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Clinical Drug studies

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https://www.readbyqxmd.com/read/28214989/exposure-response-analyses-of-blood-pressure-and-heart-rate-changes-for-methylphenidate-in-healthy-adults
#1
Liang Li, Yaning Wang, Ramana S Uppoor, Mehul U Mehta, Tiffany Farchione, Mitchell V Mathis, Hao Zhu
The aim of the study was to evaluate the exposure-response (E-R) relationships of blood pressure (BP) and heart rate (HR) changes in healthy adults taking methylphenidate (MPH). Intensive time profiles of BP and HR from healthy adults in placebo and MPH treatment arms of seven clinical trials from the FDA internal database were utilized for this analysis. The analysis model contains a circadian component for placebo effect and an E-R component to describe drug effect. Internal validation was performed using goodness-of-fit plots and visual predictive check...
February 18, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28214985/melatonin-alleviates-the-epilepsy-associated-impairments-in-hippocampal-ltp-and-spatial-learning-through-rescue-of-surface-glur2-expression-at-hippocampal-ca1-synapses
#2
Yue Ma, Xiaolong Sun, Juan Li, Ruihua Jia, Fang Yuan, Dong Wei, Wen Jiang
Epilepsy-associated cognitive impairment is common, and negatively impacts patients' quality of life. However, most antiepileptic drugs focus on the suppression of seizures, and fewer emphasize treatment of cognitive dysfunction. Melatonin, an indolamine synthesized primarily in the pineal grand, is reported to be neuroprotective against several central nervous system disorders. In this study, we investigated whether melatonin could reverse cognitive dysfunction in lithium-pilocarpine treated rats. Chronic treatment with melatonin (8 mg/kg daily for 15 days) after induction of status epilepticus significantly alleviated seizure severity, reduced neuronal death in the CA1 region of the hippocampus, improved spatial learning (as measured by the Morris water maze test), and reversed LTP impairments, compared to vehicle treatment...
February 18, 2017: Neurochemical Research
https://www.readbyqxmd.com/read/28214983/pooled-analysis-of-four-non-interventional-studies-effectiveness-and-tolerability-of-the-antidepressant-agomelatine-in-daily-practice
#3
Gerd Laux, Bettina Barthel, Göran Hajak, Matthias Lemke, Hans-Peter Volz
INTRODUCTION: Meta-analyses are useful to increase knowledge and strengthen evidence about antidepressant treatment supplementary to individual studies. METHODS: A pooled analysis of four multicenter, open-label, prospective, non-interventional studies (2009-2013) was performed to provide further evidence about the antidepressant effectiveness and tolerability of agomelatine (25-50 mg/day) in a large number of non-selected German outpatients with major depressive disorder...
February 18, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28214924/characteristics-and-outcomes-of-rheumatoid-arthritis-patients-who-started-biosimilar-infliximab
#4
Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Soyoung Won, Chan-Bum Choi, So-Young Bang, Seung-Jae Hong, Hyoun Ah Kim, Eun-Mi Koh, Hye-Soon Lee, Chang-Hee Suh, Dae-Hyun Yoo, Sang-Cheol Bae
To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab...
February 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28214841/drug-dosing-and-estimated-renal-function-any-step-forward-from-effersoe
#5
Mads Hornum, Bo Feldt-Rasmussen
Drug dosing in accordance with the renal function is a long-standing challenge to clinicians. For many years it has been evident that in many clinical situations there is no easy way to correctly dose any drug that is mainly cleared by the kidneys. Despite the development of many formulas for estimating the glomerular filtration rate, they all have serious shortcomings. Much effort has been put in to develop estimation formulas to evaluate the renal function as an alternative to direct methods with the aim of safely dosing drugs that are mainly cleared by the kidneys...
