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https://www.readbyqxmd.com/read/28107570/efficacy-and-safety-of-interleukin-17-antagonists-in-patients-with-plaque-psoriasis-a-meta-analysis-from-phase-3-randomized-controlled-trails
#1
Dan Wu, Si-Yuan Hou, Shuai Zhao, Lin-Xin Hou, Ting Jiao, Nan-Nan Xu, Ning Zhang
BACKGROUND: The interleukin-17 (IL-17) cytokine pathway plays a key role in the development of psoriasis. Antibodies targeting IL-17 or blocking its receptor may be a new therapeutic approach for psoriasis. To assist treatment selection in daily practice it is essential to understand the benefit and risk profile of IL-17 antagonists. OBJECTIVE: We performed a meta-analysis to evaluate the efficacy and safety of IL-17 antagonists in patients with psoriasis. METHODS: We searched a number of databases for relevant randomized clinical trials (RCTs) published before May 2016...
January 20, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28107397/efficacy-and-safety-of-everolimus-for-maintenance-immunosuppression-of-kidney-transplantation-a-meta-analysis-of-randomized-controlled-trials
#2
Jinyu Liu, Dong Liu, Juan Li, Lan Zhu, Chengliang Zhang, Kai Lei, Qiling Xu, Ruxu You
BACKGROUND: Conversion to everolimus is often used in kidney transplantation to overcome calcineurin inhibitor (CNI) nephrotoxicity but there is conflicting evidence for this approach. OBJECTIVES: To investigate the benefits and harm from randomized clinical trials (RCTs) involving the conversion from CNI to everolimus after kidney transplantation. METHODS: Databases were searched up to March 2016. Two reviewers independently assessed trials for eligibility and quality, and extracted data...
2017: PloS One
https://www.readbyqxmd.com/read/28105618/-efficacy-analysis-of-fecal-microbiota-transplantation-in-the-treatment-of-406-cases-with-gastrointestinal-disorders
#3
Ning Li, Hongliang Tian, Chunlian Ma, Chao Ding, Xiaolong Ge, Lili Gu, Xuelei Zhang, Bo Yang, Yue Hua, Yifan Zhu, Yan Zhou
OBJECTIVE: To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for gastrointestinal disorders. METHODS: Retrospective analysis of the clinical data of 406 patients who underwent FMT from May 2014 to April 2016 in the Intestinal Microenvironment Treatment Centre of Nanjing General Hospital was performed, including patients with constipation(276 cases), recurrent Clostridium Difficile infection (RCDI, 61 cases), ulcerative colitis(44 cases), irritable bowel syndrome (15 cases) and Crohn's disease(10 cases)...
January 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/28103945/a-randomized-blinded-controlled-usa-field-study-to-assess-the-use-of-fluralaner-topical-solution-in-controlling-canine-flea-infestations
#4
Cheyney Meadows, Frank Guerino, Fangshi Sun
BACKGROUND: Orally administered fluralaner effectively controls fleas and ticks on dogs for 12 weeks. This study evaluates the flea control efficacy achieved with topically applied fluralaner in dogs. METHODS: This investigator-blinded, multi-center randomized, positive controlled study evaluated flea control efficacy in dogs following a single owner-applied treatment of topical fluralaner. A positive control group received three treatments, at 4-week intervals, of a commercial formulation of fipronil/(S)-methoprene...
January 19, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/28103942/a-randomized-blinded-controlled-usa-field-study-to-assess-the-use-of-fluralaner-topical-solution-in-controlling-feline-flea-infestations
#5
Cheyney Meadows, Frank Guerino, Fangshi Sun
BACKGROUND: Fleas are a common ectoparasite of domestic cats and there is a need for novel treatments that improve feline flea control. METHODS: This investigator-blinded, multi-center randomized, positive-controlled study evaluated the flea control in cats provided by a single owner-applied treatment with a fluralaner topical formulation compared with a positive control. Households with up to five healthy cats, all at least 12 weeks of age and weighing at least 1...
