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Advances in Therapy

John R Wheatley, Terence C Amis, Sharon A Lee, Renee Ciesla, Gilbert Shanga
INTRODUCTION: This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. METHODS: Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline...
May 22, 2019: Advances in Therapy
Alfio Ferlito, Kenneth O Devaney, Jennifer L Hunt, Henrik Hellquist
A new edition of the World Health Organization (WHO) Histological classification of tumours of the hypopharynx, larynx, trachea and parapharyngeal space was published in 2017. We have considered this classification regarding laryngeal neoplasms and discuss the grounds for said revision. Many of the laryngeal neoplasms described in the literature and in the previous WHO edition from 2005 have been omitted from this current revision. Many are described elsewhere in the book but it may give the new generation of pathologists/surgeons/oncologists the false impression that these tumour entities do not exist in the larynx...
May 22, 2019: Advances in Therapy
Xin Du, Yang Zheng, Ping Yang, Shuren Ma, Zaixin Yu, Xi Su, Junbo Ge, Maria Leonsson-Zachrisson, Xianhong Wang, Jing Sun, Lu Bai, Chang-Sheng Ma
INTRODUCTION: Ticagrelor is an oral, reversible, direct-acting P2Y12 receptor inhibitor approved for the prevention of cardiovascular events in acute coronary syndrome (ACS). In China, drug intensive monitoring regulations for new drugs require additional safety data post-approval. METHODS: YINGLONG, a single-arm, phase-IV, 1-year, non-interventional study, described the safety of ticagrelor 90 mg twice daily in Chinese patients (≥ 18 years) with ACS treated with ≥ 1 dose of ticagrelor...
May 22, 2019: Advances in Therapy
Akifumi Kurata, Hidetoshi Furuie, Tomoko Ishizuka, Takafumi Nakatsu, Takako Shimizu, Manabu Kato, Yasuhiro Nishikawa, Hitoshi Ishizuka
INTRODUCTION: To investigate the absolute bioavailability of esaxerenone and the effects of food on its pharmacokinetics (PK) after a single oral dose in healthy Japanese subjects. METHODS: Twenty-four Japanese males aged 20-45 years were randomised to six groups (each n = 4) in this single-centre, open-label, three-way, three-period crossover study. Esaxerenone (5 mg) was administered in the fasting state as a single oral dose, single intravenous infusion over 1 h, or in the postprandial state as a single oral dose...
May 22, 2019: Advances in Therapy
Toby M Maher, Wim Wuyts
A proportion of patients with interstitial lung diseases (ILDs), including the ILDs that are commonly associated with autoimmune diseases, develop a progressive fibrosing phenotype characterised by worsening of lung function, dyspnoea and quality of life, and early mortality. No drugs are approved for the treatment of ILDs other than idiopathic pulmonary fibrosis (IPF). At present, immunomodulatory medications are the mainstay of treatment for non-IPF ILDs. However, with the exception of systemic sclerosis-associated ILD, the evidence to suggest that immunosuppression may preserve lung function in patients with these ILDs comes only from retrospective, observational, or uncontrolled studies...
May 22, 2019: Advances in Therapy
Fritz H Hengerer, Gerd U Auffarth, Christoffer Riffel, Ina Conrad-Hengerer
INTRODUCTION: To evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject® , Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden. METHODS: Eyes with POAG, pseudoexfoliative glaucoma (PXG), appositional narrow-angle glaucoma (NAG, with open-angle configuration in the area of implantation), or secondary glaucoma were included in this prospective, non-randomized, consecutive case series...
May 22, 2019: Advances in Therapy
Sook Jin Seong, Boram Ohk, Woo Youl Kang, Mi-Ri Gwon, Bo Kyung Kim, Seungil Cho, Dong Heon Yang, Hae Won Lee, Young-Ran Yoon
INTRODUCTION: Amlodipine, valsartan, and rosuvastatin are among the medications widely coadministered for the treatment of hyperlipidemia accompanied by hypertension. The aim of this study was to investigate the possible pharmacokinetic drug-drug interactions between amlodipine, valsartan, and rosuvastatin in healthy Korean male volunteers. METHODS: In this phase 1, open-label, multiple-dose, two-part, two-period, fixed-sequence study, the enrolled subjects were randomized into two parts (A and B)...
