Read by QxMD icon Read

serious adverse event

Brinda Emu, Jeffrey Fessel, Shannon Schrader, Princy Kumar, Gary Richmond, Sandra Win, Steven Weinheimer, Christian Marsolais, Stanley Lewis
BACKGROUND: Ibalizumab, a humanized IgG4 monoclonal antibody, blocks the entry of human immunodeficiency virus type 1 (HIV-1) by noncompetitive binding to CD4. METHODS: In this single-group, open-label, phase 3 study, we enrolled 40 adults with multidrug-resistant (MDR) HIV-1 infection in whom multiple antiretroviral therapies had failed. All the patients had a viral load of more than 1000 copies of HIV-1 RNA per milliliter. After a 7-day control period in which patients continued to receive their current therapy, a loading dose of 2000 mg of ibalizumab was infused; the viral load was quantified 7 days later...
August 16, 2018: New England Journal of Medicine
Floris F van den Brand, Carin M J van Nieuwkerk, Bart J Verwer, Ynto S de Boer, Nanne K H de Boer, Chris J J Mulder, Elisabeth Bloemena, Christine M Bakker, Jan M Vrolijk, Joost P H Drenth, Adriaan C I T L Tan, Frank Ter Borg, Martijn J Ter Borg, Sven J van den Hazel, Akin Inderson, Maarten E Tushuizen, Gerd Bouma
BACKGROUND: Azathioprine (AZA) and mercaptopurine (MP) are the cornerstone of steroid-sparing strategies in autoimmune hepatitis (AIH). Up to 20% of patients do not tolerate or respond to these regimens. AIM: To retrospectively evaluate the tolerability and efficacy of tioguanine (thioguanine) (TG) therapy in selected patients with AIH and AIH variant syndromes. METHODS: Records of 52 patients who received TG therapy were retrieved from nine hospitals in the Netherlands...
August 15, 2018: Alimentary Pharmacology & Therapeutics
Joanne Blair, Andrew McKay, Colin Ridyard, Keith Thornborough, Emma Bedson, Matthew Peak, Mohammed Didi, Francesca Annan, John W Gregory, Dyfrig Hughes, Carrol Gamble
BACKGROUND: The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. OBJECTIVES: (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients...
August 2018: Health Technology Assessment: HTA
Y N Prashantha, P N Suman Rao, Saudamini Nesargi, B S Chandrakala, Kalyan Chakravarthy Balla, A Shashidhar
BACKGROUND: Different methods have been used for therapeutic hypothermia for neonates with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). As standard cooling devices are expensive, there is a need to establish the safety and efficacy of low-cost devices such as ice packs (IP) and phase changing material (PCM). AIM: To assess the efficacy and safety of therapeutic hypothermia (TH) and the clinico-laboratory profile of neonates who underwent cooling with IP or PCM...
August 15, 2018: Paediatrics and International Child Health
Michael Chez, Shawn Kile, Christopher Lepage, Carol Parise, Bobbie Benabides, Andrea Hankins
Prior studies have demonstrated successful irritability treatment using dopaminergic antagonists in autistic patients. The purpose of this pilot study was to assess the effect of dextromethorphan/quinidine (DM/Q) in autistic adults (18-60 years of age). This was a randomized, blinded, crossover, study of 14 patients randomized to DM/Q or a placebo for 8 weeks, washed out for 4 weeks, then crossed over to the opposite treatment. There were no serious adverse events. Subjects were significantly lower on the Aberrant Behavioral Checklist for Irritability (ABC-IR) (F1,10  = 7...
August 14, 2018: Journal of Autism and Developmental Disorders
QiQi Zhou, Meghan L Verne, Jeremy Z Fields, John J Lefante, Sarpreet Basra, Habeeb Salameh, G Nicholas Verne
BACKGROUND: More effective treatments are needed for patients with postinfectious, diarrhoea-predominant, irritable bowel syndrome (IBS-D). Accordingly, we conducted a randomised, double-blind, placebo-controlled, 8-week-long trial to assess the efficacy and safety of oral glutamine therapy in patients who developed IBS-D with increased intestinal permeability following an enteric infection. METHODS: Eligible adults were randomised to glutamine (5 g/t.i.d.) or placebo for 8 weeks...
