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New diabetes trials

Emily E Regier, Manu V Venkat, Kelly L Close
IN BRIEF Concerns raised about the cardiovascular safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies. After more than 7 years and six completed and published trials to date, this is an opportune time to consider whether these studies, as currently designed and conducted, accurately assess the long-term benefit/risk profile of new therapies and whether they represent an optimal use of limited health care resources...
October 2016: Clinical Diabetes: a Publication of the American Diabetes Association
Alexander N Shikov, Olga N Pozharitskaya, Valery G Makarov
PURPOSE: Aralia elata var. mandshurica (Rupr. & Maxim.) J.Wen syn. A. mandshurica Rupr. & Maxim is evaluated for its medicinal application. The aim of this study is to analyze pharmacological studies on A. elata var. mandshurica published until December 2015. METHODS: The information regarding the chemistry, safety, effectiveness, and pharmacological and clinical effects of A. elata was systematically collected from the scientific literature through library catalogs; online services such as E-library...
November 15, 2016: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
Bin Shen, Yu Zhang, Wei Dai, Yupo Ma, Yongping Jiang
BACKGROUND: Hematopoietic CD34(+) stem cells are widely used in the clinical therapy of complicated blood diseases. Stem cell factor Sall4B is a zinc finger transcription factor that plays a vital role in hematopoietic stem cell expansion. The purpose of our current study is to further evaluate how Sall4B might affect the expansion of CD34(+) cells derived from nonhuman primates. METHODS: Sall4B was overexpressed in nonhuman primate bone marrow-derived CD34(+) cells via a lentiviral transduction system...
October 20, 2016: Stem Cell Research & Therapy
John J Wroblewski, Allen Y Hu
BACKGROUND AND OBJECTIVE: To evaluate the effects of squalamine (OHR-102; Ohr Pharmaceuticals, New York, NY) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) on macular edema (ME) secondary to retinal vein occlusion (RVO). PATIENTS AND METHODS: Twenty consecutive, treatment-naïve patients with RVO-related ME received topical squalamine and intravitreal ranibizumab 0.5 mg for 10 weeks, followed by randomization to continue or discontinue squalamine...
October 1, 2016: Ophthalmic Surgery, Lasers & Imaging Retina
Rohit Kedia, Supriya Kulkarni, Meredith Ross, Vijay Shivaswamy
The dramatic rise in the prevalence of obesity and diabetes is associated with increased morbidity, mortality, and public health care costs worldwide. The need for new, effective, and long-lasting drugs is urgent. Recent research has focused on the role of the inhibitors of sodium- glucose co-transporter 2 (SGLT-2). Clinical trials have shown that SGLT-2 inhibitors have glycemic efficacy and weight-lowering potential. Dual drug therapy is a recommended therapy for patients with new-onset type 2 diabetes who need significant glycemic control...
2016: Patient Preference and Adherence
Daniel W Jones
Hypertension and Chronic Kidney Disease are both common. The vast majority of patients with chronic kidney disease (CKD) have hypertension. Hypertension can be both a cause and a result of CKD. Many patients with CKD, both diabetic and non-diabetic have overt proteinuria (>300 mg/day). Patients with proteinuria are at higher risk for progression of kidney disease and for atherosclerosis. Because patients with CKD are often excluded from hypertension trials with hard outcomes, there has been until recently less data than ideal to consider in making decisions...
September 2016: Journal of Hypertension
David John Webb
Treatment-resistant hypertension (TRH) is defined as the failure to achieve an office BP target of <140/90 mmHg (<130/80 mmHg in patients with chronic kidney disease (CKD) or diabetes) in patients with hypertension (HT), despite adherence to at least 3 antihypertensive medications at optimal tolerated doses, ideally including a diuretic (Calhoun et al., Circulation 2008). TRH identifies patients with hard-to-treat HT, who might benefit from specialist investigation and treatment. Although some studies put the prevalence of TRH as >10%, these levels may be inflated by white-coat hypertension and poor adherence...