May 22, 2019: Advances in Therapy
Gesine van Mark, Stefanie Lanzinger, Stefan Sziegoleit, Franz Josef Putz, Mesut Durmaz, Michaela Borscheller, Thomas Danne, Jochen Seufert, Reinhard W Holl, Peter Bramlage
INTRODUCTION: Insulin glargine 300 U/ml (U300) was registered based on the EDITION clinical trial program. The aim of this database analysis was to describe the profile of adult U300 recipients with type-1 (T1DM) or type-2 diabetes (T2DM). METHODS: The analysis was based on data from the German DIVE/DPV registries. Patients were sampled in May (DIVE) and in March 2018 (DPV) and divided into those who commenced U300 within the 1st year (early adopters) or 2nd year (late adopters)...
May 22, 2019: Advances in Therapy
Theodoros Empeslidis, Matthew Storey, Theodoros Giannopoulos, Vassileios Konidaris, Paris G Tranos, Evangelia S Panagiotou, Irini C Voudouragkaki, Anastasios G Konstas
Emerging anti-vascular endothelial growth factor (anti-VEGF) therapies for neovascular age-related macular degeneration (nAMD) have revolutionised medical retina practice and the management and eventual outcome of nAMD. Recent research has focused on evaluating and comparing the efficacy of the two most widely employed anti-VEGF agents, bevacizumab and ranibizumab; however, a subgroup of patients with nAMD demonstrates a suboptimal response to standard therapy. We have therefore conducted a review of pertinent studies published until August 2018 which have documented the clinical efficacy when switching to a different anti-VEGF...
May 17, 2019: Advances in Therapy
Jihoon Yun, Jihyun Kim, Jihyun Chung, Su-Jeong Hwang, Su Jin Park
INTRODUCTION: Stability information for the trastuzumab biosimilar SB3 is limited to 48 h at 2-8 °C for the reconstituted solution and 24 h at up to 30 °C for diluted solutions. Extended physicochemical stability and biological activity were assessed to evaluate the advanced preparation of reconstituted and diluted SB3. METHODS: Under controlled and aseptic conditions, the stability of reconstituted and diluted SB3 was evaluated using several assessments and according to the UK's National Health Service guidance...
May 17, 2019: Advances in Therapy
Tawfeg Ben-Omran, Luis Masana, Genovefa Kolovou, Gema Ariceta, F Javier Nóvoa, Allan M Lund, Martin P Bogsrud, María Araujo, Osamah Hussein, Daiana Ibarretxe, Rosa M Sanchez-Hernández, Raul D Santos
INTRODUCTION: Homozygous familial hypercholesterolaemia (HoFH) is a rare, autosomal disease affecting the clearance of low-density lipoprotein cholesterol (LDL-C) from circulation, and leading to early-onset atherosclerotic cardiovascular disease (ASCVD). Treatment consists mainly of statins, lipoprotein apheresis (LA) and, more recently, the microsomal triglyceride transfer protein inhibitor lomitapide. Lomitapide is not licensed for use in children, but has been made available through an expanded access programme or on a named patient basis...
May 17, 2019: Advances in Therapy
Jörg Mahlich, Aranzazu Alba, Laila El Hadad, Marie-Kristin Leisten, Wiebke K Peitsch
INTRODUCTION: Our aim was to study drug survival and associated costs of biologic treatment in a German real-world cohort of biologic-naïve psoriasis patients. METHODS: We utilized a German claims database base with 3,682,561 enrolled patients between 2001 and 2015. Kaplan-Meier curves were plotted to show the persistence of different biologics. To determine factors that influence persistence, a Cox regression analysis was performed. In addition, associated costs were calculated 12 months before and after treatment start with biologics...
May 17, 2019: Advances in Therapy
Daniel Aletaha, Andrew J Epstein, Martha Skup, Patrick Zueger, Vishvas Garg, Remo Panaccione
INTRODUCTION: Immune-mediated inflammatory diseases (IMIDs) cause significant impairment in quality of life. Although they share similar genetic factors, environmental precipitants, and pathophysiological mechanisms, there is little evidence on the risk of developing subsequent IMIDs after an initial IMID diagnosis. We sought to assess the risk of developing subsequent IMIDs among patients diagnosed with an initial IMID. METHODS: This retrospective matched cohort study used a large US commercial health insurance claims database (01/01/2006-09/30/2015)...
May 17, 2019: Advances in Therapy
Yin Zhou, Garth Funston, Georgios Lyratzopoulos, Fiona M Walter
Bladder and kidney cancer are the 10th and 7th most common cancers in the United Kingdom (UK). They present with symptoms that are typically investigated via the same diagnostic pathway. However, diagnosing these cancers can be challenging, especially for kidney cancer, as many of the symptoms are non-specific and occur commonly in patients without cancer. Furthermore, the recognition and evaluation of these symptoms may differ because of the lack of supporting high-quality evidence to inform management, a problem also reflected in currently ambiguous guidelines...
