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https://www.readbyqxmd.com/read/29454255/effects-of-adjunctive-eslicarbazepine-acetate-on-neurocognitive-functioning-in-children-with-refractory-focal-onset-seizures
#1
Sergiusz Jóźwiak, P Veggiotti, J Moreira, H Gama, F Rocha, P Soares-da-Silva
PURPOSE: This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS). METHODS: Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg/kg/day (target dose), and maintained for 8weeks, followed by one-year open-label follow-up...
February 13, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29453628/safety-tolerability-and-preliminary-activity-of-imgn529-a-cd37-targeted-antibody-drug-conjugate-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-a-dose-escalation-phase-i-study
#2
Anastasios Stathis, Ian W Flinn, Sumit Madan, Kami Maddocks, Arnold Freedman, Steven Weitman, Emanuele Zucca, Mihaela C Munteanu, M Lia Palomba
Background CD37 is expressed on B-cell lymphoid malignancies, thus making it an attractive candidate for targeted therapy in non-Hodgkin lymphoma (NHL). IMGN529 is an antibody-drug conjugate comprising a CD37-binding antibody linked to the maytansinoid DM1, a potent anti-mitotic agent. Methods This first-in-human, phase 1 trial recruited adult patients with relapsed or refractory B-cell NHL. The primary objective was to determine the maximum tolerated dose (MTD) and recommended phase 2 dose. Secondary objectives were to evaluate safety, pharmacokinetics, and preliminary clinical activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453627/a-phase-i-and-pharmacokinetic-study-of-taladegib-a-smoothened-inhibitor-in-japanese-patients-with-advanced-solid-tumors
#3
Hideki Ueno, Shunsuke Kondo, Shusuke Yoshikawa, Koichi Inoue, Valérie Andre, Masaomi Tajimi, Haruyasu Murakami
Background This phase I dose-escalation study investigated the safety of the Smoothened inhibitor taladegib in Japanese patients with advanced solid tumors. Methods Patients received taladegib orally once daily for 28-day cycles, using a 3 + 3 dose-escalation method. The primary objective was the safety and tolerability of taladegib at doses up to the global recommended dose (400 mg). Secondary objectives included pharmacokinetics, changes in skin glioma-associated oncogene homolog 1 (Gli1) transcript levels, and antitumor activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453626/drug-approval-based-on-randomized-phase-3-trials-for-relapsed-malignancy-analysis-of-oncologic-drugs-granted-accelerated-approval-publications-and-clinical-trial-databases
#4
Sumimasa Nagai, Keiya Ozawa
Background As relapsed disease is frequently the first target of newly developed therapies, it is vital to address the difficulty in demonstrating the efficacy of new drugs for relapsed malignancy in randomized phase 3 trials. Methods We analyzed the approved indications, target populations, and development status of post-marketing confirmatory trials of all oncology-related drugs that were granted accelerated approval for both hematological and solid malignancies. Furthermore, we searched for randomized phase 3 trials for adult patients with relapsed lymphoid malignancy, other than chronic lymphocytic leukemia (CLL) and multiple myeloma (MM)...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453305/frequency-and-outcomes-of-reduced-dose-non-vitamin-k-antagonist-anticoagulants-results-from-orbit-af-ii-the-outcomes-registry-for-better-informed-treatment-of-atrial-fibrillation-ii
#5
Benjamin A Steinberg, Peter Shrader, Karen Pieper, Laine Thomas, Larry A Allen, Jack Ansell, Paul S Chan, Michael D Ezekowitz, Gregg C Fonarow, James V Freeman, Bernard J Gersh, Peter R Kowey, Kenneth W Mahaffey, Gerald V Naccarelli, James A Reiffel, Daniel E Singer, Eric D Peterson, Jonathan P Piccini
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. METHODS AND RESULTS: We analyzed data from the ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients...
February 16, 2018: Journal of the American Heart Association
https://www.readbyqxmd.com/read/29453217/time-spent-in-inactive-disease-before-mtx-withdrawal-is-relevant-with-regard-to-the-flare-risk-in-patients-with-jia
#6
Jens Klotsche, Kirsten Minden, Martina Niewerth, Gerd Horneff
OBJECTIVES: To determine the reasons of methotrexate (MTX) discontinuation, frequency of adverse events (AE) and whether the time in inactive disease before MTX withdrawal disease is associated with the risk of disease flare. METHODS: Patients with juvenile idiopathic arthritis (JIA) beginning treatment with MTX were prospectively observed in the national JIA biologic register Biologika in der Kinderrheumatologie/Biologics in Paediatric Rheumatology and its follow-up register Juvenile arthritis Methotrexate/Biologics long-term Observation...
