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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/28438257/pharmacokinetics-and-relative-bioavailability-of-two-allopurinol-tablets-in-healthy-chinese-volunteers%C3%A2
#1
Zhen-Yan Hou, Hua-Lin Cai, Yang Deng, Zhi-Hua Li, Si-Si Cao, Ying Chen, Yao Li, Miao Yan, Bi-Kui Zhang
OBJECTIVE: To evaluate the pharmacokinetics and relative bioavailability of two allopurinol tablets in healthy Chinese volunteers. METHODS: A single-center, randomized, cross-over, two-period study design was conducted in healthy male subjects who were identified as not carrying the HLA-B*58:01 allele. Under fasting conditions, a single oral dose of 300 mg test or reference tablets was given with a 1-week washout period. The blood samples were collected for up to 12 hours after the administration and the plasma concentrations of allopurinol were determined by high performance liquid chromatography...
April 25, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28427498/plasma-and-saliva-concentrations-of-abacavir-tenofovir-darunavir-and-raltegravir-in-hiv-1-infected-patients%C3%A2
#2
Eiko Yamada, Ritsuo Takagi, Yoshinari Tanabe, Hiroshi Fujiwara, Naoki Hasegawa, Shingo Kato
OBJECTIVE: We studied the relationships between plasma and saliva concentrations of antiretroviral drugs to explore whether saliva can be used for therapeutic drug monitoring (TDM). METHODS: Abacavir (ABC), tenofovir (TFV), darunavir (DRV), and raltegravir (RAL) in plasma and saliva from 30 HIV-1-infected patients were quantified using liquid chromatography-tandem mass spectrometry. RESULTS: Mean saliva-to-plasma concentration ratios were 0...
April 21, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28427497/mirtazapine-induced-steatosis%C3%A2
#3
Elin Thomas, Hasan Haboubi, Namor Williams, Aled Lloyd, Chin Lye Ch'ng
Mirtazapine is a commonly used drug indicated for the treatment of severe depression. It works as a presynaptic α2-adrenoreceptor antagonist that increases central noradrenergic and serotonergic neurotransmission, and it is metabolized by the p450 cytochrome oxidase system. There is evidence within the literature to suggest a link between antidepressants and increased liver enzymes, although case reports demonstrating a link between mirtazapine specifically and steatosis are sparse. Here, we present a case of mirtazapine-induced steatosis in a 48-year-old office worker...
April 21, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406092/safety-of-azathioprine-and-6-mercaptopurine-in-patients-with-inflammatory-bowel-disease-na%C3%A3-ve-to-thiopurine-treatment%C3%A2
#4
Ram Alaish, David Lundgren, Ole B Suhr, Mårten Werner, Pontus Karling
OBJECTIVES: To determine if 6-mercaptopurine (MP) is better tolerated than azathioprine (AZA) as the initial thiopurine treatment in patients suffering from inflammatory bowel disease (IBD). Switching patients with IBD from AZA to MP is advocated in patients intolerant to AZA. However, no study has determined if MP is more suited than AZA as a first-line treatment for patients who are naïve to thiopurine treatment. STUDY: The tolerance of AZA and MP treatments in clinical practice was retrospectively evaluated from start to 12 months after initiating treatment in 113 patients with IBD who were all naïve to thiopurines (82 patients treated with AZA and 31 patients with MP)...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406091/daptomycin-associated-eosinophilic-pneumonia-with-rechallenge-a-case-report%C3%A2
#5
Melanie Nickerson, Ashish Bhargava, Pramodini B Kale-Pradhan
PURPOSE: A case of daptomycin-associated acute eosinophilic pneumonia (AEP) with positive rechallenge is reported. SUMMARY: AEP associated with daptomycin is reported in the literature, and the product labeling contains a warning and precaution statement. Criteria for diagnosing daptomycin-induced AEP varies and generally includes bronchoalveolar lavage (BAL) eosinophils ≥ 25%. We report a case of a 70-year-old woman with cough, shortness of breath, and altered mental status who presented ~ 9 days after starting therapy with daptomycin to treat methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406090/pharmacokinetic-comparison-using-two-tablets-of-an-evogliptin-metformin-xr-2-5-500%C3%A2-mg-fixed-dose-combination-vs-1-tablet-each-of-evogliptin-5-mg-and-metformin-xr-1-000-mg%C3%A2
