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Advances in Therapy | Page 2

Michael J Noss, Renee Ciesla, Gilbert Shanga
INTRODUCTION: Two multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping. METHODS: Subjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)...
June 17, 2019: Advances in Therapy
Samantha A Armstrong, Stephen V Liu
Small cell lung cancer (SCLC) is a highly lethal subtype of lung cancer that has seen few therapeutic advances, despite ongoing concerted efforts. Immunotherapy has been an effective option in other carcinogen-related cancers and has shown modest activity in SCLC. Monotherapy with the anti-PD-1 antibody nivolumab in patients with at least two prior lines of therapy was associated with a response rate of 11.9% and a median duration of response of 17.9 months, leading to accelerated approval by the Food and Drug Administration (FDA) as third-line therapy for SCLC...
June 17, 2019: Advances in Therapy
Susan Martin, Kristina Chen, Nimanee Harris, Montserrat Vera-Llonch, Alan Krasner
INTRODUCTION: A patient-reported outcome (PRO) measure specific to chronic hypoparathyroidism is lacking to facilitate the evaluation of treatment. A PRO measure that followed the recommendations of the US Food and Drug Administration (FDA) PRO guidance was created to address key hypoparathyroidism symptoms. METHODS: A literature review was conducted to identify symptoms of hypoparathyroidism and any existing PRO measures appropriate for evaluating these symptoms, followed by concept elicitation interviews involving six individuals with hypoparathyroidism...
June 10, 2019: Advances in Therapy
Richard Markus, Helen J McBride, Monica Ramchandani, Vincent Chow, Jennifer Liu, Dan Mytych, Gary Fanjiang
ABP 501 [United States: AMJEVITA™ (adalimumab-atto); European Union: AMGEVITA® (adalimumab)] is the first approved biosimilar to adalimumab [reference product (RP)], a monoclonal antibody (mAb) targeting tumor necrosis factor-alfa (TNF-α). ABP 501 has received approval for use in indications that adalimumab RP is approved for, except those protected by regulatory exclusivity. A systematic step-wise totality of evidence (TOE) approach formed the basis of approval of ABP 501; this involved methodical accumulation of scientifically robust comparative data supporting similarity in analytical, preclinical, and clinical [pharmacokinetics (PK)], efficacy, safety and immunogenicity) evaluations...
June 10, 2019: Advances in Therapy
Attila Simon, Csaba András Dézsi
INTRODUCTION: Hypertension and hypercholesterolaemia are important contributors to the development and progression of atherosclerosis. The coexistence of these two conditions is rather common: hypercholesterolaemia is present in 40-60% of hypertensive patients. Remarkably, patient compliance with antihypertensive regimens is better than with statin therapy. Thus, the inclusion of statins and blood pressure-lowering agents into a fixed combination might even double the effectiveness of statin therapy, and thereby achieve significantly greater reduction of cardiovascular risk...
June 10, 2019: Advances in Therapy
Jörgen Syk, Ines Vinge, Mikael Sörberg, Mikko Vahteristo, Paula Rytilä
Unfortunately, the mean difference in change from baseline ACT was incorrectly reported in the abstract as 19.0 vs. 20.8 instead of 18.9 vs. 20.7.
June 9, 2019: Advances in Therapy
Yifei Liu, Min Yang, Vishvas Garg, Eric Q Wu, Jessie Wang, Martha Skup
INTRODUCTION: A systematic literature review was conducted to review and summarize the economic impact of non-medical switching (NMS) from biologic originators to their biosimilars (i.e., switching a patient's medication for reasons irrelevant to the patient's health). METHODS: English publications reporting healthcare resource utilization (HRU) or costs associated with biosimilar NMS were searched in PubMed and EMBASE over the past 10 years and from selected scientific conferences over the past 3 years, along with gray literature for all biologics with an approved biosimilar (e...
June 5, 2019: Advances in Therapy
Samuel J P Malkin, Monika Russel-Szymczyk, Marek Psota, Lucia Hlavinkova, Barnaby Hunt
INTRODUCTION: Glucagon-like peptide-1 (GLP-1) receptor agonists represent a class of treatments for type 2 diabetes that offer multifactorial benefits, including glycemic control, weight loss and low hypoglycemia risk. Once-weekly semaglutide is a novel GLP-1 analog that has been associated with improved glycemic control and reduced body mass index (BMI) versus once-weekly GLP-1 receptor agonist dulaglutide in SUSTAIN 7, which is reimbursed in patients with a BMI > 35 kg/m2 in Slovakia...
June 5, 2019: Advances in Therapy
Jiri Sliva, Chrysoula N Pantzartzi, Martin Votava
Inosine pranobex (IP), commonly known as inosine acedoben dimepranol, isoprinosine and methisoprinol, has been proven to positively impact the host's immune system, by enhancing T-cell lymphocyte proliferation and activity of natural killer cells, increasing levels of pro-inflammatory cytokines, and thereby restoring deficient responses in immunosuppressed patients. At the same time, it has been shown that it can affect viral RNA levels and hence inhibit growth of several viruses. Due to its immunomodulatory and antiviral properties, and its safety profile, it has been widely used since 1971 against viral infections and diseases, among which subacute sclerosis panencephalitis, herpes simplex virus, human papilloma virus, human immunodeficiency virus, influenza and acute respiratory infections, cytomegalovirus and Epstein-Barr virus infections...
June 5, 2019: Advances in Therapy
Jason E Hawkes, Manish Mittal, Matthew Davis, Diana Brixner
INTRODUCTION: Pharmaceutical firms have begun offering online prescription management systems to facilitate prescription processing. This study evaluated the impact of the HUMIRA Complete Pro (HCPro) online prescription management system on the rate of abandonment and the time to first fill for patients prescribed adalimumab (ADA). A retrospective cohort analysis of patients initiating ADA treatment with or without use of the HCPro online prescription processing system was used to evaluate the impact of HCPro on treatment initiation outcomes...
