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Impactful clinical trials

Lingling He, Xiaoli Liu, Lijia Wang, Zhiyun Yang
The findings regarding the effects of thiazolidinediones (TZDs) in nonalcoholic steatohepatitis (NASH) patients have been inconsistent, and the assessment of different clinical variables for evaluating the effects of TZDs confound a direct comparison of the results of different randomized clinical trials (RCTs), especially with regard to lifestyle changes. In this paper, we performed a meta-analysis of randomized controlled trials to clarify the effects of TZD treatment with and without lifestyle changes on histological markers of NASH and clinical variables related to insulin resistance (IR), hyperlipidemia, and obesity...
October 2016: Medicine (Baltimore)
Daniel Nava Rodrigues, Gunther Boysen, Semini Sumanasuriya, George Seed, Angelo M De Marzo, Johann de Bono
Prostate cancer (PCa) is a clinically heterogeneous disease and current treatment strategies are based largely on anatomical and pathological parameters. In the recent past, several DNA sequencing studies of primary and advanced PCa have revealed recurrent patterns of genomic aberrations that expose mechanisms of resistance to available therapies and potential new drug targets. Suppression of androgen receptor (AR) signalling is the cornerstone of advanced prostate cancer treatment. Genomic aberrations of the androgen receptor or alternative splicing of its mRNA are increasingly recognized as biomarkers of resistance to AR-targeted therapy such as abiraterone or enzalutamide...
October 18, 2016: Journal of Pathology
Iris K Minichmayr, André Schaeftlein, Joseph L Kuti, Markus Zeitlinger, Charlotte Kloft
OBJECTIVES: We aimed to assess linezolid pharmacokinetics in the plasma and interstitial space fluid (ISF) of patients with sepsis, diabetic foot infections or cystic fibrosis and healthy volunteers. The impacts of joint characteristics and disease on plasma and target-site exposure were to be identified together with the benefit of dose intensification in critically ill patients. METHODS: Rich plasma (n = 1598) and ISF concentrations in subcutaneous adipose (n = 1430) and muscle tissue (n = 1089) measured by microdialysis were pooled from three clinical trials with 51 individuals receiving 600 mg of intravenous and oral linezolid...
October 17, 2016: Clinical Pharmacokinetics
James J Hsieh, David Chen, Patricia I Wang, Mahtab Marker, Almedina Redzematovic, Ying-Bei Chen, S Duygu Selcuklu, Nils Weinhold, Nancy Bouvier, Kety H Huberman, Umesh Bhanot, Michael S Chevinsky, Parul Patel, Patrizia Pinciroli, Helen H Won, Daoqi You, Agnes Viale, William Lee, A Ari Hakimi, Michael F Berger, Nicholas D Socci, Emily H Cheng, Jennifer Knox, Martin H Voss, Maurizio Voi, Robert J Motzer
BACKGROUND: Metastatic renal cell carcinoma (RCC) patients are commonly treated with vascular endothelial growth factor (VEGF) inhibitors or mammalian target of rapamycin inhibitors. Correlations between somatic mutations and first-line targeted therapy outcomes have not been reported on a randomized trial. OBJECTIVE: To evaluate the relationship between tumor mutations and treatment outcomes in RECORD-3, a randomized trial comparing first-line everolimus (mTOR inhibitor) followed by sunitinib (VEGF inhibitor) at progression with the opposite sequence in 471 metastatic RCC patients...
October 14, 2016: European Urology
Jennifer L Schroeck, James Ford, Erin L Conway, Kari E Kurtzhalts, Megan E Gee, Krista A Vollmer, Kari A Mergenhagen
PURPOSE: Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. METHODS: A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population...
October 14, 2016: Clinical Therapeutics
Mariane Curado Borges, Fabiana de Miranda Moura Dos Santos, Rosa Weiss Telles, Marcus Vinícius Melo de Andrade, Maria Isabel Toulson Davisson Correia, Cristina Costa Duarte Lanna
BACKGROUND: Studies have shown that omega-3 fatty acids reduce the concentrations of eicosanoids, cytokines, chemokines, C-reactive protein (CRP) and other inflammatory mediators. OBJECTIVE: To investigate the effects of omega-3 fatty acids on circulating levels of inflammatory mediators and biochemical markers in women with systemic lupus erythematosus (SLE). METHODS: Experimental clinical study (clinical trial: NCT02524795); 49 women with SLE (ACR1982/1997) were randomized: 22 to the omega-3 group (daily intake of 1080mg EPA+200mg DHA, for 12 weeks) and 27 to the control group...
