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Clinical Therapeutics

Maxine D Fisher, Ancilla W Fernandes, Temitope O Olufade, Paul J Miller, Mark S Walker, Moon Fenton
PURPOSE: The goal of this study was to describe patient characteristics, health resource utilization (HRU), and costs associated with treating recurrent or refractory head and neck cancer (HNC) among patients with disease progression in the community oncology setting. METHODS: This retrospective observational study was conducted by using data from the Vector Oncology Data Warehouse. Patients had been diagnosed with locally advanced or metastatic (stage III-IVc) HNC between January 1, 2007, and October 1, 2015...
March 9, 2018: Clinical Therapeutics
Tara Castellano, Kathleen N Moore, Laura L Holman
PURPOSE: The goal of this study was to compile a review of topics pertinent to the use of immune checkpoint inhibitors in gynecologic malignancies, including foundation for use, current agents available and trials in gynecologic cancers, special populations of interest, identification and management of toxicities, and considerations in predictive biomarkers and response assessment. METHODS: A literature review of selected topics in reference to immune checkpoint inhibitors and gynecologic cancers was conducted on PubMed and the US Food and Drug Administration drug search application...
March 9, 2018: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
March 9, 2018: Clinical Therapeutics
Mariko Kita, Robert J Fox, Ralf Gold, Gavin Giovannoni, J Theodore Phillips, Sujata P Sarda, Jessica Kong, Vissia Viglietta, Sarah I Sheikh, Macaulay Okwuokenye, Ludwig Kappos
No abstract text is available yet for this article.
March 7, 2018: Clinical Therapeutics
Leigh A Cantrell, Linda R Duska
No abstract text is available yet for this article.
March 6, 2018: Clinical Therapeutics
Liping Yan, Xiaohong Kan, Limei Zhu, Kaijin Xu, Jianjun Yin, Li Jie, Yong Li, Ji Yue, Wenyu Cui, Juan Du, Lihua Wang, Shouyong Tan, Xiangao Jiang, Zhong Zeng, Shenghui Xu, Lin Wang, Yu Chen, Weiguo He, Xusheng Gao, Dapeng Bai, Chengjie Zhao, Xiaofeng Yan, Yuyin Zhu, Yumei Fan, Lanpin Xie, Aihua Deng, Qing Zhang, Heping Xiao
PURPOSE: We designed a prospective, multicenter, randomized, controlled study to assess a 5-month regimen compared with the standard regimen on previously treated patients with pulmonary tuberculosis (TB). METHODS: We enrolled 917 sputum smear-positive patients undergoing additional treatment in 27 major tuberculosis hospitals in China. Patients were randomly assigned to a test group (n = 626)treated with a 5-month regimen of moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide or a reference group (n = 291) treated with an 8-month regimen of isoniazid, rifampicin, and streptomycin...
March 5, 2018: Clinical Therapeutics
Cynae Johnson, Amir Anthony Jazaeri
Use of immune checkpoint inhibitors targeting cytotoxic T-lymphocyte-associated antigen 4 and programmed cell death protein 1 have led to improved survival outcomes for advanced solid-tumor malignancies. This report helps the reader gain a better understanding of adverse events in patients with ovarian cancer on checkpoint inhibitor therapy. We describe 3 hypothetical case vignettes of patients with gynecologic cancer on checkpoint inhibitor immunotherapy and discuss common immune-related adverse events. The typical presentation and onset of immune-related events are different from those associated with conventional chemotherapy...
March 5, 2018: Clinical Therapeutics
John K Marshall, Louis Bessette, Carter Thorne, Neil H Shear, Gerald Lebovic, Sebastien K Gerega, Brad Millson, Driss Oraichi, Tania Gaetano, Sandra Gazel, Martin G Latour, Marie-Claude Laliberté
PURPOSE: Adalimumab (ADA) is a tumor necrosis factor-α inhibitor indicated for use in various immune-mediated inflammatory diseases. Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care's Patient Support Program (PSP), which provides personalized services, including tailored interventions in the form of nurse-provided care coach calls (CCCs), with the goal of improving patients' experiences and outcomes. The primary objective of this study was to evaluate the impact of PSP services, including CCCs and patient characteristics, on persistence with and adherence to ADA for those patients enrolled in the PSP...