June 5, 2019: Advances in Therapy
Jun Yuan, Guang Ma Xu, Jiawang Ding
INTRODUCTION: Although aspirin (ASA) is the mainstay of treatment for the prevention of recurrent ischemic stroke, the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial showed ASA monotherapy to be inferior to clopidogrel in preventing recurrent adverse cardiovascular outcomes in patients with high cardiac risks. Here, we aimed to systematically compare ASA versus clopidogrel monotherapy for the treatment of patients with stable coronary artery disease (CAD)...
June 1, 2019: Advances in Therapy
Jean-Bernard Auliac, Pascal Dô, Sophie Bayle, Hélène Doubre, Florent Vinas, Jacques Letreut, Lionel Falchero, Pierre Alexandre Hauss, Pascal Thomas, Christos Chouaid
BACKGROUND: Mutation of human receptor tyrosine kinase epidermal growth factor receptor-2 (HER2) is a rare event, found in approximately 1% non-small cell lung cancers (NSCLC). The objective was to investigate the clinical characteristics and management of HER2-mutated NSCLCs in a real-life setting. METHODS: This multicenter study described NSCLCs harboring HER2 mutations diagnosed between January 2012 and December 2014, according their clinical characteristics, management, and outcomes: response rate (RR), progression-free survival (PFS), and overall survival (OS)...
June 1, 2019: Advances in Therapy
Kyeong Ok Kim, Margot A Schwartz, Otto S T Lin, Michael V Chiorean, Michael Gluck
INTRODUCTION: Fecal microbiota transplantation resolves recurrent Clostridium difficile infections in greater than 82% of patients. Highly screened, processed universal donor fecal material is available. We compared cost and scheduling efficiency of fecal microbiota transplantation by universal donors to patient-directed donors. METHODS: Medical records from a prospectively maintained database of recurrent C. difficile patients who underwent fecal microbiota transplantation between 2012 and 2017 were reviewed retrospectively...
June 1, 2019: Advances in Therapy
Richard F Pollock, Gorden Muduma
No abstract text is available yet for this article.
June 1, 2019: Advances in Therapy
Ayşegül Aksan, Axel Dignass, Jürgen Stein
No abstract text is available yet for this article.
June 1, 2019: Advances in Therapy
Mark A Moyad, Larry E Robinson, Julie M Kittelsrud, Stuart G Reeves, Susan E Weaver, Aireen I Guzman, Mark E Bubak
The article ''Immunogenic Yeast-Based Fermentation Product Reduces Allergic Rhinitis-Induced Nasal Congestion: A Randomized, Double-Blind, Placebo-Controlled Trial'', written by Mark A. Moyad, Larry E. Robinson, Julie M. Kittelsrud, Stuart G. Reeves, Susan E. Weaver, Aireen I. Guzman, Mark E. Bubak was originally published electronically on the publisher's internet portal (currently Springer-Link) on 12 August, 2009.
June 1, 2019: Advances in Therapy
Dipen Patel, Ahmed Shelbaya, Raymond Cheung, Jyoti Aggarwal, Sang Hee Park, Javier Coindreau
INTRODUCTION: Evidence supports the clinical benefits of early aggressive biologic treatment in patients with rheumatoid arthritis (RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but the cost-effectiveness of early intervention with originator biologics such as tumor necrosis factor inhibitors (TNFis) or their biosimilars has not been well studied. METHODS: We developed a Markov model to estimate lifetime costs and utilities for patients with established RA who do not respond to methotrexate (MTX) therapy...
May 30, 2019: Advances in Therapy
Dmitrii N Fiev, Andrey Z Vinarov, Dmitrii G Tsarichenko, Phillip Yu Kopylov, Yuri L Demidko, Abram L Syrkin, Leonid M Rapoport, Yuri G Alyaev, Pyotr V Glybochko
INTRODUCTION: This study examined the dynamics of 24-h electrocardiogram (ECG) monitoring parameters (Holter monitoring) in patients with ischemic heart disease (IHD) before and after conservative or surgical treatment of patients with voiding and storage lower urinary tract symptoms (LTS) due to benign prostatic hyperplasia (BPH). METHODS: A total of eighty-three 57 to 81-year-old (mean age 70.4 ± 5.75 years) patients with LUTS/BPH and accompanying IHD were examined and treated at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of Sechenov University...
May 30, 2019: Advances in Therapy
Shiwei Tang, Ping Zhao, Liang Zheng, Chengming Wen, Ling Wang, Xuehua Jiang
INTRODUCTION: Factors that impact the pharmacokinetics of dapoxetine, a 5-HT selective reuptake inhibitor used for the treatment of premature ejaculation, have not been clearly identified. This study aimed to evaluate the effects of consumption of a high-fat meal and cytochrome P450 (CYP) 2D6 polymorphisms on the pharmacokinetics of dapoxetine in healthy Chinese men. METHODS: Twenty-two healthy volunteers were enrolled and classified based on their CYP2D6 genotype...
May 30, 2019: Advances in Therapy
Alexander M Faschinger, Nicole Sessler
INTRODUCTION: Pegaspargase, a pegylated asparaginase, is a core component in the treatment of acute lymphoblastic leukemia. Pegaspargase in liquid form has a limited shelf life of 8 months due to depegylation, leading to changes in purity and potency over time. Lyophilization is an approach that can improve the stability of biological drug conjugates. METHODS: Here we describe the development of a lyophilized formulation of pegaspargase and present results of a series of tests demonstrating that the lyophilized form has comparable physicochemical properties to the liquid form...
May 28, 2019: Advances in Therapy
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