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Clinical Therapeutics

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https://www.readbyqxmd.com/read/28729087/real-world-effectiveness-of-biologic-disease-modifying-antirheumatic-drugs-for-the-treatment-of-rheumatoid-arthritis-after-etanercept-discontinuation-in-the-united-kingdom-france-and-germany
#1
Nanxin Li, Keith A Betts, Andrew J Messali, Martha Skup, Vishvas Garg
PURPOSE: The purpose of this study was to assess the real-world effectiveness of patients with rheumatoid arthritis (RA) who discontinued etanercept treatment and subsequently received another tumor necrosis factor α (TNF-α) inhibitor or a non-TNF-α biologic in the United Kingdom, France, and Germany. METHODS: Medical record data of patients with RA were collected from a panel of rheumatologists in the United Kingdom, France, and Germany. Patients were required to have a diagnosis of RA, be ≥18 years old, and have initiated use of another TNF-α inhibitor (adalimumab, certolizumab pegol, golimumab, or infliximab) or a non-TNF-α biologic (abatacept or tocilizumab) between January 2014 and May 2015 after discontinuing use of etanercept...
July 17, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28716293/costs-of-providing-infusion-therapy-for-rheumatoid-arthritis-in-a-hospital-based-infusion-center-setting
#2
Jordana Schmier, Kristine Ogden, Nancy Nickman, Michael T Halpern, Mary Cifaldi, Arijit Ganguli, Yanjun Bao, Vishvas Garg
PURPOSE: Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA...
July 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28709688/multidisciplinary-consensus-on-the-nonadherence-to-clinical-management-of-inhaled-therapy-in-spanish-asthma-patients
#3
Antolín López-Viña, Jordi Giner, Jesús Molina, Javier Palicio, Javier Plaza, José Antonio Quintano, Santiago Quirce, Cristina Soria, Ana María Uréndez, Vicente Plaza
PURPOSE: Rates of nonadherence to asthma treatment in Spain are between 24% and 76%, which results in poor disease control and increased health care costs. The main objective of this multidisciplinary consensus was to investigate the opinions of health professionals and patients regarding adherence to inhaled therapy in Spain. The results will help to identify the causes of nonadherence and to establish strategies to detect and correct the problem. METHODS: This research was conducted by using a modified Delphi method organized into 2 rounds and involving a panel of 64 physicians, 16 nurses, and 10 community pharmacists...
July 11, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28705450/clinical-outcome-and-antimicrobial-therapeutic-drug-monitoring-for-the-treatment-of-infections-in-acute-burn-patients
#4
Anna Silva Machado, Maura S Oliveira, Cristina Sanches, Carlindo Vieira da Silva Junior, David S Gomez, Rolf Gemperli, Silvia Regina Cavani Jorge Santos, Anna S Levin
PURPOSE: In critical burn patients, the pharmacokinetic parameters (absorption, distribution, metabolism, and excretion) of many classes of drugs, including antibiotics, are altered. The aim of this study was to compare 2 groups of burn patients undergoing treatment for health care-associated infections with and without therapeutic drug monitoring. METHODS: A retrospective analysis of a clinical intervention (ie, a before/after study) was conducted with patients with health care-associated pneumonia, burn infection, bloodstream infection, and urinary tract infection in the burn intensive care unit of a tertiary care hospital...
July 10, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28689692/patient-and-provider-factors-affecting-clinical-inertia-in-patients-with-type-2-diabetes-on-metformin-monotherapy
#5
Rohan Mahabaleshwarkar, Frank Gohs, Holly Mulder, Nick Wilkins, Andrea DeSantis, William E Anderson, Flavia Ejzykowicz, Swapnil Rajpathak, H James Norton
PURPOSE: Our aim was to determine the extent of clinical inertia and the associated patient and provider factors in patients with type 2 diabetes on metformin monotherapy (MM) at a large integrated health care system in the United States. METHODS: The study cohort included patients with type 2 diabetes aged 18 to 85 years, on MM between January 2009 and September 2013, who experienced MM failure (had an uncontrolled glycosylated hemoglobin [HbA1c] reading (≥8...
