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Advances in Therapy

Mat Nicholls, Ajay Manjoo, Peter Shaw, Faizan Niazi, Jeffrey Rosen
INTRODUCTION: This study aims to compare the properties of currently available intra-articular hyaluronate (IA-HA) products widely available in the USA to those of healthy knee synovial fluid with respect to their bulk rheological properties. We hypothesize that products would have differing rheological properties, with some more closely resembling the properties and physiological aspects of healthy joint fluid HA. METHODS: We obtained reported HA product molecular weights, as well as measurements of the presence of cross-linking, zero shear rate viscosity, shear thinning ratio, and crossover frequency for the following IA-HA products available in the USA: Euflexxa® , Orthovisc® , Supartz® , Monovisc® , Synvisc® , Synvisc-One® , Gel-One® , and Hyalgan® ...
March 14, 2018: Advances in Therapy
Carlo Cattaneo, Jaime Kulisevsky, Viviana Tubazio, Paola Castellani
INTRODUCTION: Chronic pain is an important yet overlooked non-motor symptom of Parkinson's disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms. OBJECTIVES: To investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment...
March 14, 2018: Advances in Therapy
Ippei Ikushima, Lene Jensen, Anne Flint, Tomoyuki Nishida, Jeppe Zacho, Shin Irie
INTRODUCTION: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects. METHODS: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0...
March 13, 2018: Advances in Therapy
Edouard J Louis, Walter Reinisch, David A Schwartz, Robert Löfberg, Anne M Robinson, Sofie Berg, Anthony W Wang, Jen-Fue Maa, Bidan Huang, Brandee Pappalardo
INTRODUCTION: Extraintestinal manifestations (EIMs) in patients with Crohn's disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate to severe CD. METHODS: EIM data were pooled from 11 induction, maintenance, and open-label extension studies of adalimumab. Resolution of EIMs was evaluated at approximately 6 months and 1 year...
March 7, 2018: Advances in Therapy
Fernando Rizzello, Ignazio Olivieri, Alessandro Armuzzi, Fabio Ayala, Vincenzo Bettoli, Luca Bianchi, Luca Cimino, Antonio Costanzo, Antonio Cristaudo, Salvatore D'Angelo, Marco Daperno, Anna Chiara Fostini, Mauro Galeazzi, Michele Gilio, Paolo Gionchetti, Paolo Gisondi, Ennio Lubrano, Antonio Marchesoni, Annamaria Offidani, Ambrogio Orlando, Daniela Pugliese, Carlo Salvarani, Raffaele Scarpa, Maurizio Vecchi, Giampiero Girolomoni
INTRODUCTION: Immune-mediated inflammatory diseases (IMIDs) are chronic autoimmune conditions that share common pathophysiologic mechanisms. The optimal management of patients with IMIDs remains challenging because the coexistence of different conditions requires the intervention of several specialists. The aim of this study was to develop a series of statements defining overarching principles that guide the implementation of a multidisciplinary approach for the management of spondyloarthritis (SpA)-related IMIDs including SpA, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and uveitis...
March 7, 2018: Advances in Therapy
Garth Funston, Helena O'Flynn, Neil A J Ryan, Willie Hamilton, Emma J Crosbie
Early diagnosis of symptomatic gynecological cancer is likely to improve patient outcomes, including survival. The primary care practitioner has a key role to play in this-they must recognize the symptoms and signs of gynecological cancer and make prompt evidence-based decisions regarding further investigation and referral. However, this is often difficult as many of the symptoms of gynecological cancers are nonspecific and are more likely to be caused by benign rather than malignant disease. As primary care is generally the first point of patient contact, those working in this setting usually encounter cancer patients at an earlier, and possibly less symptomatic, stage than practitioners in secondary care...
March 7, 2018: Advances in Therapy
Missak Haigentz, Carlos Suarez, Primoz Strojan, Juan P Rodrigo, Alessandra Rinaldo, Carol R Bradford, June Corry, Robert P Takes, Alfio Ferlito
The new 8th edition AJCC/UICC staging system for human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC), developed to account for improved survival outcomes over HPV-negative cancers, includes anatomic features strictly associated with tumor-node-metastasis (TNM) and does not account for patient-specific characteristics that may impact prognosis. This commentary evaluates the evidence of smoking as an adverse prognostic factor in HPV-associated OPSCC. We review the multifactorial biological, clinical, and social/behavioral characteristics of smokers with OPSCC that impact outcomes, discuss current challenges with incorporating smoking history in prognostic classifications, and consider opportunities for future investigation...
