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Ogale S.,Genentech | Hitraya E.,Genentech | Henk H.J.,Health Economics and Outcomes Research
BMC Musculoskeletal Disorders

Background: The role of biologic therapies in the treatment of rheumatoid arthritis has expanded, but dosing patterns in the first versus subsequent lines of therapy have not been thoroughly explored. Methods. In order to describe patterns of biologic agent utilization among patients with rheumatoid arthritis, health care claims data on use of abatacept, rituximab, or the anti-tumor necrosis factor (TNF) agents etanercept, adalimumab, and infliximab in first- or subsequent-line settings were used to form patient cohorts. Variables included: starting dose (first administration or fill), maintenance dose (third administration or fill), average dose, dose escalation, inter-infusion interval, and discontinuation (gap in therapy > 60 days or switch). Time to discontinuation was assessed with Kaplan-Meier curves and Cox proportional hazards models. Results: Over 1 year, average (SD) doses of first-line etanercept (N = 1593; 45.4 [8.8] mg/week), adalimumab (N = 1040; 40.7 [10.4] mg/2 weeks), and abatacept (N = 360; 715.4 [214.5] mg/4 weeks) were similar to the starting and maintenance doses; the average infliximab dose (N = 538; 441.0 [209.2] mg/8 weeks) was greater than the starting and maintenance doses. Trends in the subsequent-line anti-TNF cohorts were similar. The percentages with a dose escalation or discontinuation were greater in the subsequent-line anti-TNF cohorts. The proportion with a dose escalation was greatest for the infliximab cohorts (61.2% first-line and 80.2% subsequent-line). The average period between abatacept infusions was 4.8 [1.4] weeks (4-week approved schedule); and 6.8 [2.6] months between rituximab courses (currently approved schedule is 6 months). Time to discontinuation was significantly shorter for subsequent-line than first-line anti-TNF therapy (median 9.7 vs. 12.5 mo; p < 0.001). The hazard ratio for discontinuing subsequent-line versus first-line anti-TNF therapy was 1.177 (p < 0.001). Conclusions: Subsequent-line anti-TNF therapy cohorts had higher rates of discontinuation, dose escalation, and shorter time to discontinuation than first-line anti-TNF cohorts. © 2011Ogale et al; licensee BioMed Central Ltd. Source

Tack J.,University Hospital | Stanghellini V.,University of Bologna | Dubois D.,Free University of Colombia | Joseph A.,Health Economics and Outcomes Research | And 2 more authors.
Neurogastroenterology and Motility

Background: Prucalopride is a 5-HT4 receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three 12-week, double-blind trials evaluated the effect of prucalopride 2 mg q.d. on common constipation symptoms in women in whom laxatives had failed to provide adequate relief. The effect of prucalopride on bowel function was outside the scope of the analysis and has been described elsewhere. Methods: Women with self-reported inadequate relief from laxatives and included in the prucalopride 2 mg or placebo arm of the trials were selected for analysis. Symptom severity was determined with the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Observed changes from baseline in individual item scores were also evaluated by calculating Cohen's D effect sizes using baseline standard deviation (SD) (>0.2-0.5, >0.5-0.8 and >0.8 for small, moderate and large effects, respectively). Key Results: Data were analyzed for 936 women. The proportion of women with a PAC-SYM severity score >2 at baseline was 50.0% for abdominal symptoms, 71.4% for stool symptoms, and 15.5% for rectal symptoms. Excluding the women without presence of a symptom at baseline from the effect size calculations showed that prucalopride 2 mg had a large effect (>0.8) on all PAC-SYM items, including abdominal pain, abdominal discomfort, bloating, straining, and painful bowel movements. For abdominal symptoms and stool symptoms, effect sizes with prucalopride 2 mg were 1.3-2.3 times larger than those with placebo. Conclusions & Inferences: Prucalopride 2 mg q.d. for 12 weeks alleviates common constipation symptoms in women in whom laxatives had failed to provide adequate relief. © 2013 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.. Source

Henk H.,Health Economics and Outcomes Research | Teitelbaum A.,OptumInsight | Kaura S.,Novartis
Current Medical Research and Opinion

