2,792 results match your criteria International Journal of Clinical Pharmacology and Therapeutics[Journal]


Prevalence of switching from two anti-TNF biosimilars back to biologic reference products in Germany
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Int J Clin Pharmacol Ther 2019 Apr 16. Epub 2019 Apr 16.

Aims: Biosimilars are becoming more and more important for the treatment of many diseases. However, it is not understood how they are tolerated. Our aim was to analyze the behavior of switching from two anti-TNF biosimilars back to biologic reference products in German patients. Read More

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http://dx.doi.org/10.5414/CP203474DOI Listing

Comparative efficacy and safety of lesinurad 200 mg and 400 mg combined with a xanthine oxidase inhibitor in hyperuricemic patients with gout: A Bayesian network meta-analysis of randomized controlled trials
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Int J Clin Pharmacol Ther 2019 Apr 16. Epub 2019 Apr 16.

Objectives: We aimed to assess the relative efficacy and safety of once-daily administration of lesinurad in combination with xanthine oxidase inhibitor (XOI) in hyperuricemic patients with gout.

Materials And Methods: A Bayesian random-effects network meta-analysis was performed to combine the direct and indirect evidence from randomized controlled trials (RCTs) for evaluating the efficacy and safety of lesinurad 200 mg + XOI, lesinurad 400 mg + XOI, and XOI monotherapy in hyperuricemic patients with gout.

Results: Three RCTs including a total of 1,537 patients fulfilled the inclusion criteria. Read More

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http://dx.doi.org/10.5414/CP203425DOI Listing
April 2019
1 Read

Association between depression and the risk of developing ventricular arrhythmias: A meta-analysis
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Int J Clin Pharmacol Ther 2019 Apr 16. Epub 2019 Apr 16.

Background: This meta-analysis aims to clarify the effects of depression on the risk of ventricular arrhythmias.

Materials And Methods: A systematic search was performed in PubMed, EMBASE, Web of Science, and the Cochrane Library. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated employing random-effects models. Read More

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http://dx.doi.org/10.5414/CP203311DOI Listing
April 2019
1 Read

Pharmacokinetics and pharmacodynamics of cinacalcet in patients with renal failure receiving hemodialysis and hemodiafiltration therapy
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Int J Clin Pharmacol Ther 2019 Apr 2. Epub 2019 Apr 2.

Objective: Few studies have focused on the effects of dialysis on cinacalcet. In addition, there is no data available on hemodiafiltration (HDF) all over the world. Therefore, we studied the pharmacokinetics (PK) and pharmacodynamics (PD) of cinacalcet in patients undergoing hemodialysis (HD) or HDF to provide more guiding information on its use in these patients, especially in China. Read More

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http://dx.doi.org/10.5414/CP203260DOI Listing
April 2019
1 Read

Kounis syndrome: A retrospective analysis of individual case safety reports from the international WHO database in pharmacovigilance
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Int J Clin Pharmacol Ther 2019 May;57(5):240-248

Objective: Kounis syndrome (KS) is an acute coronary syndrome with coronary spasm, acute myocardial infarction and stent thrombosis that can be associated with a variety of drugs as an adverse drug reaction (ADR). To characterize this rare phenomenon, we analyzed all cases of KS in the WHO database for pharmacovigilance.

Materials And Methods: All cases of KS worldwide until December 31, 2017, were included and analyzed in terms of age, sex, country, year of ADR, seriousness, clinical outcome, suspected drugs, administration, reported reaction, and -MedDRA terms. Read More

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http://dx.doi.org/10.5414/CP203344DOI Listing
May 2019
1 Read
1.044 Impact Factor

Comparison of CYP3A5*3 genotyping assays for personalizing immunosuppressive therapy in heart transplant patients
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Int J Clin Pharmacol Ther 2019 Mar 22. Epub 2019 Mar 22.

Objective: This study aimed to compare a novel point-of-care assay that involves a flap endonuclease reaction performed using GTS-7000® to a conventional assay that involves DNA sequencing performed using 3130xl Genetic Analyzers*.

Materials And Methods: This study enrolled 74 patients who underwent heart transplantation at the National Cerebral and Cardiovascular Center between May 2004 and October 2016. Each patient was genotyped as cytochrome P450 (CYP) 3A5*1/*1, -CYP3A5*1/*3, or CYP3A5*3/*3. Read More

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http://dx.doi.org/10.5414/CP203381DOI Listing
March 2019
2 Reads

Evaluation of folic acid supplementation by concomitant administration of ethinyl estradiol + levonorgestrel in healthy female subjects
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Int J Clin Pharmacol Ther 2019 Mar 22. Epub 2019 Mar 22.

Objectives: Folic acid supplementation prevents 50 - 75% of cases of neural tube defects. This study evaluated the folic acid supplementation after oral administration of the ethinyl estradiol 0.02 mg + levonorgestrel 0. Read More

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http://dx.doi.org/10.5414/CP203293DOI Listing
March 2019
1 Read

Use of azilsartan medoxomil in the primary-care setting in Germany: A real-world evidence study
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Int J Clin Pharmacol Ther 2019 Mar 8. Epub 2019 Mar 8.

Objective: To evaluate azilsartan medoxomil (AZM) (Edarbi) utilization patterns in the primary-care setting in Germany.

