2,781 results match your criteria International Journal of Clinical Pharmacology and Therapeutics[Journal]


Lines of therapy with biological drugs in dermatology, gastroenterology, and rheumatology practices in Germany
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Int J Clin Pharmacol Ther 2019 Feb 10. Epub 2019 Feb 10.

Objective: The goal of the present study was to investigate lines of therapy with biological drugs in patients followed in dermatology, gastroenterology, and rheumatology practices in Germany.

Materials And Methods: The study included patients aged 18 years or over who had received a biological therapy in dermatology, gastroenterology, or rheumatology practices in Germany in 2017 (index date). The primary outcome of the study was the prevalence of different lines of therapy (first-, second-, third-, and at least fourth-line therapies) by type of practice, age, and gender. Read More

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http://dx.doi.org/10.5414/CP203371DOI Listing
February 2019

Evaluation of bleeding adverse events associated with oral P2Y12 inhibitors use in the Food and Drug Administration adverse event reporting system
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Int J Clin Pharmacol Ther 2019 Feb 10. Epub 2019 Feb 10.

Introduction: P2Y12 inhibitors show different bleeding-related safety profiles in premarketing trials. However, little is known about their potential safety from spontaneous reporting systems and postmarketing data.

Objective: To describe and evaluate the bleeding-related adverse events associated with use of P2Y12 inhibitors utilizing data from the FDA Adverse Event Reporting System (FAERS) database. Read More

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http://dx.doi.org/10.5414/CP203365DOI Listing
February 2019

Comparison of N-glycans expressed in tumor tissues with those expressed in adjacent non-tumor tissues of colorectal cancer patients
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Authors:
Eunhee Ji

Int J Clin Pharmacol Ther 2019 Feb 10. Epub 2019 Feb 10.

Background: The associations between colorectal cancer (CRC) progression and changes in N-glycan expression suggest the potential for new biomarkers and targeted cancer therapies. This study was performed to analyze N-glycans and to compare their expression profiles in tumor and corresponding adjacent non-tumor (control) tissues in stage I and IV CRC patients to examine N-glycans as potential prognostic markers.

Materials And Methods: Six adult CRC patients, including 3 in stage I and 3 in stage IV who underwent curative surgery were enrolled in this study. Read More

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http://dx.doi.org/10.5414/CP203332DOI Listing
February 2019

Acute tubulointerstitial nephritis caused by rifampicin: An increasing and often overlooked side effect in elderly patients
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Int J Clin Pharmacol Ther 2019 Feb 10. Epub 2019 Feb 10.

Background: There are many side effects of antituberculous drugs, however, renal failure is relatively rare. Therefore, this side effect is thought to be unrecognized by most physicians. We experienced one case of acute renal failure caused by antituberculous therapy (rifampicin). Read More

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http://dx.doi.org/10.5414/CP203287DOI Listing
February 2019
2 Reads

Modified serum creatinine-derived equations with muscle mass-adjusted estimation of renal function and serum cystatin C-derived estimated glomerular filtration rate in elderly individuals
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Int J Clin Pharmacol Ther 2019 Feb 1. Epub 2019 Feb 1.

Aims: Serum creatinine (Cr)-derived estimated renal function indices are overestimated in elderly patients with reduced muscle mass (MM). We sought to identify equations correlated with measured glomerular filtration rate (mGFR) and assess the effect of bioelectrical impedance analysis (BIA)- or arm muscle circumference (AMC)-determined MM on performance.

Materials And Methods: This study involved 20 elderly patients aged 76. Read More

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http://dx.doi.org/10.5414/CP203279DOI Listing
February 2019

Cardiac toxicity of combined vemurafenib and cobimetinib administration
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Int J Clin Pharmacol Ther 2019 Feb 1. Epub 2019 Feb 1.

