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Clinical Therapeutics

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https://www.readbyqxmd.com/read/28645879/risk-for-venous-thromboembolism-recurrence-among-rivaroxaban-treated-patients-who-continued-versus-discontinued-therapy-analyses-among-patients-with-vte
#1
Alok A Khorana, Jeffrey S Berger, Philip S Wells, Roger Seheult, Veronica Ashton, François Laliberté, Concetta Crivera, Dominique Lejeune, Jeff Schein, Peter Wildgoose, Patrick Lefebvre, Scott Kaatz
PURPOSE: The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE. METHODS: A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment)...
June 20, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28641997/uterine-artery-embolization-and-surgical-methods-for-the-treatment-of-symptomatic-uterine-leiomyomas-a-systemic-review-and-meta-analysis-followed-by-indirect-treatment-comparison
#2
REVIEW
Marcelo C M Fonseca, Rodrigo Castro, Marcio Machado, Tania Conte, Manoel J B C Girao
PURPOSE: There is significant discussion and uncertainty about the optimal management of symptomatic uterine leiomyomas (SULs). Nonsurgical procedures such as uterine artery embolization (UAE) have been developed. The goal of this study was to conduct a meta-analysis and an indirect treatment comparison to examine the comparative efficacy and safety of the surgical procedures to treat SULs compared with UAE. METHODS: MEDLINE, EMBASE, Lilacs, and the Cochrane Central Register of Controlled Trials databases were searched from inception to February 2016...
June 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28641996/impact-of-paliperidone-palmitate-versus-oral-atypical-antipsychotics-on-health-care-resource-use-and-costs-in-veterans-with-schizophrenia-and-comorbid-substance-abuse
#3
Patrick Lefebvre, Erik Muser, Kruti Joshi, Maral DerSarkissian, Rachel H Bhak, Mei Sheng Duh, Brian Shiner, Yinong Young-Xu
PURPOSE: Almost half of all patients diagnosed with schizophrenia have a history of substance abuse (SA). However, data on treatment of schizophrenia with paliperidone palmitate (PP) among patients with comorbid SA are limited. The objective of this study was to compare all-cause and SA-related health care resource utilization and costs in veterans with schizophrenia and co-occurring SA who were treated with PP versus oral atypical antipsychotics (OAAs). METHODS: Veterans Health Administration electronic health record data were used to conduct a retrospective longitudinal study in veterans with schizophrenia who initiated PP or OAA between January 1, 2010 and June 30, 2016, had ≥12 months of enrollment before treatment initiation (baseline), were diagnosed with SA, and had ≥1 Global Assessment of Functioning score during baseline...
June 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28641995/acetylator-status-impacts-amifampridine-phosphate-firdapse%C3%A2-pharmacokinetics-and-exposure-to-a-greater-extent-than-renal-function
#4
Peter E Haroldsen, Zlatko Sisic, Joe Datt, Donald G Musson, Gary Ingenito
PURPOSE: The purpose of this study is to evaluate safety, tolerability, and pharmacokinetic (PK) properties of amifampridine phosphate (Firdapse™) and its major inactive 3-N-acetyl metabolite in renally impaired and healthy individuals with slow acetylator (SA) and rapid acetylator (RA) phenotypes. METHODS: This was a Phase I, multicenter, open-label study of the PK properties and safety profile of amifampridine phosphate in individuals with normal, mild, moderate, or severely impaired renal function...
June 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28629610/a-model-for-assessing-the-clinical-and-economic-benefits-of-bone-forming-agents-for-reducing-fractures-in-postmenopausal-women-at-high-near-term-risk-of-osteoporotic-fracture
#5
Claire E O'Hanlon, Anju Parthan, Morgan Kruse, Shannon Cartier, Bjorn Stollenwerk, Yawen Jiang, John P Caloyeras, Daria B Crittenden, Richard Barron
PURPOSE: The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment. METHODS: Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab...