February 16, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29452942/early-safety-and-efficacy-of-the-combination-of-bedaquiline-and-delamanid-for-the-treatment-of-patients-with-drug-resistant-tuberculosis-in-armenia-india-and-south-africa-a-retrospective-cohort-study
#7
Gabriella Ferlazzo, Erika Mohr, Chinmay Laxmeshwar, Catherine Hewison, Jennifer Hughes, Sylvie Jonckheere, Naira Khachatryan, Virginia De Avezedo, Lusine Egazaryan, Amir Shroufi, Stobdan Kalon, Helen Cox, Jennifer Furin, Petros Isaakidis
BACKGROUND: Bedaquiline and delamanid have been approved for treatment of multidrug-resistant (MDR) tuberculosis in the past 5 years. Because of theoretical safety concerns, patients have been unable to access the two drugs in combination. Médecins Sans Frontières has supported the use of combination bedaquiline and delamanid for people with few treatment options since 2016. We describe early safety and efficacy of regimens containing the bedaquiline and delamanid combination in patients with drug-resistant tuberculosis in Yerevan, Armenia; Mumbai, India; and Khayelitsha, South Africa...
February 13, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29452601/reactive-hyperemia-index-rhi-and-cognitive-performance-indexes-are-associated-with-histologic-markers-of-liver-disease-in-subjects-with-non-alcoholic-fatty-liver-disease-nafld-a-case-control-study
#8
Antonino Tuttolomondo, Salvatore Petta, Alessandra Casuccio, Carlo Maida, Vittoriano Della Corte, Mario Daidone, Domenico Di Raimondo, Rosaria Pecoraro, Roberto Fonte, Anna Cirrincione, Rita Zafonte, Daniela Cabibi, Calogero Cammà, Vito Di Marco, Anna Licata, Franco Magliozzo, Giulio Marchesini, Giovanni Merlino, Antonio Craxì, Antonio Pinto
BACKGROUND: No study evaluated vascular health markers in subjects with non-alcoholic fatty liver disease (NAFLD) through a combined analysis of reactive hyperemia peripheral arterial tonometry (RH-PAT) and arterial stiffness indexes. AIM OF THE STUDY: We aimed to assess whether NAFLD and its histological severity are associated with impairment of arterial stiffness and RH-PAT indexes in a mixed cohort of patients with biopsy-proven NAFLD. MATERIALS AND METHODS: The Kleiner classification was used to grade NAFLD grade...
February 16, 2018: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/29452497/no-signal-of-interactions-between-influenza-vaccines-and-drugs-used-for-chronic-diseases-a-case-by-case-analysis-of-the-vaccine-adverse-event-reporting-system-and-vigibase
#9
Carla Carnovale, Emanuel Raschi, Luca Leonardi, Ugo Moretti, Fabrizio De Ponti, Marta Gentili, Marco Pozzi, Emilio Clementi, Elisabetta Poluzzi, Sonia Radice
BACKGROUND: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. RESEARCH DESIGN AND METHODS: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i...
February 16, 2018: Expert Review of Vaccines
https://www.readbyqxmd.com/read/29452450/-cost-comparison-of-licensed-intravitreal-therapies-for-insufficiently-anti-vegf-responding-fovea-involving-diabetic-macular-edema-in-germany
#10
Aljoscha S Neubauer, Christos Haritoglou, Michael W Ulbig
BACKGROUND: In the treatment of center-involving diabetic macular edema, despite initial therapy with an anti-VEGF compound, an insufficient response may occur. Further therapy options include a switch of anti-VEGF products or to corticosteroid implants, such as Fluocinolone acetonide or Dexamethasone. OBJECTIVES: Firstly, to investigate systematically which evidence-based study data are available describing the efficacy of in-label treatments after primary anti-VEGF treatment, secondly, to investigate which costs go along for the healthcare provider...