Vemurafenib and cobimetinib are extremely effective in treating V600E-mutated metastatic melanoma, but their use is associated with toxic cardiac effects. Vemurafenib-induced prolonged QTc interval may be associated with ventricular fibrillation and sudden cardiac death. Cobimetinib-induced myocardial damage may lead to severely reduced heart function and lethal heart failure. Read More

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http://dx.doi.org/10.5414/CP203379DOI Listing
February 2019
1 Read

A meta-analysis of the influence of genetic polymorphisms on valproic acid pharmacokinetics
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Int J Clin Pharmacol Ther 2019 Jan 28. Epub 2019 Jan 28.

Objectives: Genetic polymorphisms in might contribute to interindividual variability in the pharmacokinetics of valproic acid (VPA). However, whether the 541A>G and 552A>C variants decrease VPA concentration remains controversial. Herein, we performed a meta-analysis to evaluate the influence of genetic polymorphisms on VPA pharmacokinetics. Read More

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http://dx.doi.org/10.5414/CP203357DOI Listing
January 2019

Voriconazole trough concentration and hepatotoxicity in patients with low serum albumin
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Int J Clin Pharmacol Ther 2019 Jan 28. Epub 2019 Jan 28.

Objective: We aimed to investigate the relationship between voriconazole (VRCZ) trough concentrations and hepatotoxicity and to evaluate whether the recommended trough concentration is adequate in our clinical setting.

Materials And Methods: A retrospective study was performed to investigate the relationship between serum VRCZ concentrations and the development of hepatotoxicity at the Kindai University Nara Hospital. Patients treated with VRCZ from March 2010 to January 2018 were identified from the medical records. Read More

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http://dx.doi.org/10.5414/CP203345DOI Listing
January 2019

Population pharmacokinetics and dosage optimization of tacrolimus in pediatric patients with nephrotic syndrome
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Int J Clin Pharmacol Ther 2019 Jan 21. Epub 2019 Jan 21.

Objectives: The aims of this study were to investigate the population pharmacokinetic (PPK) characteristics of tacrolimus in Chinese children with nephrotic syndrome and to apply it in clinical practice.

Materials And Methods: A total of 137 concentrations from 61 patients were collected from routine therapeutic drug monitoring data between 2011 and 2018. Population modeling was performed with the nonlinear mixed-effects model (NONMEM) program, using a one-compartment model with first-order absorption and elimination. Read More

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http://dx.doi.org/10.5414/CP203355DOI Listing
January 2019
3 Reads

Adherence to the guidelines for antiulcer drug prescription in patients receiving low-dose aspirin therapy in Japan
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Int J Clin Pharmacol Ther 2019 Jan 21. Epub 2019 Jan 21.

Objective: Prevalence of guideline adherence for antiulcer drug prescription in patients receiving low-dose aspirin (LDA) therapy was examined and the association of risk factors with the adherence was assessed.

Materials And Methods: A retrospective cohort study using a population-based longitudinal healthcare database was conducted. Claims data between January 2005 and April 2016 were analyzed. Read More

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http://dx.doi.org/10.5414/CP203370DOI Listing
January 2019
1 Read

Multiple severe vertebral fractures during the 3-month period following a missed dose of denosumab in a postmenopausal woman with osteoporosis previously treated with alendronate
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Int J Clin Pharmacol Ther 2019 Jan 21. Epub 2019 Jan 21.

Denosumab is a monoclonal antibody that decreases bone resorption and increases bone mass and strength in trabecular and cortical bone leading to a reduction in fracture in women and men. Its effects are reversed after discontinuation. Recently, there has been concern about the discontinuation of denosumab and the increased risk of multiple vertebral fractures that would be associated with rapid bone loss due to high bone turnover and consequent increase in markers of bone remodeling, far above the baseline values. Read More

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http://dx.doi.org/10.5414/CP203361DOI Listing
January 2019
1 Read

A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects
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Int J Clin Pharmacol Ther 2019 Jan 21. Epub 2019 Jan 21.

Objective: To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of the proposed biosimilar IBI305 with those of bevacizumab in healthy male subjects.