March 6, 2018: Advances in Therapy
Hrvoje Barić, Veljko Đorđević, Ivan Cerovečki, Vladimir Trkulja
INTRODUCTION: The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults. METHODS: Data sources. Six electronic databases ("generalized anxiety (disorder)" and "randomized trial") and reference lists of identified publications were searched to March 2017. STUDY SELECTION: Eligibility: full-text publications (English, German language); CAM versus conventional treatment, placebo/sham or no treatment; GAD diagnosed according to standard criteria; and a validated scale for disease severity...
March 5, 2018: Advances in Therapy
Maria Glezer, Yuri Vasyuk, Yuri Karpov
INTRODUCTION: Heart rate (HR) reduction is an integral part of antianginal therapy, but many patients do not reach the guideline-recommended target of less than 60 bpm despite high use of beta-blockers (BB). Failure to uptitrate BB doses may be partly to blame. To explore other options for lowering HR and improving angina control, CONTROL-2 was initiated to compare the efficacy and tolerability of the combination of BBs with ivabradine versus uptitration of BBs to maximal tolerated dose, in patients with stable angina...
March 5, 2018: Advances in Therapy
Bruno K Rodiño-Janeiro, María Vicario, Carmen Alonso-Cotoner, Roberto Pascua-García, Javier Santos
Irritable bowel syndrome (IBS), one of the most frequent digestive disorders, is characterized by chronic and recurrent abdominal pain and altered bowel habit. The origin seems to be multifactorial and is still not well defined for the different subtypes. Genetic, epigenetic and sex-related modifications of the functioning of the nervous and immune-endocrine supersystems and regulation of brain-gut physiology and bile acid production and absorption are certainly involved. Acquired predisposition may act in conjunction with infectious, toxic, dietary and life event-related factors to enhance epithelial permeability and elicit mucosal microinflammation, immune activation and dysbiosis...
March 1, 2018: Advances in Therapy
Susanne V Fleig, Bettina Weger, Hermann Haller, Florian P Limbourg
INTRODUCTION: We conducted a prospective, non-interventional, multicenter study to examine the effect of a fixed-dose combination of perindopril/amlodipine in patients with arterial hypertension. METHODS: Patients who were previously untreated or required a change in medication were treated with a fixed combination of perindopril/amlodipine (3.5/2.5 or 7.0/5.0 mg) for 12 weeks. Changes in office, home and ambulatory blood pressure (BP) were recorded. Adherence was assessed by the Hill-Bone medication adherence scale...
March 1, 2018: Advances in Therapy
Yuichiro Yamada, Yasuo Terauchi, Hirotaka Watada, Yasuhiko Nakatsuka, Kazuhito Shiosakai, Takuo Washio, Takashi Taguchi
INTRODUCTION: G protein-coupled receptor 119 (GPR119) is a promising target for the treatment of type 2 diabetes mellitus (T2DM), as both insulin and glucagon-like peptide-1 secretion can be promoted with a single drug. We compared the efficacy and safety of the GPR119 agonist DS-8500a with placebo and sitagliptin 50 mg in Japanese patients with T2DM. METHODS: This randomized, double-blind, parallel-group comparison study was conducted in Japan (trial registration NCT02628392, JapicCTI-153068)...
February 27, 2018: Advances in Therapy
Sarah L Anderson, Joel C Marrs
This article reviews current literature on the role of pharmacists in the transition of care (TOC) for patients with heart failure (HF) and the impact of their contributions on therapeutic and economic outcomes. Optimizing the TOC for patients with HF from the hospital to the community/home is crucial for improving outcomes and decreasing high rates of hospital readmissions, which are associated with increased morbidity, mortality, and costs. A multidisciplinary team approach to the management of patients with HF facilitates the transition from the hospital to the ambulatory care setting, allowing for the consideration of medical, pharmacological, and lifestyle variables that impact the care of individual patients...