February 16, 2018: Klinische Monatsblätter Für Augenheilkunde
https://www.readbyqxmd.com/read/29452338/potential-benefits-of-prasugrel-and-ticagrelor-is-diabetics-are-not-substantiated-by-the-food-and-drug-administration-adverse-event-repository
#11
Victor L Serebruany, Moo Hyun Kim, Nikita Lomakin
No abstract text is available yet for this article.
February 14, 2018: European Heart Journal. Cardiovascular Pharmacotherapy
https://www.readbyqxmd.com/read/29452300/therapeutic-strategy-for-rheumatoid-arthritis-patients-who-have-achieved-remission
#12
Bruno Fautrel
Once remission or low disease activity (LDA) is attained in established rheumatoid arthritis (RA) patients, attempting disease-modifying anti-rheumatic drug (DMARD) tapering appears to be a viable option to avoid patient overtreatment. Potential benefits include reduction in the treatment burden and the risk of adverse events, although the latter has not been demonstrated convincingly.The feasibility of DMARD discontinuation has been tested in numerous studies or trials. All have revealed a high risk of relapse, ranging from 56% to 87% at one year...
February 13, 2018: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/29451407/advancements-in-drug-development-for-diarrhea-predominant-irritable-bowel-syndrome
#13
Giovanni Dothel, Maria Raffaell Barbaro, Emanuel Raschi, Giovanni Barbara, Fabrizio De Ponti
Introduction Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered This review summarizes the latest advancements in the pipeline of IBS-D drugs focusing on new pharmacological targets, efficacy and safety of medicinal products considering the recent harmonization of regulatory requirements by the FDA and the EMA...
February 16, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29450893/dofetilide-for-suppression-of-atrial-fibrillation-in-hypertrophic-cardiomyopathy-a-case-series-and-literature-review
#14
JoEllyn C Moore, Lena Trager, Lucille E Anzia, Walid Saliba, Mohamed Bassiouny, Mandeep Bhargava, Mina Chung, Milind Desai, Ross Garberich, Harry Lever, Bruce D Lindsay, Jay Sengupta, Patrick Tchou, Oussama Wazni, Bruce L Wilkoff
BACKGROUND: Limited medical options are available for rhythm control in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). There are no published reports of dofetilide use in this population. METHODS: A retrospective chart review was conducted on1,404 patients loaded on dofetilide for AF suppression at the Cleveland Clinic from 2008-2012, 25 of whom were found to have HCM. RESULTS: The HCM cohort was 32% female, 76% with persistent AF, mean age of 59 ± 10 years and mean ejection fraction (EF) of 54 ± 9 %...
February 16, 2018: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/29450890/efficacy-and-safety-of-eslicarbazepine-acetate-monotherapy-in-patients-converting-from-carbamazepine
#15
Ladislav Pazdera, Michael R Sperling, Jay H Harvey, Maria C Sam, Laura A Strom, David Blum, Todd Grinnell, Hailong Cheng
OBJECTIVE: To evaluate the influence of prior use of carbamazepine (CBZ) and other antiepileptic drugs (AEDs) with a putatively similar mechanism of action (inhibition of voltage-gated sodium channels; VGSCs) on seizure outcomes and tolerability when converting to eslicarbazepine acetate (ESL), using data pooled from 2 controlled conversion-to-ESL monotherapy trials (studies: 093-045, 093-046). METHODS: Adults with treatment-resistant focal (partial-onset) seizures were randomized 2:1 to ESL 1600 or 1200 mg once daily...
February 16, 2018: Epilepsia
https://www.readbyqxmd.com/read/29450684/application-and-impact-of-run-in-studies
#16
Michael Fralick, Jerry Avorn, Jessica M Franklin, Abdurrahman Abdurrob, Aaron S Kesselheim
BACKGROUND: A run-in phase is often employed prior to randomization in a clinical trial to exclude non-adherent patients, placebo responders, active drug non-responders, or patients who do not tolerate the active drug. This may impact the generalizability of trial results. OBJECTIVE: To determine if clinical outcomes differed between randomized controlled trials with run-in phases compared with randomized controlled trials of the same medication without run-in phases...