Design: A phase I, randomized, double-blinded, two-arm, parallel-group study.

Settings: The study was conducted in The First Hospital of Jilin University, Changchun, China, from March 2017 to November 2017. Read More

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http://dx.doi.org/10.5414/CP203349DOI Listing
January 2019
10 Reads

Comparative efficacy and safety of biosimilar rituximab and originator rituximab in combination with methotrexate in patients with active rheumatoid arthritis: A Bayesian network meta-analysis
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Int J Clin Pharmacol Ther 2018 Dec 21. Epub 2018 Dec 21.

Objective: We aimed to assess the relative efficacy and safety of biosimilar rituximab and originator rituximab plus methotrexate (MTX) compared to those of placebo plus MTX in patients with active rheumatoid arthritis (RA).

Materials And Methods: We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of biosimilar+MTX and rituximab+MTX versus placebo+MTX (MTX group) in patients with active RA despite treatment with MTX and/or tumor necrosis factor (TNF) blockers.

Results: Six RCTs involving 1,747 patients met inclusion criteria. Read More

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http://dx.doi.org/10.5414/CP203360DOI Listing
December 2018
2 Reads

Trastuzumab biosimilar in metastatic breast cancer: Evaluating equivalence with originator using network meta-analysis
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Int J Clin Pharmacol Ther 2018 Dec 21. Epub 2018 Dec 21.

Objective: The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have recently approved four different trastuzumab biosimilars, marketed by different pharmaceutical companies. Biosimilars, unlike their originators, are typically supported by less clinical data about safety and efficacy. The objective of our analysis was to demonstrate that one of the approved trastuzumab biosimilars (MYL-1401O) is as effective as its originator in terms of hazard ratio (HR) of progression-free survival (PFS). Read More

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http://dx.doi.org/10.5414/CP203351DOI Listing
December 2018
12 Reads

Genotype-based enrichment study design for minimizing the sample size in bioequivalence studies using tolterodine and CYP2D6 genotype
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Int J Clin Pharmacol Ther 2019 Feb;57(2):110-116

Objective: The objective of this study was to explore a pharmacogenomic information-based enrichment study design for reducing the sample size in bioequivalence (BE) studies using tolterodine and CYP2D6 genotypes.

Materials And Methods: A BE study of tolterodine was performed in a randomized, open-label, 2×2 cross-over design. A two one-sided test (TOST) was executed for pharmacokinetic (PK) parameters of tolterodine, and their geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were estimated. Read More

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http://dx.doi.org/10.5414/CP203297DOI Listing
February 2019

Pharmacokinetic comparison of gemigliptin 50 mg and metformin 500 mg as a fixed-dose combination and loose combination
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Int J Clin Pharmacol Ther 2019 Feb;57(2):117-124

Background: Metformin and dipeptidyl peptidase-4 (DPP-IV) inhibitors are commonly combined to treat patients with diabetes mellitus (DM). A new fixed-dose combination (FDC) drug containing gemigliptin, a DPP-IV inhibitor, and sustained-release metformin has been developed. This study aimed to compare the PKs and tolerability of FDC versus loose combination of gemigliptin 50 mg and metformin 500 mg. Read More

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http://dx.doi.org/10.5414/CP203289DOI Listing
February 2019

Comparison of the effects of peramivir and oseltamivir on the rise in platelet count in patients with or without proven influenza
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Int J Clin Pharmacol Ther 2018 Dec 11. Epub 2018 Dec 11.