May 17, 2019: Advances in Therapy
Matteo Bassetti, Daniele Roberto Giacobbe, Niki Patel, Glenn Tillotson, Jill Massey
INTRODUCTION: Infections due to Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae are associated with increased morbidity and high mortality. Meropenem-vaborbactam (MV) is a novel β-lactam/β-lactamase inhibitor combination active against KPC-producing Enterobacteriaceae. The aim of this post hoc analysis of the TANGO-II randomized controlled trial was to assess the efficacy of MV versus best available therapy (BAT) in the subgroup of patients without prior antimicrobial failure...
May 16, 2019: Advances in Therapy
Xingshun Qi, Yiling Li, Ran Wang, Lianjie Lin, Jing Li, Lijun Wang, Shuang Zheng, Yonghong Sun, Lixin Zhao, Xiaolin Fu, Mengchun Wang, Xinping Qiu, Han Deng, Chen Hong, Qianqian Li, Hongyu Li, Xiaozhong Guo
BACKGROUND AND AIMS: Endoscopy is necessary for assessment of esophageal varices (EVs) in cirrhotic patients, but its use is limited because of the poor compliance of patients and shortage of public health resources at primary hospitals or rural areas, especially in less well developed countries. A multicenter cross-sectional study aimed to establish a novel non-invasive score for prediction of EVs in cirrhotic patients who had never undergone endoscopy. METHODS: Patients with liver cirrhosis regardless of acute upper gastrointestinal bleeding (AUGIB) who underwent the first-time upper gastrointestinal endoscopy at 11 hospitals in Liaoning Province, China were considered...
May 15, 2019: Advances in Therapy
Stacey Kowal, Eliza Kruger, Pinar Bilir, James H Holmes, William Hickerson, Kevin Foster, Scott Nystrom, Jeremiah Sparks, Narayan Iyer, Katie Bush, Andrew Quick
INTRODUCTION: When introducing a new intervention into burn care, it is important to consider both clinical and economic impacts, as the financial burden of burns in the USA is significant. This study utilizes a health economic modeling approach to estimate cost-effectiveness and burn center budget-impact for the use of the RECELL® Autologous Cell Harvesting Device to prepare autologous skin cell suspension (ASCS) compared to standard of care (SOC) split-thickness skin graft (STSG) for the treatment of severe burn injuries requiring surgical intervention for definitive closure...
May 7, 2019: Advances in Therapy
Alba Piroli, Tommaso Cutilli, Ettore Lupi, Franco Marinangeli, Giustino Varrassi, Antonella Paladini
Difficult airway management and intraoperative tube damage are important problems during maxillofacial surgery. Damage occurs frequently during the surgery, and the anesthesiologist must be ready to find a quick and safe solution. Replacing the damaged endotracheal tube involves additional difficulties, and various factors must be evaluated. We present two cases of nasotracheal tube (NTT) damage suffered during maxillofacial surgery. The different intraoperative conditions led us to decide for the replacement of NTT in one case and for conservative action in the other...
May 7, 2019: Advances in Therapy
Katie Linden, Conor McQuillan, Paul Brennan, Ian B A Menown
INTRODUCTION: Many important clinical trials in cardiology were published or presented at major international meetings throughout 2018. This paper aims to offer a concise overview of these significant advances and to put them into clinical context. METHODS: Trials presented at the major international cardiology meetings during 2018 were reviewed including The American College of Cardiology, EuroPCR, The European Society of Cardiology, PCR London Valves, Transcatheter Cardiovascular Therapeutics, and the American Heart Association...
May 7, 2019: Advances in Therapy
Lynn R Webster, Eric R Kinzler, Carmela Pantaleon, Matthew Iverson, Stefan Aigner
INTRODUCTION: Oxycodone ARIR is a novel oral, abuse-deterrent, immediate-release (IR) formulation with physical and chemical properties that deter misuse and abuse by non-oral routes. In this single-dose pharmacokinetic study, we assessed the relative bioavailability of oxycodone for Oxycodone ARIR and IR oxycodone, and the effect of food on Oxycodone ARIR following oral administration. METHODS: This open-label, randomized study in healthy adults compared the relative bioavailability of Oxycodone ARIR 30 mg to IR oxycodone 30 mg under fasted conditions, and Oxycodone ARIR under fed versus fasted conditions...
May 7, 2019: Advances in Therapy
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