February 15, 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/29450636/comparing-the-efficacy-of-low-dose-vs-high-dose-cyclophosphamide-regimen-as-induction-therapy-in-the-treatment-of-proliferative-lupus-nephritis-a-single-center-study
#17
Sonal Mehra, Jignesh B Usdadiya, Vikramraj K Jain, Durga Prasanna Misra, Vir Singh Negi
Cyclophosphamide (CYC) has been the backbone immunosuppressive drug to achieve sustained remission in lupus nephritis (LN). The aim was to evaluate the efficacy and compare adverse effects of low and high dose intravenous CYC therapy in Indian patients with proliferative lupus nephritis. An open-label, parallel group, randomized controlled trial involving 75 patients with class III/IV LN was conducted after obtaining informed consent. The low dose group (n = 38) received 6 × 500 mg CYC fortnightly and high dose group (n = 37) received 6 × 750 mg/m 2 CYC four-weekly followed by azathioprine...
February 15, 2018: Rheumatology International
https://www.readbyqxmd.com/read/29450468/activity-and-safety-of-cetuximab-plus-modified-folfoxiri-followed-by-maintenance-with-cetuximab-or-bevacizumab-for-ras-and-braf-wild-type-metastatic-colorectal-cancer-a-randomized-phase-2-clinical-trial
#18
Chiara Cremolini, Carlotta Antoniotti, Sara Lonardi, Giuseppe Aprile, Francesca Bergamo, Gianluca Masi, Roberta Grande, Giuseppe Tonini, Claudia Mescoli, Giovanni Gerardo Cardellino, Luigi Coltelli, Lisa Salvatore, Domenico Cristiano Corsi, Cristiana Lupi, Donatello Gemma, Monica Ronzoni, Emanuela Dell'Aquila, Federica Marmorino, Francesca Di Fabio, Maria Laura Mancini, Lorenzo Marcucci, Gabriella Fontanini, Vittorina Zagonel, Luca Boni, Alfredo Falcone
Importance: The combination of a triple-drug chemotherapy regimen with an anti-epidermal growth factor receptor (EGFR) agent as a first-line treatment of metastatic colorectal cancer (mCRC) showed promising activity along with safety concerns in single-arm phase 2 trials. The role of maintenance following chemotherapy and anti-EGFR and the optimal regimen to be adopted are not established. Objectives: To evaluate the activity and safety of cetuximab plus modified FOLFOXIRI (mFOLFOXIRI) and explore the role of maintenance with cetuximab or bevacizumab in RAS and BRAF wild-type mCRC...
February 15, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29450210/sofosbuvir-based-direct-acting-antiviral-therapies-for-hcv-in-people-receiving-opioid-substitution-therapy-an-analysis-of-phase-3-studies
#19
Jason Grebely, Jordan J Feld, David Wyles, Mark Sulkowski, Liyun Ni, Joe Llewellyn, Heshaam M Mir, Nika Sajed, Luisa M Stamm, Robert H Hyland, John McNally, Diana M Brainard, Ira Jacobson, Stefan Zeuzem, Marc Bourlière, Graham Foster, Nezam Afdhal, Gregory J Dore
Background: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6)...
February 2018: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/29449960/physician-initiated-clinical-study-of-limb-ulcers-treated-with-a-functional-peptide-sr-0379-from-discovery-to-a-randomized-double-blind-placebo-controlled-trial
#20
Hironori Nakagami, Ken Sugimoto, Takahiro Ishikawa, Taku Fujimoto, Toshifumi Yamaoka, Misa Hayashi, Eiji Kiyohara, Hiroshi Ando, Yuta Terabe, Yoichi Takami, Koichi Yamamoto, Yasushi Takeya, Minoru Takemoto, Masaya Koshizaka, Tamotsu Ebihara, Ayumi Nakamura, Mitsunori Nishikawa, Xiang Jing Yao, Hideki Hanaoka, Ichiro Katayama, Koutaro Yokote, Hiromi Rakugi
SR-0379 is a functional peptide that has wound healing effect with anti-microbial action, making it an ideal drug to prevent infection. To evaluate the safety, efficacy, and pharmacokinetics of SR-0379 for the treatment of leg ulcers, a physician-initiated, phase I/IIa, first-in-patient clinical study was designed. A multi-center, double-blind, randomized clinical study was conducted from October 2015 to September 2016. The inclusion criteria for leg ulcers were (1) diabetes or critical limb ischemia and (2) wound size <6 cm in diameter...
2018: NPJ Aging and Mechanisms of Disease
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