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Concept: Bayer

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Background Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. Methods In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. Results A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. Conclusions Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).

Concepts: Clinical trial, Blood, Stroke, Thrombosis, Warfarin, Dose, Aspirin, Bayer

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Abstract Background: The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies. Materials and Methods: In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared. Results: In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use. Conclusions: The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals.

Concepts: Clinical trial, Diabetes mellitus, Evaluation, Diabetes, Blood sugar, Blood glucose monitoring, International Organization for Standardization, Bayer

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The emergence of antibiotics and their active metabolites in aquatic ecosystem has motivated the development of sensitive and reliable sensors to monitor traces of antibiotics and metabolites in drinking water sources (i.e. surface water). The surface enhanced Raman scattering (SERS) technique, which is widely recognized as a high sensitivity method for molecular vibrational detection, is potentially a powerful tool for trace environmental contamination analysis. The main goal of this work is to demonstrate pharmaceutical and metabolite multiplexing detection using the SERS approach. Periodic metallic nanostructures were fabricated using laser interference lithography (LIL) and used as SERS substrates (platform that supports the SERS effect). The LIL method allowed excellent substrate-to-substrate geometric parameters variations; for instance, the variations in periodicity were determined to be less than 1%. A common fluoroquinolone (FQ) parent-and-metabolite pair, enrofloxacin (ENRO) and ciprofloxacin (CIPRO), was targeted for multiplexing detection on the relative uniform substrates fabricated by LIL. The quantifications of the analytes mixtures were achieved by chemometric analysis (i.e. non-negative matrix factorization with alternating least square algorithm (NMF-ALS)). The limit of the quantification (LOQ) of the present method is in the ppm-level with less than 10% spatial variation in the SERS signal.

Concepts: Water, Scattering, Raman scattering, Clostridium difficile, Ciprofloxacin, Quinolone, Aquatic ecosystem, Bayer

0

The development of efficient solar driven catalytic system for the degradation of antibiotics has become increasingly important in environmental protection and remediation. Non-noble-metal NiS and MoS2 nanosheet co-modified graphitic C3N4 ternary heterostructure has been synthesized via a facile combination of hydrothermal and ultrasound method, and the ternary heterostructure has been utilized for photocatalytic degradation of antibiotic agents. The antibiotics of ciprofloxacin (CIP) and tetracycline hydrochloride (TC) were photodegraded by the hybrid under the visible light. The optimal photodegradation rate of the ternary heterostructure reaches about 96% after 2h irradiation, which is 2.1 times higher than that of pure g-C3N4 for TC degradation. The photocatalytic degradation rates of the ternary heterostructure for both CIP and TC obey the pseudo-first-order kinetic model. The enhanced visible light adsorption and charge separation efficiency contribute to the photocatalytic performance of the ternary heterostructure. This work provides new insights and pathways by which efficient degradation of antibiotics can be achieved and will stimulate further studies in this important field.

Concepts: Energy, Light, Catalysis, Antibiotic, Clostridium difficile, Visible spectrum, Quinolone, Bayer

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A 49-year-old man with known livedoid vasculopathy presented with recurrent painful (VAS 8/10) ulceration and necrosis on the foot (Figure 1). He was formerly treated with prostacyclin infusions, acetylsalicylic acid, intravenous immunoglobulins, different systemic antibiotics and a skin grafting. At admission an antithrombotic therapy with enoxaparin (Clexane(®) ) in a dose of 1 mg/ kg bodyweight (100 mg) once daily was initiated. This article is protected by copyright. All rights reserved.

Concepts: Myocardial infarction, All rights reserved, Copyright, Bayer

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The ecotoxicological effects of Ciprofloxacin hydrochloride (CIP) were tested on population densities of plankton assemblages consisting of two algae (Isochrysis galbana and Platymonas subcordiformis) and a rotifer (Brachionus plicatilis). The I. galbana showed a significant decrease in densities when concentrations of CIP were above 2.0 mg L(-1) in single-species tests, while P. subcordiformis and B. plicatilis were stable in densities when CIP were less than10.0 mg L(-1). The equilibrium densities of I. galbana in community test increased with CIP concentrations after falling to a trough at 5.0 mg L(-1), showed a completely different pattern of P. subcordiformis which decreased with CIP concentrations after reaching a peak at 30.0 mg L(-1). The observed beneficial effect was a result of interspecies interactions of trophic cascade that buffered for more severe direct effects of toxicants. The community test-based NOEC of CIP (2.0 mg L(-1)), embodying the indirect effects, was different from the extrapolated one derived by single-species tests (0.5 mg L(-1)), but all lacked confidence interval. A CIP threshold concentration of obvious relevance to ecological interaction was calculated with a simplified plankton ecological model, achieving a value of 1.26 mg L(-1) with a 95% bootstrapping confidence interval from 1.18 to 1.31 mg L(-1).

