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Pulmonary pharmacokinetics

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https://www.readbyqxmd.com/read/29785570/phase-1b-investigation-of-the-mek-inhibitor-binimetinib-in-patients-with-advanced-or-metastatic-biliary-tract-cancer
#1
R S Finn, D H Ahn, M M Javle, B R Tan, C D Weekes, J C Bendell, A Patnaik, G N Khan, D Laheru, R Chavira, J Christy-Bittel, E Barrett, M B Sawyer, Tanios S Bekaii-Saab
Background The MAPK pathway plays a central role in regulation of several cellular processes, and its dysregulation is a hallmark of biliary tract cancer (BTC). Binimetinib (MEK162), a potent, selective oral MEK1/2 inhibitor, was assessed in patients with advanced BTC. Patients and Methods An expansion cohort study in patients who received ≤1 line of therapy for advanced BTC was conducted after determination of the maximum tolerated dose in this Phase 1 trial. Patients received binimetinib 60 mg twice daily...
May 22, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29777329/population-pharmacokinetics-of-theophylline-in-adult-chinese-patients-with-asthma-and-chronic-obstructive-pulmonary-disease
#2
Yanjiao Ma, Ling Xue, Xin Chen, Yingbo Kang, Yong Wang, Liqing Wang
Background Theophylline has a narrow therapeutic range and large interindividual variability in blood levels, so a thorough understanding of its pharmacokinetic characteristics is essential. Population pharmacokinetic (PPK) approaches could achieve it and many PPK studies of theophylline have been reported in infants. However, none was conducted in Chinese adults and none has explored the effect of CYP1A2 genotypes on the PPK characteristics of theophylline in adults. Objective To evaluate the PPK characteristics of theophylline and to assess the possible influence of covariates, including CYP1A2 genotypes, on theophylline clearance in Chinese adult patients...
May 18, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29763659/safety-and-pharmacokinetics-of-budesonide-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-bgf-mdi-in-healthy-adult-subjects-of-japanese-descent
#3
Paul Dorinsky, Paolo DePetrillo, Shahid Siddiqui, Andrea Maes, Colin Reisner
INTRODUCTION: BGF MDI, a budesonide, glycopyrronium, and formoterol fumarate dihydrate triple fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology, is currently in Phase III global development for chronic obstructive pulmonary disease. METHODS: This was a Phase I, randomized, double-blind, placebo-controlled, ascending-dose, crossover study to assess the safety and pharmacokinetic profiles of two doses of BGF MDI in healthy adult subjects of Japanese descent (NCT02197975)...
May 12, 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29762864/population-pharmacokinetic-analysis-of-fluticasone-furoate-umeclidinium-vilanterol-via-a-single-inhaler-in-patients-with-copd
#4
Rashmi Mehta, Eleni Pefani, Misba Beerahee, Noushin Brealey, Helen Barnacle, Ruby Birk, Chang-Qing Zhu, David A Lipson
A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-vilanterol, 100 μg/62...
May 15, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29731374/-inhaled-chemotherapy-part-2-clinical-practice-and-potential-applications
#5
REVIEW
R Rosière, J Hureaux, V Levet, K Amighi, N Wauthoz
Lung tumours have a high incidence and cause many deaths worldwide. Despite progresses in treatment with targeted therapies and immunotherapies, the global 5-year survival rate remains low. In this context, inhaled chemotherapy could provide a means to intensify current therapeutic modalities. This review is based on clinical studies of inhaled chemotherapy against lung tumours. The advantages of this approach in terms of pharmacokinetic ratio and therapeutic index are presented as well as the limitations including contraindications and pulmonary side effects...
May 3, 2018: Revue des Maladies Respiratoires
https://www.readbyqxmd.com/read/29724397/randomized-study-of-the-effects-of-aerochamber-plus-%C3%A2-flow-vu-%C3%A2-on-the-efficacy-pharmacokinetics-and-safety-of-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-in-patients-with-chronic-obstructive-pulmonary-disease
#6
Faisal Fakih, Selwyn Spangenthal, Barry Sigal, Patrick Darken, Andrea Maes, Shahid Siddiqui, Michael Gillen, Colin Reisner, Ubaldo J Martin
OBJECTIVES: This study compared the efficacy, pharmacokinetics (PK), and safety of GFF MDI (Bevespi Aerosphere® ), a fixed-dose combination of glycopyrronium and formoterol fumarate dihydrate (14.4/10 μg) delivered by a metered dose inhaler (MDI) formulated using innovative co-suspension delivery technology, in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) with and without the Aerochamber Plus® Flow-Vu® valved holding chamber (VHC). METHODS: In this multicenter, open-label, crossover, Phase III study (NCT02454959), patients were randomized to receive GFF MDI 14...