Background: Skeletal complications of malignant bone disease are common among patients with both solid tumors and multiple myeloma (MM). Zoledronic acid (ZOL; Zometa*) is an intravenous bisphosphonate with proven efficacy in reducing the incidence of skeletal complications and delaying the time to a first skeletal complication. This study was designed to assess the continued benefit of ZOL treatment over a prolonged period. Methods: This was a retrospective claims analysis study using information gathered from two national US managed-care plan databases. Patients ≥18 years of age with a single type of solid tumor or MM who were diagnosed with bone lesions and experienced at least one skeletal complication (before or after receiving ZOL) were included. Results: Of the 28,385 patients, those with lung and breast cancer composed the largest group. Greater percentages of MM and breast cancer patients were treated with ZOL. On average, those with renal cell carcinoma and lung cancer had a longer time between bone metastasis diagnosis and start of therapy with ZOL. Compared with an untreated cohort, patients treated with ZOL had a 24 reduction in incidence of fracture, a 45 reduction in incidence of spinal cord compression, and a 56 reduction in risk of mortality. Patients with persistence with ZOL over 180 days had a reduced incidence of fracture before controlling for other factors. Conclusions: Patients treated with ZOL had reduced risks of fracture, spinal cord compression, and mortality compared with patients in the no-treatment cohort. Longer persistence with ZOL was associated with better outcomes. Greatest benefits were observed for patients treated on a regular basis with ZOL for a period beyond 18 months. © 2012 Informa UK Ltd. Source

Gilligan A.M.,Health Economics and Outcomes Research | Skrepnek G.H.,The University of Oklahoma Health Sciences Center
Health Policy and Planning

Background Although the Eastern Mediterranean Region (EMR) healthcare sector has been expanding rapidly, many differences exist across socioeconomic status, clinical practice standards and healthcare systems. Objective Predict production functions of health by measuring socioeconomic and expenditure factors that impact life expectancy in the EMR. Methods Data from the World Health Organization (WHO) Global Health Observatory and the World Bank were used for this cross-sectional, time-series study spanning 21 nations in the EMR from 1995 to 2010. The primary outcome was life expectancy at birth. Covariates of interest included sociodemographic and health indicators. To both establish and validate appropriate categorization of countries, a cluster analysis was undertaken to group cases by taking selected characteristics into account. A variance-component, multilevel mixed-effects linear model was employed that incorporated a finite, Almon, distributed lag of 5 years and bootstrapping with 5000 simulations to model the production function of life expectancy. Results Results of the cluster analysis found four groupings. Clusters 1 and 2, composed of six total countries, generally represented non-industrialized/least developed countries. Clusters 3 and 4, totalling 15 nations, captured more industrialized nations. Overall, gross domestic product (GDP) (P=0.011), vaccination averages (P=0.026) and urbanization (P=0.026), were significant positive predictors of life expectancy. No significant predictors existed for Cluster 1 countries. Among Cluster 2 nations, physician density (P=0.014) and vaccination averages (P=0.044) were significant positive predictors. GDP (P=0.037) and literacy (P=0.014) were positive significant predictors among Cluster 3 nations. GDP (P=0.002), health expenditures (P=0.002) and vaccination averages (P=0.014) were positive significant predictors in Cluster 4 countries. Conclusion Predictors of life expectancy differed between non-industrialized and industrialized nations, with the exception of vaccination averages. Non-industrialized/least developed nations were associated with adjusted life expectancies of >14% lower than their industrialized peers. Continued work to address differences in the quality of and access to care in the EMR is required. © 2014 The Author; all rights reserved. Source

Finkelstein E.A.,National University of Singapore | DiBonaventura M.D.,Health Economics and Outcomes Research | Burgess S.M.,Allergan, Inc. | Hale B.C.,Allergan, Inc.
Journal of Occupational and Environmental Medicine

Objective: To quantify per capita and aggregate medical expenditures and the value of lost productivity, including absenteeism and presenteeism, because of overweight, and grade I, II, and III obesity among U.S. employees. Methods: Cross-sectional analysis of the 2006 Medical Expenditure Panel Survey and the 2008 National Health and Wellness Survey. Results: Among men, estimates range from-$322 for overweight to $6087 for grade III obese men. For women, estimates range from $797 for overweight to $6694 for grade III. In aggregate, the annual cost attributable to obesity among full-time employees is $73.1 billion. Individuals with a body mass index >35 represent 37% of the obese population but are responsible for 61% of excess costs. Conclusions: Successful efforts to reduce the prevalence of obesity, especially among those with a body mass index >35, could result in significant savings to employers. Copyright © 2010 by American College of Occupational and Environmental Medicine. Source

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