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Drug, trial and diabetes

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https://www.readbyqxmd.com/read/29934374/heart-failure-after-ischemic-stroke-or-tia-in-insulin-resistant-patients-without-diabetes-treated-with-pioglitazone
#1
Lawrence H Young, Catherine M Viscoli, Gregory G Schwartz, Silvio E Inzucchi, Jeptha P Curtis, Mark J Gorman, Karen L Furie, Robin Conwit, Erica Spatz, Anne Lovejoy, J Dawn Abbott, Daniel L Jacoby, Daniel M Kolansky, Frederick S Ling, Steven E Pfau, Walter N Kernan
Background -The Insulin Resistance Intervention after Stroke (IRIS) trial demonstrated that pioglitazone reduced risk for both cardiovascular events and diabetes in insulin resistant patients. However, concern remains that pioglitazone may increase risk for heart failure (HF) in susceptible individuals. Methods -In IRIS, patients with insulin resistance but without diabetes were randomized to pioglitazone or placebo (1:1) within 180 days of an ischemic stroke or TIA and followed for up to 5 years. To identify patients at higher HF risk with pioglitazone we performed a secondary analysis of IRIS participants without HF history at entry...
June 22, 2018: Circulation
https://www.readbyqxmd.com/read/29933718/effects-of-coenzyme-q10-supplementation-on-serum-values-of-adiponectin-leptin-8-isoprostane-and-malondialdehyde-in-women-with-type-2-diabetes
#2
Mahsa Gholami, Parvin Zarei, Bahman Sadeghi Sedeh, Fatemeh Rafiei, Ali Khosrowbeygi
Patients with type 2 diabetes mellitus (T2DM) have been known to be suffering from coenzyme Q10 (CoQ10) deficiency which results in some complications in them. The purpose of this clinical trial study was to evaluate the effects of CoQ10 supplementation on serum values of adiponectin (A), leptin (L), 8-isoprostane, malondialdehyde (MDA), the A/L ratio in women with T2DM. Sixty-eight women with T2DM were enrolled in the current study and were randomly divided into drug (n = 34) and placebo (n = 34) groups who were consuming 100 mg CoQ10 and 100 mg cellulose acetate per day for 12 weeks, respectively...
June 22, 2018: Gynecological Endocrinology
https://www.readbyqxmd.com/read/29933016/potential-therapeutic-applications-of-the-genus-annona-local-and-traditional-uses-and-pharmacology
#3
REVIEW
A M Quílez, M A Fernández-Arche, M D García-Giménez, R De la Puerta
ETHNO-PHARMACOLOGICAL RELEVANCE: Annona species (Annonaceae) have long been used as traditional herbal medicines by native peoples in tropical areas. In different countries they are used against a large variety of illnesses, such as parasitic and infectious diseases, cancer, diabetes, peptic ulcers, and mental disorders. AIM OF THE STUDY: This review aims to achieve a comprehensive understanding of the research conducted so far on the local and traditional uses, pharmacological activities, mechanism of actions of active compounds, toxicity, and possible interactions with other drugs of the Annona species...
June 19, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29932012/choroideremia-molecular-mechanisms-and-development-of-aav-gene-therapy
#4
Maria I Patrício, Alun R Barnard, Kanmin Xue, Robert E MacLaren
INTRODUCTION: Choroideremia is an X-linked inherited retinal degeneration that causes blindness in afflicted males by middle age. The causative gene, CHM, plays a key role in intracellular trafficking pathways, and its disruption impairs cell homeostasis. Areas covered: The mechanism by which mutations in CHM cause choroideremia is still under debate. Here we describe the molecular defects in choroideremia cells regarding both the deficiency of prenylation and the involvement of Rab GTPases...
June 22, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29926837/efficacy-of-epalrestat-plus-%C3%AE-lipoic-acid-combination-therapy-versus-monotherapy-in-patients-with-diabetic-peripheral-neuropathy-a-meta-analysis-of-20-randomized-controlled-trials
#5
Ming Zhao, Jia-Yi Chen, Yu-Dong Chu, Ya-Bin Zhu, Lin Luo, Shi-Zhong Bu
Objective: To evaluate the efficacy of α-lipoic acid (ALA) plus epalrestat combination therapy in the treatment of diabetic peripheral neuropathy (DPN). Data Sources: The electronic databases of PubMed, Medline, Embase, the Cochrane Library, the Chinese National Knowledge Infrastructure, the Wanfang Database and the Chinese Biomedical Database were used to retrieve relevant studies without language restrictions. The search was conducted from the inception of each database to 7 October 2016...
