Afdhal N.H.,Beth Israel Deaconess Medical Center |
Giannini E.G.,University of Genoa |
Tayyab G.,Lahore General Hospital |
Mohsin A.,Services Hospital Lahore |
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.
Berger W.E.,Allergy and Asthma Associates of Southern California |
Shah S.,Collegeville |
Lieberman P.,University of Memphis |
Hadley J.,Specialty Care Center |
And 4 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.
News Article | November 21, 2016
Nine seniors and one junior make up the semifinalists for the 2016 Gagliardi Trophy, an accolade presented by Jostens and the J-Club of Saint John’s University to the most outstanding football player in NCAA Division III. The Gagliardi Trophy, given annually since 1993, recognizes excellence in athletics, academics and community service. The award is named after John Gagliardi, Saint John's legendary Hall of Fame head football coach who retired in 2012 with 489 career victories, the most in college football history. The 24th Gagliardi Trophy will be presented on Wednesday, Dec. 14, in Salem, Va., at a banquet kicking off the Division III championship weekend, which culminates in the Stagg Bowl on Friday, Dec. 16. The four finalists, who will be announced Dec. 6, will be on hand for the announcement of the winner and presentation of the trophy at the banquet. The trophy design features a sculpture of Gagliardi and a player, representing the teacher-coach and the student-athlete in a one-on-one sideline consultation. Hand-cast in bronze on a polished wood base, the trophy stands nearly two feet tall and weighs approximately 64 pounds. The words "The Gagliardi Trophy presented by Jostens & J-Club” are printed on the acrylic panel behind the figures. The words “Division III 2016 Player of the Year" and "Honoring Excellence in Football, Academics and Community Service" are etched on two panels below the figures. Nominations were submitted by colleges across the country, and the final 10 were selected by the J-Club Board of Directors. The Gagliardi Trophy national-selection committee is comprised of 40 former small college football players, former Gagliardi Trophy recipients, business leaders, academicians and sports writers from around the country. Each casts a ballot ranking the 10 semifinalists. A fan vote, which will serve as the 41st committee member, will be launched on D3football.com Nov. 21 and run until Monday, Dec. 5. Nine of the 10 semifinalists (addressed further down the press release) played Nov. 19 in the first round of the Division III national playoffs: Barnes, Flood, Hanson, Heitland, LiCata, Mullins, Riddle, Tomlin and Ward. About Jostens Jostens is a trusted partner in the academic and achievement channel, providing products, programs and services that help its customers celebrate moments that matter. The company's products include yearbooks, publications, jewelry and consumer goods that serve the K-12 educational, college and professional sports segments. Founded in 1897 and based in Minneapolis, Minn., Jostens is a subsidiary of Newell Brands and can be found online at http://www.jostens.com. About Newell Brands Newell Brands (NYSE: NWL) is a leading global consumer goods company with a strong portfolio of well-known brands, including Paper Mate®, Sharpie®, Dymo®, EXPO®, Parker®, Elmer’s®, Coleman®, Jostens®, Marmot®, Rawlings®, Oster®, Sunbeam®, FoodSaver®, Mr. Coffee®, Rubbermaid Commercial Products®, Graco®, Baby Jogger®, NUK®, Calphalon®, Rubbermaid®, Contigo®, First Alert®, Waddington and Yankee Candle®. For hundreds of millions of consumers, Newell Brands makes life better every day, where they live, learn, work and play. This press release and additional information about Newell Brands are available on the company’s website, http://www.newellbrands.com. About Saint John's University J-Club Founded in 1959, the Saint John's University J-Club is a dues-based booster organization of former Johnnie student-athletes, parents and fans, and plays a key role in support of the SJU varsity programs, intramurals and club sports. Saint John's is a private liberal arts college for men located in Collegeville, Minn.
