Journal Title
Title of Journal: Ann Hematol
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Abbravation: Annals of Hematology
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Publisher
Springer-Verlag
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Authors: Peter Kaskel Silja Tuschy Alexander Wagner Christian Bannert Oliver A Cornely Axel Glasmacher HansPeter Lipp Andrew J Ullmann
Publish Date: 2007/10/11
Volume: 87, Issue: 4, Pages: 311-319
Abstract
As antifungal agents are frequently used in hematology and oncology economic data on the empirical therapy of suspected systemic fungal infection are pivotal Data were analyzed according to 1 the rate of nephrotoxicity related to treatment with caspofungin in comparison to liposomal amphotericin B LAmB from a randomized clinical trial 2 the effect of nephrotoxicity on length of hospital stay from a European observational study and 3 an example of total bottomup cost in a department of hematology in Germany All estimates include 95 confidence intervals CI using twostage Monte Carlo simulation on binominal and Gaussian random variables from separate studies with comparable populations Overall 89 95 CI 59–121 fewer patients of 100 randomized experienced worsening of renal function with caspofungin vs LAmB giving a number needed to treat for one patient to be harmed by LAmB of 12 95 CI 8–17 This was estimated to translate into 53 extra days in hospital 95 CI 16–91 per event or 048 days 95 CI 014–088 worth €298 95 CI 89–554 per patient receiving LAmB rather than caspofungin From the hospital perspective use of caspofungin was estimated to be costneutral compared to LAmB at a per diem total hospital cost of €428 with and €1284 without consideration of supplementary reimbursement Zusatzentgelt of both LAmB and caspofungin The data presented in this scenario show that use of caspofungin in hematology–oncology departments in Germany results in shorter hospital stays and is at least costneutral compared to use of LAmBPresented in part at the Joint Annual Meeting of the German Austrian and Swiss Society for Haematology and Oncology Leipzig Germany November 4–8 2006 V377 and the International Society for Pharmacoeconomics and Outcomes Research 9th Annual European Congress Copenhagen Denmark October 28–31 2006 A303Patients with hematological disorders are at considerable risk for systemic fungal infections 1 2 3 In particular infections caused by organisms of the genera Aspergillus and Candida are an increasingly recognized threat to immunocompromised patients This results in a high burden to the European healthcare system 1 2 3 4Early clinical diagnosis of invasive fungal infection is difficult due to the nonspecific clinical picture and the plethora of risk factors 3 Microbiological challenges include availability of tissue cytology and cultures and/or nonspecific microbiological culture results 1 Radiological confirmation of diagnosis can be delayed due to the limitations of chest radiographs and the specificity of CT scans can be limited 5 6At present liposomal amphotericin B LAmB and caspofungin are approved for empirical therapy of suspected fungal infection In a randomized controlled trial RCT in patients with persistent fever and neutropenia the efficacy of caspofungin was recently found to be noninferior to that of LAmB 7 In addition caspofungin was found to be far better tolerated than LAmB in terms of nephrotoxicity 26 vs 115 p 0001 7 The occurrence of nephrotoxicity in association with liposomal and other formulations of AmB has been shown to prolong the length of hospital stay in Europe by an average of 53 days 8 No concrete economic data are available as yet on the financial impact of this on hospitals that treat these patients 4 However now that reimbursement of services in different countries is increasingly being based on diagnosticrelated groups DRGs the economic impact on the economics of less tolerable agents on hematology–oncology departments could be considerableIn a recently published doubleblind RCT performed in hematology–oncology patients with persistent fever and neutropenia the efficacy of caspofungin was found to be noninferior to that of LAmB 7 In this trial 556 patients received caspofungin and 539 received LAmB mean duration 13 and 125 days respectively In most of the patients the underlying condition was acute myeloid leukemia AML diagnosed in 364 caspofungin patients 655 and 339 LAmB patients 629 The primary efficacy endpoint a favorable overall response was achieved by 339 of patients in the caspofungin group and 337 in the LAmB group 952 CI −56 60 7 Nephrotoxicity defined as doubling of the serum creatinine level or if the serum creatinine level was elevated at enrolment an increase of at least 1 mg per deciliter 88 μmol per liter formed part of the safety analyses There was less nephrotoxicity 26 of patients treated with caspofungin vs 115 of patients treated with LAmB p 0001 7
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