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Boehringer Ingelheim

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
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
(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
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
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
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
Kenji Egusa, Fumiaki Okazaki, Joerg Schiewe, Ulrike Werthmann, Markus Wolkenhauer
BACKGROUND: The identification of different (pseudo) polymorphs of an active pharmaceutical ingredient in dry powder formulations is of importance during development and entire product lifecycle, e.g., quality control. Whereas determination of polymorphic differences of pure substances is rather easy, in dry powder formulations, it is generally difficult and the difficulties increase particularly, if the substance of interest is present only in low concentrations in the formulation. Such a formulation is Spiriva(®) inhalation powder (Boehringer Ingelheim), which contains only 0...
September 2017: Drugs in R&D
Yumin Zhou, Nan-Shan Zhong, Xiaochen Li, Shuyun Chen, Jinping Zheng, Dongxing Zhao, Weimin Yao, Rongchang Zhi, Liping Wei, Bingwen He, Xiangyan Zhang, Changli Yang, Ying Li, Fenglei Li, Juan Du, Jianping Gui, Bin Hu, Chunxue Bai, Ping Huang, Gang Chen, Yongjian Xu, Changzheng Wang, Biao Liang, Yinhuan Li, Guoping Hu, Hui Tan, Xianwei Ye, Xitao Ma, Yan Chen, Xiwei Hu, Jia Tian, Xiaodan Zhu, Zhe Shi, Xiufang Du, Minjing Li, Shengming Liu, Ronghuan Yu, Jianping Zhao, Qianli Ma, Canmao Xie, Xiongbin Li, Tao Chen, Yingxiang Lin, Lizhen Zeng, Changxiu Ye, Weishu Ye, Xiangwen Luo, Lingshan Zeng, Shuqing Yu, Wei-Jie Guan, Pixin Ran
BACKGROUND: Patients with mild or moderate chronic obstructive pulmonary disease (COPD) rarely receive medications, because they have few symptoms. We hypothesized that long-term use of tiotropium would improve lung function and ameliorate the decline in lung function in patients with mild or moderate COPD. METHODS: In a multicenter, randomized, double-blind, placebo-controlled trial that was conducted in China, we randomly assigned 841 patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 (mild) or 2 (moderate) severity to receive a once-daily inhaled dose (18 μg) of tiotropium (419 patients) or matching placebo (422) for 2 years...
September 7, 2017: New England Journal of Medicine
E D Tzika, P D Tassis, V G Papatsiros, E M Pferschy-Wenzig, A Siochu, R Bauer, C Alexopoulos, S C Kyriakis, C Franz
The study aimed to investigate the possible anti-inflammatory activity of larch sawdust as feed supplement in lactating sows' diet and its possible effect on the prevalence of Postpartum Dysgalactia Syndrome under field conditions. In a Greek farrow-to-finish pig farm, fifteen sows were randomly and equally allocated to a negative control group (NC group), a positive control group (PC group), and a treatment group (LT group). The animals of the first two groups received 99% basic diet and 1% corn starch, while LT group animals received 99% basic diet and 1% larch sawdust...
March 1, 2017: Polish Journal of Veterinary Sciences
Dragos Vinereanu, Renato D Lopes, M Cecilia Bahit, Denis Xavier, Jie Jiang, Hussein R Al-Khalidi, Wensheng He, Ying Xian, Andrea O Ciobanu, Deepak Y Kamath, Kathleen A Fox, Meena P Rao, Sean D Pokorney, Otavio Berwanger, Carlos Tajer, Pedro G M de Barros E Silva, Mayme L Roettig, Yong Huo, Christopher B Granger
BACKGROUND: Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. METHODS: This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group)...
August 25, 2017: Lancet
Christopher P Cannon, Deepak L Bhatt, Jonas Oldgren, Gregory Y H Lip, Stephen G Ellis, Takeshi Kimura, Michael Maeng, Bela Merkely, Uwe Zeymer, Savion Gropper, Matias Nordaby, Eva Kleine, Ruth Harper, Jenny Manassie, James L Januzzi, Jurrien M Ten Berg, P Gabriel Steg, Stefan H Hohnloser
BACKGROUND: Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding. METHODS: In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups)...
October 19, 2017: New England Journal of Medicine
Guang Ning, Tushar Bandgar, Uwe Hehnke, Jisoo Lee, Juliana C N Chan
INTRODUCTION: Asian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes. METHODS: Data from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations...
September 2017: Advances in Therapy
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