March 5, 2018: Clinical Therapeutics
Xavier Pivot, Jean Paul Deslypere, Lisa Soyeon Park, Michael Jinwoo Kim, Wonjae Lee, Jeonghyeon Lee
PURPOSE: This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*. METHODS: In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC0-∞ . Equivalence was determined by using the predefined margins of 0...
March 1, 2018: Clinical Therapeutics
Lian A van Meijel, Sandra P van den Heuvel-Bens, Lisa J Zimmerman, Ellen Bazelmans, Cees J Tack, Bastiaan E de Galan
PURPOSE: Automated bolus calculation may benefit patients with poorly controlled type 1 diabetes who are relatively new to continuous subcutaneous insulin infusion (CSII). This study investigated the effect of automated bolus calculation on glucose variability, glucose control, and diabetes-related quality of life in patients with reasonably well-controlled type 1 diabetes, accustomed to treatment with CSII for several years. METHODS: This open-label, single-center study included 32 patients (mean age, 45...
March 1, 2018: Clinical Therapeutics
Chen Peng, Ying Ding, Xin Yi, Yupei Shen, Zhiqiang Dong, Limei Cao, Qiang Li, Haiyan Ren, Lin He, Daizhan Zhou, Xu Chen
PURPOSE: Ischemic stroke (IS) is one of the most common neurologic diseases and is the main cause of death and disability in the Chinese population. This retrospective cohort study was performed to elucidate the relationship between single nucleotide polymorphisms (SNPs) in cytochrome P450 genes and the therapeutic effect of atorvastatin. METHODS: A total of 192 cases of IS were enrolled in the study. All patients were treated with atorvastatin, and their lipid levels and proportions were measured...
February 27, 2018: Clinical Therapeutics
Eric M Maiese, Claire Ainsworth, Jean-Gabriel Le Moine, Outi Ahdesmäki, Judith Bell, Emma Hawe
PURPOSE: New therapies, including daratumumab plus lenalidomide plus dexamethasone (DRd) and daratumumab plus bortezomib plus dexamethasone (DVd), have recently been approved in the United States for patients with multiple myeloma (MM) who have received at least 1 prior line of therapy. However, few treatments have been compared in head-to-head clinical trials to determine the most efficacious therapy. In an update of the POLLUX (Phase 3 Study Comparing DRd Versus Rd in Subjects with Relapsed or Refractory Multiple Myeloma [RRMM]) trial, median progression-free survival (PFS) for DRd was not reached; the hazard ratio compared with Rd was 0...
February 27, 2018: Clinical Therapeutics
Chuntao Wu, Stephanie Tcherny-Lessenot, Wanju Dai, Yunxun Wang, Hayet Kechemir, Sampada Gandhi, Stephen Lin, Juhaeri Juhaeri
PURPOSE: There are few data on the risk for peripheral neuropathy associated with dronedarone, a newer antiarrhythmic medicine. The objective of this study was to assess whether dronedarone is potentially associated with an increased risk for peripheral neuropathy compared with other antiarrhythmics, including amiodarone, sotalol, flecainide, and propafenone. METHODS: The MarketScan database was used for identifying patients who were at least 18 years of age, had atrial fibrillation or flutter, and had not been diagnosed with peripheral neuropathy in the 180-day period prior to or on the date of the first prescription of an antiarrhythmic between July 20, 2009, and December 31, 2011...
February 27, 2018: Clinical Therapeutics
Rahul P Patel, Jilson Jacob, Mohammed Sedeeq, Long Chiau Ming, Troy Wanandy, Syed Tabish R Zaidi, Gregory M Peterson
PURPOSE: The aim was to investigate the stability of cefazolin in elastomeric infusion devices. METHODS: Elastomeric devices (Infusor LV) that contain cefazolin (3 g/240 mL and 6 g/240 mL) were prepared and stored at 4°C for 72 hours and then at 35°C for 12 hours, followed by 25°C for 12 hours. An aliquot was withdrawn at predefined time points and analyzed for the concentration of cefazolin. Samples were also assessed for changes in pH, solution color, and particle content...
