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Global blood safety

Rong Qiu, Dainius Balis, George Capuano, John Xie, Gary Meininger
: Metformin is typically the first pharmacologic treatment recommended for type 2 diabetes mellitus (T2DM), but many patients do not achieve glycemic control with metformin alone and eventually require combination therapy with other agents. Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was assessed in a comprehensive Phase 3 clinical development program consisting of ~10,000 participants, of which ~80% were on background therapy that consisted of metformin alone or in combination with other antihyperglycemic agents (AHAs; e...
October 12, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Wolfgang Wiedemair, Zeljko Tukovic, Hrvoje Jasak, Dimos Poulikakos, Vartan Kurtcuoglu
Encapsulated microbubbles (MBs) serve as endovascular agents in a wide range of medical ultrasound applications. The oscillatory response of these agents to ultrasonic excitation is determined by MB size, gas content, viscoelastic shell properties and geometrical constraints. The viscoelastic parameters of the MB capsule vary during an oscillation cycle and change irreversibly upon shell rupture. The latter results in marked stress changes on the endothelium of capillary blood vessels due to altered MB dynamics...
October 12, 2016: Biomechanics and Modeling in Mechanobiology
Asrar Ahmad, Monica Kohli, Anita Malik, Megha Kohli, Jaishri Bogra, Haider Abbas, Rajni Gupta, B B Kushwaha
PURPOSE: In this study, we aimed to correlate thromboelastography (TEG) variables versus conventional coagulation profile in all patients presenting with pre-eclampsia/eclampsia and to see whether TEG would be helpful for evaluating coagulation in parturients before regional anaesthesia. MATERIALS AND METHODS: This was a prospective study on 100 pre-eclampsia/eclampsia patients undergoing lower-segment caesarean section under regional anaesthesia. Two blood samples were collected...
October 2016: Journal of Obstetrics and Gynaecology of India
Seong-Choon Choe
There are several classes of anti-hypertensive agents in the world, the most recently developed agent is angiotensin receptor blocker (ARB). There are already 8 ARBs in the market, but still medical unmet need for treatment of hypertension is existed. The 'ideal' anti-hypertensive agent would have a number of characteristics: (1) effective in lowering blood pressure to recommend goals; (2) high efficacy as monotherapy; (3) rapid onset of effect; (4) convenient once-daily administration to maximize compliance; (5) sustained efficacy over 24 hours; (6) response increases with higher doses (clear dose-response effect); and (7) optimum tolerability profile...
September 2016: Journal of Hypertension
Stuart Isaacson, Holly A Shill, Steven Vernino, Adam Ziemann, Gerald J Rowse
BACKGROUND: Neurogenic orthostatic hypotension (nOH) is associated with insufficient norepinephrine release in response to postural change. OBJECTIVE: The objective of this study was to evaluate the long-term safety and durability of efficacy of the norepinephrine precursor droxidopa in patients with symptomatic nOH. METHODS: This multinational study consisted of 3 sequential phases: a 3-month open-label droxidopa treatment phase followed by a 2-week double-blind, placebo-controlled withdrawal phase, and a 9-month open-label extension phase in which all patients received droxidopa...
September 13, 2016: Journal of Parkinson's Disease
Miguel Nasser Hissa
BACKGROUND: Diabetes mellitus (DM) is considered a global epidemic, and patient self-management education and support are critical in preventing and reducing the risk of complications. Self-monitoring of blood glucose (SMBG) is essential for care of individuals with DM, helping patients to achieve and maintain target blood glucose levels. The purpose of this study is to compare the satisfaction of insulinized DM patients on SMBG with use of investigational blood glucose meter (BGM) versus their routine device...
2016: Diabetology & Metabolic Syndrome
Stephen Flach, Graeme Scarfe, Jeffrey Dragone, Jie Ding, Mark Seymour, Mike Pennick, Todd Pankratz, Steven Troy, Jay Getsy
PURPOSE: Chronic constipation is a prevalent gastrointestinal disorder globally. It is often treated with medications such as laxatives. Newer therapies to improve gastric motility include the selective 5-hydroxytryptamine receptor-4 agonist prucalopride, which is licensed for the treatment of chronic constipation in adults. The aim of this study was to investigate the pharmacokinetic properties and excretion of prucalopride in healthy individuals, using a microtracer approach with (14)C radioactivity detection using liquid scintillation counting and accelerator mass spectrometry...