June 16, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28625506/long-term-cost-effectiveness-of-two-glp-1-receptor-agonists-for-the-treatment-of-type-2-diabetes-mellitus-in-the-italian-setting-liraglutide-versus-lixisenatide
#6
Barnaby Hunt, Nana Kragh, Ceilidh C McConnachie, William J Valentine, Maria C Rossi, Roberta Montagnoli
PURPOSE: Maintaining glycemic control is the key treatment target for patients with type 2 diabetes mellitus. In addition, the glucagon-like peptide-1 (GLP-1) receptor agonists may be associated with other favorable treatment characteristics, such as reduction in body weight and reduced risk of hypoglycemia compared with traditional diabetes interventions. The aim of the present analysis was to compare the long-term cost-effectiveness of 2 GLP-1 receptor agonists, liraglutide 1.8 mg and lixisenatide 20 μg (both administered once daily), in the treatment of patients with type 2 diabetes failing to achieve glycemic control with metformin monotherapy in the Italian setting...
June 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28625505/bioequivalence-study-of-a-new-fixed-dose-combination-tablet-containing-s-amlodipine-nicotinate-and-olmesartan-medoxomil-in-healthy-korean-male-subjects
#7
Mi Jin Oh, Hyun Hwan Hwang, Hyun Gyu Kim, Geun Hyeog Lee, Yun-Seok Cho, Sun Young Lee, Soo Yeon Kang, Kyung Hee Cho, Yun Young Lee, Yun Jeong Lee, Choon-Gon Jang, Seok-Yong Lee
PURPOSE: A fixed-dose combination (FDC) pill of amlodipine (relatively old calcium channel blocker as dihydropyridine) and olmesartan (relatively new angiotensin II receptor blocker) is used for hypertension that is not adequately controlled with a single-formulation drug. Because the FDC is a one-pill formulation, and amlodipine and olmesartan have different mechanisms of action, it is expected to improve patients' medication compliance and have an increased blood pressure-lowering efficacy...
June 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28624124/erratum-to-choosing-wisely-the-top-5-list-of-recommendations-from-the-italian-panel-of-the-national-guidelines-for-the-management-of-acute-pharyngitis-in-children-clin-ther-2017-39-646-649
#8
Elena Chiappini, Barbara Bortone, Giuseppe Di Mauro, Susanna Esposito, Luisa Galli, Massimo Landi, Andrea Novelli, Paola Marchisio, Gian Luigi Marseglia, Nicola Principi, Maurizio de Martino
No abstract text is available yet for this article.
June 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28624123/population-pharmacokinetic-pharmacodynamics-modeling-of-ibutilide-in-chinese-healthy-volunteers-and-patients-with-atrial-fibrillation-af-and-or-atrial-flutter-afl
#9
Zhijun Zeng, Li Wang, Lu Hua, Juanjuan Jiang, Huimin Pang, Yiling Huang, Yishi Li, Lei Tian
PURPOSE: The goal of this study was to develop a population pharmacokinetic (PK) and PK/pharmacodynamics (PD) model for ibutilide, to evaluate the time course of its effect on QT interval in Chinese. METHODS: The population PK and PK/PD model were developed using data from 40 Chinese healthy volunteers using nonlinear mixed-effects modeling, and the final population PK/PD model was applied on 100 patients with atrial fibrillation (AF) and/or atrial flutter (AFL)...
June 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28619503/clinical-pharmacokinetics-of-levornidazole-in-elderly-subjects-and-dosing-regimen-evaluation-using-pharmacokinetic-pharmacodynamic-analysis
#10
Beining Guo, Gaoli He, Xiaojie Wu, Jicheng Yu, Guoying Cao, Yi Li, Yaxin Fan, Yuancheng Chen, Yaoguo Shi, Yingyuan Zhang, Jing Zhang
PURPOSE: Levornidazole, the levo-isomer of ornidazole, is a third-generation nitroimidazole derivative newly developed after metronidazole, tinidazole, and ornidazole. An open-label, parallel-controlled, single-dose study was conducted for the investigation of the pharmacokinetic (PK) profile of levornidazole and its metabolites in healthy elderly Chinese subjects, and for the evaluation of 2 dosing regimens in the elderly. METHODS: Levornidazole was intravenously administered at 500 mg to healthy elderly (aged 60-80 years) or young subjects (aged 19-45 years)...