February 26, 2018: Clinical Therapeutics
Shuchi N Joshi, Nuggehally R Srinivas, Deven V Parmar
PURPOSE: Our aim was to develop and validate the extrapolative performance of a regression model using a limited sampling strategy for accurate estimation of the area under the plasma concentration versus time curve for saroglitazar. METHODS: Healthy subject pharmacokinetic data from a well-powered food-effect study (fasted vs fed treatments; n = 50) was used in this work. The first 25 subjects' serial plasma concentration data up to 72 hours and corresponding AUC0-t (ie, 72 hours) from the fasting group comprised a training dataset to develop the limited sampling model...
February 26, 2018: Clinical Therapeutics
Monica Hagan Vetter, John L Hays
PURPOSE: Epithelial ovarian cancer (EOC) is the leading cause of gynecologic cancer death in the United States. Most patients will ultimately fail platinum-based chemotherapy and have the disease recur. Interest is increasing in the use of targeted therapies in the treatment of EOC. This review focuses on the current use of targeted therapeutics in EOC as well as future directions. METHODS: A literature search of Medline and PubMed was conducted (January 2000-October 2017) to identify recent reports of targeted drugs in EOC...
February 23, 2018: Clinical Therapeutics
James A McKinnell, Shelby Corman, Dipen Patel, Grace H Leung, Lynne M Gordon, Thomas P Lodise
PURPOSE: Clinicians and stewardship programs are challenged with positioning of novel, higher priced antibiotic agents for the treatment of clinical infections. We developed a decision-analytic model to describe costs, including drug, total treatment costs, and health care outcomes, associated with telavancin (TLV) compared with vancomycin (VAN) for patients with Staphylococcus aureus (SA) hospital-acquired bacterial pneumonia (HABP). METHODS: This decision-analytic model assessed the treatment of SA-HABP with TLV versus VAN...
February 14, 2018: Clinical Therapeutics
Anna Duda-Sobczak, Dorota Zozulinska-Ziolkiewicz, Marzena Wyganowska-Swiatkowska
It is well established that hyperglycemia affects periodontal outcomes. A body of evidence, predominantly over the past 20 years supports significant independent associations between periodontal disease and glycemic control or complications of diabetes. Association between periodontal tissue and hyperglycemia is possible through altered cellular immunity, increased proliferation of bacteria, microangiopathy, and formation of the advanced glycation end products. However, most studies focus solely on patients with type 2 diabetes or diabetes in general...
February 8, 2018: Clinical Therapeutics
Soon Jun Hong, Han Saem Jeong, Jeong Cheon Ahn, Dong-Hun Cha, Kyung Heon Won, Weon Kim, Sang Kyoon Cho, Seok-Yeon Kim, Byung-Su Yoo, Ki Chul Sung, Seung-Woon Rha, Joon-Han Shin, Kyoo Rok Han, Wook Sung Chung, Min Su Hyon, Han Cheol Lee, Jang-Ho Bae, Moo-Yong Rhee, Jun Kwan, Dong Woon Jeon, Ki Dong Yoo, Hyo-Soo Kim
PURPOSE: Combination therapy with ezetimibe and statins is recommended in cases of statin intolerance or insufficiency. The objective of this study was to compare the efficacy and safety of combination therapy with ezetimibe and rosuvastatin versus those of rosuvastatin monotherapy in patients with hypercholesterolemia. METHODS: I-ROSETTE (Ildong ROSuvastatin & ezETimibe for hypercholesTElolemia) was an 8-week, double-blind, multicenter, Phase III randomized controlled trial conducted at 20 hospitals in the Republic of Korea...
February 2, 2018: Clinical Therapeutics
Caridad Pontes, Josep Ramon Marsal, Josep Maria Elorza, Maria Aragón, Daniel Prieto-Alhambra, Rosa Morros
PURPOSE: Recent controversies on the safety profiles of opioids and paracetamol (acetaminophen) have led to changes in clinical guidance on osteoarthritis (OA) management. We studied the existing association between the use of different OA drug therapies and the risk for acute coronary events. METHODS: A cohort of patients with clinically diagnosed OA (according to ICD-10 codes) was identified in the SIDIAP database. Within the cohort, cases with incident acute coronary events (acute myocardial infarction or unstable angina) between 2008 and 2012 were identified using ICD-10 codes and data from hospital admission...
February 2, 2018: Clinical Therapeutics
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