September 2016: Clinical Therapeutics
Vanesa González-Núñez, Claus Bachert, Joaquim Mullol
INTRODUCTION: Rupatadine is a second-generation H1-antihistamine with dual affinity for histamine H1 and PAF receptors. Rupatadine is indicated for the treatment of allergic rhinitis and urticaria. AREAS COVERED: A Medline search was conducted to identify preclinical and clinical studies of rupatadine. This was supplemented with additional articles obtained from online sources. The focus of this review is on the safety profile of rupatadine. EXPERT OPINION: The review of these data indicates that rupatadine is highly selective for histamine H1-receptors, exhibits additional PAF antagonism in in vitro and in vivo studies, does not cross the blood-brain barrier, and has similar adverse events comparable with other second-generation antihistamines...
October 2016: Expert Opinion on Drug Safety
Olivier Garraud, Luiz Amorim Filho, Syria Laperche, Claude Tayou-Tagny, Bruno Pozzetto
Transfusion has been tainted with the risk of contracting an infection - often severe - and fears about this risk are still prevailing, in sharp contrast with the actual risk in Western countries. Those actual risks are rather immunological, technical (overload) or metabolic. Meanwhile, in developing countries and particularly in Africa, transfusion transmitted infections (TTIs) are still frequent, because of both the scarcity of volunteer blood donors and resources and the high incidence and prevalence of infections...
July 2016: La Presse Médicale
Melvin D Lobo, Paul A Sobotka, Atul Pathak
Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious...
July 11, 2016: European Heart Journal
Hyung-Sik Kim, Ji Hyun Lee, Kyoung-Hwan Roh, Hee Jin Jun, Kyung-Sun Kang, Tae-Yoon Kim
Mesenchymal stem cells (MSCs) have been proven to be therapeutically effective against atopic dermatitis (AD) in preclinical studies. However, the safety and efficacy of MSCs against AD have not yet been investigated in a clinical study. To establish the safety and efficacy of human umbilical cord blood-derived MSCs (hUCB-MSCs) in AD, thirty-four adult patients with moderate-to-severe AD were enrolled in two phase trials with a follow-up for 1 month and 3 months, respectively. Patients were randomly allocated to receive low dose (2...
June 3, 2016: Stem Cells
I Vasilenko, E Vlasova, V Metelin, A Balkanov, O Bichenkov
INTRODUCTION: Close correlation between oncologic diseases and blood coagulation disturbances dictates a necessity of prognosis of the main disease course and contemporary prevention of the thrombotic complications revealed. For this purpose, the global test for the hemostasis system assessment was used to reveal bleeding and thrombogenesis risks - "Thrombodynamics" (TD) allowing analysis in the real time of the thrombogenesis parameters in conditions the most resembling the natural functioning of the blood coagulation system...
April 2016: Thrombosis Research
Parvin Safavi, Ali Hasanpour-Dehkordi, Maryam AmirAhmadi
Although pharmacotherapy with atypical antipsychotics is common in child psychiatry, there has been little research on this issue. To compare the efficacy and safety of risperidone and aripiprazole in the treatment of preschool children with disruptive behavior disorders comorbid with attention deficit-hyperactivity disorder (ADHD). Randomized clinical trial conducted in a university-affiliated child psychiatry clinic in southwest Iran. Forty 3-6-year-old children, diagnosed with oppositional defiant disorder comorbid with ADHD, were randomized to an 8-week trial of treatment with risperidone or aripiprazole (20 patients in each group)...
April 2016: Journal of Advanced Pharmaceutical Technology & Research
Scott Hasler, Amanda Kleeman, Richard Abrams, Jisu Kim, Manya Gupta, Mary K Krause, Tricia J Johnson
OBJECTIVES: To measure the impact of a local patient safety intervention and a national guideline to reduce unnecessary red blood cell (RBC) transfusions in the Department of Medicine of an academic medical center. STUDY DESIGN: This was a retrospective, pre-post study. METHODS: In May 2013, a clinical practice guideline, modeled after the 2012 AABB recommendations for RBC use, was implemented with the goal of decreasing unnecessary RBC transfusions...