January 19, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/28101624/the-safety-and-efficacy-of-cardiac-contractility-modulation-in-heart-failure-a%C3%A2-meta-analysis-of-clinical-trials
#6
X Liu, H J Yang, H Q Ping, S Qiu, S Shi, B Yang
BACKGROUND: Cardiac contractility modulation (CCM) has developed as a promising treatment device for heart failure (HF). This meta-analysis aimed at systematically reviewing the latest available published trials to provide evidence on the safety and efficacy of CCM in patients with HF. METHODS: We searched the Cochrane Central Resister of Controlled Trials, PubMed, and EMBASE in May 2016 to identify eligible clinical trials comparing CCM with sham treatment or with usual care...
January 18, 2017: Herz
https://www.readbyqxmd.com/read/28099988/exercise-based-rehabilitation-programmes-for-pulmonary-hypertension
#7
REVIEW
Norman R Morris, Fiona D Kermeen, Anne E Holland
BACKGROUND: Individuals with pulmonary hypertension (PH) have reduced exercise capacity and quality of life. Despite initial concerns that exercise training may worsen symptoms in this group, several studies have reported improvements in functional capacity and well-being following exercise-based rehabilitation in PH. OBJECTIVES: To assess the efficacy and safety of exercise-based rehabilitation for people with PH. Primary outcomes were exercise capacity, adverse events during the intervention period and health-related quality of life (HRQoL)...
January 19, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28099789/ehr-related-medication-errors-in-two-icus
#8
Pascale Carayon, Shimeng Du, Roger Brown, Randi Cartmill, Mark Johnson, Tosha B Wetterneck
The objective of this study was to describe the frequency, potential harm, and nature of electronic health record (EHR)-related medication errors in intensive care units (ICUs). Using a secondary data analysis of a large database of medication safety events collected in a study on EHR technology in ICUs, we assessed the EHR relatedness of a total of 1622 potential preventable adverse drug events (ADEs) identified in a sample of 624 patients in 2 ICUs of a medical center. Thirty-four percent of the medication events were found to be EHR related...
January 2017: Journal of Healthcare Risk Management: the Journal of the American Society for Healthcare Risk Management
https://www.readbyqxmd.com/read/28092307/the-prosit-bio-cohort-a-prospective-observational-study-of-patients-with-inflammatory-bowel-disease-treated-with-infliximab-biosimilar
#9
Gionata Fiorino, Natalia Manetti, Alessandro Armuzzi, Ambrogio Orlando, Angela Variola, Stefanos Bonovas, Fabrizio Bossa, Giovanni Maconi, Renata DʼIncà, Paolo Lionetti, Laura Cantoro, Walter Fries, Maria L Annunziata, Francesco Costa, Maria M Terpin, Livia Biancone, Claudio C Cortelezzi, Arnaldo Amato, Sandro Ardizzone, Silvio Danese, Luisa Guidi, Giulia Rizzuto, Arianna Massella, Angelo Andriulli, Alessandro Massari, Greta Lorenzon, Silvia Ghione, Anna Kohn, Agostino Ventra, Vito Annese
BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28091703/bolus-application-of-landiolol-and-esmolol-comparison-of-the-pharmacokinetic-and-pharmacodynamic-profiles-in-a-healthy-caucasian-group
#10
Günther Krumpl, Ivan Ulc, Michaela Trebs, Pavla Kadlecová, Juri Hodisch
PURPOSE: The aim of this prospective study was to compare in non-Asian subjects the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of two short-acting cardioselective β1-adrenergic antagonists, landiolol and esmolol, after administration of three different bolus dosages. MATERIALS AND METHODS: We conducted a single-center, prospective, double-blinded, randomized study in three cross-over periods with 12 healthy subjects (7 women and 5 men, mean age of 24...