Objective: Neuraminidase (sialidase) inhibitors are considered to delay platelet clearance through the inhibition of platelet desialylation. A novel neuraminidase inhibitor, peramivir, was recently approved for intravenous administration by the US FDA. We aimed to compare the effects of peramivir and oseltamivir on patient platelet count. Read More

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http://dx.doi.org/10.5414/CP203366DOI Listing
December 2018
1 Read

Association between use of antiemetics, antipsychotics, or antidepressants and the risk of Parkinson's disease
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Int J Clin Pharmacol Ther 2019 Feb;57(2):73-81

Objective: Antipsychotics, antidepressants, and antiemetics are well-known causative agents of parkinsonism. However, it is not certain that the use of these medications increases the risk of Parkinson's disease (PD). We aim to define the risk of PD associated with use of antipsychotic, antidepressant, or antiemetic therapy. Read More

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http://dx.doi.org/10.5414/CP203354DOI Listing
February 2019
1 Read

Risk of malignant lymphoma in patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs and methotrexate
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Int J Clin Pharmacol Ther 2019 Feb;57(2):63-72

Objective: This study investigated whether using biological disease-modifying antirheumatic drugs (bDMARDs) further increases the risk of malignant lymphoma in patients with rheumatoid arthritis undergoing methotrexate therapy using spontaneous adverse reaction databases in different countries.

Materials And Methods: Patient data were acquired from the US Food and Drug Administration's Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Online Database (CVARD) from the first quarter of 2004 to the end of 2015. Data subset analysis was performed to investigate whether the use of bDMARDs further increased the risk of malignant lymphoma in patients receiving methotrexate therapy. Read More

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http://dx.doi.org/10.5414/CP203341DOI Listing
February 2019
10 Reads

Sputum induction for assessment of biomarkers in early respiratory drug development
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Int J Clin Pharmacol Ther 2019 Jan;57(1):20-23

Objective: To study the success rate and reproducibility of sputum induction (SI) in healthy subjects (HS) and asthma patients (AP).

Materials And Methods: 130 HSs/APs were recruited for early-phase studies to evaluate sputum biomarkers. SI and sample processing were performed according to standard protocols. Read More

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http://dx.doi.org/10.5414/CP203294DOI Listing
January 2019
1 Read

Bioequivalence of fluticasone propionate and salmeterol (FS) given by the FS Spiromax® and Seretide Accuhaler® systems
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Int J Clin Pharmacol Ther 2019 Jan;57(1):43-54

Objective: To determine pharmacokinetic (PK) profiles of fluticasone propionate (FP) and salmeterol (SAL) in healthy volunteers following administration as two inhalations from the FS Spiromax 500/50 µg and Seretide Accuhaler 50/500 µg inhalers, without (study 1, n = 79) and with charcoal block (study 2, n = 77). Safety was also assessed.

Materials And Methods: In two single-center, open-label, randomized two-period crossover studies, PK parameters were calculated from plasma drug concentrations obtained pre-dose through 36 hours post-dose. Read More

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http://dx.doi.org/10.5414/CP203216DOI Listing
January 2019
1 Read

The association between clopidogrel and 2-oxo-clopidogrel plasma levels and the long-term clinical outcome after acute myocardial infarction
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Int J Clin Pharmacol Ther 2019 Feb;57(2):82-93

Background And Objectives: A significant number of ischemic events occur after acute myocardial infarction (MI), even when adhering to dual antiplatelet therapy including aspirin and clopidogrel. The aim of our study was to investigate the association between the concentration of the prodrug clopidogrel and its intermediary metabolite 2-oxo-clopidogrel plasma as well as demographic and clinical factors, and the long-term clinical outcome in patients with their first acute MI, ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction NSTEMI, treated with percutaneous coronary intervention (PCI).

Materials And Methods: This study included 172 consecutive patients with their first acute MI, 88 STEMI, and 84 NSTEMI, treated with PCI. Read More

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http://dx.doi.org/10.5414/CP203190DOI Listing
February 2019
17 Reads

Pharmacokinetic and bioequivalence study of sugar-coated and film-coated eperisone tablets in healthy subjects: A randomized, open-label, three-way, reference-replicated crossover study
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Int J Clin Pharmacol Ther 2019 Jan;57(1):55-62

Objective: Eperisone hydrochloride is used in the treatment of musculoskeletal disorders as a muscle relaxant via blocking of calcium channels. In this study, we aimed to investigate the within-subject variability (CV) of reference eperisone formulation for highly-variable drugs and to perform bioequivalence study of two oral formulations (sugar- and film-coated tablets) of eperisone hydrochloride 50 mg in healthy subjects by reference-replicated crossover study.