June 2018: Neural Regeneration Research
https://www.readbyqxmd.com/read/29925930/elevated-t-cell-levels-in-peripheral-blood-predict-poor-clinical-response-following-rituximab-treatment-in-new-onset-type-1-diabetes
#6
Peter S Linsley, Carla J Greenbaum, Mario Rosasco, Scott Presnell, Kevan C Herold, Matthew J Dufort
Biologic treatment of type 1 diabetes (T1D) with agents including anti-CD3 (otelixizumab and teplizumab), anti-CD20 (rituximab), LFA3Ig (alafacept), and CTLA4Ig (abatacept) results in transient stabilization of insulin C-peptide, a surrogate for endogenous insulin secretion. With the goal of inducing more robust immune tolerance, we used systems biology approaches to elucidate mechanisms associated with C-peptide stabilization in clinical trial blood samples from new-onset T1D subjects treated with the B cell-depleting drug, rituximab...
June 21, 2018: Genes and Immunity
https://www.readbyqxmd.com/read/29925691/pan-ampk-activator-o304-improves-glucose-homeostasis-and-microvascular-perfusion-in-mice-and-type-2-diabetes-patients
#7
Pär Steneberg, Emma Lindahl, Ulf Dahl, Emmelie Lidh, Jurate Straseviciene, Fredrik Backlund, Elisabet Kjellkvist, Eva Berggren, Ingela Lundberg, Ingela Bergqvist, Madelene Ericsson, Björn Eriksson, Kajsa Linde, Jacob Westman, Thomas Edlund, Helena Edlund
AMPK activated protein kinase (AMPK), a master regulator of energy homeostasis, is activated in response to an energy shortage imposed by physical activity and caloric restriction. We here report on the identification of PAN-AMPK activator O304, which - in diet-induced obese mice - increased glucose uptake in skeletal muscle, reduced β cell stress, and promoted β cell rest. Accordingly, O304 reduced fasting plasma glucose levels and homeostasis model assessment of insulin resistance (HOMA-IR) in a proof-of-concept phase IIa clinical trial in type 2 diabetes (T2D) patients on Metformin...
June 21, 2018: JCI Insight
https://www.readbyqxmd.com/read/29923298/low-incidence-of-gastrointestinal-adverse-events-over-time-with-a-fixed-ratio-combination-of-insulin-glargine-and-lixisenatide-vs-lixisenatide-alone
#8
Jennifer M Trujillo, Michelle Roberts, Terry Dex, Jason Chao, Pa-C John White, James LaSalle
This post hoc analysis of gastrointestinal (GI) adverse events (AEs) from the phase 3 LixiLan-L (NCT02058160) and LixiLan-O (NCT02058147) trials aimed to determine the frequency and timing of nausea, vomiting, and diarrhea for iGlarLixi, a titratable, fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, vs iGlar alone or iGlar and lixisenatide alone, in patients with type 2 diabetes uncontrolled with oral antidiabetes drugs (OADs) or basal insulin ± OADs. In iGlarLixi-treated patients, the rate of GI AEs during initial weeks of treatment was lower vs patients treated with lixisenatide alone (9...
June 19, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29921013/immunosuppressive-drug-therapy-for-preventing-rejection-following-lung-transplantation-in-cystic-fibrosis
#9
REVIEW
Ian J Saldanha, Oluwaseun Akinyede, Karen A Robinson
BACKGROUND: For people with cystic fibrosis and advanced pulmonary damage, lung transplantation is an available and viable option. However, graft rejection is an important potential consequence after lung transplantation. Immunosuppressive therapy is needed to prevent episodes of graft rejection and thus subsequently reduce morbidity and mortality in this population. There are a number of classes of immunosuppressive drugs which act on different components of the immune system. There is considerable variability in the use of immunosuppressive agents after lung transplantation in cystic fibrosis...
