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Clinical Pharmacology: Advances and Applications

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https://www.readbyqxmd.com/read/29403319/a-review-of-the-pharmacology-and-clinical-efficacy-of-brivaracetam
#1
REVIEW
Pavel Klein, Anyzeila Diaz, Teresa Gasalla, John Whitesides
Brivaracetam (BRV; Briviact) is a new antiepileptic drug (AED) approved for adjunctive treatment of focal (partial-onset) seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A) with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10-1,000 mg) and multiple (200-800 mg/day) oral dosing...
2018: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29276415/crth2-antagonists-in-asthma-current-perspectives
#2
REVIEW
Dave Singh, Arjun Ravi, Thomas Southworth
Chemoattractant receptor-homologous molecule expressed on TH2 cells (CRTH2) binds to prostaglandin D2. CRTH2 is expressed on various cell types including eosinophils, mast cells, and basophils. CRTH2 and prostaglandin D2 are involved in allergic inflammation and eosinophil activation. Orally administered CRTH2 antagonists are in clinical development for the treatment of asthma. The biology and clinical trial data indicate that CRTH2 antagonists should be targeted toward eosinophilic asthma. This article reviews the clinical evidence for CRTH2 involvement in asthma pathophysiology and clinical trials of CRTH2 antagonists in asthma...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29270033/olaratumab-a-platelet-derived-growth-factor-receptor-%C3%AE-blocking-antibody-for-the-treatment-of-soft-tissue-sarcoma
#3
REVIEW
Alexandra Pender, Robin L Jones
The outcome of patients with unresectable or metastatic soft tissue sarcoma (STS) remains poor with few treatment options. A number of randomized trials in the first-line setting have shown no difference in overall survival between combination anthracycline schedules and single-agent doxorubicin. A Phase Ib/randomized Phase II trial of doxorubicin with or without the platelet-derived growth factor receptor-α (PDGFRα)-blocking antibody, olaratumab, demonstrated a significant difference in median overall survival in favor of the olaratumab arm...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29225480/role-of-afatinib-in-the-treatment-of-advanced-lung-squamous-cell-carcinoma
#4
REVIEW
Tiziana Vavalà
Lung cancer treatment has considerably changed over the last few years: the identification of druggable oncogenic alterations and innovative immunotherapic approaches granted lung cancer patients the possibility of more efficient and less toxic therapeutic options than chemotherapy. Nowadays, lung squamous cell carcinomas (SqCCs) patients have the chance to benefit from novel treatment alternatives, including immune checkpoint blockade and anti-angiogenic agents and, given positive trial results, from afatinib, a second generation tyrosine kinase inhibitor (TKI) that irreversibly antagonizes ErbB family tyrosine kinase receptors...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29184451/population-pharmacokinetics-of-pomalidomide-in-patients-with-relapsed-or-refractory-multiple-myeloma-with-various-degrees-of-impaired-renal-function
#5
Yan Li, Xiaomin Wang, Edward O'Mara, Meletios A Dimopoulos, Pieter Sonneveld, Katja C Weisel, Jeffrey Matous, David S Siegel, Jatin J Shah, Elisabeth Kueenburg, Lars Sternas, Chloe Cavanaugh, Mohamed Zaki, Maria Palmisano, Simon Zhou
Pomalidomide is an immunomodulatory drug for treatment of relapsed or refractory multiple myeloma (rrMM) in patients who often have comorbid renal conditions. To assess the impact of renal impairment on pomalidomide exposure, a population pharmacokinetics (PPK) model of pomalidomide in rrMM patients with various degrees of impaired renal function was developed. Intensive and sparse pomalidomide concentration data collected from two clinical studies in rrMM patients with normal renal function, moderately impaired renal function, severely impaired renal function not requiring dialysis, and with severely impaired renal function requiring dialysis were pooled over the dose range of 2 to 4 mg, to assess specifically the influence of the impaired renal function as a categorical variable and a continuous variable on pomalidomide clearance and plasma exposure...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29123429/assessment-of-prescribed-medications-and-pattern-of-distribution-for-potential-drug-drug-interactions-among-chronic-kidney-disease-patients-attending-the-nephrology-clinic-of-lagos-university-teaching-hospital-in-sub-saharan-west-africa
