Document Detail


Therapeutic drug monitoring of posaconazole in patients with acute myeloid leukemia or myelodysplastic syndrome.
MedLine Citation:
PMID:  23027198     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Posaconazole is a broad-spectrum triazole antifungal available as an oral suspension. Pharmacokinetic data showed a high variability of plasma posaconazole concentrations (PPCs) in patients, suggesting a potential interest in drug monitoring. The aim of our prospective study was to measure the PPCs in prophylactically treated patients to evaluate the impact of different factors on these concentrations. In 40 patients treated prophylactically with posaconazole for acute myeloid leukemia or myelodysplastic syndrome between February 2009 and August 2010, PPCs were measured at day 7 of treatment and then twice weekly. Demographic data, clinical data (including gastrointestinal disorders, comedications, and treatment compliance), caloric and fat intake, and biological data were collected and evaluated. We obtained 275 measurements of PPCs, with a median of 430 ng/ml. PPCs were significantly lower in patients with mucositis (P < 0.001), nausea (P = 0.03), diarrhea (P = 0.03), or vomiting (P = 0.05). PPCs were higher in patients with a higher caloric intake (P = 0.02), while the proportion of fat intake had no influence on PPCs (P = 0.84). The concomitant use of proton pump inhibitors decreased the PPCs (P = 0.02), while the use of tacrolimus increased the PPC (P = 0.03). In the multivariate analysis, the factors influencing the PPCs independently were the concomitant use of tacrolimus (P < 0.001), the presence of mucositis (P = 0.01), and food intake (P = 0.02). Our study confirmed the high variability of posaconazole bioavailability and showed the significant influence of gastrointestinal disorders, food intake, and concomitant medication on the PPCs. However, the optimal PPCs still remain to be defined and correlated with clinical efficacy.
Authors:
M Vaes; M Hites; F Cotton; A M Bourguignon; M Csergö; C Rasson; L Ameye; D Bron; F Jacobs; M Aoun
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-10-01
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  56     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-13     Completed Date:  2013-02-28     Revised Date:  2013-12-04    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  6298-303     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Antifungal Agents / administration & dosage,  therapeutic use*
Biological Availability
Chromatography, High Pressure Liquid
Drug Monitoring
Female
Food-Drug Interactions
Gastrointestinal Diseases / metabolism
Hematopoietic Stem Cell Transplantation
Humans
Immunosuppressive Agents / adverse effects
Leukemia, Myeloid, Acute / metabolism*
Male
Middle Aged
Multivariate Analysis
Myelodysplastic Syndromes / metabolism*
Prospective Studies
Spectrophotometry, Ultraviolet
Tacrolimus / adverse effects
Triazoles / administration & dosage,  therapeutic use*
Young Adult
Chemical
Reg. No./Substance:
0/Antifungal Agents; 0/Immunosuppressive Agents; 0/Triazoles; 6TK1G07BHZ/posaconazole; WM0HAQ4WNM/Tacrolimus
Comments/Corrections

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