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Robyn K Pollom, Timothy Costigan, Lyndon B Lacaya, Liza L Ilag, Priscilla A Hollander
INTRODUCTION: To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D). METHODS: This subgroup analysis of a phase 3, randomized, double-blind, multinational, 24-week study compared LY IGlar and SA IGlar on several clinical efficacy (change in glycated hemoglobin (A1c), basal insulin dose, weight) and safety outcomes (incidence of adverse events, insulin antibodies, hypoglycemia incidence and rates) in patients either ≥ 65 or < 65 years...
March 14, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Stephan Boehringer, Paulius Ruzgys, Luca Tamò, Saulius Šatkauskas, Thomas Geiser, Amiq Gazdhar, David Hradetzky
A challenge for gene therapy is absence of safe and efficient local delivery of therapeutic genetic material. An efficient and reproducible physical method of electrospray for localized and targeted gene delivery is presented. Electrospray works on the principle of coulombs repulsion, under influence of electric field the liquid carrying genetic material is dispersed into micro droplets and is accelerated towards the targeted tissue, acting as a counter electrode. The accelerated droplets penetrate the targeted cells thus facilitating the transfer of genetic material into the cell...
March 5, 2018: Scientific Reports
Atsutaka Yasui, Ganghyuck Lee, Tetsuaki Hirase, Tatsuroh Kaneko, Stefan Kaspers, Maximilian von Eynatten, Tomoo Okamura
INTRODUCTION: Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, ameliorates hyperglycemia in patients with type 2 diabetes (T2D) by inducing sustained glucosuria. Empagliflozin treatment was previously associated with a transient increase in 24-h urine volume in Caucasian patients with T2D, however comparable evidence in Japanese T2D individuals is scarce. We therefore assessed acute and chronic changes in 24-h urine volume and fluid intake with empagliflozin in Japanese patients with T2D...
February 27, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Sandhya Mehta, Sabyasachi Ghosh, Stephen Sander, Effie Kuti, William K Mountford
BACKGROUND: Multiple studies have reported that type 2 diabetes mellitus (T2DM) is a major risk factor for cardiovascular diseases (CVD), and presence of T2DM and CVD increases risk of death. There is growing interest in examining the effects of antidiabetic treatments on the reduction of cardiovascular events in T2DM adults with a history of CVD and thus at higher risk of cardiovascular events. OBJECTIVE: To estimate the incremental all-cause health care utilization and costs among adults with T2DM and a history of CVD compared with adults without a history of CVD, using a national linked electronic medical records (EMR) and claims database...
March 2018: Journal of Managed Care & Specialty Pharmacy
Matthieu Raveau, Denis Polygalov, Roman Boehringer, Kenji Amano, Kazuhiro Yamakawa, Thomas J McHugh
Down syndrome, the leading genetic cause of intellectual disability, results from an extra-copy of chromosome 21. Mice engineered to model this aneuploidy exhibit Down syndrome-like memory deficits in spatial and contextual tasks. While abnormal neuronal function has been identified in these models, most studies have relied on in vitro measures. Here, using in vivo recording in the Dp(16)1Yey model, we find alterations in the organization of spiking of hippocampal CA1 pyramidal neurons, including deficits in the generation of complex spikes...
February 27, 2018: ELife
(no author information available yet)
Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions...
February 20, 2018: Journal of Managed Care & Specialty Pharmacy
J Luebke, M Neuburger, J F Jordan, T Wecker, D Boehringer, B Cakir, T Reinhard, A Anton
PURPOSE: Bleb-related infections are serious complications after trabeculectomy. They can be limited to the bleb or disseminate and lead to endophthalmitis. We herein report on all bleb-related infections that have been diagnosed at the Eye Center of the University of Freiburg, Germany, since 1999. METHODS: We reviewed a total of 1816 consecutive trabeculectomies that were performed at our hospital between the years 1999 and 2014 (353 without and 1463 with intraoperative application of mitomycin C)...
February 9, 2018: International Ophthalmology
Edward Stuttfeld, Christopher H S Aylett, Stefan Imseng, Daniel Boehringer, Alain Scaiola, Evelyn Sauer, Michael N Hall, Timm Maier, Nenad Ban
The mammalian target of rapamycin (mTOR) is a key protein kinase controlling cellular metabolism and growth. It is part of the two structurally and functionally distinct multiprotein complexes mTORC1 and mTORC2. Dysregulation of mTOR occurs in diabetes, cancer and neurological disease. We report the architecture of human mTORC2 at intermediate resolution, revealing a conserved binding site for accessory proteins on mTOR and explaining the structural basis for the rapamycin insensitivity of the complex.