April 2016: American Journal of Managed Care
Sally Wenzel, Mario Castro, Jonathan Corren, Jorge Maspero, Lin Wang, Bingzhi Zhang, Gianluca Pirozzi, E Rand Sutherland, Robert R Evans, Vijay N Joish, Laurent Eckert, Neil M H Graham, Neil Stahl, George D Yancopoulos, Mariana Louis-Tisserand, Ariel Teper
BACKGROUND: Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist, irrespective of baseline eosinophil count...
July 2, 2016: Lancet
Kozo Yamamoto, Kazuhito Yokoyama, Takehisa Matsukawa, Sayaka Kato, Shinji Kato, Kazuhisa Yamada, Tatsuhiko Hirota
To evaluate the safety and efficacy of prolonged ingestion of Lactobacillus acidophilus L-92 (L-92) on skin symptoms in adult atopic dermatitis (AD) patients, a placebo-controlled double-blinded parallel-group comparison study was performed. This included daily administration of heat-killed and dried L-92 or placebo for 24wk in 50 AD patients who were 16yr old or older. The severity of skin symptoms was evaluated at baseline and at 4, 8, 12, 16, 20, and 24wk during the intervention using the investigator global assessment, eczema area and severity index, and scoring atopic dermatitis...
July 2016: Journal of Dairy Science
Logan K Wink, Ryan Adams, Zemin Wang, James E Klaunig, Martin H Plawecki, David J Posey, Christopher J McDougle, Craig A Erickson
BACKGROUND: Social impairment is a defining feature of autism spectrum disorder (ASD) with no demonstrated effective pharmacologic treatments. The goal of this study was to evaluate efficacy, safety, and tolerability of oral N-acetylcysteine (NAC), an antioxidant whose function overlaps with proposed mechanisms of ASD pathophysiology, targeting core social impairment in youth with ASD. METHODS: This study was a 12-week randomized, double-blind, placebo-controlled trial of oral NAC in youth with ASD...
2016: Molecular Autism
Swathi Putta, Nagendra Sastry Yarla, Eswar Kumar Kilari, Challa Surekha, Gjumrakch Aliev, Madhihalli Basavaraju Divakara, Mysore Sridhar Santosh, Ramith Ramu, Farhan Zameer, Nagendra Prasad Mn, Ramakrishna Chintala, Pidugu Vijaya Rao, Yallappa Shiralgi, Bhadrapura Lakkappa Dhananjaya
Diabetes is a major chronic metabolic disorder globally and around of 285 million people are affected by the disease and the number is expected to double in the next two decades. The major focus of anti-diabetic therapies is to enhance insulin production, sensitivity and/or reduce the blood glucose level. Although several synthetic drugs have been developed as antidiabetic agents but their utility has been hampered due to their side effects and poor efficacy. In this scenario, research on natural products has been gained importance due their safety profile in toxicity studies...
2016: Current Topics in Medicinal Chemistry
Albert Farrugia
The infection by blood-borne pathogens of a large proportion of the treated hemophilia population over the 1970s to 1990s represents a major tragedy that is embedded in the history of this condition. To avoid this historical repetition, the community of patients, treaters, and policy makers that contribute to hemophilia care need to learn from the events that gave rise to it. This requires an appreciation of the measures, which, through scientific developments, have enhanced greatly the safety of plasma-derived coagulation factor concentrates (pd CFCs)...
July 2016: Seminars in Thrombosis and Hemostasis
Rolf Rossaint, Bertil Bouillon, Vladimir Cerny, Timothy J Coats, Jacques Duranteau, Enrique Fernández-Mondéjar, Daniela Filipescu, Beverley J Hunt, Radko Komadina, Giuseppe Nardi, Edmund A M Neugebauer, Yves Ozier, Louis Riddez, Arthur Schultz, Jean-Louis Vincent, Donat R Spahn
BACKGROUND: Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution. METHODS: The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies...
2016: Critical Care: the Official Journal of the Critical Care Forum
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