#6
Sumin Yoon, Su-Jin Rhee, Sang-In Park, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, SeungHwan Lee, Kyung-Sang Yu
OBJECTIVES: The aim of this study was to compare the pharmacokinetic (PK) characteristics of evogliptin and metformin following the administration of 2 evogliptin/metformin extended-release (XR) 2.5/500 mg FDC tablets with the coadministration of separate evogliptin 5-mg and metformin XR 1,000-mg tablets (separate formulations). METHODS: A randomized, two-period, two-sequence crossover study was conducted. Subjects were randomly assigned to receive 2 FDC tablets or the individual tablets, followed by a 14-day washout period and the administration of the alternate treatment...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406089/patterns-of-benzodiazepine-prescribing-by-neuropsychiatrists-and-general-practitioners-for-elderly-patients-in-germany-in-2014%C3%A2
#7
Thomas Mell, Louis Jacob, Ida Fuhr, Sandra Dick, Michael A Rapp, Karel Kostev
BACKGROUND: The patterns of benzodiazepine prescriptions in older adults are of general and scientific interest as they are not yet well understood. The aim of this study was to compare the prescription patterns of benzodiazepines in elderly people in Germany to determine the share or proportion treated by general practitioners (GP) and neuropsychiatrists (NP). METHODS: This study included 31,268 and 6,603 patients between the ages of 65 and 100 with at least one benzodiazepine prescription in 2014 from GP and NP, respectively...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28406088/population-pharmacokinetics-of-vancomycin-in%C3%A2-chinese-infants%C3%A2
#8
Xiao-Yan Sheng, Chao-Yang Chen, Ling-Yue Ma, Ya-Ou Liu, Ying Zhou, Yi-Min Cui
OBJECTIVE: To determine the pharmacokinetics (PK) of vancomycin in Chinese infant patients using a population pharmacokinetic (PKK) approach in order to provide support for individualized vancomycin therapy. METHOD: The data included 72 sets of steady-state peak and trough serum concentrations from 61 infants (0 - 1 years). PPK analysis was performed using the nonlinear mixed-effects modeling software. Inter- and intraindividual variability was estimated for the clearance and distribution volume of vancomycin...
April 13, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28372635/trends-in-the-prescribing-of-atypical-antipsychotics-in-elderly-patients-with-dementia-in-korea%C3%A2
#9
Namjoo Seo, Inmyung Song, Heyekyung Park, Dongmun Ha, Ju-Young Shin
OBJECTIVE: In 2005, the Food and Drug Administration warned that atypical antipsychotics (AAPs) increased mortality in elderly patients with dementia. We investigated AAP prescribing in elderly patients with dementia in the ambulatory setting in Korea and the factors affecting AAP prescribing in elderly patients with dementia. METHODS: Subjects ≥ 65 years of age with at least one diagnosis of dementia (ICD-10: F00-F03, G30, G31.8) from January 1 to December 31, 2013 were identified from a health insurance database...
April 4, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28372634/-total-evidence-network-meta-analysis-as-a-tool-for-improving-the-assessment-of-biosimilars-application-to-etanercept-in-rheumatoid-arthritis%C3%A2
#10
Andrea Messori, Sabrina Trippoli, Claudio Marinai
Since biosimilars generally have undergone less clinical research than originators, their place in therapy can be strengthened by increasing the amount of clinical evidence supporting their approval. This report describes an approach in which a "total evidence" network meta-analysis is performed that compares the biosimilar not only with the originator but also with the previous standard of care. This analysis was retrospectively applied to etanercept biosimilar in rheumatoid arthritis (end-point = ACR50)...