September 22, 2016: Revista Brasileira de Reumatologia
Dick Oepkes, Lieve C Page-Christiaens, Caroline J Bax, Mireille N Bekker, Catia M Bilardo, Elles M J Boon, G Heleen Schuring-Blom, Audrey B C Coumans, Brigitte H Faas, Robert-Jan H Galjaard, Attie T Go, Lidewij Henneman, Merryn V E Macville, Eva Pajkrt, Ron F Suijkerbuijk, Karin Huijsdens-vanAmsterdam, Diane Van Opstal, E J Joanne Verweij, Marjan M Weiss, Erik A Sistermans
OBJECTIVE: To evaluate the clinical impact of nationwide implementation of genome-wide Non-Invasive Prenatal Testing (NIPT) in pregnancies at increased risk for fetal trisomies 21, 18 and 13. METHOD: Women with elevated risk based on first trimester combined testing (FCT ≥ 1:200) or medical history, not advanced maternal age alone, were offered NIPT as contingent screening test, performed by Dutch University Medical laboratories. We analyzed uptake, test performance, redraw/failure rate, turn-around time and pregnancy outcome...
October 17, 2016: Prenatal Diagnosis
Susanne Hafner, Sabine Haubensak, Tanusree Paul, Oliver Zolk
Background | Differences (polymorphisms) in genes encoding drug targets, drug transport proteins, or drug metabolizing enzymes may be responsible, among other factors, for the observed variation in patients' responses to medications. The field of pharmacogenetics aims to identify patients at higher genetically-determined risk of adverse effects or poor response to medication. This information would allow for modification of dosage or substitution with alternative therapy. However, there is a lack of awareness of pharmacogenetic clinical practise guidelines...
October 2016: Deutsche Medizinische Wochenschrift
Christian L Johnson, Yorick Soeder, Marc H Dahlke
PURPOSE OF REVIEW: The current review presents an update on the existing preclinical and human experience of mesenchymal stromal cell (MSC) therapies for post-transplant immunomodulation. RECENT FINDINGS: Although results from early clinical studies have demonstrated that the application of autologous and allogeneic MSC to be both safe and feasible in a solid organ transplantation setting, for example in liver, the efficacy of MSC immunotherapy demonstrated in preclinical models has yet to be replicated in human clinical trials...
October 7, 2016: Current Opinion in Organ Transplantation
Laura Orlando, Giuseppe Viale, Emilio Bria, Eufemia Stefania Lutrino, Isabella Sperduti, Luisa Carbognin, Paola Schiavone, Annamaria Quaranta, Palma Fedele, Chiara Caliolo, Nicola Calvani, Mario Criscuolo, Saverio Cinieri
AIM: Pathological predictive factors are the most important markers when selecting early breast cancer adjuvant therapy. In randomized clinical trials the variability in pathology report after central pathology review is noteworthy. We evaluated the discordance rate (DR) and inter-rater agreement between local and central histopathological report and the clinical implication on treatment decision. METHODS: A retrospective analysis was conducted in a series of consecutive early breast cancer tumors diagnosed by local pathologists and subsequently reviewed at the Pathology Division of European Institute of Oncology...
October 13, 2016: Breast: Official Journal of the European Society of Mastology
Paul R Lambert, John Carey, Anthony A Mikulec, Carl LeBel
OBJECTIVE: To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease. STUDY DESIGN: Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months. SETTING: Fifty-two academic and community otolaryngology centers. PATIENTS: One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive. INTERVENTION: Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo...
September 30, 2016: Otology & Neurotology
Ahmer M Hameed, Henry C Pleass, Germaine Wong, Wayne J Hawthorne
BACKGROUND: The two main options for renal allograft preservation are static cold storage (CS) and machine perfusion (MP). There has been considerably increased interest in MP preservation of kidneys, however conflicting evidence regarding its efficacy and associated costs have impacted its scale of clinical uptake. Additionally, there is no clear consensus regarding oxygenation, and hypo- or normothermia, in conjunction with MP, and its mechanisms of action are also debated. The primary aims of this article were to elucidate the benefits of MP preservation with and without oxygenation, and/or under normothermic conditions, when compared with CS prior to deceased donor kidney transplantation...
October 2016: Medicine (Baltimore)
Judith L Griffin, Marie Yersin, Stéphanie Baggio, Katia Iglesias, Venetia-Sofia Velonaki, Karine Moschetti, Bernard Burnand, Jean-Blaise Wasserfallen, Francis Vu, Corine Ansermet, Olivier Hugli, Jean-Bernard Daeppen, Patrick Bodenmann
OBJECTIVES: Frequent Emergency Department (ED) users have an elevated mortality, yet little is known about risk factors. Our aim was to characterize deceased frequent ED users and determine predictors of mortality. METHODS: This is a post-hoc analysis of all-cause mortality among frequent ED users participating in a randomized clinical trial on case management at the Lausanne University Hospital (Switzerland). We enrolled 250 frequent ED users (5+ visits/past year) in a 12-month randomized clinical trial; those with an estimated survival of fewer than 18 months were excluded...