Materials And Methods: This is a retrospective cohort study among patients receiving AZM in the primary-care setting in Germany. Prescription patterns - including patient demographics, off-label use, use in specific populations, concomitant use of other antihypertensive drugs, and drugs potentially causing interactions with AZM - were analyzed in two periods (01/2012 - 12/2013 and 01/2014 - 11/2016) using the primary-care physician panel of German IMS Disease Analyzer, a patient-level electronic medical records database. Read More

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http://dx.doi.org/10.5414/CP203359DOI Listing

11β-hydroxysteroid dehydrogenase type 1 is associated with antiretroviral therapy-induced increase in low-density lipoprotein cholesterol
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Int J Clin Pharmacol Ther 2019 Mar 8. Epub 2019 Mar 8.

Objective: To investigate the association between 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activity and antiretroviral therapy (ART)-induced increase in low-density lipoprotein cholesterol (LDL).

Materials And Methods: We enrolled 62 patients and used liquid chromatography-tandem mass spectrometry to measure 11β-HSD1 activity, which was expressed as a ratio of the sum of urinary tetrahydrocortisol and allo-tetrahydrocortisol concentrations to urinary tetrahydrocortisone concentration. Patient data, including baseline laboratory values, were extracted from medical records for logistic regression analyses of factors associated with LDL increase during ART. Read More

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http://dx.doi.org/10.5414/CP203298DOI Listing

Pharmacokinetics and bioequivalence of two fenofibrate choline formulations in healthy subjects under fed and fasted condition
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Int J Clin Pharmacol Ther 2019 Apr;57(4):217-228

Objective: The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two formulations (the original capsule ("reference") and the new tablet ("test") formulations) of 135-mg choline fenofibrate under fed and fasted conditions.

Materials And Methods: This was an open-label, randomized, single-dose, crossover bioequivalence study in healthy Korean males. A total of 40 individuals were separately enrolled in the high-fat fed and the fasting study, respectively, and were randomized in a 1:1 ratio into two sequences. Read More

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http://dx.doi.org/10.5414/CP203353DOI Listing
April 2019
16 Reads

A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects
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Int J Clin Pharmacol Ther 2019 Apr;57(4):207-216

Objective: Ertugliflozin is approved in the US and European Union as a stand-alone product for adults with type 2 diabetes mellitus as once daily (QD) dosing. The approved fixed-dose combination (FDC) of ertugliflozin and immediate-release metformin is dosed twice daily (BID). This study assessed steady-state pharmacokinetics (PK; area under the concentration-time curve over 24 hours (AUC)) and pharmacodynamics (PD; urinary glucose excretion over 24 hours (UGE)) for ertugliflozin 5 and 15 mg total daily doses administered BID or QD. Read More

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http://dx.doi.org/10.5414/CP203343DOI Listing
April 2019
3 Reads

Lines of therapy with biological drugs in dermatology, gastroenterology, and rheumatology practices in Germany
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Int J Clin Pharmacol Ther 2019 Apr;57(4):182-187

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
April 2019
1 Read

Evaluation of adverse events involving bleeding associated with oral P2Y12 inhibitors use in the Food and Drug Administration adverse event reporting system.

Int J Clin Pharmacol Ther 2019 Apr;57(4):175-181

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
April 2019
15 Reads

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 May;57(5):249-258

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
May 2019
1 Read

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 May;57(5):264-269

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
May 2019
3 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 May;57(5):229-239

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
May 2019
1 Read

Cardiac toxicity of combined vemurafenib and cobimetinib administration
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Int J Clin Pharmacol Ther 2019 May;57(5):259-263

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
May 2019
2 Reads

A meta-analysis of the influence of UGT1A6 genetic polymorphisms on valproic acid pharmacokinetics
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Int J Clin Pharmacol Ther 2019 Mar;57(3):144-151

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
March 2019
1 Read

Voriconazole trough concentration and hepatotoxicity in patients with low serum albumin
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Int J Clin Pharmacol Ther 2019 Mar;57(3):135-143

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
March 2019
1 Read

Population pharmacokinetics and dosage optimization of tacrolimus in pediatric patients with nephrotic syndrome
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Int J Clin Pharmacol Ther 2019 Mar;57(3):125-134

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
March 2019
6 Reads

Adherence to guidelines for antiulcer drug prescription in patients receiving low-dose aspirin therapy in Japan.

Int J Clin Pharmacol Ther 2019 Apr;57(4):197-206

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
April 2019
4 Reads

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 Mar;57(3):163-166

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
March 2019
5 Reads

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 Mar;57(3):167-174

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
March 2019
24 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 2019 Apr;57(4):188-196

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
April 2019
3 Reads

Trastuzumab biosimilar in metastatic breast cancer: Evaluating equivalence with originator using network meta-analysis
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Int J Clin Pharmacol Ther 2019 Mar;57(3):160-162

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
March 2019
21 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
4 Reads

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
2 Reads

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 2019 Mar;57(3):152-159

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
March 2019
2 Reads

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
2 Reads

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
17 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
3 Reads

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
2 Reads

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
32 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
23 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
6 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
7 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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http://dx.doi.org/10.5414/CP203372DOI Listing
December 2018
9 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
18 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
10 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
2 Reads

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
15 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
14 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
5 Reads

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
5 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
6 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
7 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
3 Reads