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Drugs in R&D

Prashanth Rawla, Tagore Sunkara, Krishna Chaitanya Thandra, Vinaya Gaduputi
BACKGROUND AND OBJECTIVE: Eosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence. METHODS: In April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central...
November 2, 2018: Drugs in R&D
Eiji Kutoh, Asuka Wada, Teruma Murayama, Jyunka Hayashi
OBJECTIVES: The aim of this study was to investigate the relations between the changes in body weight and those of glycemic and non-glycemic parameters in drug-naïve subjects with type 2 diabetes mellitus (T2DM) treated with canagliflozin monotherapy. METHODS: Subjects received 50-100 mg/day canagliflozin monotherapy for 3 months (n = 36), and were then divided into two groups: (1) those who lost weight [changes in (Δ)BMI ≤ - 0.45, p < 0.00001: Group L(ost), n = 20); and (2) those who did not lose weight [ΔBMI > - 0...
October 15, 2018: Drugs in R&D
Léa Darnaud, Fabien Lamoureux, Cendrine Godet, Sandrine Pontier, Alexia Debard, Nicolas Venisse, Pauline Martins, Didier Concordet, Peggy Gandia
BACKGROUND: Isavuconazole is a new antifungal prodrug for the treatment of invasive aspergillosis and mucormycosis. As no clear pharmacokinetic-pharmacodynamic relationship has been established for patients, therapeutic drug monitoring is not currently required. However, as isavuconazole is a new drug, clinicians are sometimes sceptical about the exposure achieved in their patients and seek pharmacokinetic exploration. A minimal response consists of determining that the patient's pharmacokinetic profile agrees with profiles reported by Desai et al...
October 10, 2018: Drugs in R&D
André R Durães, Yasmin de Souza Lima Bitar, José Admirço L Filho, Igor S Schonhofen, Edmundo J N Camara, Leonardo Roever, Hugo E D P Cardoso, Kevan M Akrami
INTRODUCTION: Mechanical heart valves (MHV) are extremely durable, but they require permanent use of anticoagulation to prevent thromboembolic events. The only approved therapeutic options are vitamin K antagonists (VKAs), such as warfarin. As a drug class, clinical management is difficult, therefore new alternatives need to be evaluated. METHODS: RIWA is a phase II/III, prospective, open-label, randomized, pilot study designed to investigate oral rivaroxaban 15 mg twice daily compared with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in patients with MHV, from August 2018 to December 2019...
October 6, 2018: Drugs in R&D
John M Slopis, Octavio Arevalo, Cynthia S Bell, Adelaide A Hebert, Hope Northrup, Roy F Riascos, Joshua A Samuels, Keri C Smith, Patti Tate, Mary Kay Koenig
BACKGROUND: Cutaneous neurofibromas cause disfigurement and discomfort in individuals with neurofibromatosis type 1 (NF-1). METHODS: The primary objective of this phase II, open-label, single-arm trial was to assess whether orally administered everolimus reduced the surface volume of cutaneous neurofibromas in patients with NF-1. RESULTS: Of 22 patients who took the study drug, 17 completed the trial; 5 patients withdrew due to adverse events...
October 3, 2018: Drugs in R&D
Bilal H Lashari, Yazhini Vallatharasu, Lakshmi Kolandra, Mohsin Hamid, Dipesh Uprety
Small cell lung cancer (SCLC) comprises about 15% of all cases of lung cancer. In recent years, owing to a change in the epidemiology of smoking habits, the incidence of the tumor has decreased; however, it remains a significant challenge to global health. While the tumor has a favorable initial response to chemoradiation, relapse is invariable, and second-line regimens may be intolerable given the severity of side effects. For patients with tumors resistant to second-line regimens, no current standard regimens exist...
