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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28636208/a-phase-i-trial-of-prn1008-a-novel-reversible-covalent-inhibitor-of-bruton-s-tyrosine-kinase-in-healthy-volunteers
#1
Patrick F Smith, Janakan Krishnarajah, Philip A Nunn, Ron J Hill, Dane Karr, D Tam, Mohammad Masjedizadeh, Jens O Funk, Steve G Gourlay
AIM: To evaluate the safety, tolerability, and PK/PD of PRN1008, a novel BTK inhibitor, in healthy volunteers, and thus determine the dose range for future clinical studies. METHODS: This was a two-part randomized, placebo controlled study in healthy volunteers using a liquid formulation. Part I was a single ascending dose design with dose levels of 50 to 1200 mg (n=6 active, 2 placebo per cohort); Part II was a multiple ascending dose design, with dose regimens ranging from 300 mg to 900 mg daily, either qd or bd for 10 days...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28631271/ocular-myasthenic-syndrome-adverse-reaction-to-omalizumab-a-case-report
#2
LETTER
Willemien S Kalteren, Marco W J Schreurs, Annelies Jorritsma-Smit, Daan J Touw, Jan Willem de Jong, Petra G M A Zweers, Fransje E Reesink
No abstract text is available yet for this article.
June 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28626983/comparison-of-systemic-pharmacodynamic-effects-of-two-combination-pressurised-metered-dose-inhalers-that-deliver-salmeterol-and-fluticasone-propionate
#3
Lester I Harrison, Victoria Sessions, Christopher J Wiggenhorn, David Chalmers, Pui Leung, John Efthimiou
AIM: The aim was to test the systemic pharmacodynamic effects of the salmeterol component of two pressurized metered dose inhalers that delivered a combination of salmeterol and fluticasone propionate (SM/FP). METHODS: This was a six-way crossover study in 43 adult subjects, using a single blind design (subject blinded to product and clinical assessor blinded for all measurements). Each subject received single doses of 2, 6, and 12 inhalations from test and reference products that delivered SM/FP as 25/125 mcg per inhalation...
June 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28621446/commentary-on-clark-et-al-the-long-and-winding-road-for-selective-androgen-receptor-modulators-sarms
#4
James T Dalton
No abstract text is available yet for this article.
June 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28603840/pretransplant-4%C3%AE-hydroxycholesterol-does-not-predict-tacrolimus-exposure-or-dose-requirements-during-the-first-days-after-kidney-transplantation
#5
Thomas Vanhove, Mahmoud Hasan, Pieter Annaert, Stefan Oswald, Dirk R J Kuypers
AIMS: The CYP3A metric 4β-hydroxycholesterol (4βOHC) has been shown to correlate with tacrolimus steady-state apparent oral clearance (CL/F). Recently, pretransplant 4βOHC was shown not to predict tacrolimus CL/F after transplantation in a cohort of renal recipients (n=79). The goal of the current study was determine whether these findings could be validated in a substantially larger cohort. METHODS: In a retrospective analysis of 279 renal recipients, tacrolimus trough concentrations (C0), daily dose, haematocrit and other relevant covariates were registered every day for the first 14 days after transplantation...
June 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28599067/external-adjustment-of-unmeasured-confounders-in-a-case-control-study-of-benzodiazepine-use-and-cancer-risk
#6
L C Thygesen, A Pottegård, A K Ersbøll, S Friis, T Stürmer, J Hallas
INTRODUCTION: Previous studies have reported diverging results on the association between benzodiazepine use and cancer risk. METHODS: We investigated this association in a matched case-control study including incident cancer cases during 2002-2009 in the Danish Cancer Registry (n=94,923) and age and sex-matched (1:8) population controls (n=759,334). Long-term benzodiazepine use was defined as ≥500 defined daily doses 1-5 years prior to the index date. We implemented propensity score (PS) calibration using external information on confounders available from a survey of the Danish population...
June 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28593681/initial-anticoagulation-in-patients-with-pulmonary-embolism-thrombolysis-unfractionated-heparin-lmwh-fondaparinux-or-doacs
#7
REVIEW
Jenneke Leentjens, Mike Peters, Anne C Esselink, Yvo Smulders, Cornelis Kramers
The initial treatment of hemodynamically stable patients with pulmonary embolism (PE) has dramatically changed since the introduction of low molecular weight heparins (LMWHs). With the recent discovery of the direct oral anticoagulant drugs (DOACs), initial treatment of PE will be simplified even further. In several large clinical trials it has been demonstrated that DOACs are non-inferior to standard therapy for the initial treatment of PE, and because of their practicability they are becoming the agents of first choice...