February 18, 2017: Nephron
https://www.readbyqxmd.com/read/28214659/clinical-outcomes-and-prognostic-factors-of-patients-with-advanced-mesothelioma-treated-in-a-phase-i-clinical-trials-unit
#6
Dionysis Papadatos-Pastos, Desam Roda, Maria Jose De Miguel Luken, Ann Petruckevitch, Awais Jalil, Marta Capelan, Vasiliki Michalarea, Joao Lima, Nikolaos Diamantis, Jaishree Bhosle, L Rhoda Molife, Udai Banerji, Johann S de Bono, Sanjay Popat, Mary E R O'Brien, Timothy A Yap
BACKGROUND: We have previously reported a prognostic score for patients in phase I trials in the Drug Development Unit, treated at the Royal Marsden Hospital (RPS). The RPS is an objective tool used in patient selection for phase I trials based on albumin, number of disease sites and LDH. Patients with mesothelioma are often selected for phase I trials as the disease remains localised for long periods of time. We have now reviewed the clinical outcomes of patients with relapsed malignant mesothelioma (MM) and propose a specific mesothelioma prognostic score (m-RPS) that can help identify patients who are most likely to benefit from early referral...
February 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28214518/potentiating-slc-transporter-activity-emerging-drug-discovery-opportunities
#7
REVIEW
Marie-Laure Rives, Jonathan A Javitch, Alan D Wickenden
Maintaining the integrity of cellular membranes is critical to protecting metabolic activities and genetic information from the environment. Regulation of transport across membranes of essential chemicals, including water, nutrients, hormones and many drugs, is therefore key to cellular homeostasis and physiological processes. The two main transporter superfamilies are ATP-binding cassette (ABC) transporters that primarily function as efflux transporters, and the solute carrier (SLC) transporters. SLC transporters encompass 52 gene families with almost 400 different human transporter genes...
February 15, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/28214449/-they-treated-me-like-crap-and-i-know-it-was-because-i-was-native-the-healthcare-experiences-of-aboriginal-peoples-living-in-vancouver-s-inner-city
#8
Ashley Goodman, Kim Fleming, Nicole Markwick, Tracey Morrison, Louise Lagimodiere, Thomas Kerr
There is growing evidence that Aboriginal peoples often experience healthcare inequalities due to racism. However, research exploring the healthcare experiences of Aboriginal peoples who use illicit substances is limited, and research rarely accounts for how multiple accounts of stigma intersect and contribute to the experiences of marginalized populations. Our research aimed to explore the healthcare experiences of Aboriginal peoples who use illicit drugs and or illicit alcohol (APWUID/A) living in Vancouver's inner city...
January 26, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/28214384/placental-pathology-in-hiv-infection-at-term-a-comparison-with-hiv-uninfected-women
#9
Emma Kalk, Pawel Schubert, Julie A Bettinger, Mark F Cotton, Monika Esser, Amy Slogrove, Colleen A Wright
OBJECTIVES: To describe and correlate placental characteristics from pregnancies in HIV-infected and HIV-negative women with maternal and infant clinical and immunological data. METHODS: Prospective descriptive study of placentas from term, uncomplicated vaginal births in a cohort of HIV-infected (n=120) and HIV-negative (n=103) women in Cape Town, South Africa. Microscopic and macroscopic features were used to determine pathological cluster diagnoses. The majority of HIV-infected women received some form of drug treatment for the prevention of vertical transmission of HIV...
February 18, 2017: Tropical Medicine & International Health: TM & IH
https://www.readbyqxmd.com/read/28214380/application-of-the-mechpeff-model-to-predict-passive-effective-intestinal-permeability-in-the-different-regions-of-the-rodent-small-intestine-and-colon
#10
D Pade, M Jamei, A Rostami-Hodjegan, D B Turner
A major component of Physiologically-Based Pharmacokinetic (PBPK) models is prediction of the rate and extent of absorption of orally dosed drugs for which knowledge of effective passive intestinal permeability (Peff ) is essential. Single pass intestinal perfusion (SPIP) studies are used to establish effective permeability in vivo but are difficult to perform in rodents while mechanistic models to predict drug Peff in rat and mouse have not been published. This work evaluates the predictive performance of the 'MechPeff' model to predict Peff in the rodent intestine based upon knowledge of regional gut physiology and drug-specific physicochemical parameters...