June 12, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28606562/the-efficacy-and-safety-of-3-types-of-interventions-for-stroke-prevention-in-patients-with-cardiovascular-and-cerebrovascular-diseases-a-network-meta-analysis
#11
Qian Sun, Shumei Chang, Songtao Lu, Yajing Zhang, Yajun Chang
PURPOSE: The goal of this study was to compare the relative efficacy and safety of different types of interventions for stroke prevention in patients with cardiovascular and cerebrovascular diseases. METHODS: This network meta-analysis (NMA) was conducted with a random effects model of Bayesian framework using Stata version 12.0. Odds ratios (ORs) and their credible intervals (CrIs) were applied for the efficacy and safety evaluation of various medical interventions, including aspirin, dipyridamole, ticlopidine, warfarin, and apixaban...
June 10, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28601434/an-open-label-single-dose-pharmacokinetic-study-of-factor-viii-activity-after-administration-of-moroctocog-alfa-af-cc-in-male-chinese-patients-with-hemophilia-a
#12
Hongzhong Liu, Runhui Wu, Pei Hu, Feifei Sun, Lihong Xu, Yali Liang, Sunil Nepal, Peng Roger Qu, Francois Huard, Joan M Korth-Bradley
PURPOSE: Hemophilia A represents up to 80% of all hemophilia cases in China. In patients with this condition, bleeding can be prevented and controlled by administering clotting factor VIII (FVIII). Since their initial availability, recombinant FVIII products have undergone several iterations to enhance their safety. Moroctocog alfa albumin-free cell culture (AF-CC) is among the third generation of recombinant FVIII products and received regulatory approval in China in August 2012. The present study characterizes the single-dose pharmacokinetic parameters of FVIII activity (FVIII:C) after administration of moroctocog alfa (AF-CC) in male Chinese patients with hemophilia A...
June 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28579209/extended-interval-dosing-of-gentamicin-in-premature-neonates-born-at-32-weeks-gestation-and-7-days-of-age
#13
Arun Sundaram, Belal Alshaikh, Deonne Dersch-Mills, Jenna Dobry, Albert R Akierman, Kamran Yusuf
PURPOSE: Extended-interval dosing (EID) regimens of gentamicin have been validated for treating confirmed or suspected early- and late-onset sepsis in preterm infants in the first week of life. Despite the marked changes in volume of distribution and renal clearance in preterm infants after the first few days of life, few studies have validated EID regimens of gentamicin in this population. The objective of the study was to evaluate an EID regimen of gentamicin in infants born at <32 weeks' gestational age and aged >7 days...
May 31, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28576299/effects-of-donor-breastmilk-feeding-on-growth-and-early-neurodevelopmental-outcomes-in-preterm-infants-an-observational-study
#14
Laura S Madore, Samudragupta Bora, Carmina Erdei, Tina Jumani, Allison R Dengos, Sarbattama Sen
PURPOSE: Donor breastmilk (DBM) has gained popularity as an alternative to formula when mother's own milk (MOM) is unavailable. The objective of this study was to evaluate the effects of a predominantly DBM diet on growth and subsequent neurodevelopment in preterm infants at a level 3 neonatal intensive care unit (NICU). METHODS: This single-center, observational cohort study compared data from preterm infants supplemented with predominantly (>50%) DBM to those from age- and weight-matched infants fed only MOM or supplemented with predominantly (>50%) preterm formula (PF)...