June 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28589543/beta-blocker-use-and-fall-risk-in-older-individuals-original-results-from-two-studies-with-meta-analysis
#8
Annelies C Ham, Suzanne C van Dijk, Karin M A Swart, Anke W Enneman, Nikita L van der Zwaluw, Elske M Brouwer-Brolsma, Natasja M van Schoor, M Carola Zillikens, Paul Lips, Lisette C P G M de Groot, Albert Hofman, Renger F Witkamp, André G Uitterlinden, Bruno H Stricker, Nathalie van der Velde
AIMS: To investigate the association between use of beta-blockers and beta-blocker characteristics - selectivity, lipid solubility, intrinsic sympathetic activity (ISA), and CYP2D6 enzyme metabolism - and fall risk. METHODS: Data from two prospective studies were used, including community-dwelling individuals, N=7,662 (the Rotterdam Study) and 2,407 (B-PROOF), all aged ≥55 years. Fall incidents were recorded prospectively. Time-varying beta-blocker use was determined using pharmacy dispensing records...
June 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28585378/4%C3%AE-hydroxycholesterol-level-significantly-correlates-with-steady-state-serum-concentration-of-the-cyp3a4-substrate-quetiapine-in-psychiatric-patients
#9
Caroline Gjestad, Tore Haslemo, Ole A Andreassen, Espen Molden
AIM: 4β-Hydroxycholesterol (4βOHC) is sensitive towards induction or inhibition of CYP3A4, but its potential usefulness as a dosing biomarker remains to be demonstrated. The aim of this study was to investigate the correlation between 4βOHC levels and steady-concentrations (Css) of quetiapine, a CYP3A4 substrate with high presystemic metabolism, in psychiatric patients. METHODS: Serum samples from 151 patients treated with quetiapine as immediate release (IR; n=98) or slow release (XR; n=53) tablets were included for analysis of 4βOHC...
June 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28580711/fluoxetine-and-raynaud-s-phenomenon-friend-or-foe
#10
LETTER
Charles Khouri, Thomas Gailland, Marion Lepelley, Matthieu Roustit, Jean-Luc Cracowski
No abstract text is available yet for this article.
June 4, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28560854/pharmacogenetic-analysis-of-irreversible-severe-cisplatin-induced-nephropathy-a-case-report-of-a-27-year-old-woman
#11
Corine de Jong, Stefan Sanders, Geert-Jan Creemers, Artur M Burylo, Margot Taks, Jan H M Schellens, Maarten J Deenen
In this report we describe a young patient diagnosed with bulky FIGO stage IIIb squamous cell cervix carcinoma with severe and irreversible nephropathy after three weekly low-doses of cisplatin. Besides several known risk factors such as hypomagnesemia and hypoalbuminemia, the patient also proved to be homozygously polymorphic for two polymorphisms within the COMT gene (c.615 + 310C>T and c.616-367C>T). As COMT polymorphism has been associated with cisplatin-induced ototoxicity, its effect on nephrotoxicity of cisplatin should be the subject of further investigation...
May 31, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28556962/treatment-of-spontaneous-preterm-labour-with-retosiban-a-phase-ii-pilot-dose-ranging-study
#12
Steven Thornton, Guillermo Valenzuela, Charlotte Baidoo, Michael J Fossler, Timothy H Montague, Linda Clayton, Marcy Powell, Jerry Snidow, Brendt Stier, David Soergel
AIMS: To investigate maternal, fetal, and neonatal safety and tolerability, pharmacodynamics, and pharmacokinetics of intravenous (IV) retosiban in pregnant women with spontaneous preterm labour (PTL) between 34(0/7) and 35(6/7) weeks' gestation. METHODS: In parts A and B of a 3-part double-blind, placebo-controlled, multi-centre study, women were randomised 3:1 (Part A) or 2:1 (Part B) to either 12-hour (h) IV retosiban followed by a single dose of oral placebo (R-P) or 12-hour IV placebo followed by single-dose oral retosiban (P-R)...
May 29, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28548279/significant-decreases-in-blood-propofol-concentrations-during-adrenalectomy-for-phaeochromocytoma
#13
Tatsunori Watanabe, Haruhiko Hiraoka, Takuya Araki, Daisuke Nagano, Tohru Aomori, Tomonori Nakamura, Koujirou Yamamoto, Hiroshi Baba
AIM: The kinetics of propofol are influenced by cardiac output. The aim of this study was to examine changes in blood propofol concentrations during phaeochromocytoma surgery using target-controlled infusion (TCI) anaesthesia with propofol. METHODS: This is a prospective observational study. Ten patients with phaeochromocytoma who underwent unilateral adrenalectomy were included. Cardiac output was measured using an arterial pressure-based cardiac output analysis method...