July 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28673504/additional-improvements-in-clinical-response-from-adjuvant-biologic-response-modifiers-in-adults-with-moderate-to-severe-systemic-lupus-erythematosus-despite-immunosuppressive-agents-a-systematic-review-and-meta-analysis
#6
REVIEW
Tatyana A Shamliyan, Paula Dospinescu
PURPOSE: The role of biologic disease-modifying drugs in patients with systemic lupus erythematosus (SLE) remains controversial. METHODS: Following systematic review and meta-analysis protocol, we searched PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov in January 2017 to identify all studies of people with SLE treated with biologic response modifiers. We performed direct frequentist random effects meta-analyses, calculated pooled relative risk and number needed to treat to achieve an outcome in 1 patient (NNT) as reciprocal to statistically significant absolute risk difference, and graded the quality of evidence by using the Grading of Recommendations Assessment, Development, and Evaluation criteria...
June 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28668628/effectiveness-and-safety-of-non-vitamin-k-antagonist-oral-anticoagulants-for-atrial-fibrillation-and-venous-thromboembolism-a-systematic-review-and-meta-analyses
#7
REVIEW
Abdulaali R Almutairi, Lili Zhou, Walid F Gellad, Jeannie K Lee, Marion K Slack, Jennifer R Martin, Wei-Hsuan Lo-Ciganic
PURPOSE: The findings from the observational studies comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban)...
June 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28668627/vigabatrin-lacks-proarrhythmic-potential-results-from-a-thorough-qt-qtc-study-in-healthy-volunteers
#8
Dwain Tolbert, Susan Reid, Stuart Harris, Ihor Bekersky
PURPOSE: A thorough QT study was performed to assess the proarrhythmic potential of vigabatrin, an antiepileptic drug approved in the United States for the treatment of infantile spasms and refractory complex partial seizures. METHODS: In this Phase I, randomized, double-blind, placebo- and active-controlled (moxifloxacin), 4-sequence, crossover study conducted at a single center, healthy participants received 1 of 4 randomly assigned treatments: 3.0g vigabatrin solution (therapeutic dose) and 1 moxifloxacin placebo tablet; 6...
June 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28652016/overall-effectiveness-of-rivaroxaban-in-patients-with-pulmonary-embolism
#9
Li Wang, Onur Baser, Phil Wells, W Frank Peacock, Craig I Coleman, Gregory J Fermann, Jeff Schein, Concetta Crivera
PURPOSE: Due to limited evidence on the impact of rivaroxaban in clinical practice, we compared the effectiveness of rivaroxaban versus standard of care (SOC) among patients in the Veterans Health Administration. METHODS: Adult patients with continuous enrollment in a health plan with medical and pharmacy benefits for ≥12 months before and ≥3 months after an inpatient diagnosis of pulmonary embolism (PE) between October 1, 2011, and June 30, 2015, and a prescription claim for an anticoagulant during the index hospitalization, were included...
June 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28652015/landscape-of-innovation-for-cardiovascular-pharmaceuticals-from-basic-science-to-new-molecular-entities
#10
Jennifer M Beierlein, Laura M McNamee, Michael J Walsh, Kenneth I Kaitin, Joseph A DiMasi, Fred D Ledley
PURPOSE: This study examines the complete timelines of translational science for new cardiovascular therapeutics from the initiation of basic research leading to identification of new drug targets through clinical development and US Food and Drug Administration (FDA) approval of new molecular entities (NMEs) based on this research. METHODS: This work extends previous studies by examining the association between the growth of research on drug targets and approval of NMEs associated with these targets...
June 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28648262/placebos-and-clinical-therapeutics
#11
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
June 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28648261/drug-safety-climate-change-causality-and-predictability
#12
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
June 22, 2017: Clinical Therapeutics
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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