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https://www.readbyqxmd.com/read/28211992/thirty-day-outcomes-for-children-and-adolescents-undergoing-laparoscopic-sleeve-gastrectomy-at-a-free-standing-children-s-hospital
#1
A L Speer, J Parekh, F G Qureshi, E P Nadler
The obesity epidemic continues to affect millions of children and adolescents. Non-surgical options do not result in significant or sustained weight loss; thus bariatric surgery has become increasingly utilized. Limited data exist regarding safety for paediatric bariatric surgery, especially outside of National Institutes of Health (NIH)-funded centres. We hypothesized that the perioperative outcomes of paediatric patients undergoing laparoscopic sleeve gastrectomy (LSG) at our free-standing children's hospital would provide adequate safety profiles...
February 17, 2017: Clinical Obesity
https://www.readbyqxmd.com/read/28211296/recommendations-for-the-medical-management-of-chronic-venous-disease-the-role-of-micronized-purified-flavanoid-fraction-mpff
#2
Ronald Bush, Anthony Comerota, Mark Meissner, Joseph D Raffetto, Steven R Hahn, Katherine Freeman
Scope A systematic review of the clinical literature concerning medical management of chronic venous disease with the venoactive therapy Micronized Purified Flavonoid Fraction was conducted in addition to an investigation of the hemodynamics and mechanism of chronic venous disease. Methods The systematic review of the literature focused on the use of Micronized Purified Flavonoid Fraction (diosmin) which has recently become available in the US, in the management of chronic venous disease. The primary goal was to assess the level of evidence of the role of Micronized Purified Flavonoid Fraction in the healing of ulcers, and secondarily on the improvement of the symptoms of chronic venous disease such as edema...
April 2017: Phlebology
https://www.readbyqxmd.com/read/28206704/lipid-lowering-efficacy-and-safety-of-alirocumab-in-patients-with-or-without-diabetes-a-sub-analysis-of-odyssey-combo-ii
#3
Lawrence A Leiter, Jose Luis Zamorano, Maja Bujas-Bobanovic, Michael J Louie, Guillaume Lecorps, Christopher P Cannon, Yehuda Handelsman
AIM: This sub-analysis of the ODYSSEY COMBO II study compared the effects of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in high cardiovascular risk patients with or without diabetes mellitus (DM) receiving maximally tolerated statin therapy. MATERIALS AND METHODS: COMBO II was a 104-week, double-blind study (n = 720) enrolling patients with documented atherosclerotic cardiovascular disease (ASCVD) and baseline LDL-C ≥70 mg/dL (1...
February 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28205322/efficacy-and-safety-of-autoinjected-exenatide-once-weekly-suspension-versus-sitagliptin-or-placebo-with-metformin-in-patients-with-type-2-diabetes-the-duration-neo-2-randomized-clinical-study
#4
Kishore M Gadde, Marion L Vetter, Nayyar Iqbal, Elise Hardy, Peter Öhman
AIMS: Glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors treat type 2 diabetes through incretin-signaling pathways. This study compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist exenatide once-weekly (Miglyol) suspension for autoinjection (QWS-AI) with the dipeptidyl peptidase-4 inhibitor sitagliptin or placebo. MATERIALS AND METHODS: In this open-label, multicenter study of patients with type 2 diabetes who had suboptimal glycemic control on metformin monotherapy, 365 patients were randomized to receive exenatide 2...
February 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28198767/anti-gal-and-anti-neu5gc-responses-in-nonimmunosuppressed-patients-following-treatment-with-rabbit-anti-thymocyte-polyclonal-iggs
#5
Apolline Salama, Gwénaëlle Evanno, Noha Lim, Juliette Rousse, Ludmilla Le Berre, Arnaud Nicot, Sophie Brouard, Kristina M Harris, Mario R Ehlers, Stephen E Gitelman, Jean-Paul Soulillou
BACKGROUND: Polyclonal anti-human thymocyte rabbit IgGs (anti-thymocyte globulin, ATG) are popular immunosuppressive drugs used to prevent or treat organ or bone-marrow allograft rejection, graft versus host disease, and autoimmune diseases. However, animal-derived glycoproteins are also strongly immunogenic and rabbit ATG induces serum sickness disease in almost all patients without additional immunosuppressive drugs, as seen in the START trial of ATG therapy in new-onset type 1 diabetes...