August 14, 2018: Gut
H Henry Li, Sarah Mycroft, Sandra Christiansen, Daniel N Wood, Henrike Feuersenger, Dipti Pawaskar, Iris Jacobs
BACKGROUND: The first subcutaneous (SC) C1-esterase inhibitor concentrate (C1-INH) was approved by the U.S. Food and Drug Administration in June 2017 as routine prophylaxis to prevent hereditary angioedema attacks in adolescents and adults at a dose of 60 IU/kg twice weekly based on the phase III Clinical Study for Optimal Management of Preventing Angioedema With Low-volume Subcutaneous C1-Inhibitor Replacement Therapy (COMPACT) trial. OBJECTIVE: This article aimed to evaluate the relationship of the C1-INH (SC) dose regimens tested in the COMPACT trial (40 IU/kg and 60 IU/kg twice weekly) and the occurrence of adverse events (AEs)...
August 14, 2018: Allergy and Asthma Proceedings:
Dominique L Braun, Benjamin Hampel, Roger Kouyos, Huyen Nguyen, Cyril Shah, Markus Flepp, Marcel Stöckle, Anna Conen, Charles Béguelin, Patrizia Künzler-Heule, Dunja Nicca, Patrick Schmid, Julie Delaloye, Mathieu Rougemont, Enos Bernasconi, Andri Rauch, Huldrych F Günthard, Jürg Böni, Jan S Fehr
Background: This study was performed to investigate the efficacy and safety of grazoprevir-elbasvir guided by baseline resistance-associated substitutions (RASs) in the Swiss HCVree Trial ( NCT02785666). Methods: We performed hepatitis C virus (HCV) RNA screening among all men who have sex with men (MSM) enrolled in the Swiss HIV Cohort Study. Individuals with replicating HCV genotype 1 or 4 infection were eligible for grazoprevir-elbasvir treatment...
August 13, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
S Omar Ali, Xiang Qing Yu, Gabriel J Robbie, Yuling Wu, Kathryn Shoemaker, Li Yu, Antonio DiGiandomenico, Ashley E Keller, Chuka Anude, Martha Hernandez-Illas, Terramika Bellamy, Judith Falloon, Filip Dubovsky, Hasan S Jafri
OBJECTIVES: MEDI3902 is a bivalent, bispecific human immunoglobulin G1κ monoclonal antibody that binds to both the Pseudomonas aeruginosa PcrV protein involved in host cell cytotoxicity and the Psl exopolysaccharide involved in P. aeruginosa colonization and tissue adherence. MEDI3902 is being developed for the prevention of nosocomial P. aeruginosa pneumonia in high-risk patients. METHODS: This phase 1 dose escalation study (NCT02255760) evaluated the safety, pharmacokinetics, anti-drug antibody (ADA) responses, and ex vivo anticytotoxicity and opsonophagocytic killing (OPK) activities of MEDI3902 after a single intravenous infusion in healthy adults 18- 60 years of age...
August 11, 2018: Clinical Microbiology and Infection
Nan Lan, Tracy H Hull, Bo Shen
BACKGROUND AND AIMS: Pouch sinus may be a serious adverse event in patients undergoing ileal pouch-anal anastomosis. The aim of this study was to compare endoscopic sinusotomy and redo pouch surgery in the management of pouch sinus. METHODS: All consecutive ulcerative colitis patients with chronic pouch sinuses treated with endoscopic sinusotomy versus redo surgery from 2006 to 2016 were identified. The primary outcomes were recurrence-free and surgery-free survivals...