September 19, 2018: Drugs in R&D
Dongmi Kim, Nicole L Ryba, Julie Kalabalik, Ligia Westrich
Currently, all second-generation antipsychotics are approved for schizophrenia. Many are also approved for bipolar disorder, with some also approved as adjunctive treatment for depression and autism-related irritability. Second-generation antipsychotics are increasingly being prescribed for indications other than those approved by the Food and Drug Administration, such as in dementia, anxiety, and post-traumatic stress disorder to name a few. Obsessive-compulsive and related disorders are a group of disorders characterized by preoccupation and repetitive behaviors...
September 2018: Drugs in R&D
Valeria Tellone, Paola Coppola, Marco Ammendola, Giorgio Di Loreto, Rossella Picollo, Alessandra Del Vecchio, Alessandro Comandini, Fabio Garofolo, Serena Tongiani
BACKGROUND: The antibacterial agent prulifloxacin, a prodrug of ulifloxacin, is indicated in the treatment of acute lower urinary tract infections, acute exacerbation of chronic bronchitis and acute bacterial rhinosinusitis. OBJECTIVE: We aimed to provide new insights on the pharmacokinetics (PK) of ulifloxacin in patients with different degrees of renal impairment. METHODS: A two-site, international, open-label, parallel-group, single- and repeated-dose study was performed...
September 2018: Drugs in R&D
Teruko Nakamura, Taisei Fujisaki, Motoaki Miyazono, Maki Yoshihara, Hiroshi Jinnouchi, Kenichi Fukunari, Yuki Awanami, Yuki Ikeda, Kohei Hashimoto, Masatora Yamasaki, Yasunori Nonaka, Makoto Fukuda, Tomoya Kishi, Yuji Ikeda
BACKGROUND: Concerns about sodium overload when using sodium polystyrene sulfonate (Na-resin) as an ion-exchange resin for the treatment of hyperkalemia led our institution to gradually shift to the use of calcium polystyrene sulfonate (Ca-resin). However, as serum potassium levels were insufficiently controlled and patients experienced constipation, we returned to using Na-resin and observed better results than previously. OBJECTIVE: As few papers have examined the potassium adsorption ability of Ca-resin compared with Na-resin, we investigated this issue within our institution...
September 2018: Drugs in R&D
Magda Opsomer, Dessislava Dimitrova, Johan Verspeelt, Amy Purrington, Abdul Mehbob, Scott Chavers, Helen Pai, Simon Vanveggel, Donghan Luo, Kimberley Brown, Christiane Moecklinghoff, Richard E Nettles, Katia Boven
In the original publication of the article, Table 2 has been published incorrectly.
September 2018: Drugs in R&D
Daniel Gil
No abstract text is available yet for this article.
September 2018: Drugs in R&D
Vance J Bray, Aaron Broadwell, Herbert S B Baraf, Shawn Black, Brenna L Brady, Joseph Tkacz, Lorraine Yarngo, Raphael J DeHoratius
PURPOSE: For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage symptoms and disease progression. This study examined the utilization and effectiveness of intravenous golimumab within a real-world population of patients with RA switching directly from infliximab, a potent anti-TNF. METHODS: Patient charts (n = 113) were collected from five US-based rheumatology practices...
September 2018: Drugs in R&D
Richard Dimelow, James G Wright, Merran MacPherson, Paul Newell, Shampa Das
OBJECTIVES: Our objective was to develop population pharmacokinetic (PK) models for ceftazidime and avibactam in the plasma and epithelial lining fluid (ELF) of healthy volunteers and to compare ELF concentrations to plasma PK/pharmacodynamic (PD) targets. METHODS: Plasma and ELF population PK models were developed for ceftazidime and avibactam concentration data from 42 subjects (NCT01395420). Two- and three-compartment plasma PK models were fitted to ceftazidime and avibactam plasma PK data, and different plasma-ELF linked models were evaluated...