February 14, 2017: Transplantation
https://www.readbyqxmd.com/read/28197977/interpreting-cardiovascular-endpoints-in-trials-of-antihyperglycemic-drugs
#6
REVIEW
Himika Chawla, Nikhil Tandon
In view of the significant cardiovascular (CV) morbidity and mortality in patients with type 2 diabetes mellitus, and concerns raised about the CV safety of some glucose-lowering drugs, the US Food and Drug Administration (FDA) issued guidance for the industry in 2008 to demonstrate CV safety for the approval of all new antihyperglycemic drugs. Seven randomized controlled trials involving around 60,000 participants have been completed so far and have demonstrated the CV safety of dipeptidyl peptidase 4 inhibitors (saxagliptin, alogliptin and sitagliptin), glucagon-like peptide-1 receptor agonists (lixisenatide, liraglutide and semaglutide) and a sodium-glucose co-transporter 2 inhibitor (empagliflozin) in patients with type 2 diabetes...
February 14, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28197833/auxiliendo-primum-non-nocere-a-preliminary-view-of-the-devote-trial-comparing-cardiovascular-safety-of-insulin-degludec-versus-insulin-glargine-in-type-2-diabetes
#7
Sanjay Kalra
A demonstration of cardiovascular safety is mandatory for all newly developed glucose-lowering agents, including insulin analogues. The vascular benefit of insulin is evident from the Diabetes Control and Complication Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), and the cardiovascular safety of insulin glargine has been demonstrated in individuals with newly diagnosed diabetes or prediabetes in the ORIGIN trial (Outcome Reduction with an Initial Glargine Intervention). The top-line results of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs...
February 14, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28197420/the-challenges-of-electronic-health-records-and-diabetes-electronic-prescribing-implications-for-safety-net-care-for-diverse-populations
#8
REVIEW
Neda Ratanawongsa, Lenny L S Chan, Michelle M Fouts, Elizabeth J Murphy
Widespread electronic health record (EHR) implementation creates new challenges in the diabetes care of complex and diverse populations, including safe medication prescribing for patients with limited health literacy and limited English proficiency. This review highlights how the EHR electronic prescribing transformation has affected diabetes care for vulnerable patients and offers recommendations for improving patient safety through EHR electronic prescribing design, implementation, policy, and research. Specifically, we present evidence for (1) the adoption of RxNorm; (2) standardized naming and picklist options for high alert medications such as insulin; (3) the widespread implementation of universal medication schedule and language-concordant labels, with the expansion of electronic prescription 140-character limit; (4) enhanced bidirectional communication with pharmacy partners; and (5) informatics and implementation research in safety net healthcare systems to examine how EHR tools and practices affect diverse vulnerable populations...
2017: Journal of Diabetes Research
https://www.readbyqxmd.com/read/28195447/safety-tolerability-and-efficacy-of-lixisenatide-as-monotherapy-in-japanese-patients-with-type-2-diabetes-mellitus-an-open-label-multicenter-study
#9
Yutaka Seino, Yasuo Terauchi, Xiangling Wang, Daisuke Watanabe, Elisabeth Niemoeller
AIM/INTRODUCTION: To assess overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Patients with type 2 diabetes mellitus, previously treated with ≤1 oral antidiabetic drugs, were enrolled in an uncontrolled, open-label, single-arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6-week run-in period. From baseline, patients received once-daily lixisenatide monotherapy (10 μg for 1 week, 15 μg for 1 week, 20 μg thereafter) for 52 weeks (first 140 patients enrolled) or 24 weeks (subsequently enrolled patients)...
February 13, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28191913/treatment-with-the-glucagon-receptor-antagonist-ly2409021-increases-ambulatory-blood-pressure-in-patients-with-type-2-diabetes
#10
Christof M Kazda, Juan Frias, Irene Foga, Xuewei Cui, Cristina B Guzman, Parag Garhyan, Cory Heilmann, Jihui Anne Yang, Thomas A Hardy
AIMS: To assess the effect of LY2409021 on systolic blood pressure (SBP) in patients with type 2 diabetes. MATERIALS AND METHODS: This 6-week, randomized, crossover study evaluated the effects of once-daily administration of LY2409021 20 mg vs those of placebo on SBP, diastolic BP (DBP), and mean arterial pressure (MAP) using 24-hour ambulatory BP monitoring (ABPM) in 270 subjects treated with diet/exercise ± metformin. Other measures included changes in glycemic control, serum lipids, and hepatic safety markers...