September 2016: Journal of Hypertension
Ernesto Schiffrin
Hypertension has been defined by the levels of BP above which lowering BP will reduce the cardiovascular risk associated with elevated BP. This level has been classically 140/90 mmHg on the basis of actuarial data from the insurance industry. However, we now know that cardiovascular risk rises progressively from levels as low as 115/75 mmHg upward with a doubling of the incidence of both coronary heart disease and stroke for every 20/10-mmHg increment of BP. In uncomplicated hypertension without cardiovascular risk factors or target organ damage, there is little randomized clinical trial evidence that lowering SBP of <160 mmHg reduces cardiovascular risk...
September 2016: Journal of Hypertension
Peter Mertens
Remarkable progress has been achieved in the field of diabetes with the development of incretin analogues, dipeptidyl peptidase IV inhibitors and novel insulin analogues; nevertheless, there is an unmet need for additional therapeutic options. The new generation of drugs, denoted gliflozines, that specifically interfere with sodium-glucose cotransporters (SGLT)-2 and exhibit a favourable impact on glucose metabolism in patients with type 2 diabetes are emerging as hopeful avenues. The resultant negative energy balance caused by glucosuria results in long-term weight losses, significantly reduced HbA1c levels approximating 0...
September 2016: Journal of Hypertension
Kazuomi Kario
Asians have specific characteristics of hypertension and related cardiovascular disease. Stroke is more common than coronary artery disease in Eastern Asian countries, while the coronary artery disease is more common than stroke in Western countries. The association slope between higher blood pressure (BP) and the risk of cardiovascular events is steeper in Asians than in Caucasians. This may partly explained by the recent result demonstrating that the morning BP surge in Asians is more extended (Hoshide, Kario, Parati et al...
September 2016: Journal of Hypertension
Masatsugu Horiuchi
Hypertensive patients have greater chances of such cardiovascular events as stroke, coronary heart disease, heart or renal failure, peripheral artery disease, and dementia. It is also well recognized that diabetes increases the cardiovascular risks in concert with hypertension. Therefore, main goals for an innovation of anti-hypertensive therapy would be to achieve further risk reduction by targeting the functional, metabolic, and structural alterations associated with hypertension. Professors Dzau and Braunwald et al proposed the concept of "the cardiovascular disease continuum" in 1991, and that hypertension may trigger the chain of events, leading to end-stage heart disease; however, this concept was quite new at that time, and there was some discussion whether "the cardiovascular disease continuum" is true or not...
September 2016: Journal of Hypertension
Dick C Chan, P Hugh R Barrett, Gerald F Watts
PURPOSE OF REVIEW: Dysregulated lipoprotein metabolism leads to increased plasma concentrations of atherogenic lipoproteins. We highlight the findings from recent studies of the effect of lipid-regulating therapies on apolipoprotein metabolism in humans employing endogenous labelling with stable isotopically labelled isotopomers. RECENT FINDINGS: Fish oil supplementation and niacin treatment both reduce fasting and postprandial triglyceride levels by decreasing the hepatic secretion of VLDL-apoB-100 (apoB) and apoB-48-containing chylomicron particles in obese and/or type 2 diabetes...
October 5, 2016: Current Opinion in Lipidology
Om P Ganda, Joanna Mitri
Despite major advances, many patients with diabetes are currently achieving suboptimal control of lipids and blood pressure. The new cholesterol guidelines by the ACC/AHA have reignited the emphasis on more intensive treatment with statins in the population at high risk of CVD, including those with diabetes. While these guidelines do not include specific lipid goals, several other guidelines have retained previously defined risk-based LDL-C and non-HDL-C goals. More recent data indicate potential benefits in CVD outcomes with non-statin therapy added to statin therapy...
November 2016: Current Cardiology Reports
P Sneha, C George Priya Doss
The pace of anti-diabetic drug discovery is very slow in spite of increasing rate of prevalence of Type 2 Diabetes which remains a major public health concern. Though extensive research steps are taken in the past decade, yet craves for better of new treatment strategies to overcome the current scenario. One such general finding is the evolution of gliptins which discriminately inhibits DPP4 (Dipeptidyl peptidase-4) enzyme. Although the mechanism of action of gliptin is highly target oriented and accurate, still its long-term use stands unknown...