February 9, 2018: ELife
Elianne J L E Vrijlandt, Georges El Azzi, Mark Vandewalker, Ned Rupp, Thomas Harper, LeRoy Graham, Stanley J Szefler, Petra Moroni-Zentgraf, Ashish Sharma, Sebastian D Vulcu, Ralf Sigmund, Bo Chawes, Michael Engel, Hans Bisgaard
BACKGROUND: Few studies have assessed the safety and efficacy of potential asthma medications in children younger than 5 years. We descriptively assessed the safety and efficacy of tiotropium, a long-acting anticholinergic drug, in children aged 1-5 years with persistent asthmatic symptoms. METHODS: This exploratory 12-week, randomised, double-blind, placebo-controlled, parallel-group, phase 2/3, regulatory multicentre trial was done at 32 hospitals, clinics, and clinical research units in 11 countries in Asia, Europe, and North America...
January 17, 2018: Lancet Respiratory Medicine
Dattanand M Sudarshana, Eleni K Konstantinou, Sruthi Arepalli, Fabiana Q Silva, Andrew P Schachat, Justis P Ehlers, Rishi P Singh
BACKGROUND AND OBJECTIVE: Previous literature assessing ocular hemorrhagic complications of anticoagulant/antiplatelet medications in routine clinical practice is limited. This study evaluates the prevalence of spontaneous ocular hemorrhagic events associated with anticoagulation/antiplatelet therapy. PATIENTS AND METHODS: A retrospective study was performed to identify patients taking anticoagulants (rivaroxaban [Xarelto; Janssen Pharmaceuticals, Beerse, Belgium], bivalirudin [Angiomax; The Medicines Company, Parsippany, NJ], lepirudin [Refludan; Bayer HealthCare Pharmaceuticals, Berlin, Germany], dabigatran [Pradaxa; Boehringer Ingelheim, Ingelheim am Rhein, Germany], and argatroban) and antiplatelet agents (clopidogrel [Plavix; Bristol-Myers Squibb, New York City, NY], prasugrel [Effient; Lilly Medical, Indianapolis, IN], and ticagrelor [Brilinta; AstraZeneca, Cambridge, UK]) who presented for an eye examination...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
Rahul Jain, An-Chen Fu, Jonathan Lim, Cheng Wang, Jessica Elder, Stephen D Sander, Hiangkiat Tan
BACKGROUND: Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring. OBJECTIVE: To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin...
January 2018: Journal of Managed Care & Specialty Pharmacy
Asher Mullard
No abstract text is available yet for this article.
December 28, 2017: Nature Reviews. Drug Discovery
Jan Luebke, Thomas Reinhard, Hansjuergen Agostini, Daniel Boehringer, Philipp Eberwein
BACKGROUND: The dislocation of the crystalline lens is a common finding in patients with Marfan syndrome (MFS). Scleral intraocular lens (IOL) fixation is an accepted treatment method of this complication. To now, no long-term data on scleral IOL fixation in MFS exist. METHODS: We present a retrospective study of 27 eyes of 17 MFS patients that underwent scleral lens fixation at our clinic between 1999 and 2012. These patients are compared to an age- and surgeon-matched group of 31 eyes of 27 patients who underwent the same procedure for reasons other than MFS...
December 6, 2017: BMC Ophthalmology
David Brown, Kristen Daniels, Solen Pichereau, Michael Sand
INTRODUCTION: This randomized, double-blind, parallel-group study investigated the safety, tolerability, pharmacokinetics (PK), and cognitive outcomes of BI 409306-a selective phosphodiesterase 9A (PDE9A) inhibitor-in patients with schizophrenia. METHODS: Patients with mild-to-moderate schizophrenia were randomized (1:1:1:1) to receive BI 409306 at 25, 50, or 100 mg or placebo once daily over 14 days. The primary endpoints were safety and tolerability; the secondary endpoints were PK and cognitive outcomes...
November 24, 2017: Neurology and Therapy
Ashley Boehringer, Krystine Garcia-Mansfield, Gurkaran Singh, Nadine Bakkar, Patrick Pirrotte, Robert Bowser
Mutations in Matrin 3 have recently been linked to ALS, though the mechanism that induces disease in these patients is unknown. To define the protein interactome of wild-type and ALS-linked MATR3 mutations, we performed immunoprecipitation followed by mass spectrometry using NSC-34 cells expressing human wild-type or mutant Matrin 3. Gene ontology analysis identified a novel role for Matrin 3 in mRNA transport centered on proteins in the TRanscription and EXport (TREX) complex, known to function in mRNA biogenesis and nuclear export...