February 13, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28191351/evaluating-the-measurement-properties-of-the-self-assessment-of-treatment-version-ii-follow-up-version-in-patients-with-painful-diabetic-peripheral-neuropathy
#11
Floortje van Nooten, Dylan Trundell, Dorota Staniewska, Jun Chen, Evan W Davies, Dennis A Revicki
Background. The Self-Assessment of Treatment version II (SAT II) measures treatment-related improvements in pain and impacts and impressions of treatment in neuropathic pain patients. The measure has baseline and follow-up versions. This study assesses the measurement properties of the SAT II. Methods. Data from 369 painful diabetic peripheral neuropathy (PDPN) patients from a phase III trial assessing capsaicin 8% patch (Qutenza®) efficacy and safety were used in these analyses. Reliability, convergent validity, known-groups validity, and responsiveness (using the Brief Pain Inventory-Diabetic Neuropathy [BPI-DN] and Patient Global Impression of Change [PGIC]) analyses were conducted, and minimally important differences (MID) were estimated...
2017: Pain Research and Treatment
https://www.readbyqxmd.com/read/28188240/lixisenatide-therapy-in-older-patients-with-type-2-diabetes-inadequately-controlled-on-their-current-antidiabetic-treatment-the-getgoal-o-randomized-trial
#12
Graydon S Meneilly, Christine Roy-Duval, Hasan Alawi, George Dailey, Diego Bellido, Carlos Trescoli, Helard Manrique Hurtado, Hailing Guo, Valerie Pilorget, Riccardo Perfetti, Hamish Simpson
OBJECTIVE: To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODS: In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks...
February 10, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28187863/a-review-of-the-clinical-efficacy-and-safety-of-insulin-degludec-and-glargine-300-u-ml-in-the-treatment-of-diabetes-mellitus
#13
REVIEW
Vincent C Woo
PURPOSE: The treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) using insulin is not ideal at this time. Despite advances made with basal insulin analogues, many individuals achieve less than optimal glycemic control or are at risk for hypoglycemia. Currently available basal insulin analogues do not deliver steady, peakless, continuous insulin for >24 hours and are associated with adverse events, including hypoglycemia. The objective of this paper was to review the clinical efficacy and safety of upcoming long-acting insulin analogues such as insulin degludec and insulin glargine 300 U/mL (Gla-300)...
February 7, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28184166/canagliflozin-improves-risk-factors-of-metabolic-syndrome-in-patients-with-type-2-diabetes-mellitus-and-metabolic-syndrome
#14
Michael J Davies, Katherine W Merton, Ujjwala Vijapurkar, Dainius A Balis, Mehul Desai
OBJECTIVE: Metabolic syndrome refers to a collection of risk factors associated with the development of cardiovascular disease and type 2 diabetes mellitus (T2DM). Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves glycemic control and reduces body weight and blood pressure (BP) in a broad range of patients with T2DM. This post hoc analysis assessed the effects of canagliflozin on the components of metabolic syndrome in patients with T2DM and metabolic syndrome. METHODS: This analysis was based on data from 2 head-to-head studies of canagliflozin in patients with T2DM on background metformin versus glimepiride (study 1) and background metformin plus sulfonylurea versus sitagliptin 100 mg (study 2)...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/28183306/third-generation-drug-eluting-stent-des-with-biodegradable-polymer-in-diabetic-patients-5%C3%A2-years-follow-up
#15
Marcus Wiemer, Sinisa Stoikovic, Alexander Samol, Zisis Dimitriadis, Juan M Ruiz-Nodar, Ralf Birkemeyer, Jacques Monsegu, Gérard Finet, David Hildick-Smith, Damras Tresukosol, Enrique Garcia Novo, Jacques J Koolen, Emanuele Barbato, Gian Battista Danzi
OBJECTIVE: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. BACKGROUND: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. METHODS: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM)...
