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Adverse drug events

J Berdeja, F Palandri, M R Baer, D Quick, J J Kiladjian, G Martinelli, A Verma, O Hamid, R Walgren, C Pitou, P L Li, A T Gerds
BACKGROUND: The Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are associated with increases in janus kinase 2 (JAK2) signaling, often resulting from the JAK2 V617F mutation. LY2784544 (gandotinib) is a potent, selective, small-molecule inhibitor of JAK2 that has potential dose-dependent selectivity for the JAK2 V617F mutation and may inhibit additional JAK2 mutant isoforms in nonclinical testing. METHODS: A multicenter, single-arm, outpatient phase 2 study evaluated the efficacy, safety, and pharmacokinetics (PK) of gandotinib administered to patients (120 mg once daily) with MPNs, including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF)...
June 30, 2018: Leukemia Research
Alyssa Wohlfahrt, Anarosa Campos, Maura D Iversen, Joshua J Gagne, Elena Massarotti, Daniel H Solomon, Candace H Feldman
OBJECTIVE: Adherence to medications among patients with rheumatic diseases is often suboptimal. Patient navigators, individuals trained in care coordination, motivational interviewing and basic rheumatology and pharmacology, have not been employed to explore and address this issue. We piloted a single-site, single arm intervention to determine the feasibility and acceptability of using rheumatology-specific navigators to understand and reduce barriers to adherence to oral disease modifying anti-rheumatic drugs (DMARDs)...
2018: PloS One
Aishwarya Vijay, Jessica E Becker, Joseph S Ross
Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed...
2018: PloS One
Jeffrey E Lancet, Geoffrey L Uy, Jorge E Cortes, Laura F Newell, Tara L Lin, Ellen K Ritchie, Robert K Stuart, Stephen A Strickland, Donna Hogge, Scott R Solomon, Richard M Stone, Dale L Bixby, Jonathan E Kolitz, Gary J Schiller, Matthew J Wieduwilt, Daniel H Ryan, Antje Hoering, Kamalika Banerjee, Michael Chiarella, Arthur C Louie, Bruno C Medeiros
Purpose CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic 5:1 drug ratio into leukemia cells to a greater extent than normal bone marrow cells. Prior clinical studies demonstrated a sustained drug ratio and exposure in vivo and prolonged survival versus standard-of-care cytarabine plus daunorubicin chemotherapy (7+3 regimen) in older patients with newly diagnosed secondary acute myeloid leukemia (sAML). Patients and Methods In this open-label, randomized, phase III trial, 309 patients age 60 to 75 years with newly diagnosed high-risk/sAML received one to two induction cycles of CPX-351 or 7+3 followed by consolidation therapy with a similar regimen...
July 19, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Tania Marusia Capusan, María Herrero-Moyano, Constanza Romina Martínez-Mera, Al Walid Freih-Fraih, Esteban Dauden
No abstract text is available yet for this article.
July 2018: JAAD Case Reports
Marija Vavlukis, Ana Vavlukis
Background: Statins are the hypolipemic treatment of choice for hyperlipidemia with confirmed atherosclerotic cardiovascular disease (ASCVD) protective effect, proven even in normolipemic patients. But in rare situations, even with a high-dose treatment regimen, or maximally tolerated statin dose treatment, treatment targets of low-density lipoprotein cholesterol (LDL-C), according to the risk profile of the patient, cannot be achieved. Combination therapy with ezetimibe is an effective treatment choice, as it is one of the few hypolipemic drugs with proven ASCVD protective effect...
2018: Drugs in Context
Balázs Vaskó, Viktória Juhász, Beáta Tóth, Anita Kurunczi, Zsolt Fekete, Joseph Krisjanis Zolnerciks, Emese Kis, Rémi Magnan, Axel Bidon-Chanal Badia, Marçal Pastor-Anglada, Eszter Hazai, Zsolt Bikadi, Ferenc Fülöp, Peter Krajcsi
1. The concentrative nucleoside transporters (CNT; solute carrier family 28 (SLC28)) and the equilibrative nucleoside transporters (ENT; solute carrier family 29 (SLC29)) are important therapeutic targets but may also mediate toxicity or adverse events. 2. To explore the relative role of the base and the monosaccharide moiety in inhibitor selectivity we selected compounds that either harbor an arabinose moiety or a cytosine moiety, as these groups had several commercially available drug members. 3. The screening data showed that more compounds harboring a cytosine moiety displayed potent interactions with the CNTs than compounds harboring the arabinose moiety...