January 13, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28089635/venetoclax-plus-rituximab-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-a-phase-1b-study
#11
John F Seymour, Shuo Ma, Danielle M Brander, Michael Y Choi, Jacqueline Barrientos, Matthew S Davids, Mary Ann Anderson, Anne W Beaven, Steven T Rosen, Constantine S Tam, Betty Prine, Suresh K Agarwal, Wijith Munasinghe, Ming Zhu, L Leanne Lash, Monali Desai, Elisa Cerri, Maria Verdugo, Su Young Kim, Rod A Humerickhouse, Gary B Gordon, Thomas J Kipps, Andrew W Roberts
BACKGROUND: Selective BCL2 inhibition with venetoclax has substantial activity in patients with relapsed or refractory chronic lymphocytic leukaemia. Combination therapy with rituximab enhanced activity in preclinical models. The aim of this study was to assess the safety, pharmacokinetics, and activity of venetoclax in combination with rituximab. METHODS: Adult patients with relapsed or refractory chronic lymphocytic leukaemia (according to the 2008 Modified International Workshop on CLL guidelines) or small lymphocytic lymphoma were eligible for this phase 1b, dose-escalation trial...
January 12, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28088251/lucerastat-an-iminosugar-with-potential-as-substrate-reduction-therapy-for-glycolipid-storage-disorders-safety-tolerability-and-pharmacokinetics-in-healthy-subjects
#12
N Guérard, O Morand, J Dingemanse
BACKGROUND: Lucerastat, an inhibitor of glucosylceramide synthase, has the potential to restore the balance between synthesis and degradation of glycosphingolipids in glycolipid storage disorders such as Gaucher disease and Fabry disease. The safety, tolerability, and pharmacokinetics of oral lucerastat were evaluated in two separate randomized, double-blind, placebo-controlled, single- and multiple-ascending dose studies (SAD and MAD, respectively) in healthy male subjects. METHODS: In the SAD study, 31 subjects received placebo or a single oral dose of 100, 300, 500, or 1000 mg lucerastat...
January 14, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28079828/vaccination-with-10-valent-pneumococcal-conjugate-vaccine-in-infants-according-to-hiv-status
#13
Shabir A Madhi, Anthonet Koen, Lisa Jose, Nadia van Niekerk, Peter V Adrian, Clare Cutland, Nancy François, Javier Ruiz-Guiñazú, Juan-Pablo Yarzabal, Marta Moreira, Dorota Borys, Lode Schuerman
BACKGROUND: Phase III, open-label, single-center, controlled study in South Africa (ClinicalTrials.gov: NCT00829010) to evaluate immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) children. METHODS: Children stratified by HIV status received PHiD-CV primary vaccination (age 6/10/14 weeks; coadministered with routine childhood vaccines) and booster dose (age 9-10 months)...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28079270/treatment-of-adults-with-idiopathic-recurrent-pericarditis-novel-use-of-immunotherapy
#14
Nicholas C Schwier, Genevieve Hale, Marie L Davies
Idiopathic recurrent pericarditis (IRP) can be challenging to treat. Even after guideline-directed, first-line treatment consisting of aspirin (ASA) or a nonsteroidal antiinflammatory drug (NSAID) in combination with colchicine therapy, recurrences still occur in greater than 20% of patients. Many patients then require treatment with long-term corticosteroids, which is not a favorable option due to their short- and long-term adverse effects. Since it is theorized that the pathophysiology of IRP may possess autoimmune sequelae, the use of immunotherapy for the treatment of IRP has emerged...
January 12, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28079022/lifitegrast-for-the-treatment-of-dry-eye-disease-results-of-a-phase-iii-randomized-double-masked-placebo-controlled-trial-opus-3
#15
Edward J Holland, Jodi Luchs, Paul M Karpecki, Kelly K Nichols, Mitchell A Jackson, Kenneth Sall, Joseph Tauber, Monica Roy, Aparna Raychaudhuri, Amir Shojaei
PURPOSE: Lifitegrast is a lymphocyte function-associated antigen-1 antagonist developed to reduce inflammation in dry eye disease (DED). We report the results of OPUS-3 (NCT02284516), a phase III study evaluating the efficacy and safety of lifitegrast versus placebo in participants with DED. DESIGN: Twelve-week, phase III, randomized, double-masked, multicenter, placebo-controlled study. PARTICIPANTS: Adults aged ≥18 years with Schirmer tear test (without anesthesia) ≥1 and ≤10 mm, corneal fluorescein staining score ≥2...