April 4, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291512/recurrent-trimethoprim-sulfamethoxazole-induced-aseptic-meningitis-with-associated-ampicillin-induced-myoclonic-twitches%C3%A2
#11
Anna Lena Fisse, Katrin Straßburger-Krogias, Ralf Gold, Gisa Ellrichmann
OBJECTIVE: To report a case of recurrent trimethoprim-sulfamethoxazole-induced aseptic meningitis with associated ampicillin-induced myoclonic twitches. MATERIALS AND METHODS: The patient was investigated using cerebral computed tomography, magnetic resonance imaging, cerebrospinal fluid examination, and electroencephalography. Written informed consent was obtained from the patient for access to clinical files for research purposes and publication. RESULTS: We present a middle-aged woman with two recurrent episodes of aseptic meningitis after treatment with trimethoprim-sulfamethoxazole...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291511/%C3%A2-intrathecal-analgesia-by-bupivacaine-is-not-enhanced-by-coadministration-of-morphine-in-patients-with-severe-cancer-related-pain-a-randomized-double-blind-cross-over-study
#12
Ingalill Reif, Anders Wincent, Carl-Olav Stiller
The objective of this randomized double blind cross-over trial was to determine if patients with severe cancer-related pain and inadequate response to systemic opioids prefer intrathecal (IT) pain relief with a combination of bupivacaine and morphine or bupivacaine only. Adult patients with cancer-related pain (n = 23) scheduled for IT analgesia at the Pain Center at the Karo-linska University Hospital Solna, Stockholm, Sweden, were included. The optimal individual flow rate of IT bupivacaine (2 mg/mL) in addition to bolus doses was titrated and maintained for 4 days...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291510/prevalence-and-predictors-of-prescription-of-antibiotics-in-pregnant-women-treated-by-gynecologists-in-germany%C3%A2
#13
Louis Jacob, Matthias Kalder, Karel Kostev
AIM: The aim of this study is to estimate the prevalence and potential predictors of the prescription of antibiotics in pregnant women treated by gynecologists in Germany. METHODS: The current study included 90,312 women aged between 18 and 45 years with a full-term documented pregnancy during the index period (2005 - 2014). The primary outcome was the proportion of pregnant women with antibiotic prescriptions. Potential predictors of antibiotic prescriptions considered in the present analysis were age, index year, and gynecological/urinary disorders...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291509/vascular-permeability-determined-using-multi-slice-spiral-ct-perfusion-can-predict-response-to-chemoradiotherapy-in-patients-with-advanced-cervical-squamous-cell-carcinoma%C3%A2
#14
Jie Liu, Hua Fan, Guang-Ping Qiu
AIM: This study aims to use multi-slice spiral computed tomography (CT) perfusion to investigate the predictive value of vascular permeability in determining the response of patients with advanced cervical squamous-cell carcinoma (CSCC) to chemoradiotherapy treatment. METHODS: 196 patients with advanced CSCC were recruited. Multi-slice spiral CT perfusion was performed before chemoradiotherapy, and perfusion parameters, such as blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability surface (PS), were obtained...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291508/parecoxib-sodium-pretreatment-reduces-myoclonus-after-etomidate-a-prospective-double-blind-randomized-clinical-trial%C3%A2
#15
Xiuze Li, Jun Liu, Mengjun Zhou, Chaojing Zhou
OBJECTIVE: Myoclonus induced by etomidate during induction of general anesthesia is a common phenomenon. This prospective, randomized, saline-controlled clinical study was performed to evaluate the effect of parecoxib sodium pretreatment on the incidence and severity of etomidate-induced myoclonus. METHODS: 60 patients, American Society of Anesthesiologists (ASA) physical status I or II, aged 20 to 60 years, who were scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia, were allocated randomly into one of two groups to receive parecoxib sodium 40 mg intravenous (group P, n = 30) or the same volume of saline (group S, n = 30) 30 minutes before administration of etomidate (0...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28291507/comparison-of-the-efficacies-of-three-empirically-selected-antibiotics-for-treating-acinetobacter-baumannii-pulmonary-infection-experience-from-a-teaching-hospital-in-china%C3%A2