News Article | November 14, 2016
A large global survey finds gaps in communication between doctors who treat rheumatoid arthritis and their patients, even though most physicians believe good communication and patient engagement are important to achieve the best outcomes. The research, "Understanding the Importance of a Patient's Role in the Management of RA: Physician- and Patient-Based Survey" was presented at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting on November 13 in Washington, DC. "Rheumatoid Arthritis (RA) is a chronic, debilitating disease affecting 1.5 million people in the United States," said Allan Gibofsky, MD, a rheumatologist at Hospital for Special Surgery and senior study author. "The survey was launched to gain a better understanding of the similarities and differences in physician and patient perspectives, with the goal of improving patient care." The RA NarRAtive Global Advisory Panel, a group of 39 rheumatology experts from around the world including Dr. Gibofsky, developed the surveys regarding RA treatment and management for both patients and health care providers. They were distributed in 15 countries between September 2014 and January 2016. More than 3900 patients and more than 1600 physicians completed the questionnaires. "Studies show that good communication and the involvement of the patient in decision-making are critical to achieve optimal care," said Dr. Gibofsky. "The hope is that this survey represents the beginning of a road map to address deficiencies so we can ultimately improve patient care." Study Title: "Understanding the Importance of a Patient's Role in the Management of RA: Physician- and Patient-Based Survey" Authors: Ara Dikranian1, James Galloway2, Joern Kekow3, Cristiano A.F Zerbini4, Maria de la Vega5, Gavin Lee6, Anna Maniccia7, Eustratios Bananis8, Dario Ponce de Leon9 and Allan Gibofsky10, 1San Diego Arthritis Medical Clinic, San Diego, CA, 2King's College, and King´s College Hospital, London, United Kingdom, 3University of Magdeburg, Clinic of Rheumatology, Magdeburg, Germany, 4Centro Paulista de Investigação Clinica, São Paulo, Brazil, 5CEIM Investigaciones Médicas, Buenos Aires, Argentina, 6Hong Kong Sanatorium & Hospital, Hong Kong SAR, China, 7Pfizer Inc, New York, NY, 8Pfizer Inc, Collegeville, PA, 9Pfizer Inc, Lima, Peru, 10Rheumatology, Weill Cornell Medicine, and Hospital for Special Surgery, New York, NY Hospital for Special Surgery (HSS) is the world's largest academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 2 in rheumatology by U.S. News & World Report (2016-2017), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at http://www. .
Finn R.S.,University of Southern California |
Press M.F.,University of Southern California |
Dering J.,University of Southern California |
O'Rourke L.,Collegeville |
And 4 more authors.
Clinical Cancer Research | Year: 2014
Purpose: Lapatinib, a dual epidermal growth factor receptor (EGFR) and HER2 inhibitor, remains unproven in non-HER2-amplified metastatic breast cancer (MBC). EGF30008, a phase III trial of letrozole and lapatinib versus letrozole and placebo, demonstrated that lapatinib significantly improves outcome for postmenopausal women with HER2-amplified, but not HER2-negative, MBC. The hypothesis that low hormone receptor status is associated with benefit in this HER2-negative cohort was tested. Experimental Design: A blinded retrospective biomarker evaluation used immunohistochemistry (IHC) to semiquantify estrogen receptor (ER) and progesterone receptor (PgR) expression (n = 821/952). HER2 status was determined by IHC and confirmed by FISH (n = 326). Effects of these biomarkers on progression-free survival (PFS) were examined in patients with available tissue. Results: In HER2-negative, ER-positive MBC, median PFS was analyzed by ER and PgR expression (H-score) by quartile (Q). There was significant improvement in patients with low ER expression (Q1, H-score <160) with lapatinib and letrozole (13.6 vs. 6.7 months; P = 0.01). No benefit was associated with stronger ER expression (Q2/3, H-score ≥160 and <250; 13.6 vs. 14.2 months; Q4, H-score ≥250; 11.2 vs. 14.2 months). There was no association between PgR H-score and benefit from lapatinib. Conclusion: In postmenopausal patients with advanced hormone receptor-positive disease, weak ER expression is associated with worse outcome with letrozole treatment compared with the combination. The addition of lapatinib significantly improved PFS for this patient subgroup and augments data supporting interaction between steroid hormone and peptide hormone signaling. A prospective study validating this hypothesis is required. © 2014 American Association for Cancer Research.
Nagy E.,University of Szeged |
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.
