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Drug, trial and diabetes

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https://www.readbyqxmd.com/read/28726152/cardiovascular-outcome-trial-update-in-diabetes-new-evidence-remaining-questions
#1
REVIEW
Rebecca Herbst, Wilburn Bolton, Afreen Shariff, Jennifer B Green
PURPOSE OF REVIEW: Seven trials of new agents to treat type 2 diabetes (T2DM) have been performed to assess cardiovascular (CV) safety. A significant amount of information regarding the effects of drugs in three classes is available, with new data from multiple other trials expected shortly. This article provides a summary of recently completed trials. RECENT FINDINGS: The dipeptidyl peptidase-4 inhibitors studied thus far do not alter the risk of major adverse CV events (MACE)...
September 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28725307/acute-pancreatitis-secondary-to-severe-hypertriglyceridemia-management-of-severe-hypertriglyceridemia-in-emergency-setting
#2
Ahmad Chaudhary, Umair Iqbal, Hafsa Anwar, Hafiz Umair Siddiqui, Madiha Alvi
Hypertriglyceridemia (HTG) is the third most common cause of acute pancreatitis (AP). The incidence of AP is around 10-20% with levels > 2,000 mg/dL. We present here a case of a 44-year-old male with history of uncontrolled diabetes mellitus and HTG admitted with severe abdominal pain. Labs revealed elevated lipase and amylase. CT of abdomen with contrast showed AP. He was found to have a triglyceride (TG) level of 6,672 mg/dL. Besides conventional treatment for AP with intravenous (IV) hydration, he was started on IV regular insulin along with dextrose saline...
June 2017: Gastroenterology Research
https://www.readbyqxmd.com/read/28721686/rationale-for-initiation-and-titration-of-the-basal-insulin-glp-1ra-fixed-ratio-combination-products-ideglira-and-iglarlixi-for-the-management-of-type-2-diabetes
#3
REVIEW
Virginia Valentine, Jennifer Goldman, Jay H Shubrook
Type 2 diabetes (T2D) is a progressive disease affecting glucose regulation and a major cause of morbidity and mortality globally. Many patients are not escalated up the treatment ladder appropriately despite failing to achieve glycemic control, with barriers such as fear of hypoglycemia, weight gain, and treatment burden recognized as factors. Exogenous basal insulin is titrated to address control of fasting plasma glucose and may preserve residual β-cell function, thus promoting a greater endogenous prandial insulin response...
July 18, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28720112/association-of-the-fda-amendment-act-with-trial-registration-publication-and-outcome-reporting
#4
REVIEW
Adam T Phillips, Nihar R Desai, Harlan M Krumholz, Constance X Zou, Jennifer E Miller, Joseph S Ross
BACKGROUND: Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. METHODS: Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA...
July 18, 2017: Trials
https://www.readbyqxmd.com/read/28715513/percutaneous-endovascular-treatment-of-infrainguinal-paod-results-of-the-psi-register-study-in-74%C3%A2-german-vascular-centers
#5
C-A Behrendt, F Heidemann, K Haustein, R T Grundmann, E S Debus
BACKGROUND: The percutaneous infrainguinal stent (PSI) register study aimed to collate all percutaneous endovascular procedures for infrainguinal peripheral arterial occlusive disease (PAOD) conducted in 74 German vascular centers between September and November 2015 (3 months). In order to obtain representative results all consecutive treatment procedures had to be submitted by the participating trial centers. MATERIAL AND METHODS: This was a prospective, nonrandomized multicenter study design...
2017: Gefässchirurgie: Zeitschrift Für Vaskuläre und Endovaskuläre Chirurgie
https://www.readbyqxmd.com/read/28713407/biorhizome-a-biosynthetic-platform-for-colchicine-biomanufacturing
#6
REVIEW
Ganapathy Sivakumar, Kamran Alba, Gregory C Phillips
Colchicine is one of the oldest plant-based medicines used to treat gout and one of the most important alkaloid-based antimitotic drugs with anticancer potential, which is commercially extracted from Gloriosa superba. Clinical trials suggest that colchicine medication could prevent atrial fibrillation recurrence after cardiac surgery. In addition, therapeutic colchicine is undergoing clinical trials to treat non-diabetic metabolic syndrome and diabetic nephropathy. However, the industrial-scale biomanufacturing of colchicine have not yet been established...