May 26, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543687/effect-of-a-single-intravenous-zoledronic-acid-administration-on-biomarkers-of-acute-kidney-injury-aki-in-patients-with-osteoporosis-a-pilot-study
#14
C Cipriani, J Pepe, C Clementelli, R Manai, L Colangelo, V Fassino, L Nieddu, S Minisola
AIMS: The pilot study was designed to evaluate the early effect of intravenous (iv) zoledronic acid (ZA) on renal function. METHODS: Five mg iv ZA was administered to 23 patients with osteoporosis (17 women and 6 men, mean age 73±7 SD years). Urinary NGAL, KIM-1, and MCP-1, plasma (p) MCP-1 and serum (s) IL-18, serum calcium (sCa), Creatinine clearance (CrCl), parathyroid hormone (PTH), plasma C-terminal FGF23 (pFGF23), serum (s) Klotho, calcium excretion (CaEx) and renal threshold phosphate concentration/GFR (TmPO4/GFR) were assessed at baseline, 24 hours (h) and day (d) 30 after administration...
May 25, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543530/when-two-is-not-better-than-one
#15
LETTER
Evan S Schwarz, Michael E Mullins, David Liss
No abstract text is available yet for this article.
May 24, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513059/fluoxetine-and-congenital-malformations-a-systematic-review-and-meta-analysis-of-cohort-studies
#16
Shan-Yan Gao, Qi-Jun Wu, Tie-Ning Zhang, Zi-Qi Shen, Cai-Xia Liu, Xin Xu, Chao Ji, Yu-Hong Zhao
AIMS: To investigate the safety of fluoxetine use during pregnancy, and to better understand the relationship between maternal fluoxetine use during the first trimester and congenital malformations in infants. METHODS: PubMed and Web of Science databases were systematically searched from inception to 21 March 2016. Additional studies were identified in a manual search of the reference lists. Two reviewers independently extracted data. A third reviewer checked the data...
May 17, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28512794/free-and-total-plasma-concentrations-of-elvitegravir-cobicistat-during-pregnancy-and-postpartum-a-case-report
#17
LETTER
Catia Marzolini, Laurent Decosterd, Ursula Winterfeld, Frédéric Tissot, Katyuska Francini, Thierry Buclin, Françoise Livio
No abstract text is available yet for this article.
May 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28511283/a-different-inhibitor-is-required-for-overcoming-entecavir-resistance-a-comparison-of-four-rescue-therapies-in-a-retrospective-study
#18
Guosheng Yuan, Chengguang Hu, Yuchen Zhou, Junwei Liu, Huaping Huang, Yuan Li, Dinghua Yang, Fuyuan Zhou, Yong-Yuan Zhang, Yuanping Zhou
AIMS: Little clinical data are available regarding reestablishing the effective inhibition of entecavir (ETV)-resistant mutants. In this retrospective study, we aimed to compare the efficacies of four treatment regimens as rescue therapy for those chronic hepatitis B (CHB) patients with ETV resistance. METHODS: A total of 65 patients with ETV resistance were assigned either with tenofovir disoproxil fumarate (TDF) monotherapy (n=21), ETV (0.5 mg) plus adefovir (ADV) combination therapy (n=19), ETV (1...
May 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28503781/assessment-of-effect-of-cyp3a-inhibition-cyp-induction-oatp1b-inhibition-and-high-fat-meal-on-pharmacokinetics-of-the-jak1-inhibitor-upadacitinib
#19
Mohamed-Eslam F Mohamed, Steven Jungerwirth, Armen Asatryan, Ping Jiang, Ahmed A Othman
AIMS: Upadacitinib (ABT-494) is a selective Janus kinase 1 inhibitor developed for treatment of auto-immune inflammatory disorders. This work evaluated effects of high-fat meal, cytochrome P450 (CYP) 3A inhibition, CYP induction, and organic anion transporting polypeptide (OATP) 1B inhibition on upadacitinib pharmacokinetics. METHODS: Two Phase 1 evaluations were conducted, each in 12 healthy subjects. In Study 1, using a randomized, 2-sequence cross-over design, a 3 mg dose of upadacitinib (immediate-release capsules) was administered alone under fasting conditions, after high-fat meal, or on Day 4 of a 6-day regimen of 400 mg once-daily ketoconazole...
May 14, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28500677/optimizing-the-dose-in-cancer-patients-treated-with-imatinib-sunitinib-and-pazopanib
#20
N A G Lankheet, I M E Desar, S F Mulder, D M Burger, D M Kweekel, C M L van Herpen, W T A van der Graaf, N P van Erp
AIM: Fixed dose oral tyrosine kinase inhibitors imatinib, sunitinib and pazopanib show a high interpatient variability in plasma exposure. A relationship between plasma exposure and treatment outcome has been established, which supports the rationale for dose optimization of these drugs. The aim of this study was to monitor how many patients reached adequate trough levels after therapeutic drug monitoring (TDM) based dose optimization in daily practice. METHODS: A cohort study was performed in patients treated with imatinib, sunitinib or pazopanib of whom follow-up drug levels were measured between August 2012 and April 2016...
May 12, 2017: British Journal of Clinical Pharmacology
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