Weller S.,Glaxosmithkline |
Chen S.,Glaxosmithkline |
Borland J.,Glaxosmithkline |
Savina P.,Glaxosmithkline |
And 2 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2014
Background:: The integrase inhibitor dolutegravir and nucleoside analogues abacavir and lamivudine are once-daily treatment options for HIV. This study (NCT01622790) evaluated, first, the bioequivalence (BE) of a fixed-dose combination (FDC) tablet containing dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (dolutegravir/abacavir/lamivudine FDC) vs coadministered dolutegravir 50 mg and abacavir/lamivudine combination tablets (Epzicom) and, second, the effect of food on the dolutegravir/abacavir/lamivudine FDC tablet. Methods:: Study part A (66 healthy subjects) was a single-dose, open-label, randomized, 2-period crossover study to evaluate the BE of the dolutegravir/abacavir/lamivudine FDC tablet and dolutegravir + abacavir/lamivudine tablets in the fasted state. In study part B, 12 subjects from part A received the dolutegravir/abacavir/lamivudine FDC tablet with a high-fat meal. BE and food effect were assessed by analysis of variance to determine the ratio of geometric least squares means and associated 90% confidence intervals for key pharmacokinetic parameters for each of dolutegravir, abacavir, and lamivudine. Results:: Sixty-two subjects completed part A. The dolutegravir/abacavir/lamivudine tablet was bioequivalent to the dolutegravir + abacavir/lamivudine tablets; 90% confidence intervals for the geometric least squares mean ratios fell within the 0.8-1.25 BE criteria. The effect of food on the dolutegravir/abacavir/lamivudine FDC tablet was similar to previous food effects observed with the separate formulations. The safety profile was comparable between treatments, with no observed serious or grade 3/4 adverse events. Conclusions:: The BE of the dolutegravir/abacavir/lamivudine FDC tablet was demonstrated; it may be administered without regard to meals. Copyright © 2014 by Lippincott Williams & Wilkins.
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.
In vitro activity of tigecycline and comparators on Acinetobacter spp. isolates collected from patients with bacteremia and MIC change during the Tigecycline Evaluation and Surveillance Trial, 2004 to 2008
Wang Y.F.W.,Grady Memorial Hospital |
Wang Y.F.W.,Emory University |
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.
News Article | February 23, 2017
US Sports Camps (USSC) once again partners with former Olympian Genai Kerr to offer Nike 5meter Water Polo Camps and Clinics in 2017. Unlike most water polo camps, Nike Water Polo Camps is a year-round camp operation; offering weekend clinics and full week camps in the Winter, Spring, Summer, and Fall. Over 25 camps and clinics are conducted annually across the USA and internationally. Both day camp packages and overnight (at select locations) are available. Led by Olympian Genai Kerr as well as former Olympians and college coaches, Nike 5meter Water Polo Camps offer outstanding coaching and take every step possible to stimulate your love for water polo in a positive and healthy environment. Genai Kerr is a USA Water Polo Olympian, coach, mentor, and true ambassador of the sport. Genai was a member of the United States Men's National Water Polo Team for 12 years and played in the 2004 Athens Olympics, 2003 & 2007 Pan American Gold Medal games, and multiple World Championships. “Nike 5meter Water Polo Camps are designed to make an immediate impact by providing the highest level of detailed position specific instruction for water polo players,” says Genai Kerr. “Not only do the staff members get in the water with the campers, dry land, mental edge and college planning activities are integrated to provide a beneficial experience for any emerging water polo player.” Locations include: Maple Ridge, BC; Berkeley, CA; Moraga, CA; Sana Cruz, CA; San Diego, CA; Santa Maria, CA; Santa Monica, CA; Chelsea Piers, CT; Miami, FL;Cincinnati, OH, Eugene, OR; Portland, OR; Collegeville, PA; Shillington, PA; Montreal, QB; Salt Lake City, UT; Port Orchard, WA; Seattle, WA; Tacoma, WA. At each water polo camp 2017 location, players receive focused instruction on both fundamental and advanced techniques. Position specific training if offered for drivers, shooters, goalies and 2 meter offense and defense. Upon arrival, campers are placed in groups with other players that have similar abilities and goals. Camp staff do their best to accommodate campers needs, keeping in consideration experience and desire to improve. Campers, parents, and coaches interested in the 2017 Nike 5meter Water Polo Camps can find more information at http://www.ussportscamps.com/waterpolo or call 1-800-645-3226. US Sports Camps (USSC), headquartered in San Rafael, California, is America's largest sports camp network and the licensed operator of Nike Sports Camps. The company has offered summer camps since 1975 with the same mission that defines it today: to shape a lifelong enjoyment of athletics through high quality sports education and skill enhancement.