January 2017: Ophthalmology
https://www.readbyqxmd.com/read/28077584/2-year-efficacy-immunogenicity-and-safety-of-vigoo-enterovirus-71-vaccine-in-healthy-chinese-children-a-randomized-open-label-study
#16
Mingwei Wei, Fanyue Meng, Shiyuan Wang, Jingxin Li, Yuntao Zhang, Qunying Mao, Yuemei Hu, Pei Liu, Nianmin Shi, Hong Tao, Kai Chu, Yuxiao Wang, Zhenglun Liang, Xiuling Li, Fengcai Zhu
BACKGROUND:  This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine. METHOD:  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years...
January 1, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28074556/qt-interval-shortening-with-isavuconazole-in-vitro-and-in-vivo-effects-on-cardiac-repolarization
#17
J Keirns, A Desai, D Kowalski, C Lademacher, S Mujais, B Parker, M J Schneidkraut, R Townsend, T Wojtkowski, T Yamazaki, M Yen, P R Kowey
Effects of isavuconazole (active moiety of isavuconazonium sulfate) on cardiac ion channels in vitro and cardiac repolarization clinically were assessed in a Phase 1, randomized, double-blind study in healthy individuals who received isavuconazole (after 2-day loading dose), at therapeutic or supratherapeutic doses daily for 11 days, moxifloxacin (400 mg QD), or placebo. A post-hoc analysis of the Phase 3 SECURE trial assessed effects on cardiac safety. L-type Ca(2+) channels were most sensitive to inhibition by isavuconazole...
January 11, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28073858/boosting-immune-responses-following-fractional-dose-inactivated-poliovirus-vaccine-a-randomized-controlled-trial
#18
Sonia Resik, Alina Tejeda, Manuel Diaz, Hiromasa Okayasu, Carolyn Sein, Natalie A Molodecky, Magile Fonseca, Nilda Alemany, Gloria Garcia, Lai Heng Hung, Yenisleydis Martinez, Roland W Sutter
BACKGROUND:  Fractional-dose administration of inactivated poliovirus vaccine (fIPV) could increase IPV affordability and stretch limited supplies. We assessed immune responses following fIPV administered intradermally, compared with full-dose IPV administered intramuscularly, among adults with a history of oral poliovirus vaccine (OPV) receipt. METHODS:  We conducted a randomized, controlled noninferiority trial in Cuba. fIPV or IPV were administered on days 0 and 28; serum was collected on days 0, 7, 28, and 56 for analysis by a neutralization assay...
January 9, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28073851/increased-risk-of-adverse-neurocognitive-outcomes-with-proprotein-convertase-subtilisin-kexin-type-9-inhibitors
#19
Abdur Rahman Khan, Chirag Bavishi, Haris Riaz, Talha A Farid, Sobia Khan, Michel Atlas, Glenn Hirsch, Sohail Ikram, Roberto Bolli
BACKGROUND: There is encouraging evidence of the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors; however, their long-term safety remains unclear. We performed a meta-analysis of studies to evaluate the long-term safety of PCSK9 inhibitors. METHODS AND RESULTS: Our search strategy yielded 11 studies (9 smaller early-phase and 2 larger outcome trials). The outcomes assessed were cumulative serious adverse events, musculoskeletal adverse events, neurocognitive adverse events, and stroke...
January 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28073687/adverse-event-detection-using-the-fda-post-marketing-drug-safety-surveillance-system-cardiotoxicity-associated-with-loperamide-abuse-and-misuse
#20
Kimberley A Swank, Eileen Wu, Cindy Kortepeter, Jana McAninch, Robert L Levin
OBJECTIVE: The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. METHODS: We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
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