#6
Olumuyiwa John Fasipe, Peter Ehizokhale Akhideno, Obiyo Nwaiwu, Alex Adedotun Adelosoye
Introduction: Life expectancy has increased significantly among chronic kidney disease (CKD) patients due to the extensive use of polypharmacy practice for medication prescriptions. This predisposes them to potential drug-drug interactions (DDIs), which can lead to an increase in morbidity, mortality, length of hospital stay, and health care cost. Methods: This was a 30-month retrospective study that reviewed the medical case records of consenting adult CKD patients from January 2014 to June 2016...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29081676/possible-involvement-of-ros-generation-in-vorinostat-pretreatment-induced-enhancement-of-the-antibacterial-activity-of-ciprofloxacin
#7
Majed M Masadeh, Karem H Alzoubi, Sayer I Al-Azzam, Ahlam M Al-Buhairan
The mechanism underlying ciprofloxacin action involves interference with transcription and replication of bacterial DNA and, thus, the induction of double-strand breaks in DNA. It also involves elevated oxidative stress, which might contribute to bacterial cell death. Vorinostat was shown to induce oxidative DNA damage. The current work investigated a possible interactive effect of vorinostat on ciprofloxacin-induced cytotoxicity against a number of reference bacteria. Standard bacterial strains were Escherichia coli ATCC 35218, Staphylococcus aureus ATCC29213, Pseudomonas aeruginosa ATCC 9027, Staphylococcus epidermidis ATCC 12228, Acinetobacter baumannii ATCC 17978, Proteus mirabilis ATCC 12459, Klebsiella pneumoniae ATCC 13883, methicillin-resistant Staphylococcus aureus (MRSA) (ATCC 43300), and Streptococcus pneumoniae (ATCC 25923)...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29042822/antipsychotic-prescription-to-identify-delirium-results-from-two-cohorts
#8
Kristin M Zimmerman, Allison M Paquin, James L Rudolph
OBJECTIVES: Detection of delirium in hospitalized patients remains challenging. The objective was to determine if the prescription of antipsychotic medications was associated with delirium. PATIENTS AND METHODS: Two patient cohorts were utilized from a tertiary Veterans Affairs hospital: a palliative care retrospective cohort and a prospective medical cohort. Patients prescribed outpatient antipsychotics were excluded. Retrospectively, delirium was identified using a validated medical record-review instrument...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/29042821/practical-recommendations-for-the-use-of-therapeutic-drug-monitoring-of-biopharmaceuticals-in-inflammatory-diseases
#9
REVIEW
Erwin Dreesen, Peter Bossuyt, Denis Mulleman, Ann Gils, Dora Pascual-Salcedo
Biopharmaceuticals directed against tumor necrosis factor-alpha, integrins, interleukins, interferons and their receptors have become key agents for the management of inflammatory diseases in the fields of gastroenterology, rheumatology, dermatology and neurology. However, response to these treatments is far from optimal. Therapeutic failure has been attributed in part to inadequate serum concentrations of the drug and the formation of antidrug antibodies (ADA). Therapeutic drug monitoring (TDM) based on drug concentrations and ADA represents a pharmacologically sound tool for guiding dosage adjustments to optimize exposure...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28790869/etanercept-enbrel-%C3%A2-alternative-storage-at-ambient-temperature
#10
Edel Shannon, Joanne Daffy, Heather Jones, Andrea Paulson, Steven M Vicik
