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Peoria Heights, IL, United States

Schuster A.,Heinrich Heine University Dusseldorf | Haliburn C.,Data Management | Doring G.,University of Tubingen | Goldman M.H.,Forest Laboratories
Thorax | Year: 2013

Purpose To assess efficacy and safety of a new dry powder formulation of inhaled colistimethate sodium in patients with cystic fibrosis (CF) aged ≥6 years with chronic Pseudomonas aeruginosa lung infection. Study design and methods A prospective, centrally randomised, phase III, open-label study in patients with stable CF aged ≥6 years with chronic P aeruginosa lung infection. Patients were randomised to Colobreathe dry powder for inhalation (CDPI, one capsule containing colistimethate sodium 1 662 500 IU, twice daily) or three 28-day cycles with twice-daily 300 mg/5 ml tobramycin inhaler solution (TIS). Study duration was 24 weeks. Results 380 patients were randomised. After logarithmic transformation of data due to a non-normal distribution, adjusted mean difference between treatment groups (CDPI vs TIS) in change in forced expiratory volume in 1 s (FEV1% predicted) at week 24 was -0.98% (95% CI -2.74% to 0.86%) in the intentionto-treat population (n=373) and -0.56% (95% CI -2.71% to 1.70%) in the per protocol population (n=261). The proportion of colistin-resistant isolates in both groups was ≤1.1%. The number of adverse events was similar in both groups. Significantly more patients receiving CDPI rated their device as 'very easy or easy to use' (90.7% vs 53.9% respectively; p<0.001). Conclusion CDPI demonstrated efficacy by virtue of non-inferiority to TIS in lung function after 24 weeks of treatment. There was no emergence of resistance of P aeruginosa to colistin. Overall, CDPI was well tolerated. Source


Lebwohl M.,Mount Sinai School of Medicine | Swanson N.,Oregon Health And Science University | Anderson L.L.,Dermatology Associates of Tyler | Melgaard A.,Data Management | And 2 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma. Treating actinic keratoses and the surrounding skin area (i.e., field therapy) can eradicate clinical and subclinical actinic keratoses. Topical field therapy currently requires weeks or months of treatment. We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities). METHODS: In four multicenter, randomized, double-blind studies, we randomly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo (vehicle), self-applied to a 25-cm 2 contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities. Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured. RESULTS: In a pooled analysis of the two trials involving the face and scalp, the rate of complete clearance was higher with ingenol mebutate than with placebo (42.2% vs. 3.7%, P<0.001). Local reactions peaked at day 4, with a mean maximum composite score of 9.1 on the local-skin-response scale (which ranges from 0 to 4 for six types of reaction, yielding a composite score of 0 to 24, with higher numbers indicating more severe reactions), rapidly decreased by day 8, and continued to decrease, approaching baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, the rate of complete clearance was also higher with ingenol mebutate than with placebo (34.1% vs. 4.7%, P<0.001). Local skin reactions peaked between days 3 and 8 and declined rapidly, approaching baseline by day 29, with a mean maximum score of 6.8. Adverse events were generally mild to moderate in intensity and resolved without sequelae. CONCLUSIONS: Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses. (Funded by LEO Pharma; ClinicalTrials.gov numbers, NCT00742391, NCT00916006, NCT00915551, and NCT00942604.) Copyright © 2012 Massachusetts Medical Society. Source


Koper K.D.,University of Utah | Hutko A.R.,Data Management | Lay T.,University of California at Santa Cruz
Geophysical Research Letters | Year: 2011

Locations of coherent short-period seismic wave radiation from the 11 March 2011 Tohoku earthquake (Mw 9.0) are imaged by back-projecting teleseismic P waves recorded across North America for a series of narrow, overlapping passbands centered at 8s, 4s, 2s, 1s, and 0.5s. Initially the energy release for all five passbands migrates slowly down-dip, however over time the two longer-period passbands show coherent energy release systematically shifted up-dip of the shorter-period source regions. Back-projection images of P waves from ten (point-source-like) aftershocks do not show a frequency-dependent trend, implying that the frequency dependence observed for the main shock is not an artifact created by 3D earth structure, depth phase interference, or some other deficiency. We conclude that the unstable sliding properties along the megathrust are segmented, with faster moment rate variations in the down-dip region and relatively smooth sliding further up-dip. © 2011 by the American Geophysical Union. Source


Lai S.-W.,China Medical University at Taichung | Lin C.-L.,China Medical University at Taichung | Lin C.-L.,Data Management | Liao K.-F.,China Medical University at Taichung | Lin C.-Y.,Taichung Tzu Chi General Hospital
Heart Rhythm | Year: 2015

BACKGROUND: There is still lack of strong evidence, based on systematic studies, that support the relationship between amiodarone use and the risk of acute pancreatitis. OBJECTIVE: The aim of this study was to explore the relationship between amiodarone use and the risk of acute pancreatitis in Taiwan. METHODS: This case-control study was based on the analysis of the claim data from Taiwan's national health insurance program from 2000 to 2011. There were 4986 subjects aged 20-84 years with a first episode of acute pancreatitis as the case group and 19,944 randomly selected subjects without acute pancreatitis matched for sex, age, and index year as the control group. Amiodarone use was defined as "current," "recent," or "past" if the most recent amiodarone prescription was filled within 3 months, between 3 and 6 months, or >6 months before the date of acute pancreatitis diagnosis, respectively. The relative risk of acute pancreatitis associated with amiodarone use was measured by the odds ratio with 95% confidence interval using the multivariable unconditional logistic regression model. RESULTS: After adjustment for confounding factors, current use of amiodarone was positively associated with acute pancreatitis (adjusted odds ratio 5.21; 95% confidence interval 3.22-8.43). There was no significant association between recent or past amiodarone use and acute pancreatitis. CONCLUSION: People with current use of amiodarone are at an increased risk of acute pancreatitis. Physicians should be more cautious about acute pancreatitis risk when prescribing amiodarone. © 2015 Heart Rhythm Society. All rights reserved. Source


Cherala S.S.,Data Management
Preventing Chronic Disease | Year: 2012

Introduction: Obesity is a national epidemic. Gastric bypass surgery may be the only option that provides significant long-term weight loss for people who are morbidly obese (body mass index [BMI] ≥40 kg/m) or for people who have a BMI of 35 or higher and have an obesity-related comorbidity. The objective of this study was to assess trends in gastric bypass surgery in New Hampshire. Methods: Data from 1996 to 2007 from the New Hampshire Inpatient Hospital Discharge data set were analyzed. Records for patients with a gastric bypass surgery code were identified, and data on patients and hospitalizations were collected. A joinpoint regression model was used to analyze trends in surgery rates. Differences between patients and payer types were analyzed by using the Cochran-Mantel-Haenszel χ test. Results: The annual rate of gastric bypass surgery increased significantly from 3.3 to 22.4 per 100,000 adults between 1996 and 2007. The in-hospital death rate decreased significantly from 11% in 1996 to 1% in 2007. A greater proportion of women (78.1% during the study period) than men had this surgery. The average charge of a surgery decreased significantly from $44,484 in 1996 to $43,907 in 2007; by 2007, total annual charges were $13.9 million. Since 1996, private or "other" payers have been charged for nearly 80% of the total discharges. Conclusion: The number of gastric bypass surgeries has increased in New Hampshire, and so have their cost. These increases may reflect a shortage in effective primary care and preventive measures to address the obesity epidemic. Source

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