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Crim C.,Research Triangle ParkNC | Crim C.,Moore Research | Dransfield M.T.,University of Alabama at Birmingham | Bourbeau J.,McGill University | And 10 more authors.
Annals of the American Thoracic Society | Year: 2015

Rationale: Radiographically confirmed pneumonia risk with inhaled corticosteroid use in chronic obstructive pulmonary disease (COPD) has not been assessed to date. Objectives: To determine the incidence of pneumonia, risk factors, and clinical attributes with inhaled fluticasone furoate (FF) in patients with COPD with an exacerbation history. Methods: Two replicate, 1-year, double-blind clinical trials enrolled subjects with COPD with moderate to very severe airflow limitation and at least one exacerbation within the prior year. Subjects were randomized 1:1:1:1 to receive inhaled once-daily vilanterol (VI) 25 μg or VI 25 μg combined with 50, 100, or 200 μg FF. Subjects were required to have a chest radiograph at screening and within 48 hours of any suspected pneumonia or exacerbation. Measurements and Main Results: Among 3,255 randomized subjects, 205 pneumonia events occurred in 181 subjects. Chest imaging was available for 195 (95%) of these events. Chest radiographs were also obtained for 1,793 (70%) of the 2,545 moderate and severe exacerbations. For VI alone and the combination with 50, 100, or 200 μg FF, reported pneumonia incidence was 3, 6, 6, and 7%, respectively. However, for events with compatible parenchymal infiltrates, the respective incidences were 2, 4, 4, and 5%. Factors associated with at least a twofold increase in the risk of pneumonia with FF/VI treatment were being a current smoker, having prior pneumonia, body mass index <25 kg/m2, and severe airflow limitation. Conclusions: Radiographically confirmed pneumonia risk is increased with inhaled FF/VI, although at less than investigator-defined rates. Modifiable pneumonia risk factors should be considered when attempting to optimize COPD management. Copyright © 2015 by the American Thoracic Society

Rattray C.,University of the West Indies | Wiener J.,Centers for Disease Control and Prevention | Legardy-Williams J.,Centers for Disease Control and Prevention | Costenbader E.,Research Triangle ParkNC | And 9 more authors.
Contraception | Year: 2015

Objective To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)]. Study design We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N= 208) or at the end ("delayed" insertion arm, N= 206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use. Results At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9-1.9; 3-month: 25.6% vs. 23.1%, PR = 1.1, 95% CI=0.8-1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of.15). Conclusions Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. Implications Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant.

Chopra I.,Duquesne University | Kamal K.M.,Duquesne University | Candrilli S.D.,Research Triangle ParkNC | Kanyongo G.,Duquesne University
Postgraduate Medicine | Year: 2014

Background: Obesity is associated with cardiovascular risk factors such as hypertension, dyslipidemia, and diabetes mellitus, as well as cardiovascular diseases. Objectives: To evaluate demographic, diagnostic, and treatment characteristics of patients with concomitant hypertension and dyslipidemia, stratified by body mass index and the attainment of blood pressure (BP) and lipid targets in obese versus nonobese patients. Methods: This retrospective study used data from GE Centricity Electronic Medical Records database (2004–2011) of a primary care physician group. Patients aged $ 18 years and having concomitant hypertension and dyslipidemia were categorized based on their body mass index: normal weight (# 24.9 kg/m2), overweight (25.0–29.9 kg/m2), and obese ($ 30.0 kg/m2). Blood pressure and lipid goal attainments were based on Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and National Cholesterol Education Program Adult Treatment Panel III guidelines, respectively. Results: A total of 9086 patients with concomitant hypertension and dyslipidemia were identified and categorized as normal weight (n = 1256), overweight (n = 3058) and obese (n = 4772). Patients who were obese were younger (, 65 years); were more likely to have diabetes mellitus (P , 0.001); had higher baseline BP and triglyceride levels and lower levels of high-density lipoprotein cholesterol (P , 0.05); and were more likely to be prescribed antihypertensives and antilipemic agents (P , 0.001). In multivariate analyses, obese patients were significantly more likely to fail to attain BP (odds ratio = 1.562, P , 0.001) and dual BP and low-density lipoprotein cholesterol (odds ratio = 1.193, P = 0.023) goals. Conclusions: Obesity appears to be an independent risk factor for the failure to attain BP and dual BP and low-density lipoprotein cholesterol goals in patients with concomitant hypertension and dyslipidemia. These findings suggest that future research is needed to determine the underlying link between obesity and failure to attain these goals. © Postgraduate Medicine