2017: Frontiers in Plant Science
https://www.readbyqxmd.com/read/28712181/comparison-of-lipid-lowering-effect-of-extra-virgin-olive-oil-and-atorvastatin-in-dyslipidaemia-in-type-2-diabetes-mellitus
#7
Tariq Mahmood Khan, Sohail Iqbal, Muhammad Adnan Rashid
BACKGROUND: Extra virgin olive oil (EVOO) is fruit oil with rich source of monounsaturated fats and powerful antioxidants. It acts as hypolipidemic agent and significant decrease of plasma lipids level was observed with EVOO use. Atorvastatin is hypolipidemic drug commonly used for treatment of hyperlipidaemia. The purpose of this study was to determine & compare the lipid lowering effect of EVOO with atorvastatin in type 2 diabetic dyslipidaemia which is leading cause of microvascular diseases...
January 2017: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28709719/metformin-effects-on-the-heart-and-the-cardiovascular-system-a%C3%A2-review-of-experimental-and-clinical-data
#8
REVIEW
L Nesti, A Natali
BACKGROUND: Metformin, the eldest and most widely used glucose lowering drug, is likely to be effective also on cardiac and vascular disease prevention. Nonetheless, uncertainty still exists with regard to its effects on the cardiovascular system as a whole and specifically on the myocardium, both at the organ and cellular levels. METHODS: We reviewed the available data on the cardiac and vascular effects of metformin, encompassing both in vitro, either tissue or isolated organ, and in vivo studies in experimental animals and humans, as well as the evidence generated by major clinical trials...
May 10, 2017: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
https://www.readbyqxmd.com/read/28709650/anticoagulation-control-in-warfarin-treated-patients-undergoing-cardioversion-of-atrial-fibrillation-from-the-edoxaban-versus-enoxaparin-warfarin-in-patients-undergoing-cardioversion-of-atrial-fibrillation-trial
#9
Gregory Y H Lip, Naab Al-Saady, James Jin, Ming Sun, Michael Melino, Shannon M Winters, Dmitry Zamoryakhin, Andreas Goette
In the Edoxaban Versus Enoxaparin-Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation (ENSURE-AF) study (NCT 02072434), edoxaban was compared with enoxaparin-warfarin in 2,199 patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF). In this multicenter prospective randomized open blinded end-point trial, we analyzed patients randomized to enoxaparin-warfarin. We determined time to achieve therapeutic range (TtTR); time in therapeutic range (TiTR); their clinical determinants; relation to sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) score; and impact on primary end points (composite of stroke, systemic embolic event[SEE], myocardial infarction [MI], and cardiovascular death [CVD] and composite of major + clinically relevant nonmajor bleeding)...
June 15, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28709443/severity-of-acute-gastrointestinal-injury-grade-is-a-predictor-of-all-cause-mortality-in-critically-ill-patients-a-multicenter-prospective-observational-study
#10
Bangchuan Hu, Renhua Sun, Aiping Wu, Yin Ni, Jingquan Liu, Feng Guo, Lijun Ying, Guoping Ge, Aijun Ding, Yunchao Shi, Changwen Liu, Lei Xu, Ronglin Jiang, Jun Lu, Ronghai Lin, Yannan Zhu, Weidong Wu, Bo Xie
BACKGROUND: In 2012, the European Society of Intensive Care Medicine proposed a definition for acute gastrointestinal injury (AGI) based on current medical evidence and expert opinion. The aim of the present study was to evaluate the feasibility of using the current AGI grading system and to investigate the association between AGI severity grades with clinical outcome in critically ill patients. METHODS: Adult patients at 14 general intensive care units (ICUs) with an expected ICU stay ≥24 h were prospectively studied...
