Evaluation of posaconazole plasma concentrations achieved with the delayed‐release tablets in Korean high‐risk patients with haematologic malignancy

Mycoses ◽  
2019 ◽  
Vol 63 (2) ◽  
pp. 131-138 ◽  
Author(s):  
Hyojin Chae ◽  
Sung‐Yeon Cho ◽  
Yunmi Yi ◽  
Jeong Joong Lee ◽  
Kyoungho Cha ◽  
...  
Keyword(s):  
High Risk ◽  
Plasma Concentrations ◽  
High Risk Patients ◽  
Delayed Release ◽  
Risk Patients

scholarly journals Elastography and Metalloproteinases in Patients at High Risk of Preterm Labor

2021 ◽  
Vol 10 (17) ◽  
pp. 3886
Author(s):  
Izabela Dymanowska-Dyjak ◽  
Aleksandra Stupak ◽  
Adrianna Kondracka ◽  
Tomasz Gęca ◽  
Arkadiusz Krzyżanowski ◽  
...  
Keyword(s):  
High Risk ◽  
Preterm Delivery ◽  
Plasma Concentrations ◽  
Cervical Length ◽  
Control Group ◽  
Study Group ◽  
Median Length ◽  
High Risk Patients ◽  
Ultrasound Evaluation ◽  
Risk Patients

Preterm birth (PTB) is the leading cause of perinatal morbidity and mortality. Its etiopathology is multifactorial; therefore, many of the tests contain the assessment of the biochemical factors and ultrasound evaluation of the cervix in patients at risk of preterm delivery. The study aimed at evaluating the socioeconomic data, ultrasound examinations with elastography, plasma concentrations of MMP-8 and MMP-9 metalloproteinases, and vaginal secretions in the control group as well as patients with threatened preterm delivery (high-risk patients). The study included 88 patients hospitalized in the Department of Obstetrics and Pregnancy Pathology, SPSK 1, in Lublin. Patients were qualified to the study group (50) with a transvaginal ultrasonography of cervical length (CL) ≤ 25 mm. The control group (38) were patients with a physiological course of pregnancy with CL > 25 mm. In the study group, the median length of the cervix was 17.49 mm. Elastographic parameters: strain and ratio were 0.20 and 0.83. In the control group, the median length of the cervix was 34.73 mm, while the strain and ratio were 0.20 and 1.23. In the study group, the concentration of MMP-8 in the serum and secretions of the cervix was on average 74.17 and 155.46 ng/mL, but in the control group, it was significantly lower, on average 58.49 and 94.19 ng/mL. The concentration of MMP-9 in both groups was on the same level. Evaluation of the cervical length and measurement of MMP-8 concentration are the methods of predicting preterm delivery in high-risk patients. The use of static elastography did not meet the criteria of a PTB marker.

scholarly journals Evaluation of Posaconazole Serum Concentrations from Delayed-Release Tablets in Patients at High Risk for Fungal Infections

2017 ◽  
Vol 61 (10) ◽  
Author(s):  
Alan Chin ◽  
Steven A. Pergam ◽  
David N. Fredricks ◽  
Andrew N. Hoofnagle ◽  
Kelsey K. Baker ◽  
...  
Keyword(s):  
High Risk ◽  
Fungal Infections ◽  
Medical Condition ◽  
Solid Organ Transplantation ◽  
Serum Levels ◽  
Therapeutic Drug ◽  
Solid Organ ◽  
High Risk Patients ◽  
Delayed Release ◽  
Risk Patients

ABSTRACT The purpose of our study was to determine the frequency of patients who achieved a therapeutic drug level after receiving posaconazole (PCZ) delayed-release tablets (DRT) for prophylaxis or treatment of invasive fungal infections (IFIs) and to examine the effect of demographic traits and treatment characteristics on PCZ serum levels. A retrospective single-center study was conducted on high-risk inpatients at the University of Washington Medical Center (UWMC) that had received PCZ and obtained PCZ serum levels for either treatment or prophylaxis between 1 August 2014 and 31 August 2015. High-risk patients were defined as those undergoing chemotherapy for a primary hematologic malignancy and those undergoing hematopoietic cell transplantation (HCT) or solid organ transplantation. Serum trough concentrations of ≥700 μg/liter and ≥1,000 μg/liter were considered appropriate for prophylaxis and treatment, respectively. The most frequent underlying medical condition was a hematological malignancy (43/53, 81%). Twenty-six of 53 patients (49%) received PCZ for prophylaxis; the rest received PCZ for treatment. A total of 37/53 (70%) patients had PCZ serum levels of ≥700 μg/liter regardless of indication, including 22/26 (85%) that received PCZ for prophylaxis. Of the patients that received PCZ for treatment, only 12/27 (44%) had PCZ serum levels of ≥1,000 μg/liter. The odds of having therapeutic PCZ serum levels were not statistically different in patients with a weight of ≥90 kg, a diarrhea grade of ≥2, a mucositis grade of ≥2, or poor dietary intake. However, the odds of having therapeutic PCZ serum levels was 5.85 times higher in patients without graft-versus-host disease (GVHD) treatment than in those with GVHD treatment. Four patients on prophylaxis (15%) developed breakthrough IFIs, one of which had a subtherapeutic level. We concluded that the use of PCZ DRT provided adequate concentrations in only 70% of our patients and that recommended dosing may lead to insufficient levels in patients treated for IFIs. Lower concentrations noted among high-risk patients with GVHD suggest a need for prospective studies evaluating therapeutic drug monitoring and/or dose adjustments among these patients.