May 2018: Respiratory Medicine
https://www.readbyqxmd.com/read/29720918/safety-of-extended-interval-tobramycin-in-cystic-fibrosis-patients-less-an-6-years-old
#7
Alexandria Arends, Rebecca Pettit
OBJECTIVES: The primary objective of this study was to assess the nephrotoxicity and ototoxicity risks of extended interval tobramycin in cystic fibrosis (CF) patients who are <6 years old. A secondary objective included analyzing pharmacokinetic parameters in this age group. METHODS: A retrospective chart review was conducted of patients with CF who were <6 years old, admitted for an acute pulmonary exacerbation from January 1, 2003, to January 1, 2014, and treated with intravenous tobramycin...
March 2018: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/29686169/risk-factors-for-multidrug-resistant-tuberculosis
#8
Cleopas Martin Rumende
In 2015, 10.4 million people developed tuberculosis (TB) and 580,000 amongst them suffered from multidrug-resistant TB (MDR-TB). From those 580,000 cases of MDR-TB, only 125,000 were detected and reported. A total of 111,000 people began to receive MDR-TB treatment in 2014 while 190,000 MDR-TB patients were estimated to have died, largely due to lack of access to effective treatment. The mechanism of drug resistance can be caused by genetic factors, factors related to previous treatment and other factors such as comorbidity with diabetes mellitus...
January 2018: Acta Medica Indonesiana
https://www.readbyqxmd.com/read/29673395/shorter-treatment-for-minimal-tuberculosis-tb-in-children-shine-a-study-protocol-for-a-randomised-controlled-trial
#9
Chishala Chabala, Anna Turkova, Margaret J Thomason, Eric Wobudeya, Syed Hissar, Vidya Mave, Marieke van der Zalm, Megan Palmer, Monica Kapasa, Perumal K Bhavani, Sarath Balaji, Priyanka A Raichur, Anne-Marie Demers, Graeme Hoddinott, Ellen Owen-Powell, Aarti Kinikar, Philippa Musoke, Veronica Mulenga, Rob Aarnoutse, Helen McIlleron, Anneke Hesseling, Angela M Crook, Mark Cotton, Diana M Gibb
BACKGROUND: Tuberculosis (TB) in children is frequently paucibacillary and non-severe forms of pulmonary TB are common. Evidence for tuberculosis treatment in children is largely extrapolated from adult studies. Trials in adults with smear-negative tuberculosis suggest that treatment can be effectively shortened from 6 to 4 months. New paediatric, fixed-dose combination anti-tuberculosis treatments have recently been introduced in many countries, making the implementation of World Health Organisation (WHO)-revised dosing recommendations feasible...
April 19, 2018: Trials
https://www.readbyqxmd.com/read/29671037/-geriatric-intensive-care-patients-perspectives-and-limits-of-geriatric-intensive-care-medicine
#10
REVIEW
U Müller-Werdan, H-J Heppner, G Michels
Critically ill geriatric patients are vitally endangered due to the aging processes of organs, the frequently existing multimorbidity with subsequent polypharmacy and the typical geriatric syndrome of functional impairments. Aging processes in organs lower the clinical threshold for organ dysfunction and organ failure. Physiological organ aging processes with practical consequences for intensive care medicine are atypical manifestion of sepsis in immunosenescence, altered pharmacokinetics, reduced tolerance to hypovolemia due to proportionally reduced water compartment of the body in old age, the frequently only apparently normal function of the kidneys and the continuous reduction in pulmonary function in old age...