October 12, 2016: Life Sciences
Siva T Gounder, Delendra Rasith Wijayanayaka, Rinki Murphy, Delwyn Armstrong, Richard G Cutfield, David Dw Kim, Michael Graham Clarke, Nicholas J Evennett, Martyn Lee Humphreys, Steven John Robinson, Michael Wc Booth
AIM: To provide a longitudinal analysis of the direct healthcare costs of providing laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery service in the context of a randomised control trial (RCT) of obese patients with type 2 diabetes in Waitemata District Health Board, Auckland, New Zealand. METHODS: The Waitemata District Health Board costing system was used to calculate costs in New Zealand Dollars (NZD) associated with all pre- and post-operative hospital clinic visits, peri-operative care, hospitalisations and medication costs up to one year after bariatric surgery...
October 14, 2016: New Zealand Medical Journal
E A Huhn, T Fischer, C S Göbl, M Todesco Bernasconi, M Kreft, M Kunze, A Schoetzau, E Dölzlmüller, W Eppel, P Husslein, N Ochsenbein-Koelble, R Zimmermann, E Bäz, H Prömpeler, E Bruder, S Hahn, I Hoesli
INTRODUCTION: As the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an 'early' oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort. METHODS AND ANALYSIS: In a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany...
October 12, 2016: BMJ Open
Eva Pedersen, Kylie Lange, Peter Clifton
BACKGROUND: People with type 2 diabetes are advised to consume an even meal distribution of carbohydrate. Whether this distribution is optimal is unknown. OBJECTIVE: Our objective was to show that omitting carbohydrate in the first meal after a fast would lead to an augmented lunch response. DESIGN: Two diets of 1-d duration that differed only in the breakfast-meal composition (carbohydrate or no carbohydrate) were consumed on sequential days in a randomized crossover study...
October 12, 2016: American Journal of Clinical Nutrition
A M Mahon, C MacGilchrist, C McIntosh, T O'Brien
BACKGROUND: Diabetes mellitus, coined the 'Black Death of the Twenty-First Century', is associated with complications, including foot ulceration with potential loss of limb. There is a need for development of new wound therapies through completion of robust clinical trials. AIMS: To profile demographics and wound characteristics of an Irish cohort with diabetes, forecast eligibility for entry to a clinical trial of advanced wound therapeutics, and adjust criteria to optimize eligibility for enrolment...
October 11, 2016: Irish Journal of Medical Science
Ka Hei Chan, Rahul Krishnan, Michael Alexander, Jonathan Rt Lakey
The islets of Langerhans are endocrine tissue clusters that secrete hormones that regulate the body's glucose, carbohydrate and fat metabolism, the most important of which is insulin, a hormone secreted by β cells within the islets. In certain instances, a person's own immune system attacks and destroys them leading to the development of Type 1 diabetes (T1D), a lifelong condition that needs daily insulin administration to maintain health and prolong survival. Islet transplantation is a surgical procedure that has demonstrated the ability to normalize blood sugar levels for up to a few years, but the need for chronic immunosuppression relegates it to a last resort that is often only used sparingly, and in seriously-ill patients...
October 10, 2016: Cell Transplantation
Mark W Kennedy, Enrico Fabris, Alexander J Ijsselmuiden, Holger Nef, Sebastian Reith, Javier Escaned, Fernando Alfonso, Niels van Royen, Wojtek Wojakowski, Adam Witkowski, Ciro Indolfi, Jan Paul Ottervanger, Harry Suryapranata, Elvin Kedhi
BACKGROUND: Fractional flow reserve (FFR) is a widely used tool for the identification of ischaemia-generating stenoses and to guide decisions on coronary revascularisation. However, the safety of FFR-based decisions in high-risk subsets, such as patients with Diabetes Mellitus (DM) or vulnerable stenoses presenting thin-cap fibro-atheroma (TCFA), is unknown. This study will examine the impact of optical coherence tomography (OCT) plaque morphological assessment and the identification of TCFA, in combination with FFR to better predict clinical outcomes in DM patients...
October 10, 2016: Cardiovascular Diabetology
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