June 18, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29915923/pharmacokinetics-and-clinical-implications-of-semaglutide-a-new-glucagon-like-peptide-glp-1-receptor-agonist
#10
REVIEW
Sylvie Hall, Diana Isaacs, Jennifer N Clements
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) came to market in the year 2005, as a new therapeutic classification, for clinical use in the management of type 2 diabetes mellitus (T2DM). Since 2005, there have been six approved products on the market, with the newest product being semaglutide (Novo Nordisk). Several studies have been conducted and completed evaluating its pharmacokinetics as a once-weekly subcutaneous injection. As a dose of 0.5 or 1 mg, semaglutide has a half-life of 7 days; therefore, it would reach steady state in 4-5 weeks...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915588/metformin-and-autoimmunity-a-new-deal-of-an-old-drug
#11
REVIEW
Francesco Ursini, Emilio Russo, Gianluca Pellino, Salvatore D'Angelo, Agostino Chiaravalloti, Giovambattista De Sarro, Roberto Manfredini, Roberto De Giorgio
Metformin ( dimethyl biguanide ) is a synthetic derivative of guanidine, isolated from the extracts of Galega officinalis , a plant with a prominent antidiabetic effect. Since its discovery more than 50 years ago, metformin represents a worldwide milestone in treatment of patients with type 2 diabetes (T2D). Recent evidence in humans indicates novel pleiotropic actions of metformin which span from its consolidated role in T2D management up to various regulatory properties, including cardio- and nephro-protection, as well as antiproliferative, antifibrotic, and antioxidant effects...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29912999/implications-of-cardiovascular-outcomes-trials-in-type-2-diabetes-for-primary-care
#12
Jeff Unger
Patients with type 2 diabetes (T2D) are at a greater risk of cardiovascular (CV) morbidity and mortality than their counterparts without diabetes. Worsening glycemic control is associated with increasing risk of CV events and mortality, but glycemic control alone does not appear sufficient to improve CV outcomes. Furthermore, some glucose-lowering drugs have been associated with an increased risk of CV events. As a result, the US Food and Drug Administration (FDA) issued guidance in 2008 for the investigation of CV risk with new diabetes therapies...
June 2018: Journal of Family Practice
https://www.readbyqxmd.com/read/29912995/an-overview-of-the-burden-of-illness-and-the-role-of-once-weekly-glucagon-like-peptide-1-receptor-agonists-in-the-treatment-of-type-2-diabetes
#13
Stephen A Brunton
Type 2 diabetes (T2D) is a debilitating condition and more people are being diagnosed each year. T2D increases patients' risk of developing disabling micro- and macrovascular complications, significantly reduces patients' quality of life, and is a substantial global economic burden. The efficacy and safety of antihyperglycemic therapies have improved over the years and have increased the lifespan for these patients. Consequently, patients are living longer with the condition and the associated comorbidities, but with a lowered quality of life...
June 2018: Journal of Family Practice
https://www.readbyqxmd.com/read/29911403/how-4-companies-became-one-co-development-under-an-outsourced-model-with-focus-on-phase-3-analysis-and-reporting-deliverables
#14
Susan Huyck, Gregory Golm, Sajda Ghani, James Mancuso, Tarra Irvin
With the growth in co-development deals between pharmaceutical companies and the increased use of contract research organizations (CROs) in drug development, more and more employees are encountering projects that require working across different companies. Navigating the mix of corporate cultures as well as variations in standards and procedures can lead to unanticipated challenges and delays. The development of ertugliflozin, a recently approved medicine for type 2 diabetes mellitus, involved both co-development and CRO engagement across 4 companies...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29911393/renal-and-cardiac-implications-of-sodium-glucose-cotransporter-2-sglt2-inhibitors-the-state-of-the-science
#15
Joseph E Cruz, Tania Ahuja, Mary Barna Bridgeman
OBJECTIVE: To review the role of the sodium-glucose cotransporter-2 (SGLT2) inhibitors in the management of type 2 diabetes (T2DM), including the effects on renal and cardiovascular (CV) outcomes. DATA SOURCES: A literature search of MEDLINE databases (1964 through May 2018) was conducted utilizing key words sodium-glucose co-transporter-2 inhibitors, SGLT2 inhibitors, and diabetes; additional limits for drug names were added. STUDY SELECTION AND DATA EXTRACTION: Available English-language data from reviews, abstracts, presentations, and clinical trials of use of SGLT2 therapy specifically detailing outcomes on CV and renal disease in humans were reviewed...