April 18, 2018: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/29661865/modeling-and-simulation-of-pretomanid-pharmacokinetics-in-pulmonary-tuberculosis-patients
#11
Michael A Lyons
Pretomanid is a nitroimidazole antibiotic in late phase clinical testing as a component of several novel antituberculosis (anti-TB) regimens. A population pharmacokinetic model for pretomanid was constructed using a Bayesian analysis of data from two phase 2 studies, PA-824-CL-007 and PA-824-CL-010, conducted with newly diagnosed adult (median age 27 years) pulmonary TB patients in Cape Town, South Africa. Combined, these studies included 63 males and 59 females administered once daily oral pretomanid doses of 50, 100, 150, 200, 600, 1000, or 1200 mg for 14 days...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29618565/pharmacokinetics-of-rifapentine-and-rifampin-in-a-rabbit-model-of-tuberculosis-and-correlation-with-clinical-trial-data
#12
Dalin Rifat, Brendan Prideaux, Radojka M Savic, Michael E Urbanowski, Teresa L Parsons, Brian Luna, Mark A Marzinke, Alvaro A Ordonez, Vincent P DeMarco, Sanjay K Jain, Veronique Dartois, William R Bishai, Kelly E Dooley
In clinical trials of two rifamycin antibiotics (rifampin and rifapentine) for treating tuberculosis (TB), patients with cavitary lung lesions did not appear to derive benefit from rifapentine. Rifapentine was found not to outperform rifampin, despite a lower minimum inhibitory concentration against Mycobacterium tuberculosis in mouse models of TB. To understand these findings, we have developed a rabbit model of TB that reliably develops lung cavities with features similar to those of patients with pulmonary cavitary TB...
April 4, 2018: Science Translational Medicine
https://www.readbyqxmd.com/read/29616842/the-discovery-and-development-of-aclidinium-bromide-for-the-treatment-of-chronic-obstructive-pulmonary-disease
#13
Mario Malerba, Alessandro Radaeli, Giuseppe Santini, Jaymin Morjaria, Nadia Mores, Chiara Mondino, Giuseppe Macis, Paolo Montuschi
Bronchodilators, including long-acting muscarinic receptor antagonists (LAMAs), are a mainstay of the pharmacological treatment of chronic obstructive pulmonary disease (COPD). LAMAs act as bronchodilators principally by antagonizing airway smooth muscle cells M3 muscarinic receptors. Aclidinium bromide is a twice-daily LAMA which was developed to improve on the efficacy and/or safety of previous LAMAs. Area covered: Herein, the authors present the pharmacotherapeutic role of aclidinium in COPD and point out unmet need in this research area...
April 4, 2018: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/29610202/-in-vitro-and-in-vivo-activities-of-ds-2969b-a-novel-gyrb-inhibitor-and-its-water-soluble-prodrug-ds11960558-against-methicillin-resistant-staphylococcus-aureus
#14
Tarani Kanta Barman, Manoj Kumar, Tarun Mathur, Eiko Namba, Diksha Singh, Tridib Chaira, Yuichi Kurosaka, Makiko Yamada, Dilip Jatashankar Upadhyay, Nobuhisa Masuda
DS-2969b is a novel GyrB inhibitor under clinical development. In this study, the in vitro activity of DS-2969b and in vivo activities of DS-2969b and its water-soluble prodrug, DS11960558, against methicillin-resistant Staphylococcus aureus (MRSA) were evaluated. DS-2969b inhibited the supercoiling activity of S. aureus DNA gyrase and the decatenation activity of its topoisomerase IV. DS-2969b showed antibacterial activity against Gram-positive aerobes but not against Gram-negative aerobes, except Moraxella catarrhalis and Haemophilus influenzae DS-2969b was active against MRSA with an MIC90 of 0...
April 2, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29610159/use-of-insulin-glargine-in-the-management-of-neonatal-hyperglycemia-in-an-elbw-infant
#15
Min J Hwang, Robert Newman, Katherine Philla, Elizabeth Flanigan
Neonatal hyperglycemia is common in extremely low birth weight (ELBW) infants because of physiologic stress, exogenous glucose infusion, and postnatal corticosteroid therapy for hypotension, adrenal insufficiency, and pulmonary immaturity. The use of long-acting insulin glargine has been described in the treatment of transient neonatal diabetes in the premature infant, but in these reports is a lack of regard to its use in the treatment of iatrogenic neonatal hyperglycemia. We present the case of an ELBW infant with significant hyperglycemia that was refractory to usual treatment but demonstrated a favorable response to long-acting subcutaneous insulin glargine...