Brealey N.,Respiratory Medicines Development Center | Gupta A.,Quantitative science India | Renaux J.,Respiratory Clinical Pharmacology Science and Study Operations | Mehta R.,Research Triangle ParkNC | And 2 more authors.
International Journal of Clinical Pharmacology and Therapeutics | Year: 2015

Two single-center, four-way, single-dose, crossover studies assessed the systemic exposure, systemic pharmacodynamics (PD), and safety profile of the closed triple fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) therapy compared with dual therapies. These are the first studies where pharmacokinetic (PK) profile assessment was possible for this inhaled triple fixed-dose combination product. Methods: Healthy volunteers were randomized to receive 4 consecutive inhalations (each administered as a single dose) via a single ELLIPTA® dry powder inhaler: in study 1 (CTT116415/NCT01691547), FF/ UMEC/VI at total doses of 400/500/100 μg, FF/UMEC 400/500 μg, UMEC/VI 500/100 μg, or FF/VI 400/100 μg; in study 2 (200587/ NCT01894386), FF/UMEC/VI at total doses of 400/500/100 μg or 400/250/100 μg, FF/VI 400/100 μg, or UMEC/VI 250/100 μg. PK and PD parameters and safety were assessed. Results: Of 88 subjects, 95% completed both studies and received all planned treatments. Total systemic exposure was similar for FF, UMEC, and VI when administered as a triple therapy compared with FF/VI and UMEC/VI. No clinically significant systemic PD findings were detected. The incidence of adverse events was low and similar across treatment arms. Conclusions: Systemic exposure to all three components of the closed triple therapy, following single-dose delivery, was similar to that seen with the dual therapies FF/VI and UMEC/VI. The delivered lung dose and safety profile of all three agents, delivered via a single inhaler, are expected to be similar to those of the dual therapies. © 2015 Dustri-Verlag Dr. K. Feistle.

Wurst K.E.,Research Triangle ParkNC | Kelly-Reif K.,University of North Carolina at Chapel Hill | Bushnell G.A.,University of North Carolina at Chapel Hill | Pascoe S.,Research Triangle ParkNC | And 2 more authors.
Respiratory Medicine | Year: 2016

Asthma-chronic obstructive pulmonary disease overlap syndrome (ACOS) is a loosely-defined clinical entity referring to patients who exhibit characteristics of both asthma and chronic obstructive pulmonary disease (COPD). Clinical definitions and classifications for ACOS vary widely, which impacts our understanding of prevalence, diagnosis and treatment of the condition. This literature review was therefore conducted to characterize the prevalence of ACOS and the effect of different disease definitions on these estimates, as this has not previously been explored. From an analysis of English language literature published from 2000 to 2014, the estimated prevalence of ACOS ranges from 12.1% to 55.2% among patients with COPD and 13.3%-61.0% among patients with asthma alone. This variability is linked to differences in COPD and asthma diagnostic criteria, disease ascertainment methods (spirometry-based versus clinical or symptom-based diagnoses and claims data), and population characteristics including age, gender and smoking. Understanding the reasons for differences in prevalence estimates of ACOS across the literature may help guide decision making on the most appropriate criteria for defining ACOS and aid investigators in designing future ACOS clinical studies aimed at effective treatment. © 2015 Elsevier Ltd. All rights reserved.

Dalal A.A.,Glaxosmithkline | Patel J.,Amgen Inc. | D'Souza A.,Xcenda | Farrelly E.,Xcenda | And 2 more authors.
Journal of Managed Care Pharmacy | Year: 2015

