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De Waele J.J.,Ghent University | Tellado J.M.,Cirugia General i | Alder J.,Bayer AG | Reimnitz P.,Bayer AG | And 3 more authors.
International Journal of Antimicrobial Agents | Year: 2013

Antibiotic therapy for complicated intra-abdominal infections (cIAIs) should provide broad-spectrum coverage both Gram-positive and Gram-negative microorganisms. The PROMISE study compared the clinical and bacteriological efficacy and safety of moxifloxacin versus ertapenem for the treatment of cIAIs. This randomised, prospective, double-dummy, double-blind, multicentre trial was designed as a non-inferiority study. The safety and efficacy of 5-14 days of daily intravenous moxifloxacin (400 mg) or ertapenem (1 g) were compared in patients with cIAIs requiring surgery and parenteral antibiotic therapy. The primary and secondary endpoints included clinical and bacteriological responses at 21-28 days after the end of treatment (TOC), respectively. Of 830 enrolled patients, 699 were efficacy valid. Moxifloxacin was non-inferior to ertapenem regarding clinical success [89.5% (315/352) versus 93.4% (324/347); 95% confidence interval (CI) -7.9%, 0.4%]. There were no significant differences between groups for any of the primary causes or types of cIAI regarding clinical response. Bacteriological success was achieved in 86.5% (257/297) of moxifloxacin-treated patients and 90.2% (249/276) of ertapenem-treated patients (95% CI -9.0%, 1.5%). There were no major differences between groups regarding the frequency or types of organisms eradicated. The incidence of adverse events (AEs) was higher with moxifloxacin than ertapenem (P = 0.039), however a similar number of drug-related AEs was seen in each group (P = 1.000). Wound infections, nausea and increased lipase were the most commonly reported AEs with both agents. The results show that moxifloxacin is a valuable treatment option for a range of community-acquired cIAIs with mild-to-moderate severity [Clinical Trials.gov Identifier: NCT00492726]. © 2012 Elsevier B.V. and the International Society of Chemotherapy. Source


Aspirin® Complex is a fixed drug combination containing acetylsalicylic acid (ASA) and pseudoephedrine hydrochloride (PSE) as active ingredients, which have pain-relieving, anti-inflammatory, fever reducing and nasal decongestant properties. The pharmaceutical form is granules for oral suspension. Each sachet contains 500mg ASA and 30mg PSE. © 2014 Elsevier GmbH. Source


Rivard G.E.,CHU Sainte Justine | Rothschild C.,Hospital Necker Enfants Malades | Toll T.,University of Barcelona | Achilles K.,Bayer Vital GmbH
Haemophilia | Year: 2013

Immune tolerance induction (ITI) can overcome inhibitory factor VIII (FVIII) antibodies in haemophilia A patients receiving FVIII replacement therapy. The objective was to evaluate the use of sucrose-formulated, full-length recombinant FVIII (rFVIII-FS) for ITI therapy. Patients (<8 years at ITI start) with severe haemophilia A and a peak inhibitor titre >5 Bethesda units (BU) who underwent ITI with any rFVIII-FS dose for ≥9 months (or until success) were eligible for this retrospective study. Efficacy analyses included descriptions of ITI treatment regimens and outcomes; ITI success was determined solely at the discretion of the investigator. Safety analyses included assessment of adverse events. Of 51 enrolled patients, 32 [high dose (≥85 IU kg-1 day-1), n = 21; low dose, n = 11] were eligible for analysis. ITI was successful in 69% (22/32) of patients (high dose, 66.7%; low dose, 72.7%) after a median of 1.4 years (range, 0.1-3.6 years). Influencing factors for ITI success were start of ITI <1 year after inhibitor detection and an inhibitor titre <10 BU at ITI start. All patients successfully tolerized with ITI continued to receive rFVIII-FS prophylaxis as maintenance therapy, with no inhibitor recurrence from the end of ITI until study enrolment. Use of rFVIII-FS for ITI was effective and well tolerated; success rates were similar to those in published studies. © 2013 Blackwell Publishing Ltd. Source


Bangoura B.,University of Leipzig | Mundt H.-C.,Bayer Animal Health GmbH | Schmaschke R.,University of Leipzig | Westphal B.,Bayer Vital GmbH | Daugschies A.,University of Leipzig
Parasitology Research | Year: 2012

The present study was designed to investigate the prevalence of the pathogenic coccidia species Eimeria bovis and Eimeria zuernii in shed-reared animals in German dairy and fattening facilities. Samples were obtained from 65 cattle farms distributed randomly across all the regions of Germany regardless of the occurrence of clinical problems. The samples were obtained rectally. Faecal consistency and the total number of oocysts per gram of faeces (OPG) were determined, along with the OPG values for E. bovis and E. zuernii. A questionnaire was completed for each farm to record information about herd size and management, along with individual animal data. Eimeria oocysts were detected in 62 of these farms, which give a prevalence of 95.4%. The farm prevalence of the pathogenic species was 76.9% for E. bovis and 83.1% for E. zuernii. The number of oocysts excreted could not be correlated significantly with farm type or farm management but depended on the floor type, the age of the calves and the time after rehousing. Furthermore, there was a positive correlation between OPG and the observation of diarrhoea. E. zuernii had a greater influence on the occurrence of diarrhoea than E. bovis. This study confirms that herd management frequently does not meet the requirements of effective coccidia control despite the fact that the pathogenic coccidia E. bovis and E. zuernii are ubiquitous in German cattle populations. © Springer-Verlag 2011. Source


Schneider T.,Praxisklinik Urologie Rhein Ruhr | Marschall-Kehrel D.,Urological Practice | Hanisch J.U.,Bayer Vital GmbH
International Journal of Clinical Practice | Year: 2010

SummaryAims: Gender, age, obesity, smoking and alcohol or caffeine intake have been shown or proposed to be risk factors for the prevalence and/or severity of the overactive bladder symptom complex (OAB) or related parameters. We have explored whether any of these factors affect the therapeutic response to a muscarinic receptor antagonist during routine clinical use. Methods: Data were analysed from 3766 OAB patients (77.1% woman, age 62.6 ± 12.8 years) participating in an observational, open-label postmarketing surveillance study of the safety and efficacy of darifenacin. Multiple logistic regression models were applied to explore the effect of potential OAB risk factors on the darifenacin treatment-associated improvement of OAB symptoms, patient's subjective rating of bladder problems and global efficacy and tolerability. Results: Age and (less consistently) gender were statistically significantly correlated with efficacy parameters, but the extent of their impact was judged to be too small to be clinically relevant. Except for a very small effect of body mass index on urgency episode improvement, none of the lifestyle-associated factors had significant effects on the efficacy of darifenacin. Except for a very small age effect, none of the potential risk factors had significant effects on global tolerability. Discussion and conclusions: We conclude that the efficacy and tolerability of a muscarinic receptor antagonist, such as darifenacin is largely independent of potential OAB risk factors, such as gender, age, obesity, smoking and alcohol or caffeine intake. © 2010 Blackwell Publishing Ltd. Source

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