August 11, 2018: Gastrointestinal Endoscopy
Mothaffar Rimawi, Jean-Marc Ferrero, Juan de la Haba-Rodriguez, Christopher Poole, Sabino De Placido, C Kent Osborne, Roberto Hegg, Valerie Easton, Christine Wohlfarth, Grazia Arpino
Purpose To assess pertuzumab plus trastuzumab and an aromatase inhibitor (AI) in patients with human epidermal growth factor receptor 2 (HER2)-positive and hormone receptor-positive metastatic/locally advanced breast cancer (MBC/LABC). Patients and Methods The PERTAIN trial (NCT01491737) is an ongoing randomized, open-label, multicenter-80 sites and eight countries-phase II trial. Patients have HER2-positive, hormone receptor-positive MBC/LABC and no prior systemic therapy with the exception of endocrine. Random assignment was 1:1 to intravenous pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) plus trastuzumab (8 mg/kg followed by 6 mg/kg every 3 weeks), and oral anastrozole (1 mg every day) or letrozole (2...
August 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Yuji Uchio, Hiroyuki Enomoto, Mitsuhiro Ishida, Toshinaga Tsuji, Toshimitsu Ochiai, Shinichi Konno
Purpose: To assess long-term safety, tolerability, and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis. Methods: In this open-label extension study (NCT02335346), Japanese patients with knee osteoarthritis and pain (Brief Pain Inventory [BPI] - Severity average pain score ≥4 at start of randomized trial) who had previously received duloxetine 60 mg/day or placebo for 14 weeks in a double-blind randomized trial entered the extension and received duloxetine 60 mg/day for 48 weeks...
2018: Journal of Pain Research
Hee Jung Jeon, Hahn-Ey Lee, Jaeseok Yang
BACKGROUND: Few post-marketing surveillance studies have examined the safety and efficacy of Rapamune® (Sirolimus) in Asian countries. This study aimed to better understand safety and efficacy of Rapamune for kidney transplant recipients in the routine clinical practice setting in Korea. METHODS: This was an open-label, non-comparative, observational, prospective, multi-center, post-marketing surveillance study conducted at 15 Korean transplant centers between 31 August 2009 and 24 September 2015...
August 13, 2018: BMC Nephrology
Robert A Kloner, Coleman Gross, Jinwei Yuan, Ansgar Conrad, Pablo E Pergola
INTRODUCTION: Hyperkalemia (potassium >5.0 mEq/L) affects heart failure patients with renal disease regardless of the use of renin-angiotensin-aldosterone system inhibitors (RAASi). The open-label TOURMALINE study showed that patiromer, a sodium-free, nonabsorbed potassium binder, lowers serum potassium of hyperkalemic patients similarly when given with or without food; unlike prior studies, patients were not required to be taking RAASi. We conducted post hoc analyses to provide the first report of patiromer in patients not taking RAASi...
August 14, 2018: Journal of Cardiovascular Pharmacology and Therapeutics
Camilla Strøm, Jakob S Stefansson, Maria Louise Fabritius, Lars S Rasmussen, Thomas A Schmidt, Janus C Jakobsen
BACKGROUND: Short-stay units are hospital units that provide short-term care for selected patients. Studies have indicated that short-stay units might reduce admission rates, time of hospital stays, hospital readmissions and expenditure without compromising the quality of care. Short-stay units are often defined by a target patient category, a target function, and a target time frame. Hypothetically, short-stay units could be established as part of any department, but this review focuses on short-stay units that provide care for participants with internal medicine diseases and conditions...
