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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
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
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
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
Mark Allison, Cecilia Hale
INTRODUCTION: Doxylamine tablets are approved as an over-the-counter sleep aid. We developed a doxylamine succinate intranasal metered-dose delivery system with the expectation of a more rapid onset of action with reduced side-effect potential compared with the oral tablet. METHODS: This phase I study randomized 24 adults with chronic intermittent sleep impairment to receive either single doses of intranasal doxylamine succinate 3.2, 6.3, or 12.7 mg or doxylamine succinate 25-mg oral tablet...
June 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
OBJECTIVE: Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen. METHODS: Subgroup analyses from a recently completed study were performed according to cancer stage (locally advanced cancer [LAC] vs. metastatic cancer) and most frequent background opioid medication (fentanyl vs. oxycodone/naloxone). The efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset of pain relief, and adverse events (AEs)...
June 2018: Drugs in R&D
Manon Auffret, Sophie Drapier, Marc Vérin
Apomorphine is now recognized as the oldest antiparkinsonian drug on the market. Though still underused, it is increasingly prescribed in Europe for patients with advanced Parkinson's disease (PD) with motor fluctuations. However, its history is far from being limited to movement disorders. This paper traces the history of apomorphine, from its earliest empirical use, to its synthesis, pharmacological development, and numerous indications in human and veterinary medicine, in light of its most recent uses and newest challenges...
June 2018: Drugs in R&D
John Marcinak, Majid Vakilynejad, Akifumi Kogame, Yoshihiko Tagawa
BACKGROUND AND AIMS: Fasiglifam, a potent, selective novel agonist of G protein-coupled receptor 40, stimulates insulin secretion at elevated blood glucose levels in a glucose-dependent manner. This study evaluated the potential effect of hepatic impairment on the pharmacokinetics and safety of a single dose of fasiglifam and its metabolite M-I. Fasiglifam's clinical development was halted due to liver safety concerns. METHODS: In this phase I, open-label study, subjects with mild or moderate hepatic impairment, along with matched controls (gender, weight, age, and smoking status), received a single, 25-mg oral dose of fasiglifam...
June 2018: Drugs in R&D
Andreas Liebl, Viswanathan Mohan, Wenying Yang, Krzysztof Strojek, Sultan Linjawi
Since clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published that highlight new aspects, including use in real-world populations. Evidence from 35 new studies confirms and builds upon previous work indicating that BIAsp 30 continues to have pharmacodynamic and clinical advantages over biphasic human insulin (BHI 30), including in real-world practice with unselected populations of patients...
March 2018: Drugs in R&D
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