BACKGROUND: Biologic disease-modifying antirheumatic drugs, including tumor necrosis factor inhibitors such as etanercept (Enbrel(®)), have improved outcomes for patients with rheumatic and other inflammatory diseases, with sustained remission being the optimal goal for patients with rheumatoid arthritis. Flexible and convenient treatment options, compatible with modern lifestyle, are important in helping patients maintain treatment and manage their disease. Etanercept drug product (DP) is available in lyophilized powder (Lyo) for solution injection, prefilled syringe, and prefilled pen presentations and is typically stored under refrigerated conditions...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28761381/nmda-receptors-are-important-regulators-of-pancreatic-cancer-and-are-potential-targets-for-treatment
#11
William G North, Fuli Liu, Liz Z Lin, Ruiyang Tian, Bonnie Akerman
Pancreatic cancer, particularly adenocarcinoma of the pancreas, is a common disease with a poor prognosis. In this study, the importance of N-methyl-D-aspartate (NMDA) receptors for the growth and survival of pancreatic cancer was investigated. Immunohistochemistry performed with antibodies against GluN1 and GluN2B revealed that all invasive adenocarcinoma and neuroendocrine pancreatic tumors likely express these two NMDA receptor proteins. These proteins were found to be membrane components of pancreatic cancer cell lines, and both channel-blocker antagonist and GluN2B antagonist significantly reduced cell viability in vitro...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28721106/adverse-reactions-in-leprosy-patients-who-underwent-dapsone-multidrug-therapy-a-retrospective-study
#12
Sanjeev Guragain, Namrata Upadhayay, Bishwa Mohan Bhattarai
OBJECTIVE: To investigate the occurrence and clinical characteristics of dapsone-related adverse drug reactions (ADRs) among leprosy patients who underwent multidrug therapy (MDT) from 2010 to 2013 in the western region of Nepal. METHODS: A retrospective review was carried out in the rehabilitation center. Data were collected from the record files of the hospital. RESULTS: From 2010 to 2013, there were 18 patients reported to have dapsone ADRs, with an occurrence rate of 0...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28721105/prediction-of-efficacy-for-conversion-from-adjunctive-therapy-to-monotherapy-with-eslicarbazepine-acetate-800-mg-once-daily-for-partial-onset-epilepsy
#13
Soujanya Sunkaraneni, Julie A Passarell, Elizabeth A Ludwig, Jill Fiedler-Kelly, Janet K Pitner, Todd A Grinnell, David Blum
PURPOSE: Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD monotherapies were previously conducted in patients with POS who were not well-controlled by 1 or 2 AEDs. This report describes modeling and simulation of plasma eslicarbazepine (primary active metabolite of ESL) concentrations and time to monotherapy study exit to predict efficacy for conversion to ESL monotherapy at a lower dose of 800 mg, as an option for patients requiring or not tolerating higher doses since this regimen is effective in adjunctive therapy for POS...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28572740/an-integrated-epidemiological-and-neural-net-model-of-the-warfarin-effect-in-managed-care-patients
#14
David M Jacobs, Filip Stefanovic, Greg Wilton, Andres Gomez-Caminero, Jerome J Schentag
INTRODUCTION: Risk assessment tools are utilized to estimate the risk for stroke and need of anticoagulation therapy for patients with atrial fibrillation (AF). These risk stratification scores are limited by the information inputted into them and a reliance on time-independent variables. The objective of this study was to develop a time-dependent neural net model to identify AF populations at high risk of poor clinical outcomes and evaluate the discriminatory ability of the model in a managed care population...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28533699/comparative-analysis-of-the-safety-and-tolerability-of-fixed-dose-artesunate-amodiaquine-versus-artemether-lumefantrine-combinations-for-uncomplicated-falciparum-malaria-in-pregnancy-a-randomized-open-label-study
#15
Osede I Iribhogbe, Igue Emmanuel, Marylove Odianosen