July 14, 2017: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/28707375/clinical-outcomes-with-reservoir-based-polymer-free-amphilimus-eluting-stents-in-real-world-patients-according-to-diabetes-mellitus-and-complexity-the-investig8-registry
#11
Gennaro Sardella, Pieter Stella, Mauro Chiarito, Antonio M Leone, Vruyr Balian, Franco Prosperi, Giovanni Sorropago, Massimo Mancone, Simone Calcagno, Carlo Briguori, Giulio G Stefanini
BACKGROUND: Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown. METHODS: Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry...
July 14, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28704915/treatment-of-diabetic-kidney-disease-current-and-future-targets
#12
REVIEW
Mi-Kyung Kim
Diabetic kidney disease (DKD) is a leading cause of end-stage renal disease in Korea and worldwide, and is a risk factor for the development of cardiovascular complications. The conventional treatments for DKD are control of blood glucose and blood pressure levels by inhibiting the renin-angiotensin system. However, the prevalence of DKD continues to increase and additional therapies are required to prevent or ameliorate the condition. Many drugs have been, or are being, developed to target the molecular mechanisms in play in DKD...
July 2017: Korean Journal of Internal Medicine
https://www.readbyqxmd.com/read/28700566/enhancing-pediatric-clinical-trial-feasibility-through-the-use-of-bayesian-statistics
#13
Robin A Huff, Jeff D Maca, Mala Puri, Earl W Seltzer
BACKGROUND: Pediatric clinical trials commonly experience recruitment challenges, including limited numbers of patients and investigators, inclusion/exclusion criteria that further reduce the patient pool, and a competitive research landscape created by pediatric regulatory commitments. To overcome these challenges, innovative approaches are needed. METHODS: This article explores the use of Bayesian statistics to improve pediatric trial feasibility, using pediatric type 2 diabetes as an example...
July 12, 2017: Pediatric Research
https://www.readbyqxmd.com/read/28699089/cardiovascular-safety-of-antidiabetic-drugs-in-the-hospital-setting
#14
REVIEW
Stacey A Seggelke, Mark C Lindsay, Ingrid Hazlett, Rebecca Sanagorski, Robert H Eckel, Cecilia C Low Wang
PURPOSE OF REVIEW: Patients with diabetes and/or stress hyperglycemia requires good glycemic control in the hospital setting, often requiring the use of glucose-lowering therapy. Standard-of-care dictates that non-insulin therapy be discontinued, with insulin therapy initiated using a basal-bolus approach. However, insulin is associated with a high risk for hypoglycemia and medical errors. Alternatives to insulin are needed in the inpatient setting, but the cardiovascular (CV) safety of non-insulin therapy is a concern...
August 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28692442/current-issues-in-allogeneic-islet-transplantation
#15
Charles A Chang, Michael C Lawrence, Bashoo Naziruddin
PURPOSE OF REVIEW: Transplantation of allogenic pancreatic islets is a minimally invasive treatment option to control severe hypoglycemia and dependence on exogenous insulin among type 1 diabetes (T1D) patients. This overview summarizes the current issues and progress in islet transplantation outcomes and research. RECENT FINDINGS: Several clinical trials from North America and other countries have documented the safety and efficacy of clinical islet transplantation for T1D patients with impaired hypoglycemia awareness...
July 7, 2017: Current Opinion in Organ Transplantation
https://www.readbyqxmd.com/read/28691311/bayesian-adaptive-dose-escalation-designs-for-simultaneously-estimating-the-optimal-and-maximum-safe-dose-based-on-safety-and-efficacy
#16
Wai Yin Yeung, Bruno Reigner, Ulrich Beyer, Cheikh Diack, Daniel Sabanés Bové, Giuseppe Palermo, Thomas Jaki
The main purpose of dose-escalation trials is to identify the dose(s) that is/are safe and efficacious for further investigations in later studies. In this paper, we introduce dose-escalation designs that incorporate both the dose-limiting events and dose-limiting toxicities (DLTs) and indicative responses of efficacy into the procedure. A flexible nonparametric model is used for modelling the continuous efficacy responses while a logistic model is used for the binary DLTs. Escalation decisions are based on the combination of the probabilities of DLTs and expected efficacy through a gain function...