February 10, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28182863/randomized-controlled-trial-of-a-community-health-worker-self-management-support-intervention-among-low-income-adults-with-diabetes-seattle-washington-2010-2014
#16
Karin Nelson, Leslie Taylor, Julie Silverman, Meghan Kiefer, Paul Hebert, Dan Lessler, James Krieger
INTRODUCTION: Community health workers (CHWs) can improve diabetes outcomes; however, questions remain about translating research findings into practical low-intensity models for safety-net providers. We tested the effectiveness of a home-based low-intensity CHW intervention for improving health outcomes among low-income adults with diabetes. METHODS: Low-income patients with glycated hemoglobin A1c (HbA1c) of 8.0% or higher in the 12 months before enrollment from 3 safety-net providers were randomized to a 12-month CHW-delivered diabetes self-management intervention or usual care...
February 9, 2017: Preventing Chronic Disease
https://www.readbyqxmd.com/read/28179966/efficacy-and-safety-of-vildagliptin-as-an-add-on-therapy-in-inadequately-controlled-type-2-diabetes-patients-treated-with-basal-insulin
#17
Daisuke Saito, Akio Kanazawa, Nayumi Shigihara, Fumihiko Sato, Toyoyoshi Uchida, Junko Sato, Hiromasa Goto, Takeshi Miyatsuka, Fuki Ikeda, Takeshi Ogihara, Chie Ohmura, Hirotaka Watada
BACKGROUND: The aim of this study was to investigate the efficacy and safety of vildagliptin as an add-on therapy for patients with type 2 diabetes mellitus inadequately controlled with basal insulin. METHODS: Twenty-four patients treated with basal insulin and oral anti-diabetes drugs were randomly allocated into two groups: the control group (did not receive any add-on drugs) and vildagliptin group (received vildagliptin 100 mg/day for 6 months). The primary outcome was changes in hemoglobin A1c (HbA1c) from baseline to end of study...
March 2017: Journal of Clinical Medicine Research
https://www.readbyqxmd.com/read/28178701/a-nonrandomized-open-label-multicenter-phase-4-pilot-study-on-the-effect-and-safety-of-iluvien%C3%A2-in-chronic-diabetic-macular-edema-patients-considered-insufficiently-responsive-to-available-therapies-respond
#18
João Figueira, José Henriques, Miguel Amaro, Vítor Rosas, Dalila Alves, José Cunha-Vaz
PURPOSE: The aim of this study was to assess the effectiveness and safety of ILUVIEN® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies. METHODS: This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12...
February 9, 2017: Ophthalmic Research
https://www.readbyqxmd.com/read/28178698/dipeptidyl-peptidase-4-inhibitors-in-chronic-kidney-disease-a-systematic-review-of-randomized-clinical-trials
#19
Simon R Walker, Paul Komenda, Suhail Khojah, Wafa Al-Tuwaijri, Kerry MacDonald, Brett Hiebert, Neil Tangri, Stewart W D Nadurak, Thomas W Ferguson, Claudio Rigatto, Navdeep Tangri
BACKGROUND: Chronic kidney disease (CKD) is common in patients with type 2 diabetes mellitus (T2DM) and limits therapeutic options. Dipeptidyl peptidase-4 (DPP-4) inhibitors represent a novel class of oral glucose-lowering agents and are known to be safe and effective in the general population. METHODS: We searched Cochrane, EMBASE, and PubMed from the time of their inception until March 2015. We included randomized controlled trials analyzing the efficacy (change in hemoglobin A1C [HbA1C]) and safety of DPP-4 agents in individuals with reduced kidney function (estimated glomerular filtration rate <60 mL/min/1...
February 9, 2017: Nephron
https://www.readbyqxmd.com/read/28178390/metabolic-and-hemodynamic-effects-of-sodium-dependent-glucose-co-transporter-2-inhibitors-on-cardio-renal-protection-in-the-treatment-of-patients-with-type-2-diabetes-mellitus
#20
REVIEW
Atsunori Kashiwagi, Hiroshi Maegawa
The specific Na+/glucose co-transporter 2 inhibitors (SGLT2 inhibitors) inhibit glucose reabsorption in proximal renal tubular cells, and both fasting and postprandial glucose significantly decrease due to urinary glucose loss. As a result, pancreatic β-cell function and peripheral insulin action significantly improve with relief from glucose toxicity. Furthermore, whole body energy metabolism changes to relative glucose deficiency and triggers increased lipolysis in fat cells, and fatty acid oxidation and then ketone body production in the liver during treatment with SGLT2 inhibitors...
February 8, 2017: Journal of Diabetes Investigation
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