A comparative clinical study was conducted to evaluate the safety and tolerability of two commonly used fixed dose artemisinin-based combinations for the treatment of uncomplicated Plasmodium falciparum malaria in the second and third trimester of pregnancy. To achieve this, a total of 155 participants were recruited for the study. Eighty of these were drawn from pregnant women who came for routine antenatal care while 40 nonpregnant participants were recruited from apparently healthy females in the community...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28280397/pharmacokinetics-and-outcome-of-tazobactam-piperacillin-in-japanese-patients-undergoing-low-flow-continuous-renal-replacement-therapy-dosage-considerations
#16
Hanako Kohama, Takeshi Ide, Kazuro Ikawa, Norifumi Morikawa, Shinichi Nishi
BACKGROUND: Tazobactam/piperacillin (TAZ/PIPC), which is often combined with continuous renal replacement therapy (CRRT), induces renal excretion and is thought to have a high component removal rate for blood purification. CRRT procedures vary depending on the country, region, and institution. It is not clear whether the dose of TAZ/PIPC for use in Japan can be determined based on studies conducted in other countries. Therefore, in this study, we examined the suitability of recommended dose in Japan...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28260952/pharmaceutical-characterization-of-novel-tenofovir-liposomal-formulations-for-enhanced-oral-drug-delivery-in-vitro-pharmaceutics-and-caco-2-permeability-investigations
#17
Crystal B Spinks, Ahmed S Zidan, Mansoor A Khan, Muhammad J Habib, Patrick J Faustino
Tenofovir, currently marketed as the prodrug tenofovir disoproxil fumarate, is used clinically to treat patients with HIV/AIDS. The oral bioavailability of tenofovir is relatively low, limiting its clinical effectiveness. Encapsulation of tenofovir within modified long-circulating liposomes would deliver this hydrophilic anti-HIV drug to the reticuloendothelial system for better therapeutic efficacy. The objectives of the current study were to prepare and pharmaceutically characterize model liposomal tenofovir formulations in an attempt to improve their bioavailability...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28260951/the-effect-of-apixaban-on-the-pharmacokinetics-of-digoxin-and-atenolol-in-healthy-subjects
#18
Charles Frost, Yan Song, Zhigang Yu, Jessie Wang, Lois S Lee, Alan Schuster, Allyson Pollack, Frank LaCreta
PURPOSE: Apixaban is often coadministered with treatments for cardiovascular comorbidities, which may lead to unintended drug-drug interactions (DDIs). The effects of apixaban on pharmacokinetics (PK) of multidose Lanoxin(®) (digoxin) and single-dose Tenormin(®) (atenolol) and the effects of single-dose atenolol on apixaban PK in healthy subjects were investigated in two Phase 1 studies. PATIENTS AND METHODS: The digoxin DDI study was an open-label, multidose, two-treatment, single-sequence study in which subjects received digoxin 0...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28138268/effect-of-food-on-the-pharmacokinetics-of-dronabinol-oral-solution-versus-dronabinol-capsules-in-healthy-volunteers
#19
D Alexander Oh, Neha Parikh, Varun Khurana, Christina Cognata Smith, Santosh Vetticaden
Dronabinol is a pharmaceutical tetrahydrocannabinol originally developed as an oral capsule. A dronabinol oral solution was recently approved, and the effects of food on absorption and bioavailability of the oral solution versus capsules were compared in an open-label, single-dose, 3-period crossover study. Healthy volunteers were randomized to either dronabinol oral solution 4.25 mg (fed) or dronabinol capsule 5 mg (fed or fasted). Dosing was separated by a 7-day washout period. Plasma pharmacokinetics were evaluated for dronabinol and its major metabolite, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-Δ9-THC)...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28058034/retrospective-analysis-of-the-effects-of-a-highly-standardized-mixture-of-berberis-aristata-silybum-marianum-and-monacolins-k-and-ka-in-patients-with-dyslipidemia
#20
Francesco Di Pierro, Pietro Putignano, Tarcisio Ferrara, Carmela Raiola, Giuliana Rapacioli, Nicola Villanova
BACKGROUND: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin...
2017: Clinical Pharmacology: Advances and Applications
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