Kaplan-Meier Estimate -
- Male -
- Middle Aged -
- Mycoses - mortality Mycoses - prevention & control
- Opportunistic Infections - prevention & control
- Risk Factors -
- Triazoles - adverse effects Triazoles - therapeutic use