July 9, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28690682/autologous-bone-marrow-derived-mononuclear-cells-transplantation-in-type-2-diabetes-mellitus-effect-on-%C3%AE-cell-function-and-insulin-sensitivity
#17
Shobhit Bhansali, Pinaki Dutta, Mukesh Kumar Yadav, Ashish Jain, Sunder Mudaliar, Meredith Hawkins, Anura V Kurpad, Deepak Pahwa, Ashok Kumar Yadav, Ratti Ram Sharma, Vivekanand Jha, Neelam Marwaha, Shipra Bhansali, Anil Bhansali
BACKGROUND: Insulin resistance and insulin deficiency are the cardinal defects in the pathogenesis of type 2 diabetes mellitus (T2DM). Despite the plethora of anti-diabetic medications, drugs specifically targeting the β-cells are still desired. Stem cell therapy has emerged as a novel therapeutics strategy to target β-cells; however, their mechanism of action has not been well defined. This study aims to examine the efficacy and safety of autologous bone marrow-derived mononuclear cells (ABM-MNCs) transplantation in T2DM, and explores the mechanistic insights into stem cells action through metabolic studies...
2017: Diabetology & Metabolic Syndrome
https://www.readbyqxmd.com/read/28690633/how-do-community-dwelling-persons-with-alzheimer-disease-fall-falls-in-the-finalex-study
#18
Niko M Perttila, Hannareeta Öhman, Timo E Strandberg, Hannu Kautiainen, Minna Raivio, Marja-Liisa Laakkonen, Niina Savikko, Reijo S Tilvis, Kaisu H Pitkala
BACKGROUND: People with dementia are at high risk for falls. However, little is known of the features causing falls in Alzheimer disease (AD). Our aim was to investigate how participants with AD fall. METHODS: In the FINALEX (Finnish Alzheimer Disease Exercise Trial) study, participants' (n = 194) falls were followed up for 1 year by diaries kept by their spouses. RESULTS: The most common reason for falls (n = 355) was stumbling (n = 61). Of the falls, 123 led to injuries, 50 to emergency department visits, and 13 to fractures...
May 2017: Dementia and Geriatric Cognitive Disorders Extra
https://www.readbyqxmd.com/read/28685623/cardiovascular-disease-prevention-strategies-for-type-2-diabetes-mellitus
#19
Niki Katsiki, Francesco Purrello, Costas Tsioufis, Dimitri P Mikhailidis
Type 2 diabetes mellitus (T2DM) is associated with several cardiovascular (CV) risk factors such as insulin resistance, obesity, hypertension, dyslipidaemia, non-alcoholic fatty liver disease as well as platelet and haemostatic abnormalities increasing the risk of thrombosis. Therefore, T2DM patients are at an increased risk for CV disease (CVD). Areas covered: This narrative review discusses the treatment of T2DM. This includes lifestyle measures (diet, exercise and smoking cessation) as well as hypolipidaemic, antihypertensive, weight reducing, antiplatelet and glucose lowering drugs...
July 7, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28682870/long-term-efficacy-and-safety-of-sodium-glucose-cotransporter-2-inhibitors-as-add-on-to-metformin-treatment-in-the-management-of-type-2-diabetes-mellitus-a-meta-analysis
#20
Jian Li, Yanping Gong, Chunlin Li, Yanhui Lu, Yu Liu, Yinghong Shao
BACKGROUND: Drug intensification is often required for patients with type 2 diabetes mellitus on stable metformin therapy. Among the potential candidates for a combination therapy, sodium-glucose transporter-2 (SGLT2) inhibitors have shown promising outcomes. This meta-analysis was performed to compare the efficacy and safety of SGLT2 inhibitors with non-SGLT2 combinations as add-on treatment to metformin. METHODS: Literature search was carried out in multiple electronic databases for the acquisition of relevant randomized controlled trials (RCTs) by following a priori eligibility criteria...
July 2017: Medicine (Baltimore)
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