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Wilson M.R.,Research Triangle ParkNC | Patel J.G.,Research Triangle ParkNC | Patel J.G.,Amgen Inc. | Coleman A.,Research Triangle ParkNC | And 3 more authors.
International Journal of COPD | Year: 2017

Background: Bronchodilators such as long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) are central to the pharmacological management of COPD. Dual bronchodilation with umeclidinium/vilanterol (UMEC/VI; 62.5/25 µg) is a novel LAMA/ LABA combination approved for maintenance treatment for patients with COPD. Objective: The objective of this study was to assess the cost-effectiveness of maintenance treatment with UMEC/VI compared with tiotropium (TIO) 18 µg, open dual LAMA + LABA treatment, or no long-acting bronchodilator treatment in patients with moderate to very severe COPD. Methods: A Markov model was developed to estimate the costs and outcomes associated with UMEC/VI treatment in patients with moderate to very severe COPD (GSK study number: HO-13-13411). Clinical efficacy, costs, utilities, and mortality obtained from the published literature were used as the model inputs. Costs are presented in US dollars based on 2015 prices. The model outputs are total costs, drug costs, other medical costs, number of COPD exacerbations, and quality-adjusted life-years (QALYs). Costs and outcomes were discounted at a 3% annual rate. Incremental cost-effectiveness ratios were calculated. One-way and probabilistic sensitivity analyses were conducted to assess the effects of changing parameters on the uncertainty of the results. Results: UMEC/VI treatment for moderate to very severe COPD was associated with lower lifetime medical costs ($82,344) compared with TIO ($88,822), open dual LAMA + LABA treatment ($114,442), and no long-acting bronchodilator ($86,751). Fewer exacerbations were predicted to occur with UMEC/VI treatment compared with no long-acting bronchodilator treatment. UMEC/VI provided an 0.11 and 0.25 increase in QALYs compared with TIO and no long-acting bronchodilator treatment, and as such, dominated these cost-effectiveness analyses. Sensitivity analyses confirmed that the results were robust. Conclusion: The results from this model suggest that UMEC/VI treatment would be dominant compared with TIO and no long-acting bronchodilator treatment, and less costly than open dual LAMA + LABA treatment in patients with moderate to very severe COPD. © 2017 Wilson et al.

Xie Y.,Research Triangle ParkNC | Holmgren S.,U.S. National Institutes of Health | Andrews D.M.K.,Research Triangle ParkNC | Wolfe M.S.,Research Triangle ParkNC
Environmental Health Perspectives | Year: 2017

Background: Evaluating the impact of federally funded research with a broad, methodical, and objective approach is important to ensure that public funds advance the mission of federal agencies. Objectives: We aimed to develop a methodical approach that would yield a broad assessment of National Toxicology Program’s (NTP’s) effectiveness across multiple sectors and demonstrate the utility of the approach through a case study. Methods: A conceptual model was developed with defined activities, outputs (products), and outcomes (proximal, intermediate, distal) and applied retrospectively to NTP’s research on hexavalent chromium (CrVI). Proximal outcomes were measured by counting views of and requests for NTP’s products by external stakeholders. Intermediate outcomes were measured by bibliometric analysis. Distal outcomes were assessed through Web and LexisNexis searches for documents related to legislation or regulation changes. Results: The approach identified awareness of NTP’s work on CrVI by external stakeholders (proximal outcome) and citations of NTP’s research in scientific publications, reports, congressional testimonies, and legal and policy documents (intermediate outcome). NTP’s research was key to the nation’s first-ever drinking water standard for CrVI adopted by California in 2014 (distal outcome). By applying this approach to a case study, the utility and limitations of the approach were identified, including challenges to evaluating the outcomes of a research program. Conclusions: This study identified a broad and objective approach for assessing NTP’s effectiveness, including methodological needs for more thorough and efficient impact assessments in the future. © 2017, Public Health Services, US Dept of Health and Human Services. All rights reserved.

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.

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