February 27, 2018: Advances in Therapy
Joe Alexander, Roger A Edwards, Luigi Manca, Roberto Grugni, Gianluca Bonfanti, Birol Emir, Edward Whalen, Stephen Watt, Bruce Parsons
INTRODUCTION: Achieving a therapeutic response to pregabalin in patients with painful diabetic peripheral neuropathy (pDPN) requires adequate upward dose titration. Our goal was to identify relationships between titration and response to pregabalin in patients with pDPN. METHODS: Data were integrated from nine randomized, placebo-controlled clinical trials as well as one 6-week open-label observational study conducted by 5808 physicians (2642 patients with pDPN) in standard outpatient settings in Germany...
February 23, 2018: Advances in Therapy
Jonathan S Myers, Imran Masood, Dana M Hornbeak, Jose I Belda, Gerd Auffarth, Anselm Jünemann, Jane Ellen Giamporcaro, Jose M Martinez-de-la-Casa, Iqbal Ike K Ahmed, Lilit Voskanyan, L Jay Katz
INTRODUCTION: This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG). METHODS: Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1-3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost...
February 23, 2018: Advances in Therapy
Ahmed M Soliman, Eric Surrey, Machaon Bonafede, James K Nelson, Jane Castelli-Haley
INTRODUCTION: The prevalence of endometriosis and the need for treatment in the USA has led to the need to explore the contemporary cost burden associated with the disease. This retrospective cohort study compared direct and indirect healthcare costs in patients with endometriosis to a control group without endometriosis. METHODS: Women aged 18-49 years with endometriosis (date of initial diagnosis = index date) were identified in the Truven Health MarketScan® Commercial database between 2010 and 2014 and female control patients without endometriosis were matched by age and index year...
February 15, 2018: Advances in Therapy
Prashanth Sunkureddi, Dawn Gibson, Stephen Doogan, John Heid, Samir Benosman, Yujin Park
INTRODUCTION: Online communities contain a wealth of information containing unsolicited patient experiences that may go beyond what is captured by guided surveys or patient-reported outcome (PRO) instruments used in clinical settings. This study described patient experiences reported online to better understand the day-to-day disease burden of ankylosing spondylitis (AS). METHODS: Unguided, English-language patient narratives reported between January 2010 and May 2016 were collected from 52 online sources (e...
February 15, 2018: Advances in Therapy
Francisco J Civantos, Barış Karakullukcu, Merrill Biel, Carl E Silver, Alessandra Rinaldo, Nabil F Saba, Robert P Takes, Vincent Vander Poorten, Alfio Ferlito
Photodynamic therapy (PDT) involves the use of a phototoxic drug which is activated by low powered laser light to destroy neoplastic cells. Multiple photosensitizers have been studied and tumors have been treated in a variety of head and neck sites over the last 30 years. PDT can effectively treat head and neck tumors, particularly those of the superficial spreading type, and the classic application of this technology has been in the patient with a wide field of dysplastic change and superficial carcinomatosis...
February 7, 2018: Advances in Therapy
Shufei Zang, Jin Chen, Yu Song, Lang Bai, Jinjun Chen, Xiaoling Chi, Fangping He, Huiping Sheng, Jing Wang, Shilong Xie, Wen Xie, Yongfeng Yang, Jing Zhang, Minghua Zheng, Zhengsheng Zou, Bingyuan Wang, Junping Shi
INTRODUCTION: Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH...
February 6, 2018: Advances in Therapy
SeungHwan Lee, Jun Gi Hwang, Sang Yeob Park, Hye Jung Lim, Sa-Won Lee, Min-Hyo Seo, JaeWoo Kim, Jang Hee Hong
BACKGROUND: Lenalidomide is used for the treatment of multiple myeloma in combination with dexamethasone. The purpose of this study was to compare the pharmacokinetics (PKs) and assess the bioequivalence of two formulations of lenalidomide 25 mg: Lenalid® 25 mg tablet (test formulation) and Revlimid® 25 mg capsule (reference formulation). METHODS: A randomized, single-dose, two-treatment, two-period, two-sequence crossover study was conducted in 42 healthy subjects...
February 6, 2018: Advances in Therapy
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