April 2018: Pediatrics
https://www.readbyqxmd.com/read/29609511/extended-release-oral-treprostinil-in-the-management-of-pulmonary-arterial-hypertension-clinical-evidence-and-experience
#16
James C Coons, Taylor Miller
Treprostinil diolamine is the first oral prostacyclin approved for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity. Clinical studies have demonstrated modest benefit as monotherapy, whereas no difference in exercise capacity was observed with combination therapy. However, these trials were limited by subtherapeutic dosing owing to intolerable adverse effects. Prostacyclin-related adverse effects, such as nausea, diarrhea, headache, flushing, and jaw pain, are prevalent. More recent pharmacokinetic and clinical studies illustrate the dose-response relationship and the importance of achieving clinically effective doses...
January 2018: Therapeutic Advances in Respiratory Disease
https://www.readbyqxmd.com/read/29601564/-nintedanib-in-the-treatment-of-fibrosing-interstital-lung-diseases
#17
REVIEW
Katarzyna Lewandowska
Nintedanib is an intracellular tyrosine kinase inhibitor approved in a treatment of idiopathic pulmonary fibrosis. It reduces the annual rate of forced vital capacity decline by approximately 50%, that results in slowing of disease progression. The drug also reduces the incidence of acute exacerbations of idiopathic pulmonary fibrosis. The efficacy of nintedanib was the same in different groups of patients, irrespectively to disease status, age, gender and race. The most frequent side effects were gastrointestinal, i...
March 27, 2018: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/29572341/in-vitro-assessment-of-pharmacokinetic-drug-drug-interactions-of-direct-oral-anticoagulants-type-5-phosphodiesterase-inhibitors-are-inhibitors-of-rivaroxaban-and-apixaban-efflux-by-p-glycoprotein
#18
Victor Margelidon-Cozzolino, Sophie Hodin, Elodie Jacqueroux, Olivier Delezay, Laurent Bertoletti, Xavier Delavenne
Direct oral anticoagulants (DOACs) could represent an interesting alternative to conventional anticoagulant treatment with vitamin K antagonists in pulmonary arterial hypertension (PAH) patients because of lower bleeding risk and their simplicity of use. P-glycoprotein (P-gp) plays a key role in DOACs pharmacokinetics. Type 5-phosphodiesterase inhibitors (PDE5i), a drug class commonly used in the treatment of PAH, have been shown to strongly inhibit P-gp. This work aimed to assess potential P-gp mediated-drug-drug interactions between PDE5i and DOACs using in vitro methods...
March 23, 2018: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/29572094/hepatic-targeted-rna-interference-provides-persistent-knockdown-of-alpha-1-antitrypsin-levels-in-zz-patients
#19
Alice M Turner, Jan Stolk, Robert Bals, Jason Lickliter, James Hamilton, Dawn R Christianson, Bruce D Given, Jonathan G Burdon, Rohit Loomba, James K Stoller, Jeffery H Teckman
BACKGROUND & AIMS: Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder causing pulmonary and liver disease. The PiZ mutation results in mis-folded alpha-1 antitrypsin protein (Z-AAT) leading to hepatocyte accumulation, fibrosis and cirrhosis. RNAi-based therapeutics silencing production of hepatic Z-AAT might benefit patients with AATD-associated liver disease. This study evaluated an RNAi therapeutic to silence production of alpha-1 antitrypsin. METHODS: Part A of this double-blind first-in-human study randomized 54 healthy volunteers (HVs) into single dose cohorts (2 placebo: 4 active), receiving escalating doses of the investigational agent ARC-AAT from 0...
March 20, 2018: Journal of Hepatology
https://www.readbyqxmd.com/read/29545716/dynamic-contrast-enhanced-mri-versus-18-f-fdg-pet-ct-which-is-better-in-differentiation-between-malignant-and-benign-solitary-pulmonary-nodules
#20
Feng Feng, Fulin Qiang, Aijun Shen, Donghui Shi, Aiyan Fu, Haiming Li, Mingzhu Zhang, Ganlin Xia, Peng Cao
Objective: To prospectively compare the discriminative capacity of dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) with that of 18 F-fluorodeoxyglucose (18 F-FDG) positron emission tomography/computed tomography (PET/CT) in the differentiation of malignant and benign solitary pulmonary nodules (SPNs). Methods: Forty-nine patients with SPNs were included in this prospective study. Thirty-two of the patients had malignant SPNs, while the other 17 had benign SPNs...
February 2018: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
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