scholarly journals Serum Concentrations of Posaconazole (PCZ) With Delayed-Release Tablets (DRT) in High-Risk Patients

2016 ◽  
Vol 3 (suppl_1) ◽  
Author(s):  
Alan Chin ◽  
Steven A. Pergam ◽  
David N Fredricks ◽  
Rupali Jain
Keyword(s):  
High Risk ◽  
Serum Concentrations ◽  
High Risk Patients ◽  
Delayed Release ◽  
Risk Patients

scholarly journals 1536. Population Pharmacokinetic Analysis of Baloxavir Morboxil, a Cap-Dependent Endonuclease Inhibitor, in Adult and Adolescent Healthy Subjects and Influenza Patients and Exposure-Response Relationships in the Patients at High-Risk of Influenza Complications

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S559-S560
Author(s):  
Hiroki Koshimichi ◽  
Sylvie Retout ◽  
Valérie F Cosson ◽  
Stefan De Buck ◽  
Yoshiyuki Tsuda ◽  
...  
Keyword(s):  
High Risk ◽  
Plasma Concentrations ◽  
Virus Titer ◽  
Population Pharmacokinetic ◽  
Phase 3 ◽  
High Risk Patients ◽  
Exposure Response ◽  
Dependent Endonuclease ◽  
Population Pk ◽  
Risk Patients

Abstract Background Baloxavir marboxil is a prodrug of baloxavir acid which is a selective inhibitor of cap-dependent endonuclease. The global Phase 3 study conducted in the influenza patients at high-risk of influenza complications (CAPSTONE-2) enrolled adult and adolescent patients from 2016 to 2018. Baloxavir marboxil demonstrated significantly shorter time to improvement of influenza symptoms (TTIIS) than placebo. The aim of this study was to build a population pharmacokinetic (PK) model of baloxavir acid and to evaluate the exposure-response relationships in high-risk patients. Methods The population PK analysis was conducted on the pooled data from 13 clinical studies: 10 phase 1 studies, a phase 2 study, and 2 phase 3 studies. A total of 11846 plasma concentrations from 1827 subjects were used for this analysis. The influence of background characteristics including risk factors of influenza complications was assessed on the PK of baloxavir acid. The individual Cmax and AUC were estimated with an empirical Bayesian approach. Exposure-response analysis was conducted for TTIIS and virus titer in the high-risk patients. Results A 3-compartment model with first-order absorption and lag time was selected as a structural PK model, and well described the plasma concentrations. The population PK analysis suggested that (1) AUC in non-Asians was 30.7% lower than that in Asians, (2) body weight significantly affected the exposures to baloxavir acid, (3) the exposures in high-risk patients were similar to those in otherwise healthy patients, and (4) no PK differences were identified regarding the risk factors for influenza complications. The exposure-response analyses showed that the body weight-based dose regimen (40 mg for the patients weighing <80 kg and 80 mg for the patients weighing ≥80 kg) shortened TTIIS and reduced virus titer for both type A and B influenza, across the entire range of baloxavir acid exposures observed in CAPSTONE-2 although subject number in the lowest exposure group was limited and it was difficult to discuss the magnitude of the responses accurately. Conclusion The results of the population PK analysis and exposure-response analyses provide useful information for understanding the pharmacokinetic and pharmacodynamic characteristics of baloxavir marboxil. Disclosures All authors: No reported disclosures.

Combination of norfloxacin and cisapride in prevention of SBP in high risk patients: A new approach

2001 ◽  
Vol 120 (5) ◽  
pp. A376-A376
Author(s):  
B JEETSANDHU ◽  
R JAIN ◽  
J SINGH ◽  
M JAIN ◽  
J SHARMA ◽  
...  
Keyword(s):  
High Risk ◽  
New Approach ◽  
High Risk Patients ◽  
Risk Patients

1610: High-Risk Patients Undergoing Radical Prostatectomy Today are Less High-Risk than in the Past

2005 ◽  
Vol 173 (4S) ◽  
pp. 436-436
Author(s):  
Christopher J. Kane ◽  
Martha K. Terris ◽  
William J. Aronson ◽  
Joseph C. Presti ◽  
Christopher L. Amling ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
High Risk Patients ◽  
The Past ◽  
Risk Patients

995: Immunohistochemical Analysis of Tumor Polyamines Discriminates High Risk Patients Undergoing Nephrectomy for Renal Cell Carcinoma

2004 ◽  
Vol 171 (4S) ◽  
pp. 263-263
Author(s):  
Nathalie Rioux-Leclercq ◽  
Florence Jouan ◽  
Pascale Bellaud ◽  
Jacques-Philippe Moulinoux ◽  
Karim Bensalah ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
High Risk ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Immunohistochemical Analysis ◽  
High Risk Patients ◽  
Risk Patients
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