BACKGROUND: There is scarce information on chronic obstructive pulmonary disease (COPD) outcomes and costs for patients with differing levels of COPD exacerbations. OBJECTIVE: To examine COPD-related and all-cause health care resource use and costs in subsequent years for frequently and infrequently exacerbating COPD patients. METHODS: Patients with a diagnosis of COPD (ICD-9-CM codes 491.xx, 492.xx, and 496.xx) were identified (1 hospitalization or 1 emergency department visit or at least 2 outpatient visits) using administrative claims data in 2007. Patients were classified in 2008 as frequent (at least 2 exacerbations/ year), infrequent (1 exacerbation/year) and nonexacerbators. Outcomes were computed during a subsequent 2-year period (2009 and 2010). Average per person estimates and total sample-level estimates were calculated. A logistic regression model estimated the predictors of having 2 or more exacerbations per year during the follow-up period. RESULTS: 61,750 COPD patients met the study criteria (mean age 67 years). Of these, 6% (n = 3,852) were frequent exacerbators; 14% were infrequent exacerbators (n = 8,416); and 80% were nonexacerbators (n = 49,482). At baseline, average all-cause health care costs per patient for frequent exacerbators were highest followed by infrequent and nonexacerbators ($12,837, $10,480, and $7,756, respectively). On average, 60% of frequent and 40% of infrequent exacerbators had at least 1 exacerbation per year in follow-up. Average annual per patient COPD-related costs for frequent exacerbators ($3,565 in 2009 and $3,528 in 2010) were more than 3 times (P < 0.05) and infrequent exacerbators ($2,264 in 2009 and $2,265 in 2010) were more than 2 times (P < 0.05) higher compared with nonexacerbators ($1,007 in 2009 and $1,027 in 2010). On a total sample-level, infrequent exacerbators were similar if not more burdensome compared with frequent exacerbators in the proportion accounted by these cohorts for total COPD-related costs (23% vs. 18%, respectively) and total number of COPD exacerbations per year (26% vs. 26%). Compared with nonexacerbators, infrequent exacerbators were 3 times (OR = 2.8, P < 0.001) significantly more likely to have 2 or more exacerbations per year in follow-up, and frequent exacerbators were 7 times (OR = 6.76, P < 0.001) significantly more likely to have 2 or more exacerbations per year in follow-up. CONCLUSIONS: Infrequent exacerbators have an increased risk for future exacerbations compared with nonexacerbators and, on a total sample-level, incur greater costs compared with frequent exacerbators, demonstrating a significant economic burden. © 2015, Academy of Managed Care Pharmacy.

Smyth E.N.,Eli Lilly and Company | Bapat B.,Research Triangle ParkNC | Ball D.E.,Eli Lilly and Company | Andre T.,University Pierre and Marie Curie | Kaye J.A.,RTI Health Solutions
Clinical Therapeutics | Year: 2015

Purpose In Europe, pancreatic cancer (PC) accounts for approximately 2.6% of all new cancer cases and is the fourth leading cause of cancer-related death. Despite substantial morbidity and mortality, limited data are available describing real-world treatment patterns and health care resource use in any European country. We evaluated PC-related treatment patterns and associated health care resource use among patients with metastatic PC in the United Kingdom and France. Methods One hundred three oncology specialists (53 in France and 50 in the United Kingdom) abstracted data from medical records of 400 patients whom they treated for metastatic PC. Eligible patients had a diagnosis of metastatic PC at age 18 years or older between January 1, 2009, and December 31, 2012; had ≥3 months of follow-up time beginning at metastatic diagnosis; and received at least 1 cancer-directed therapy for metastatic disease. Information on patient demographics, Eastern Cooperative Oncology Group performance status, location of primary tumor, presence of comorbidities, adverse events, and complications were collected. Data on cancer-directed treatments and supportive care measures were evaluated. All analyses were descriptive. Findings Approximately two thirds of patients were men, and median age at metastatic disease diagnosis was 62.2 years. Nearly all patients (97.3%) received chemotherapy to treat metastatic disease, 9.3% received radiation therapy, and 7.8% received a targeted therapy. Overall, the most frequently administered first-line regimens for metastatic disease were gemcitabine alone (46.0%), a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX; 20.1%); gemcitabine/capecitabine (10.8%); and gemcitabine/oxaliplatin (9.5%). Approximately 40% of patients in France and 15% of patients in the United Kingdom received second-line systemic therapy, whereas 20% of patients in France and 3.4% of patients in the United Kingdom received third-line systemic therapy for metastatic disease. Overall, 52.5% of patients experienced at least one complication of PC. More than two thirds of patients had ≥1 office visit unrelated to chemotherapy administration, 54.0% had ≥1 inpatient hospitalization, 36.8% had ≥1 emergency department visit, and 25.3% had ≥1 pain management clinic visit. A total of 26.5% of patients in France and 42.5% in the United Kingdom entered hospice or long-term care. Implications This study provides new, detailed information for patients with metastatic PC in real-world settings in 2 European countries. A small proportion of patients received >1 line of systemic therapy for metastatic disease, which is likely due to the aggressiveness of this disease and the lack of effective therapeutic options. © 2015 The Authors.

Mukerjee S.,U.S. Environmental Protection Agency | Smith L.,Alion Science and Technology Corporation | Brantley H.,U.S. Environmental Protection Agency | Brantley H.,Research Triangle ParkNC | And 4 more authors.
Atmospheric Pollution Research | Year: 2015

Modeled traffic data were used to develop traffic exposure zones (TEZs) such as traffic delay, high volume, and transit routes in the Research Triangle area of North Carolina (USA). On–road air pollution measurements of nitrogen dioxide (NO2), carbon monoxide (CO), carbon dioxide (CO2), black carbon (BC), coarse (PM2.5–10), fine (PM2.5) particulate matter and ultrafine particles (UFPs) were made on routes that encountered these TEZs. Results indicated overall greater traffic pollutant levels in high volume and delay road sections than bus routes or areas of higher signal light density. The combination of delineating roadways into TEZs with highly time resolved on–road measurements demonstrated how pollutant levels can vary within roadways. © Author(s) 2015.