Materials And Methods: 36 healthy Korean male subjects were recruited, and 33 subjects completed the study. Read More

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http://dx.doi.org/10.5414/CP203346DOI Listing
January 2019
11 Reads

Donepezil decreases heart rate in elderly patients with Alzheimer's disease.

Int J Clin Pharmacol Ther 2019 Feb;57(2):94-100

Objective: Donepezil is an acetylcholinesterase inhibitor (AChI) that improves cognitive function in Alzheimer's disease (AD) patients. However, AChIs are usually associated with peripheral adverse reactions. Here, we investigated the cardiac outcomes in elderly AD patients treated with donepezil. Read More

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http://dx.doi.org/10.5414/CP203257DOI Listing
February 2019
3 Reads

Pill-count and the arithmetic of risk.

Authors:
Barry G Woodcock

Int J Clin Pharmacol Ther 2018 Dec;56(12):571

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https://www.dustri.com/index.php?id=8&artId=17754&do
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http://dx.doi.org/10.5414/CP203373DOI Listing
December 2018
5 Reads

Pill-count and the arithmetic of risk: Evidence that polypharmacy is a health status marker rather than a predictive surrogate for the risk of adverse drug events.

Int J Clin Pharmacol Ther 2018 Dec;56(12):572-576

With advancing age there is an increase in the disease burden and thus in the number of drugs prescribed to this patient group. It is often assumed that an increase in pill count is associated per se with an increase in the number of medication errors (e.g. Read More

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https://www.dustri.com/index.php?id=8&artId=17751&do
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http://dx.doi.org/10.5414/CP203372DOI Listing
December 2018
7 Reads

Insulin depot absorption modeling and pharmacokinetic simulation with insulin glargine 300 U/mL
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Int J Clin Pharmacol Ther 2019 Jan;57(1):1-10

Objective: Mathematical models of insulin absorption have been used to predict plasma insulin concentrations after administration, but few are specifically applicable to insulin glargine, which precipitates subcutaneously after injection.

Materials And Methods: The formation and redissolution of subcutaneous depots of insulin glargine 100 U/mL (Gla-100) and insulin glargine 300 U/mL (Gla-300) are modeled. Surface-area-dependent redissolution is introduced to established diffusion and absorption pathways, and pharmacokinetic (PK) profiles are simulated and subsequently validated using experimental data from euglycemic glucose clamp studies. Read More

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http://dx.doi.org/10.5414/CP203269DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6298133PMC
January 2019
7 Reads

Pharmacokinetics and safety of transdermal and oral granisetron in healthy Chinese subjects: An open-label, randomized, crossover study
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Int J Clin Pharmacol Ther 2019 Jan;57(1):24-31

Aims: To examine the pharmacokinetics and safety of granisetron during transdermal delivery and oral administration to healthy Chinese male subjects.

Materials And Methods: A single 34.3 mg/52 cm transdermal delivery patch of granisetron and the 1-mg tablet of granisetron were dosed to subjects in an open-label, randomized, crossover study. Read More

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http://dx.doi.org/10.5414/CP203327DOI Listing
January 2019
9 Reads

Clozapine drug-induced pancreatitis of intermediate latency of onset confirmed by de-challenge and re-challenge
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Int J Clin Pharmacol Ther 2019 Jan;57(1):37-40

Definitive causality for medication-induced illnesses is difficult to determine, as often there are other causes for the condition. Additionally, for disease management there are often alternative treatment paths, and it is therefore clinically unnecessary to re-challenge with the suspected drug causing an adverse reaction; however, that was not the case in this clinical situation. Providers augmented treatment for this patient, but returned to the only therapy that controlled her condition, clozapine, as there appeared to be limited suitable alternatives. Read More

