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Berger W.E.,Allergy and Asthma Associates of Southern California | Shah S.,Collegeville | Lieberman P.,University of Memphis | Hadley J.,Specialty Care Center | And 3 more authors.
Journal of Allergy and Clinical Immunology: In Practice | Year: 2014

Background: MP29-02 is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate (FP) in an advanced delivery system for the treatment of seasonal allergic rhinitis. Objective: The objective of this study was to evaluate the long-term safety of MP29-02 in subjects with chronic allergic (perennial) or nonallergic (vasomotor) rhinitis. Methods: This was a 1-year, randomized, open-label, active-controlled, parallel-group study in subjects with chronic allergic or nonallergic rhinitis. A total of 612 subjects were randomized in a 2:1 ratio to (1) MP29-02, one spray per nostril twice daily (total daily doses of azelastine hydrochloride and FP were 548mcg and 200 mcg, respectively); or (2) FP, 2sprays per nostril once daily (total daily dose 200 mcg). Safety and tolerability assessments were made at months 1, 3, 6, 9, and 12. Results: The incidence of treatment-related adverse events was low with both MP29-02 (9.4%) and FP (11.1%), with no evidence of late-occurring adverse events. Nasal examinations showed no evidence of nasal mucosal ulcerations or septal perforations with MP29-02, and the overall incidence of adverse findings was reduced as the study progressed. There were no unusual or unexpected ocular examination findings and no clinically important laboratory findings or clinically important differences between groups in fasting AM serum cortisol levels after 12 months of treatment. Conclusions: MP29-02 was well tolerated. There were no safety findings that would preclude the long-term use of MP29-02 in the treatment of allergic rhinitis. © 2014 American Academy of Allergy, Asthma & Immunology. Source


Wang Y.F.W.,Grady Memorial Hospital | Wang Y.F.W.,Emory University | Dowzicky M.J.,Collegeville
Diagnostic Microbiology and Infectious Disease | Year: 2010

The Tigecycline Evaluation and Surveillance Trial is a global surveillance study established in 2004 to monitor the activity of tigecycline, a new glycylcycline, and several comparators against an array of important Gram-positive and Gram-negative pathogens. In this study, we examined 1591 isolates of Acinetobacter from blood samples collected from 352 centers globally between 2004 and 2008. Tigecycline showed an MIC90 (1 μg/mL) globally, with a maximum regional value of 4 μg/mL (Middle East) reported. Antimicrobial susceptibility was notably higher among nonintensive care unit (non-ICU) isolates than isolates collected from ICUs. Carbapenem-resistant Acinetobacter were more prevalent in the Middle East, Latin America, and Asia/Pacific rim than in Europe or North America. Tigecycline creep was noted between 2004 and 2007, corresponding closely to changes in MIC90. © 2010 Elsevier Inc. Source


Zartler E.R.,Collegeville
ACS Medicinal Chemistry Letters | Year: 2014

Fragonomics is the process of using small, relatively simple molecules to generate chemical starting points for hit generation. Fragonomics has come of age and is now one of the major concepts in hit generation. What is its future? © 2014 American Chemical Society. Source


Afdhal N.H.,Beth Israel Deaconess Medical Center | Giannini E.G.,University of Genoa | Tayyab G.,Postgraduate Medical Institute | Mohsin A.,Services Institute of Medical science | And 10 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure. METHODS: We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period. RESULTS: A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P<0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups. CONCLUSIONS: Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number, NCT00678587.) Copyright © 2012 Massachusetts Medical Society. Source


Nagy E.,University of Szeged | Dowzicky M.J.,Collegeville
Scandinavian Journal of Infectious Diseases | Year: 2010

The Tigecycline Evaluation and Surveillance Trial (TEST) is a global surveillance study designed to monitor the in vitro activity of the broad-spectrum antimicrobial tigecycline against nosocomial- and community-acquired pathogens. In this study the in vitro activity of tigecycline against 1256 anaerobic pathogens collected across Europe has been compared to the activity of several comparator antibiotics. The pathogens examined in this study included Bacteroides, Prevotella, Anaerococcus, Clostridium, Finegoldia and Peptostreptococcus. Low minimum inhibitory concentration (MIC90) values were noted against Gram-positive anaerobes for most agents on the test panel, with the exceptions of cefoxitin and clindamycin. Low MIC90s were also reported against Gram-negative isolates for most agents, with the exceptions of clindamycin and, to a lesser degree, piperacillintazobactam. The lowest MIC90s against both Gram-negative and Gram-positive organisms were typically noted for the carbapenem meropenem and tigecycline. Tigecycline showed the lowest MIC90 against the key pathogen Clostridium difficile (0.25 mg/l). These in vitro results indicate that tigecycline may be useful in the treatment of infections caused by or involving anaerobic pathogens. © 2009 Informa UK Ltd. Source

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