August 13, 2018: Cochrane Database of Systematic Reviews
Sonia Johnson, Danielle Lamb, Louise Marston, David Osborn, Oliver Mason, Claire Henderson, Gareth Ambler, Alyssa Milton, Michael Davidson, Marina Christoforou, Sarah Sullivan, Rachael Hunter, David Hindle, Beth Paterson, Monica Leverton, Jonathan Piotrowski, Rebecca Forsyth, Liberty Mosse, Nicky Goater, Kathleen Kelly, Mel Lean, Stephen Pilling, Nicola Morant, Brynmor Lloyd-Evans
BACKGROUND: High resource expenditure on acute care is a challenge for mental health services aiming to focus on supporting recovery, and relapse after an acute crisis episode is common. Some evidence supports self-management interventions to prevent such relapses, but their effect on readmissions to acute care following a crisis is untested. We tested whether a self-management intervention facilitated by peer support workers could reduce rates of readmission to acute care for people discharged from crisis resolution teams, which provide intensive home treatment following a crisis...
August 4, 2018: Lancet
Mari Kishibe, Hiroyoshi Nozaki, Mizue Fujii, Shin Iinuma, Sawa Ohtsubo, Satomi Igawa, Kyoko Kanno, Masaru Honma, Kan Kishibe, Kensaku Okamoto, Akemi Ishida-Yamamoto
Azathioprine (AZA)-metabolizing enzyme gene polymorphism is strongly related to thiopurine-induced leukocytopenia, which has not been well recognized in dermatological practice. We tried to see whether NUDT15 gene polymorphism can be the most susceptible genetic factor for AZA toxicity and the gene screening is beneficial to avoid the adverse events of AZA for the treatment of skin diseases. A retrospective study was carried out on 15 adult Japanese patients who were treated with AZA. Gene polymorphism of thiopurine-metabolizing enzymes NUDT15 R139C, ITPA 94C>A, TPMT*2, TPMT*3B and TPMT*3C was analyzed...
August 13, 2018: Journal of Dermatology
Fernando Rizzello, Marta Mazza, Marco Salice, Carlo Calabrese, Andrea Calafiore, Massimo Campieri, Paolo Gionchetti
Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that use novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of beclomethasone dipropionate compared to other conventional corticosteroids. Areas covered: We reviewed the mechanism of action, efficacy and safety of beclomethasone dipropionate in the treatment of UC...
August 11, 2018: Expert Opinion on Drug Safety
Xuejing Li, Suhui Qie, Xianying Wang, Yingying Zheng, Yang Liu, Guoqiang Liu
OBJECTIVES: To investigate the safety and efficacy of once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide as monotherapy or add-on to other antihyperglycaemic agents (AHAs) in patients with type 2 diabetes mellitus (T2DM). METHODS: PubMed, Embase, Cochrane library and were searched from the inception to January 18, 2018. Randomised controlled trials (RCTs) comparing semaglutide with placebo or other AHAs in T2DM patients were included in our meta-analysis...
August 12, 2018: Endocrine
Radoslav Chekerov, Felix Hilpert, Sven Mahner, Ahmed El-Balat, Philipp Harter, Nikolaus De Gregorio, Claudius Fridrich, Susanne Markmann, Jochem Potenberg, Ralf Lorenz, Guelten Oskay-Oezcelik, Marcus Schmidt, Petra Krabisch, Hans-Joachim Lueck, Rolf Richter, Elena Ioana Braicu, Andreas du Bois, Jalid Sehouli
BACKGROUND: Antiangiogenic therapy has known activity in ovarian cancer. The investigator-initiated randomised phase 2 TRIAS trial assessed the multi-kinase inhibitor sorafenib combined with topotecan and continued as maintenance therapy for platinum-resistant or platinum-refractory ovarian cancer. METHODS: We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 trial at 20 sites in Germany. Patients (≥18 years) with platinum-resistant ovarian cancer previously treated with two or fewer chemotherapy lines for recurrent disease were stratified (first vs later relapse) in block sizes of four and randomly assigned (1:1) using a web-generated response system to topotecan (1·25 mg/m2 on days 1-5) plus either oral sorafenib 400 mg or placebo twice daily on days 6-15, repeated every 21 days for six cycles, followed by daily maintenance sorafenib or placebo for up to 1 year in patients without progression...
August 9, 2018: Lancet Oncology
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"