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http://dx.doi.org/10.5414/CP203314DOI Listing
January 2019

Vitamin D is a potential antidepressant in psychiatric outpatients
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Int J Clin Pharmacol Ther 2018 Dec;56(12):585-596

Background: Anxiety and depression are globally-common disorders. In Jordan, the number of people visiting psychiatric clinics has been increasing over the past few years. Low level of vitamin D is associated with musculoskeletal pain (MSP) and is increasingly linked to the pathology of mental disorders. Read More

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http://dx.doi.org/10.5414/CP203309DOI Listing
December 2018
10 Reads

A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects
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Int J Clin Pharmacol Ther 2019 Jan;57(1):11-19

Objective: Phase I, open-label, randomized, single-dose, 3-period crossover study assessing pharmacokinetics (PK) and safety of ZX008, a liquid oral formulation of fenfluramine (FFA) under development for adjunctive treatment of Dravet syndrome and Lennox-Gastaut syndrome, administered with and without a combined antiepileptic drug (AED) regimen of stiripentol (STP), valproate (VPA), and clobazam (CLB) (STP regimen).

Materials And Methods: 26 healthy adults were administered the following treatments: ZX008 0.8 mg/kg; STP 3,500 mg, CLB 20 mg, VPA 25 mg/kg (max. Read More

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http://dx.doi.org/10.5414/CP203276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6298132PMC
January 2019
6 Reads

A polypharmacy risk prediction model for elderly patients based on sociodemographic and clinical factors
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Int J Clin Pharmacol Ther 2018 Dec;56(12):577-584

Objective: Elderly people take increasing amounts of medication. The aim of our study was to determine the effects of different sociodemographic and clinical factors on polypharmacy and to develop a risk prediction model in outpatients aged 65 years and older.

Materials And Methods: Cross-sectional, observational, descriptive study of outpatients aged 65 years and older scheduled for a specialist visit. Read More

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http://dx.doi.org/10.5414/CP203238DOI Listing
December 2018

Effect of purple grape juice on the pharmacokinetics of digoxin: Results of a food-drug interaction study
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Int J Clin Pharmacol Ther 2019 Feb;57(2):101-109

Objective: Digoxin is a glycosidic, cardiotonic plant extract with a narrow therapeutic window. The purpose of the study was to investigate the effects of purple grape juice on the pharmacokinetics of digoxin in rats.

Materials And Methods: A randomized, controlled, single- and multiple-dose study was conducted to evaluate the pharmacokinetic profiles of orally and intravenously administered digoxin. Read More

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http://dx.doi.org/10.5414/CP203273DOI Listing
February 2019
4 Reads

Pharmacokinetics and safety of salbutamol/ambroxol fixed-dose combination granules in healthy Chinese subjects
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Int J Clin Pharmacol Ther 2018 Dec;56(12):597-603

Objectives: The aim of the study was to investigate the pharmacokinetics and tolerability of salbutamol/ambroxol fixed-dose combination granules following single and multiple dosing in healthy Chinese subjects.

Materials And Methods: This was a randomized, open-label, two-period, one-sequence study (n = 12). Each subject received a single oral dose in period 1 and multiple doses in period 2. Read More

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http://dx.doi.org/10.5414/CP203212DOI Listing
December 2018
5 Reads

NSAIDs may prevent EGFR-TKI-related skin rash in non-small cell lung cancer patients
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Int J Clin Pharmacol Ther 2018 Nov;56(11):551-554

Objectives: Skin rash is a common adverse event induced by epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). Here, we aimed to predict factors that reduce EGFR-TKI-related skin rash.

Materials And Methods: We conducted a single-center, retrospective study to predict factors that reduce skin rash in patients undergoing treatment for non-small cell lung cancer (NSCLC) with EGFR-TKIs using Cox proportional hazards model. Read More

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http://dx.doi.org/10.5414/CP203323DOI Listing
November 2018
3 Reads

Tea consumption and risk of breast cancer: A meta-analysis.