July 19, 2018: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
Fernanda S Tonin, Laiza M Steimbach, Leticia P Leonart, Vinicius L Ferreira, Helena H Borba, Thais Piazza, Ariane G Araújo, Fernando Fernandez-Llimos, Roberto Pontarolo, Astrid Wiens
PURPOSE: Although randomized controlled trials (RCTs) are the gold standard for the assessment of clinical outcomes, long-term extension trials (LTEs) and observational cohorts may help generate evidence. Our goal was to compare the discontinuation rates of abatacept, rituximab, and tocilizumab in rheumatoid arthritis (RA) reported in different study designs. METHODS: A systematic review was conducted with searches in PubMed, Scopus, and the Cochrane Library, plus a manual search, for RCTs, LTEs, and observational cohorts reporting discontinuation rates by any of three causes (all-cause, inefficacy, adverse events)...
July 18, 2018: European Journal of Clinical Pharmacology
Yuya Horinouchi, Yasumasa Ikeda, Keijo Fukushima, Masaki Imanishi, Hirofumi Hamano, Yuki Izawa-Ishizawa, Yoshito Zamami, Kenshi Takechi, Licht Miyamoto, Hiromichi Fujino, Keisuke Ishizawa, Koichiro Tsuchiya, Toshiaki Tamaki
Renal tubulointerstitial injury, an inflammation-associated condition, is a major cause of chronic kidney disease (CKD). Levels of activated factor X (FXa), a blood coagulation factor, are increased in various inflammatory diseases. Therefore, we investigated the protective effects of an FXa inhibitor against renal tubulointerstitial injury using unilateral ureteral obstruction (UUO) mice (a renal tubulointerstitial fibrosis model) and the Food and Drug Administration Adverse Events Reporting System (FAERS) database...
July 18, 2018: Scientific Reports
Maria Maiarù, Charlotte Leese, Michelangelo Certo, Irene Echeverria-Altuna, Antonina S Mangione, Jason Arsenault, Bazbek Davletov, Stephen P Hunt
Chronic pain is a widespread debilitating condition affecting millions of people worldwide. Although several pharmacological treatments for relieving chronic pain have been developed, they require frequent chronic administration and are often associated with severe adverse events, including overdose and addiction. Persistent increased sensitization of neuronal subpopulations of the peripheral and central nervous system has been recognized as a central mechanism mediating chronic pain, suggesting that inhibition of specific neuronal subpopulations might produce antinociceptive effects...
July 18, 2018: Science Translational Medicine
Tae-Won Yang, Jangsup Moon, Tae-Joon Kim, Jin-Sun Jun, Jung-Ah Lim, Soon-Tae Lee, Keun-Hwa Jung, Kyung-Il Park, Ki-Young Jung, Kon Chu, Sang Kun Lee
Levetiracetam (LEV) is effective for focal and generalized epilepsy and is used worldwide because of its relatively few drug interactions and favorable tolerability. However, some psychiatric adverse events (PAEs) have been reported, resulting in drug withdrawal. The pathophysiology of LEV-induced PAE has not yet been elucidated. In this study, we investigated the relationship between PAEs and human leukocyte antigen (HLA) genes. Eleven epilepsy patients, who developed PAEs after the administration of LEV and spontaneously improved after drug withdrawal, were enrolled retrospectively...
2018: PloS One
Jason R Goldsmith, Akbar K Waljee, Tom George, Alexandra Brown, Hae Mi Choe, Mohamed Noureldin, Steven J Bernstein, Peter D R Higgins
OBJECTIVES: To switch patients with ulcerative colitis (UC) from costlier 5-aminosalicylic acid compounds to sulfasalazine and assess (1) the cost savings, (2) the barriers to switching, and (3) adverse events (AEs) and adherence at 3 months after the drug switch. STUDY DESIGN: An open-label, pharmacist-administered drug switch program coordinated at an academic inflammatory bowel disease center. METHODS: A clinical pharmacist contacted patients with UC who were prescreened by physicians and covered by specific insurers to enroll them in the drug switch program...
July 2018: American Journal of Managed Care
Steven C Marcus, Richard C Hermann, Sara Wiesel Cullen
OBJECTIVES: The past 20 years have seen the emergence of a national movement to improve hospital-based healthcare safety in the United States. However, much of the foundational work and subsequent research have neglected inpatient psychiatry. The aim of this article was to advance a comprehensive approach for conceptualizing patient safety in inpatient psychiatry as framed by an application of the Institute of Medicine patient safety framework. METHODS: This article develops a framework for characterizing patient safety in hospital-based mental health care...
July 17, 2018: Journal of Patient Safety
Arshad Javaid, Mazhar Ali Khan, Faheem Jan, Mifra Rauf, Mir Azam Khan, Anila Basit, Sumaira Mehreen
Introduction: Pakistan ranks 4th among 22 multidrug resistant tuberculosis (MDR-TB) high burden countries. The increasing rate of MDR-TB in Pakistan underscores the importance of effective treatment programs of drug-resistant TB. Clinical management of MDR-TB requires prolonged multidrug regimens that often cause adverse events (AEs). Materials and Methods: This retrospective case series study include all patients who were enrolled for MDR-TB treatment during January 2014 till April 2015 at Programmatic Management of Drug Resistant TB (PMDT) unit at tertiary care hospital, Lady Reading Hospital (LRH) Peshawar Pakistan...