#16
Ping Li, Xiaobo Wang, Weixia Wang, Xiaojing Zhao
OBJECTIVE: Infections due to multidrug- and extensively drug-resistant forms of Acinetobacter baumannii (MDR-AB and XDR-AB, respectively) have become increasingly prevalent. This retrospective study compared the outcomes of patients infected with MDR-AB or XDR-AB and treated with one of three antibiotics. METHODS: Enrolled were patients with MDR-AB or XDR-AB pulmonary infection based on their first sputum culture. Patients were treated empirically with carbapenems (n = 46), tigecycline (n = 25), or cefoperazone/sulbactam (cefina-SB; n = 35)...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28290274/relative-bioavailability-of-an-empagliflozin-25-mg-linagliptin-5-mg-fixed-dose-combination-tablet%C3%A2
#17
Stephan Glund, Michaela Mattheus, Frank Runge, Peter Rose, Christian Friedrich
OBJECTIVE: This relative bioavailability study compared a fixed-dose combination (FDC) tablet of empagliflozin 25 mg/linagliptin 5 mg with the corresponding individual components. In addition, the effect of food on the bioavailability of the FDC was studied, and the standard-dissolving formulation FDC was compared with a slow-dissolving side batch. METHODS: An open-label, randomized, crossover study design was used (ClinicalTrials.gov Identifier NCT01189201). Healthy volunteers (n = 42) each received three single-dose treatments: FDC standard dissolution, individual tablets, and either FDC standard dissolution with food or FDC slow dissolution...
March 14, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28257285/population-pharmacokinetics-of-vancomycin-in-chinese-pediatric-patients%C3%A2
#18
Taotao Liu, Chen Deng, Daohai Cheng, Tianyan Zhou, Hua Lu, Wenxing Wei, Wei Lu
OBJECTIVE: This study was conducted to develop a population pharmacokinetic (PopPK) model for vancomycin and to detect the significant covariates that influence the PopPKs to facilitate individualized therapy for Chinese pediatric patients. METHODS: Patients ≤ 10 years old who received vancomycin for ≥ 72 hours between 2007 and 2010 were analyzed using a nonlinear mixed-effects modeling approach (-NONMEM). A one-compartment model with first-order elimination was chosen to depict the data...
March 3, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28257283/presentation-of-coefficient-of-variation-for-bioequivalence-sample-size-calculation%C3%A2
#19
Yi Lin Lee, Wen Yao Mak, Irene Looi, Jia Woei Wong, Kah Hay Yuen
The current study aimed to further contribute information on intrasubject coefficient of variation (CV) from 43 bioequivalence studies conducted by our center. Consistent with Yuen et al. (2001), current work also attempted to evaluate the effect of different parameters (AUC0-t, AUC0-∞, and Cmax) used in the estimation of the study power. Furthermore, we have estimated the number of subjects required for each study by looking at the values of intrasubject CV of AUC0-∞ and have also taken into consideration the minimum sample-size requirement set by the US FDA...
March 3, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28157070/overall-survival-in-response-to-sorafenib-with%C3%A2-transarterial-chemoembolization-for-bclc%C3%A2-stage-b-hepatocellular-carcinoma-propensity%C3%A2-score-analysis%C3%A2
#20
Yonghui Huang, Bin Chen, Ni Liu, Nan Li, Haitao Dao, Wei Chen, Jianyong Yang
OBJECTIVE: Barcelona clinic liver cancer (BCLC) stage B hepatocellular carcinoma (HCC) is a heterogeneous disease group. Transarterial chemoembolization (TACE) is indicated for BCLC stage B HCC, while sorafenib is indicated for BCLC stage C HCC. This study aimed to evaluate the efficacy of TACE+sorafenib compared with TACE monotherapy in the treatment of BCLC stage B HCC. MATERIALS: Patients with BCLC stage B unresectable HCC. METHODS: This was a retrospective study in patients with BCLC stage B HCC who received TACE (n = 144) or TACE+sorafenib (n = 46) between January 2008 and January 2014...
February 3, 2017: International Journal of Clinical Pharmacology and Therapeutics
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