Int J Clin Pharmacol Ther 2018 Dec;56(12):617-619

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http://dx.doi.org/10.5414/CP203303DOI Listing
December 2018
2 Reads

Evaluation of reference-scaled average bioequivalence of two oral formulations of abiraterone acetate in healthy Chinese subjects
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Int J Clin Pharmacol Ther 2018 Nov;56(11):562-570

Objective: This study was designed to evaluate the pharmacokinetic (PK) properties and bioequivalence (BE) of two 250-mg tablet formulations of abiraterone acetate: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult Chinese subjects under fasted (n = 40) and fed (n = 40) conditions.

Materials And Methods: The comparison was performed using a single-dose, open, randomized, and four-way replicate study. The concentration of abiraterone in blood samples taken over 48 hours was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS). Read More

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https://www.dustri.com/index.php?id=8&artId=17622&do
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http://dx.doi.org/10.5414/CP203295DOI Listing
November 2018
13 Reads

Changes in blood concentration of mycophenolic acid and FK506 in a heart-transplant patient treated with plasmapheresis
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Int J Clin Pharmacol Ther 2019 Jan;57(1):32-36

Objective: Prior to heart transplant, sensitization to human leukocyte antigen can occur after blood transfusions used during implantation of ventricular assist devices. The result is an increased risk of antibody-mediated rejection (AMR) after heart transplant. While plasmapheresis (PPH) treats serious AMR cases, what subsequent changes occur in the blood concentrations of immunosuppressive agents is still unknown. Read More

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http://dx.doi.org/10.5414/CP203278DOI Listing
January 2019
2 Reads

Predictability of serum vancomycin concentrations using the kinetic estimated glomerular filtration rate formula for critically ill patients
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Int J Clin Pharmacol Ther 2018 Dec;56(12):612-616

Objective: To evaluate the predictability of serum vancomycin concentrations of critically ill patients using the new kinetic estimated glomerular filtration rate (KeGFR) and other three established eGFR formulae.

Materials And Methods: We calculated serum vancomycin concentrations using software provided by the manufacturer of vancomycin.

Results: Data were collected from 122 hospitalized adults. Read More

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http://dx.doi.org/10.5414/CP203266DOI Listing
December 2018

Time-to-onset of cold and flu symptom relief: A randomized, double-blind, placebo-controlled pilot study for a multi-symptom combination product.

Int J Clin Pharmacol Ther 2018 Dec;56(12):604-611

Objective: Evaluate effects of a multisymptom tablet on cold and flu symptoms within 4 hours post-administration.

Materials And Methods: This was a randomized, double-blind, placebo-controlled study in adults with cold and flu symptoms. Eligible participants with at least moderate common cold or flu symptoms and symptom onset ≤ 48 hours before screening were assigned to a single multiple-active-ingredient tablet (containing paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate) or placebo tablet. Read More

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http://dx.doi.org/10.5414/CP203259DOI Listing
December 2018
2 Reads
1.040 Impact Factor

Pharmacodynamic effects of voglibose administered alone, administered with metformin, and administered with metformin in a fixed-dose combination in healthy Korean subjects
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Int J Clin Pharmacol Ther 2018 Nov;56(11):544-550

Objective: This study aimed at exploring the effects of metformin on the pharmacodynamics of voglibose, while investigating the pharmacodynamics between a fixed-dose combination (FDC) of voglibose/metformin and coadministered doses of voglibose and metformin tablets in healthy Korean subjects.