Krueger W.S.,Oak Ridge Institute for Science and Education | Krueger W.S.,Research Triangle ParkNC | Hilborn E.D.,U.S. Environmental Protection Agency | Dufour A.P.,U.S. Environmental Protection Agency | And 2 more authors.
Zoonoses and Public Health | Year: 2016

To understand the etiological burden of disease associated with acute health symptoms [e.g. gastrointestinal (GI), respiratory, dermatological], it is important to understand how common exposures influence these symptoms. Exposures to familiar and unfamiliar animals can result in a variety of health symptoms related to infection, irritation and allergy; however, few studies have examined this association in a large-scale cohort setting. Cross-sectional data collected from 50 507 participants in the United States enrolled from 2003 to 2009 were used to examine associations between animal contact and acute health symptoms during a 10-12 day period. Fixed-effects multivariable logistic regression estimated adjusted odds ratios (AORs) and 95% confident intervals (CI) for associations between animal exposures and outcomes of GI illness, respiratory illness and skin/eye symptoms. Two-thirds of the study population (63.2%) reported direct contact with animals, of which 7.7% had contact with at least one unfamiliar animal. Participants exposed to unfamiliar animals had significantly higher odds of self-reporting all three acute health symptoms, when compared to non-animal-exposed participants (GI: AOR = 1.4, CI = 1.2-1.7; respiratory: AOR = 1.5, CI = 1.2-1.8; and skin/eye: AOR = 1.9, CI = 1.6-2.3), as well as when compared to participants who only had contact with familiar animals. Specific contact with dogs, cats or pet birds was also significantly associated with at least one acute health symptom; AORs ranged from 1.1 to 1.5, when compared to participants not exposed to each animal. These results indicate that contact with animals, especially unfamiliar animals, was significantly associated with GI, respiratory and skin/eye symptoms. Such associations could be attributable to zoonotic infections and allergic reactions. Etiological models for acute health symptoms should consider contact with companion animals, particularly exposure to unfamiliar animals. Prevention of pet-associated zoonotic diseases includes commonsense measures such as hand-washing, but are often overlooked by pet owners and non-pet owners alike. © 2016 Blackwell Verlag GmbH.

Boklage S.H.,Otsuka America Pharmaceutical Inc. | Mangel A.W.,Research Triangle ParkNC | Ramamohan V.,Research Triangle ParkNC | Mladsi D.,Research Triangle ParkNC | Wang T.,Otsuka America Pharmaceutical Inc.
Patient Preference and Adherence | Year: 2016

Background: The treatment failure rate for Helicobacter pylori eradication therapy is ~20% due to poor patient compliance and increased antibiotic resistance. This analysis assessed the cost-effectiveness of universal post-treatment testing to confirm eradication of H. pylori infection in adults. Methods: Decision-analytic models evaluated the cost-effectiveness of universal post-treatment testing (urea breath test [UBT] or monoclonal fecal antigen test [mFAT]) vs no testing (Model 1), and UBT vs mFAT after adjusting for patient adherence to testing (Model 2) in adults who previously received first-line antimicrobial therapy. Patients testing positive received second-line quadruple therapy; no further action was taken for those testing negative or with no testing (Model 1) or for those nonadherent to testing (Model 2). In addition to testing costs, excess lifetime costs and reduced quality-adjusted life-years (QALYs) due to continuing H. pylori infection were considered in the model. Results: Expected total costs per patient were higher for post-treatment testing (UBT: US$325.76; mFAT: US$242.12) vs no testing (US$182.41) in Model 1 and for UBT (US$336.75) vs mFAT (US$326.24) in Model 2. Expected QALYs gained per patient were 0.71 and 0.72 for UBT and mFAT, respectively, vs no testing (Model 1), and the same was 0.37 for UBT vs mFAT (Model 2). The estimated incremental costs per QALY gained for post-treatment testing vs no testing were US$82.90–US$202.45 and, after adjusting for adherence, US$28.13 for UBT vs mFAT. Conclusion: Universal post-treatment testing was found to be cost-effective for confirming eradication of H. pylori infection following first-line therapy. Better adherence to UBT relative to mFAT was the key to its cost-effectiveness. © 2016 Boklage et al.

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