February 18, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28214288/an-accelerator-mass-spectrometry-enabled-microtracer-study-to-evaluate-the-first-pass-effect-on-the-absorption-of-yh4808
#11
Anhye Kim, Byung-Yong Yu, Stephen R Dueker, Kwang-Hee Shin, Hwa Suk Kim, Hyungmi Ahn, Joo-Youn Cho, Kyung-Sang Yu, In-Jin Jang, Howard Lee
(14) C-labeled YH4808, a novel potassium-competitive acid blocker, was intravenously administered as a microtracer at 80 μg (11.8 kBq or 320 nCi) concomitantly with the non-radiolabeled oral drug at 200 mg to determine the absolute bioavailability and to assess the effect of pharmacogenomics on the oral absorption of YH4808. The absolute bioavailability was low and highly variable (mean, 10.1%; range, 2.3-19.3%), and M3 and M8, active metabolites of YH4808, were formed 22.6- and 38.5-fold higher after oral administration than intravenous administration, respectively...
February 18, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28214273/candidaemia-due-to-candida-parapsilosis-species-complex-at-a-hospital-in-brazil-clinical-characteristics-and-antifungal-susceptibility-profile
#12
Débora de Souza Olartechea de Alencar, Rosianne Assis de Sousa Tsujisaki, Fernanda Luiza Espinosa Spositto, Maína de Oliveira Nunes, Adriana Araújo de Almeida, Marilena Dos Anjos Martins, Marcia de Souza Carvalho Melhem, Marilene Rodrigues Chang
BACKGROUND: Recent decades have seen a global emergence of candidaemia caused by non-Candida albicans Candida species, particularly the Candida parapsilosis complex. AIMS: To evaluate the clinical features and antifungal susceptibility profiles of isolates belonging to the C. parapsilosis species complex in patients with candidaemia in a midwestern Brazilian tertiary-care teaching hospital. METHODS: Yeast identification was performed using an automated Vitek 2 Compact system...
February 14, 2017: Revista Iberoamericana de Micología
https://www.readbyqxmd.com/read/28214184/-systemic-lupus-erythematosus-and-lymphopenia-clinical-and-pathophysiological-features
#13
M Martin, A Guffroy, X Argemi, T Martin
Lymphopenia is frequent in systemic lupus erythematosus (SLE) and profound (<500/mm(3)) in 10% of cases. T lymphocytes, especially CD4+, are more affected than B cells. The pathophysiological mechanisms are complex, involving lymphocytotoxic antibodies, excess of apoptosis, increased susceptibility of T cells to complement mediated cytolysis, as well as lymphopoiesis impairment and lymphocyte sequestration. Lymphopenia in SLE is independent from other cytopenia and immunosuppressive drug regiments, and associated with disease activity, risk of flare and damage scores...
February 14, 2017: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/28214075/asymmetric-total-synthesis-of-tetrahydroprotoberberine-derivatives-and-evaluation-of-their-binding-affinities-at-dopamine-receptors
#14
David Y W Lee, Jing Liu, Shuzhen Zhang, Peng Huang, Lee-Yuan Liu-Chen
Cocaine addiction remains a serious challenge for clinical and medical research because there is no effective pharmacological treatment. l-THP, a natural product isolated from Corydalis yanhusuo W.T. Wang, is one of the most frequently used traditional herbs to treat drug addiction in China. Our laboratory first reported that its demethylated metabolites l-ICP, l-CD, and l-CP had high affinity at dopamine D1, D2, and D5 receptors. Here we report the chemical synthesis of these metabolites and other derivatives and their binding affinities at dopamine receptors...
January 31, 2017: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28213717/the-minor-collagens-in-articular-cartilage
#15
REVIEW
Yunyun Luo, Dovile Sinkeviciute, Yi He, Morten Karsdal, Yves Henrotin, Ali Mobasheri, Patrik Önnerfjord, Anne Bay-Jensen
Articular cartilage is a connective tissue consisting of a specialized extracellular matrix (ECM) that dominates the bulk of its wet and dry weight. Type II collagen and aggrecan are the main ECM proteins in cartilage. However, little attention has been paid to less abundant molecular components, especially minor collagens, including type IV, VI, IX, X, XI, XII, XIII, and XIV, etc. Although accounting for only a small fraction of the mature matrix, these minor collagens not only play essential structural roles in the mechanical properties, organization, and shape of articular cartilage, but also fulfil specific biological functions...