September 2018: Drugs in R&D
Magda Opsomer, Dessislava Dimitrova, Johan Verspeelt, Amy Purrington, Abdul Mehbob, Scott Chavers, Helen Pai, Simon Vanveggel, Donghan Luo, Kimberley Brown, Christiane Moecklinghoff, Richard E Nettles, Katia Boven
INTRODUCTION: We evaluated cardiovascular disease (CVD) risk associated with darunavir treatment and examined the demographic/clinical characteristics of darunavir users based on data from Janssen-sponsored clinical trials, post-marketing pharmacovigilance databases, and administrative claims databases. METHODS: First, selected CVD events [myocardial infarction, stroke, sudden death, invasive cardiovascular procedures (coronary artery angioplasty or bypass, or carotid endarterectomy)] were analyzed in 19 Janssen-sponsored phase 2-4 studies (incidence rates estimated from pooled data; 95% confidence intervals derived from Poisson distribution)...
September 2018: Drugs in R&D
Syed Ahmed Zaki, Mohan B Krishnamurthy, Atul Malhotra
BACKGROUND AND OBJECTIVE: Octreotide is a somatostatin analogue and has been used off-label for a variety of conditions. There are no specific guidelines for the use of octreotide in neonates and its safety and efficacy have not been systematically evaluated. The objective of this study is to present our experience of using octreotide therapy in neonates. METHODS: This is a retrospective study of neonates who received octreotide therapy during their hospital stay over a 15 years period (2003-2017) in a tertiary neonatal centre...
September 2018: Drugs in R&D
Jordi Guitart, María Isabel Vargas, Vicente De Sanctis, Jordi Folch, Rafael Salazar, José Fuentes, Joan Coma, Julia Ferreras, Jordi Moya, Albert Tomás, Pere Estivill, Francisco Rodelas, Antonio Javier Jiménez, Almudena Sanz
In the Original Publication.
July 9, 2018: Drugs in R&D
Marie Cullberg, Cecilia Arfvidsson, Bengt Larsson, Anna Malmgren, Patrick Mitchell, Ulrika Wählby Hamrén, Heather Wray
OBJECTIVE: The aim of this study was to summarise the pharmacokinetic findings from eight phase I studies in healthy volunteers given oral AZD5069, a selective small-molecule CXCR2 antagonist. METHODS: 240 healthy volunteers across eight phase I studies received single (0.1-200 mg) or multiple once- or twice-daily (10-120 mg) oral AZD5069 as solution, suspension, capsules or tablets. Pharmacokinetics were evaluated using non-compartmental analysis methods. RESULTS: AZD5069 was rapidly absorbed (time to maximum concentration ~ 2 h) under fasting conditions...
June 2018: Drugs in R&D
Sebastiano Buti, Maddalena Donini, Melissa Bersanelli, Alessia Gattara, Francesco Leonardi, Rodolfo Passalacqua
In the Original Publication of the article, In Introduction part, 7th line, the value "5-100nM" has been published incorrectly. The correct value should read as "Plasma concentration of 50-100ng/ml". In the Original Publication of the article, page 591, Table 2 has been published incorrectly. The corrected table is shown in the following page.
June 2018: Drugs in R&D
José López-Cedrún, Sebastián Videla, Miguel Burgueño, Inma Juárez, Samir Aboul-Hosn, Rafael Martín-Granizo, Joan Grau, Miguel Puche, José-Luis Gil-Diez, José-Antonio Hueto, Anna Vaqué, Mariano Sust, Carlos Plata-Salamán, Antoni Monner
BACKGROUND: Co-crystal of tramadol-celecoxib (CTC), containing equimolar quantities of the active pharmaceutical ingredients (APIs) tramadol and celecoxib (100 mg CTC = 44 mg rac-tramadol hydrochloride and 56 mg celecoxib), is a novel API-API co-crystal for the treatment of pain. We aimed to establish the effective dose of CTC for treating acute pain following oral surgery. METHODS: A dose-finding, double-blind, randomised, placebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778-21) was performed in male and female patients aged ≥ 18 years experiencing moderate to severe pain following extraction of two or more impacted third molars requiring bone removal...
June 2018: Drugs in R&D
Manon Auffret, Sophie Drapier, Marc Vérin
In the original publication, the name of the author in T.
June 2018: Drugs in R&D
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