June 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29910024/dulaglutide-versus-insulin-glargine-in-patients-with-type-2-diabetes-and-moderate-to-severe-chronic-kidney-disease-award-7-a-multicentre-open-label-randomised-trial
#16
Katherine R Tuttle, Mark C Lakshmanan, Brian Rayner, Robert S Busch, Alan G Zimmermann, D Bradley Woodward, Fady T Botros
BACKGROUND: Many antihyperglycaemic drugs, including insulin, are primarily cleared by the kidneys, restricting treatment options for patients with kidney disease. Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist that is not cleared by the kidneys, and confers a lower risk of hypoglycaemia than does insulin. We assessed the efficacy and safety of dulaglutide in patients with type 2 diabetes and moderate-to-severe chronic kidney disease. METHODS: AWARD-7 was a multicentre, open-label trial done at 99 sites in nine countries...
June 14, 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29903781/how-good-are-gps-at-adhering-to-a-pragmatic-trial-protocol-in-primary-care-results-from-the-addition-cambridge-cluster-randomised-pragmatic-trial
#17
Michael Laxy, Edward C F Wilson, Clare E Boothby, Simon J Griffin
OBJECTIVE: To assess the fidelity of general practitioners' (GPs) adherence to a long-term pragmatic trial protocol. DESIGN: Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010...
June 14, 2018: BMJ Open
https://www.readbyqxmd.com/read/29901815/exposure-response-modeling-analyses-for-sirukumab-a-human-monoclonal-antibody-targeting-interleukin-6-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis
#18
Yan Xu, Chuanpu Hu, Yanli Zhuang, Benjamin Hsu, Zhenhua Xu, Amarnath Sharma, Honghui Zhou
To characterize the dose-exposure-response relationship of sirukumab, an anti-interleukin 6 human monoclonal antibody, in the treatment of moderately to severely active rheumatoid arthritis (RA), we conducted exposure-response (E-R) modeling analyses based on data from two pivotal phase 3 placebo-controlled trials of sirukumab in patients with RA who were inadequate responders to nonbiologic disease-modifying antirheumatic drugs or anti-tumor necrosis factor α agents. A total of 2176 patients were included for the analyses and received subcutaneous administration of either placebo or sirukumab 50 mg every 4 weeks or 100 mg every 2 weeks...
June 14, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29901406/recommendations-for-initiating-use-of-afrezza-inhaled-insulin-in-individuals-with-type-1-diabetes
#19
Jeremy Pettus, Tricia Santos Cavaiola, Steven V Edelman
Treatment with Afrezza® (insulin human) inhalation powder in individuals with type 1 diabetes (T1D) reduces HbA1c levels similar to rapid-acting insulin analogs, but with significantly less hypoglycemia due to its unique time action profile. Examinations of studies of Afrezza pharmacokinetics/pharmacodynamics, relevant clinical trials, and U.S. Food and Drug Administration (FDA) documentation suggest that current FDA-mandated dosing recommendations for initiating Afrezza treatment may not result in optimal glycemic control for individuals with T1D...
June 14, 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29887300/detection-of-asymptomatic-drug-induced-hypoglycemia-using-continuous-glucose-monitoring-in-older-people-systematic-review
#20
REVIEW
K Mattishent, Y K Loke
AIM: We conducted a systematic review of the use of continuous glucose monitoring (CGM) in older patients, in order to consolidate the growing evidence base in this area. METHODS: Our protocol was registered on PROSPERO (CRD42017068523). We searched SCI Web of Science, Ovid SP MEDLINE and EMBASE from January 2010 to June 2017 for observational studies and randomized controlled trial of CGM in older patients (mean age 65 or older) with diabetes. We excluded studies that involved only hospitalized patients...
May 18, 2018: Journal of Diabetes and its Complications
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