March 2018: Tüberküloz Ve Toraks
Leos Pleva, Pavel Kukla, Jana Zapletalova, Ota Hlinomaz
BACKGROUND: The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. OBJECTIVES: We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. METHODS: We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study...
July 18, 2018: Catheterization and Cardiovascular Interventions
Isabel Wustrow, Nikolaus Sarafoff, Bernhard Haller, Lisa Rössner, Dirk Sibbing, Stefanie Schüpke, Tareq Ibrahim, Aida Anetsberger, Heribert Schunkert, Karl-Ludwig Laugwitz, Adnan Kastrati, Isabell Bernlochner
OBJECTIVES: We aimed to assess the impact of omitting aspirin on clinical outcomes in a real-world collective of patients receiving oral anticoagulation (OAC) therapy who were treated with a current-generation drug-eluting stent (DES) or an everolimus-eluting bioresorbable vascular scaffold (BVS). BACKGROUND: Limited data are available regarding the clinical benefit of triple antithrombotic therapy (TAT) with aspirin compared with dual antithrombotic therapy (DAT) without aspirin in patients undergoing percutaneous coronary intervention (PCI) and requiring OAC...
July 18, 2018: Catheterization and Cardiovascular Interventions
C I Hatleberg, L Ryom, A d'Arminio Monforte, E Fontas, P Reiss, O Kirk, W El-Sadr, A Phillips, S de Wit, F Dabis, R Weber, M Law, J D Lundgren, C Sabin
OBJECTIVES: Previous studies have suggested that hypertension in HIV-positive individuals is associated primarily with traditional risk factors such as older age, diabetes and dyslipidaemia. However, controversy remains as to whether exposure to antiretroviral (ARV) drugs poses additional risk, and we investigated this question in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) cohort. METHODS: The incidence of hypertension [systolic blood pressure (BP) > 140 and/or diastolic BP > 90 mmHg and/or initiation of antihypertensive treatment] was determined overall and in strata defined by demographic, metabolic and HIV-related factors, including cumulative exposure to each individual ARV drug...
July 18, 2018: HIV Medicine
William E Rudgard, Christine A Hirsch, Anthony R Cox
OBJECTIVE: To explore amateur endurance athletes' use and views about non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: An online cross-sectional survey of amateur athletes at four athletic clubs. KEY FINDINGS: Of a sample of 129 of amateur athletes, 68% (n = 88) reported using NSAIDs in the previous 12 months (84.4% in triathletes, 70.9% in runners and 52.5% in cyclists). Overall, ibuprofen was the most popular drug (n = 48). There was a lack of knowledge of adverse drug reactions, with only 26% of use advised by a doctor or pharmacist...
July 18, 2018: International Journal of Pharmacy Practice
Russell Scott, Jerry Morgan, Zachary Zimmer, Raymond L H Lam, Edward A O'Neill, Keith D Kaufman, Samuel S Engel, Annaswamy Raji
AIMS: To compare the efficacy and safety of the DPP-4 inhibitor sitagliptin with the SGLT-2 inhibitor dapagliflozin in patients with type 2 diabetes and mild renal insufficiency. MATERIALS AND METHODS: Patients with HbA1c 7.0 to 9.5% (53 to ≤80 mmol/mol) and eGFR 60 to <90 mL/min/1.73m2 on metformin (≥1500 mg/day) ± sulfonylurea were randomized to sitagliptin 100 mg (N=307) or dapagliflozin 5 mg titrated to 10 mg (N=306) once-daily for 24 weeks. A longitudinal data analysis model was used to test the primary hypothesis that sitagliptin is non-inferior to dapagliflozin in reducing HbA1c at Week 24, with superiority to be tested if non-inferiority is met...
July 18, 2018: Diabetes, Obesity & Metabolism
Jeannette Kadel, Sebastian Bauer, Anke M Hermsen, Ilka Immisch, Lara Kay, Karl Martin Klein, Susanne Knake, Katja Menzler, Philipp S Reif, Felix Rosenow, Adam Strzelczyk
BACKGROUND: Emergency treatment with benzodiazepines is indicated in prolonged seizures, seizure clusters and status epilepticus. OBJECTIVE: The aim of this study was to evaluate the use of emergency medication in adult patients with epilepsy. PATIENTS AND METHODS: All adult epilepsy patients attending the epilepsy outpatient clinics of the university hospitals in Frankfurt and Marburg in 2015 were asked to participate in this questionnaire-based, retrospective survey...
July 17, 2018: CNS Drugs
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