November 6, 2017: Scientific Reports
Pavel Goriacko, Vicken Yaghdjian, Issam Koleilat, Mark Sinnett, Harshal Shukla
PURPOSE: To describe the use of idarucizumab (Praxbind, Boehringer Ingelheim) in routine clinical practice at a large urban academic medical center. SUMMARY: Seven total doses of idarucizumab were administered to six unique patients from October 31, 2015, to October 31, 2016. The reversal agent was used in conjunction with local bleeding control measures, blood product transfusions, and acid-suppressive therapy. In 86% of cases, idarucizumab administration resulted in a successful cessation of bleeding by clinical assessment...
November 2017: P & T: a Peer-reviewed Journal for Formulary Management
Lindsay G S Bengtson, Yanni Yu, Weijia Wang, Feng Cao, Erin M Hulbert, Ryan Wolbeck, Caitlin A Elliott, Ami R Buikema
BACKGROUND: Asthma is a common disorder that affects approximately 8% of the U.S. POPULATION: Treatment guidelines indicate inhaled corticosteroids (ICS) as the mainstay treatment, yet poor asthma control is common among ICS-treated patients. Treatment escalation (ICS dose increase and other controller therapy add-ons) is used to manage symptoms. Real-world studies of postescalation outcomes may inform treatment decisions. OBJECTIVES: To (a) describe characteristics and treatment patterns among asthma patients who escalated treatment and (b) assess outcomes (exacerbations, uncontrolled asthma, and health care resource utilization [HCRU]) after escalation...
November 2017: Journal of Managed Care & Specialty Pharmacy
Kohjiro Ueki, Takayoshi Sasako, Yukiko Okazaki, Masayuki Kato, Sumie Okahata, Hisayuki Katsuyama, Mikiko Haraguchi, Ai Morita, Ken Ohashi, Kazuo Hara, Atsushi Morise, Kazuo Izumi, Naoki Ishizuka, Yasuo Ohashi, Mitsuhiko Noda, Takashi Kadowaki
BACKGROUND: Limited evidence suggests that multifactorial interventions for control of glucose, blood pressure, and lipids reduce macrovascular complications and mortality in patients with type 2 diabetes. However, safe and effective treatment targets for these risk factors have not been determined for such interventions. METHODS: In this multicentre, open-label, randomised, parallel-group trial, undertaken at 81 clinical sites in Japan, we randomly assigned (1:1) patients with type 2 diabetes aged 45-69 years with hypertension, dyslipidaemia, or both, and an HbA1c of 6·9% (52·0 mmol/mol) or higher, to receive conventional therapy for glucose, blood pressure, and lipid control (targets: HbA1c <6·9% [52·0 mmol/mol], blood pressure <130/80 mm Hg, LDL cholesterol <120 mg/dL [or 100 mg/dL in patients with a history of coronary artery disease]) or intensive therapy (HbA1c <6·2% [44·3 mmol/mol], blood pressure <120/75 mm Hg, LDL cholesterol <80 mg/dL [or 70 mg/dL in patients with a history of coronary artery disease])...
December 2017: Lancet Diabetes & Endocrinology
Julian Liebenberg, Josephus Fourie, Wilfried Lebon, Diane Larsen, Lenaïg Halos, Frédéric Beugnet
Twelve healthy dogs were studied in this parallel group, blinded, randomised, and negative controlled efficacy study. On Day -1, the 12 dogs included were ranked within sex in descending order of individual pre-treatment (Day -5) fed mosquito counts and randomly allocated by blocks of two dogs to the untreated control group or the afoxolaner-treated group. NexGard(®) (Merial, now part of Boehringer Ingelheim Animal Health) was administered orally on Day 0 in accordance with the European label instructions...
2017: Parasite: Journal de la Société Française de Parasitologie
Scott A Lear, Weihong Hu, Sumathy Rangarajan, Danijela Gasevic, Darryl Leong, Romaina Iqbal, Amparo Casanova, Sumathi Swaminathan, R M Anjana, Rajesh Kumar, Annika Rosengren, Li Wei, Wang Yang, Wang Chuangshi, Liu Huaxing, Sanjeev Nair, Rafael Diaz, Hany Swidon, Rajeev Gupta, Noushin Mohammadifard, Patricio Lopez-Jaramillo, Aytekin Oguz, Katarzyna Zatonska, Pamela Seron, Alvaro Avezum, Paul Poirier, Koon Teo, Salim Yusuf
BACKGROUND: Physical activity has a protective effect against cardiovascular disease (CVD) in high-income countries, where physical activity is mainly recreational, but it is not known if this is also observed in lower-income countries, where physical activity is mainly non-recreational. We examined whether different amounts and types of physical activity are associated with lower mortality and CVD in countries at different economic levels. METHODS: In this prospective cohort study, we recruited participants from 17 countries (Canada, Sweden, United Arab Emirates, Argentina, Brazil, Chile, Poland, Turkey, Malaysia, South Africa, China, Colombia, Iran, Bangladesh, India, Pakistan, and Zimbabwe)...
September 21, 2017: Lancet
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