Background: Alzheimer's disease (AD) is a neurodegenerative disorder incurring significant social and economic costs. This study uses a US administrative claims database to evaluate the effect of AD on direct healthcare costs and utilization, and to identify the most common reasons for AD patients' emergency room (ER) visits and inpatient admissions.
Omadacycline is the first intravenous and oral 9-aminomethylcycline in clinical development for use against multiple infectious diseases including acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), and urinary tract infections (UTI). The comparative in vitro activity of omadacycline was determined against a broad panel of Gram-positive clinical isolates, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), Lancefield groups A and B beta-hemolytic streptococci, penicillin-resistant Streptococcus pneumoniae (PRSP), and Haemophilus influenzae (H. influenzae). The omadacycline MIC 90 s for MRSA, VRE, and beta-hemolytic streptococci were 1.0 g/ml, 0.25 g/ml, and 0.5 g/ml, respectively, and the omadacycline MIC 90 s for PRSP and H. influenzae were 0.25 g/ml and 2.0 g/ml, respectively. Omadacycline was active against organisms demonstrating the two major mechanisms of resistance, ribosomal protection and active tetracycline efflux. In vivo efficacy of omadacycline was demonstrated using an intraperitoneal infection model in mice. A single intravenous dose of omadacycline exhibited efficacy against Streptococcus pneumoniae, Escherichia coli, and Staphylococcus aureus, including tet(M) and tet(K) efflux-containing strains and MRSA strains. The 50% effective doses (ED 50 s) for Streptococcus pneumoniae obtained ranged from 0.45 mg/kg to 3.39 mg/kg, the ED 50 s for Staphylococcus aureus obtained ranged from 0.30 mg/kg to 1.74 mg/kg, and the ED 50 for Escherichia coli was 2.02 mg/ kg. These results demonstrate potent in vivo efficacy including activity against strains containing common resistance determinants. Omadacycline demonstrated in vitro activity against a broad range of Gram-positive and select Gram-negative pathogens, including resistance determinant-containing strains, and this activity translated to potent efficacy in vivo.W idespread resistance to antibiotics, including resistance to the older tetracyclines (tetracycline, doxycycline, and minocycline), has limited their usefulness in recent years (1, 2). New tetracycline derivatives that inhibit resistant organisms have been approved or are in development, including the glycylcyclines and specifically tigecycline, and fluorocyclines, including eravacycline (TP-434), and both tigecycline and eravacycline have potent Grampositive and Gram-negative in vitro activity (3-6). The discovery of the 9-aminomethyl class of tetracyclines has led to the identification of omadacycline (PTK 0796) that is poised to begin phase 3 clinical trials in acute bacterial skin and skin structure infections (ABSSSI), community-acquired (CA) bacterial pneumonia (CABP), and urinary tract infections (UTI) with both an intravenous (i.v.) and oral tablet formulation. Omadacycline, (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-9{[(2,2-dimethylpropyl)amino]methyl}-3, 10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide, contains a four-ring carbocyclic skelet...
The National Study on the Costs and Outcomes of Trauma Care (NSCOT) was designed to address the need for better information on the value of trauma center care. It is a multi-institutional, prospective study that involved the examination of costs and outcomes of care received by over 5,000 adult trauma patients 18 to 84 years of age treated at 69 hospitals located in 12 states. The study had three major objectives: (1) to examine variations in care provided to trauma patients in Level I trauma centers and nontrauma center hospitals; (2) to determine the extent to which differences in care correlate with patient outcome, where outcome is defined not just in terms of mortality and morbidity, but also in terms of major functional outcomes at 3 months and 12 months after injury; and (3) to estimate acute and 1-year treatment costs for trauma center and nontrauma center care, and to describe the relationship between costs and effectiveness for trauma centers and nontrauma centers. In this article, we describe the design of the NSCOT study and point to some of the methodological challenges faced in its implementation and in the analysis of the data. We also present a description of the study population to serve as a basis of future reports. We conclude with lessons learned and some recommendations for future research.
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