Concepts: Statistics, Interval finite element, Population density, Confidence interval, Brachionus plicatilis, Rotifers, Quinolone, Bayer

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Indaziflam (Esplanade™, Bayer CropScience) is a cellulose biosynthesis inhibiting (CBI) herbicide that is a unique mode of action for resistance management and has broad spectrum activity at low application rates. This research further explores indaziflam’s activity on monocotyledons and dicotyledons, and evaluates indaziflam’s potential for restoring non-crop sites infested with invasive winter annual grasses.

Concepts: Bayer

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In this work, the photo-Fenton process at near-neutral pH was applied for the removal of the β-lactam antibiotic oxacillin (OXA) in water using artificial and sunlight. Initially, the main variables of the process (Fe(II), H2O2, and light power) were optimized by a statistical factorial design (2(3) with center points). The experimental design indicated that 90 μmol L(-1) of Fe(II), 10 mmol L(-1) of H2O2, and 30 W of power light were the favorable conditions for degradation of OXA at 203 μmol L(-1). In the photo-Fenton system, the H2O2 alone, UV-light/H2O2, and Fe(II)/H2O2 subsystems presented a significant participation on antibiotic removal. Moreover, based on the primary organic transformation products, a mechanism of OXA degradation was proposed. Under the favorable operational conditions, both the pollutant and the antimicrobial activity were eliminated after 50 min of process application. Although at 480 min of treatment, only 5% of mineralization was achieved, the level of biodegradability of the solutions increased from 0.08 to 0.98. Interestingly, the presence of pharmaceutical additives (glucose, isopropanol, and oxalic acid) had a moderate interference on the efficiency of the pollutant removal. Additionally, the treatment at pilot scale of the β-lactam antibiotic in a pharmaceutical complex matrix using solar radiation allowed the complete removal of the pollutant and its associated antimicrobial activity in a very short time period (5 min). These results evidenced the applicability of the photo-Fenton process to treat wastewaters from pharmaceutical industry loaded with β-lactam antibiotics at near neutral pH values efficiently.

Concepts: Medicine, Ultraviolet, Light, Sun, Sunlight, PH, Systems engineering, Bayer

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Management and care of individuals with hemophilia A advanced immensely with the introduction of recombinant factor VIII (rFVIII) replacement products. This review provides a historical overview of rFVIII development with a focus on Bayer’s rFVIII (with albumin) and sucrose-formulated rFVIII (rFVIII-FS), the only rFVIII products cloned in baby hamster kidney (BHK) cells with >25 years of proven safety and efficacy. Areas covered: We review the advances in rFVIII technology and the efficacy and safety data for BHK-derived rFVIII/rFVIII-FS from clinical trials, investigator-initiated studies, and observational studies. Innovative products with new treatment potentials (eg, BAY 81-8973 and BAY 94-9027) built on this established safety and efficacy profile are also briefly discussed. The literature search strategy included targeted searches (PubMed) with manual article selection and other product-specific searches. Expert commentary: Development of rFVIII products and related improvements in viral safety and manufacturing efficiency have guaranteed an adequate supply of factor products worldwide and increased prophylaxis use. The net effects have been joint health preservation, reduction in morbidity and mortality, and quality-of-life enhancements. Current treatment challenges include lack of adherence to prophylaxis and inhibitor development; extended-half-life rFVIII products and non-FVIII replacement therapies in development may help overcome these challenges.

Concepts: Clinical trial, Mortality rate, Observational study, Effectiveness, Factor VIII, Hamster, Bayer

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BACKGROUND This retrospective clinical investigation aimed to evaluate the short-term effectiveness and safety of SBCAS for symptomatic bilateral high-grade CS. MATERIAL AND METHODS From 2009 to 2014, 145 patients were recruited. Among them, 70 underwent SBCAS, and other 75 patients underwent SAMM and served as controls. The immediate postprocedural complications and postprocedural neurological evaluation, as well as restenosis at 6-month and 1-year follow-ups in the SBCAS group are reported. Additionally, baseline risk factors for ischemic stroke, adverse effects of drugs, and outcomes at 30-day, 6-month, and 1-year follow-ups were compared between the 2 groups. RESULTS Our data did not reveal significant differences between the 2 groups in baseline risk factors for ischemic stroke. In the SBCAS group, both HPS (5.7%) and HD (40%) occurred, but they were not very severe, and no patients had postprocedural neurological deficit. Moreover, restenosis only occurred in 3 patients at 3 stent placement sites (4.3%) at 1-year follow-up. Adverse effects of drugs did not occur in SBCAS group, but adverse effects of Bayer aspirin and Lipitor occurred in 4 patients (5.4%) and 18 patients (24.3%), respectively, at 6-month follow-up in the control group. Furthermore, there were significant differences in outcomes between the 2 groups at 30-day, 6-month, and 1-year follow-ups, in that NIHSS, CS ratio, and incidence of endpoint events, as well as 1-year cumulative probability of endpoint events, were all lower in the SBCAS group than in the control group (p<0.05). CONCLUSIONS Compared to SAMM, we found that SBCAS was more effective and safer for symptomatic bilateral high-grade CS.

Concepts: Clinical trial, Effect, Stroke, Effectiveness, Stent, Aspirin, Adverse drug reaction, Bayer