May 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28571613/declining-skeletal-muscle-function-in-diabetic-peripheral-neuropathy
#15
REVIEW
Prodromos Parasoglou, Smita Rao, Jill M Slade
PURPOSE: The present review highlights current concepts regarding the effects of diabetic peripheral neuropathy (DPN) in skeletal muscle. It discusses the lack of effective pharmacologic treatments and the role of physical exercise intervention in limb protection and symptom reversal. It also highlights the importance of magnetic resonance imaging (MRI) techniques in providing a mechanistic understanding of the disease and helping develop targeted treatments. METHODS: This review provides a comprehensive reporting on the effects of DPN in the skeletal muscle of patients with diabetes...
May 29, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28554533/therapeutic-use-of-filgrastim-for-established-febrile-neutropenia-is-cost-effective-among-patients-with-solid-tumors-and-lymphomas
#16
Xiao Jun Wang, Wei Xiang Tong, Alexandre Chan
PURPOSE: With the emergence of biosimilar filgrastim to the market, there is a gradual decrease in the listed price of the originator product of filgrastim over the years, and this could have an impact on the cost-effectiveness of filgrastim in the treatment of febrile neutropenia (FN). A cost-effectiveness analysis would allow clinicians to make informed decision when considering the therapeutic filgrastim among low-risk FN patients. This study aims to evaluate the cost-effectiveness of adding therapeutic filgrastim to antibiotics in the treatment of established FN among patients with solid tumors and lymphomas...
May 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28554531/some-reflections-on-neuropathies
#17
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
May 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28554530/electrical-muscle-stimulation-induces-an-increase-of-vegfr2-on-circulating-hematopoietic-stem-cells-in-patients-with-diabetes
#18
Asa Hidmark, Ioannis Spanidis, Thomas H Fleming, Nadine Volk, Volker Eckstein, Jan B Groener, Stefan Kopf, Peter P Nawroth, Dimitrios Oikonomou
PURPOSE: External electric muscle stimulation (EMS) of the thigh muscles was found to reduce pain resulting from diabetic neuropathy (DN), a vascular complication of diabetes. This study investigated circulating hematopoietic stem cells (HSCs) after EMS treatment. Impaired function of HSCs and the subpopulation endothelial progenitor cells (EPCs), important for neovascularization and endothelial repair, has been associated with DN. METHODS: Twenty-four patients with painful DN were treated 3 times with EMS over a period of 1 week...
May 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28545804/knemometry-assessment-of-short-term-growth-in-children-with-asthma-receiving-fluticasone-furoate-for-2-weeks-a-randomized-placebo-controlled-crossover-trial
#19
Ole D Wolthers, Sally Stone, Philippe Bareille, Susan Tomkins, Sanjeev Khindri
PURPOSE: A dry powder inhaler formulation of the inhaled corticosteroid fluticasone furoate (FF) is being evaluated for use in children. An important potential risk associated with the use of inhaled corticosteroids in children is growth suppression. Therefore, the aim of this study was to assess the short-term lower leg growth in children with asthma treated for 2 weeks with inhaled FF versus placebo from the ELLIPTA inhaler. METHODS: Prepubertal children with persistent asthma (n = 60; aged 5 to <12 years) were recruited into a randomized, double-blind, placebo-controlled, 2-way crossover, noninferiority study...
May 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28545803/impact-of-a-multidisciplinary-heart-failure-postdischarge-management-clinic-on-medication-adherence
#20
Lingyun Lu, Cynthia A Jackevicius, Noelle K de Leon, Alberta L Warner, Donald S Chang, Freny Vaghaiwalla Mody
PURPOSE: Disease management programs have been associated with improved adherence to heart failure (HF) medications. However, there remain limited data on the benefit of a comprehensive multidisciplinary HF postdischarge management (PDM) clinic that promptly follows HF-related hospitalization on evidence-based HF medication adherence. OBJECTIVE: The aim of this study was to evaluate the effects of an HF-PDM clinic on adherence to evidence-based HF medication therapy...
May 22, 2017: Clinical Therapeutics
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