February 17, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28213685/prasugrel-for-japanese-patients-with-acute-coronary-syndrome-in-short-term-clinical-practice-prasfit-practice-i-a-postmarketing-observational-study
#16
Masato Nakamura, Tomoko Iizuka, Kei Sagawa, Kenji Abe, Shuichi Chikada, Miyuki Arai
: Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period...
February 17, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28213589/sh479-a-betulinic-acid-derivative-ameliorates-experimental-autoimmune-encephalomyelitis-by-regulating-the-th17-treg-balance
#17
Jing Li, Ji Jing, Yang Bai, Zhen Li, Roumei Xing, Binhe Tan, Xueyun Ma, Wenwei Qiu, Changsheng Du, Bing Du, Fan Yang, Jie Tang, Stefan Siwko, Mingyao Liu, Huaqing Chen, Jian Luo
CD4+ T helper cells, especially Th17 cells, combined with immune regulatory network dysfunction, play key roles in autoimmune diseases including multiple sclerosis (MS). Betulinic acid (BA), a natural pentacyclic triterpenoid, has been reported to be involved in anti-inflammation, in particular having an inhibitory effect on pro-inflammatory cytokine IL-17 and IFN-γ production. In this study, we screened BA derivatives and found a BA derivative, SH479, which had a greater inhibitory effect on Th17 differentiation...
February 17, 2017: Molecular Pharmacology
https://www.readbyqxmd.com/read/28213566/a-randomised-phase-iib-study-of-mavrilimumab-a-novel-gm-csf-receptor-alpha-monoclonal-antibody-in-the-treatment-of-rheumatoid-arthritis
#18
Gerd R Burmester, Iain B McInnes, Joel Kremer, Pedro Miranda, Mariusz Korkosz, Jiri Vencovsky, Andrea Rubbert-Roth, Eduardo Mysler, Matthew A Sleeman, Alex Godwood, Dominic Sinibaldi, Xiang Guo, Wendy I White, Bing Wang, Chi-Yuan Wu, Patricia C Ryan, David Close, Michael E Weinblatt
OBJECTIVES: Despite the therapeutic value of current rheumatoid arthritis (RA) treatments, agents with alternative modes of action are required. Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, was evaluated in patients with moderate-to-severe RA. METHODS: In a phase IIb study (NCT01706926), patients with inadequate response to ≥1 synthetic disease-modifying antirheumatic drug(s), Disease Activity Score 28 (DAS28)-C reactive protein (CRP)/erythrocyte sedimentation rate ≥3...
February 17, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28213480/a-common-genetic-variant-risk-score-is-associated-with-drug-induced-qt-prolongation-and-torsade-de-pointes-risk-a-pilot-study
#19
David G Strauss, Jose Vicente, Lars Johannesen, Ksenia Blinova, Jay W Mason, Peter Weeke, Elijah R Behr, Dan M Roden, Raymond Woosley, Gulum Kosova, Michael A Rosenberg, Christopher Newton-Cheh
Background -Drug-induced QT interval prolongation, a risk factor for life-threatening ventricular arrhythmias, is a potential side effect of many marketed and withdrawn medications. The contribution of common genetic variants previously associated with baseline QT interval to drug-induced QT prolongation and arrhythmias is not known. Methods -We tested the hypothesis that a weighted combination of common genetic variants contributing to QT interval at baseline, identified through genome-wide association studies, can predict individual response to multiple QT-prolonging drugs...
February 17, 2017: Circulation
https://www.readbyqxmd.com/read/28213381/outcomes-of-treatment-with-direct-acting-antivirals-for-infection-with-hepatitis-c-virus-genotypes-1-4-in-an-ambulatory-care-setting
#20
Timothy A Bach, Kathy Zaiken
PURPOSE: Outcomes with direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) genotypes 1-4 were determined. METHODS: A total of 360 patients at 36 clinical sites in Massachusetts with HCV genotypes 1-4 and a prescription for at least one DAA medication between May 2011 and October 2015 were included. The primary investigator completed a retrospective and concurrent chart review, and data were collected through April 2016. RESULTS: A total of 446 patients were assessed for eligibility into the study, with 86 patients excluded...
March 1, 2017: American Journal of Health-system Pharmacy: AJHP
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