Materials And Methods: A randomized, open-label, 2×3×3 crossover study with a 9-day washout period was conducted in 30 healthy subjects. All subjects received orally administered voglibose alone, individual voglibose and metformin tablets, or FDC 3 times daily for 5 days. Read More

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https://www.dustri.com/article_response_page.html?artId=1759
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http://dx.doi.org/10.5414/CP203146DOI Listing
November 2018
10 Reads

Basic characteristics and representativeness of the German Disease Analyzer database
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Int J Clin Pharmacol Ther 2018 Oct;56(10):459-466

Purpose: The aim of this study was to evaluate the representativeness of diagnoses in the Disease Analyzer (DA) database for major chronic diseases (cancer, dementia, diabetes).

Materials And Methods: DA contains anonymized longitudinal data on drug prescriptions, diagnoses as well as medical and demographic data directly obtained from the computer system of a representative sample of practices throughout Germany. DA contains data from 2,498 practices with 7. Read More

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http://dx.doi.org/10.5414/CP203320
DOI Listing
October 2018
1 Read

Bioequivalence study of the antiepileptic drug levetiracetam in concentrated solution for injection versus oral tablets in healthy Chinese subjects under fasting conditions: A randomized, open-label, three-way crossover study
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Int J Clin Pharmacol Ther 2018 Nov;56(11):555-561

Objective: The objective of this study was to evaluate the bioequivalence between single-dose intravenous (IV) infusion injection (the infusion time was 15 minutes and 45 minutes) and tablets of 1,000 mg levetiracetam in healthy Chinese male subjects.

Materials And Methods: This was a randomized, open-label, three-way crossover bioequivalence study. All of the 24 healthy male subjects received a treatment of 45-minute IV infusion, 15-minute IV infusion, and oral tablets. Read More

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http://dx.doi.org/10.5414/CP203274DOI Listing
November 2018
5 Reads

Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men
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Int J Clin Pharmacol Ther 2018 Nov;56(11):507-517

Objective: Namilumab is an investigational human monoclonal antibody to human granulocyte-macrophage colony-stimulating factor (GM-CSF). A phase I study of repeated namilumab dosing (150 or 300 mg subcutaneously) in non-Japanese patients with rheumatoid arthritis reported no safety concerns. The objective of this study was to report the safety (primary endpoint) and pharmacokinetic/pharmacodynamic effects of namilumab in healthy Japanese and Caucasian men aged 20 - 45 years (NCT02354599). Read More

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http://dx.doi.org/10.5414/CP203235DOI Listing
November 2018
8 Reads

Adverse effects of chronic nicotine exposure on the kidney: Potential human health implications of experimental findings
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Int J Clin Pharmacol Ther 2018 Nov;56(11):501-506

With the increasing popularity of E-cigarettes, chronic exposure to nicotine (NIC) is emerging as a novel risk factor for the kidney. NIC increases oxidative stress in the kidneys, which impairs the viability and function of renal tubular and endothelial cells, alters renal hemodynamics, and compromises overall kidney function. Moreover, long-term NIC exposure increases the risk of development and progression of chronic kidney diseases and may escalate the impact of coexisting morbidities such as obesity-associated renal disease, hypertension, renal transplant status, or the toxicity of various anticancer agents. Read More

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http://dx.doi.org/10.5414/CP203302DOI Listing
November 2018
1.044 Impact Factor

Efficacy and safety of a fixed-dose combination of D-norpseudoephedrine, triiodothyronine, atropine, aloin, and diazepam in obese patients
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Int J Clin Pharmacol Ther 2018 Nov;56(11):531-538

Objective: A fixed-dose combination (FDC) of D-norpseudoephedrine, tri-iodothyronine, atropine, aloin, and diazepam is used in Mexico for the short-term treatment of obesity; however, its efficacy and safety have been scarcely studied. The aim of this study was to analyze the efficacy and safety of this FDC in Mexican adult overweight and obese patients by a prospective, uncontrolled, multicenter, phase IV open-label study.

Materials And Methods: 3,290 patients with a body mass index (BMI) ˃ 27 kg/m were included in the current study. Read More

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http://dx.doi.org/10.5414/CP203292DOI Listing
November 2018
18 Reads