October 4, 2016: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
Nicholas W Gilpin, Jeff L Weiner
Post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly co-morbid in humans. Although we have some understanding of the structural and functional brain changes that define each of these disorders, and how those changes contribute to the behavioral symptoms that define them, little is known about the neurobiology of co-morbid PTSD and AUD, which may be due in part to a scarcity of adequate animal models for examining this research question. The goal of this review is to summarize the current state-of-the-science on co-morbid PTSD and AUD: we summarize epidemiological data documenting the prevalence of this co-morbidity, review what is known about the potential neurobiological basis for the frequent co-occurrence of PTSD and AUD, and discuss successes and failures of past and current treatment strategies...
October 17, 2016: Genes, Brain, and Behavior
Jake S Burrell, Simon Walker-Samuel, Jessica K R Boult, Lauren C J Baker, Yann Jamin, Jane Halliday, John C Waterton, Simon P Robinson
The aim of this study was to use the combined carbogen-ultrasmall superparamagnetic iron oxide (CUSPIO) magnetic resonance imaging (MRI) method, which uses spatial correlations in independent susceptibility imaging biomarkers, to investigate and compare the impact of tumor size and anatomical site on vascular structure and function in vivo. Mice bearing either subcutaneous or orthotopic PC3 LN3 prostate tumors were imaged at 7 T, using a multi-gradient echo sequence to quantify R2, before and during carbogen (95% O2/5% CO2) breathing, and subsequently following intravenous administration of USPIO particles...
October 2016: Topics in Magnetic Resonance Imaging: TMRI
Zena Eh Moore, Menno T van Etten, Jo C Dumville
BACKGROUND: Pressure ulcers, which are localised injury to the skin or underlying tissue, or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful, and impact negatively on the individual's quality of life. International guidelines suggest bed rest as a component of the treatment strategy to manage pressure ulcers among wheelchair users. The potential benefits and risks need to be considered when assessing the effectiveness of bed rest as an intervention for treating pressure ulcers in this population...
October 17, 2016: Cochrane Database of Systematic Reviews
Amirhossein Sahebkar, Matteo Pirro, Željko Reiner, Arrigo Cicero, Gianna Ferretti, Mario Simental-Mendía, Luis E Simental-Mendía
BACKGROUND: Plasma homocysteine is an independent non-traditional risk factor for atherosclerotic cardiovascular disease. The impact of statin therapy on plasma homocysteine is not conclusive. OBJECTIVE: To evaluate the effect of statin therapy on plasma homocysteine concentrations in a systematic review and meta-analysis of controlled clinical trials. The secondary aim was to assess the comparative effect of statins versus fibrates on plasma homocysteine levels in head-to-head trials...
October 7, 2016: Current Medicinal Chemistry
Orsolya E Lunacsek, Arliene Ravelo, Anna D Coutinho, Sebastien J Hazard, Mark R Green, Joanne Willey, Michael Eaddy, Hans-Peter Goertz
BACKGROUND: Real-world evidence is lacking on the impact of bevacizumab added to carboplatin/paclitaxel (Bev + CP) therapy versus CP alone for patients with non-squamous non-small cell lung cancer (NS-NSCLC), particularly in those excluded from clinical trials. METHODS: This is a retrospective electronic medical record analysis of patients who received first-line therapy with Bev + CP or CP between 1 October 2006 and 30 June 2013. We identified four subsets: elderly patients (≥65 years), patients with brain/central nervous system (CNS) metastases, patients with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, and patients receiving anticoagulation...
September 2016: Drugs—Real World Outcomes
Muthiah Vaduganathan, Akshay S Desai
Composite angiotensin receptor-neprilysin inhibition (ARNi) represents a novel pharmacologic strategy for treatment of heart failure with reduced ejection fraction (HFrEF). In the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial of 8399 subjects with HFrEF, treatment with the ARNi LCZ696 (sacubitril/valsartan) was associated with statistically important reductions in cardiovascular death, all-cause mortality, and the composite of cardiovascular death or heart failure hospitalization in comparison with enalapril...
November 2016: Current Cardiology Reports
Stefan Stefanovic, Markus Wallwiener, Uros Karic, Christoph Domschke, Luka Katic, Florin-Andrei Taran, Aleksandra Pesic, Andreas Hartkopf, Peyman Hadji, Martin Teufel, Florian Schuetz, Christof Sohn, Peter Fasching, Andreas Schneeweiss, Sara Brucker
PURPOSE: The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness...
October 17, 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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