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      A longitudinal, retrospective cohort study on the impact of roflumilast on exacerbations and economic burden among chronic obstructive pulmonary disease patients in the real world

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          Abstract

          Background

          Roflumilast is approved in the United States to reduce the risk of COPD exacerbations in patients with severe COPD. Exacerbation rates, health care resource utilization (HCRU), and costs were compared between roflumilast patients and those receiving other COPD maintenance drugs.

          Methods

          LifeLink™ Health Plan Claims Database was used to identify patients diagnosed with COPD who initiated roflumilast (roflumilast group) or ≥3 other COPD maintenance drugs (non-roflumilast group) from May 1, 2011 to December 31, 2012. Patients must have been enrolled for 12 months before (baseline) and 3 months after (postindex) the initiation date, ≥40 years old, not systemic corticosteroid dependent, and without asthma diagnosis at baseline. Difference-in-difference models compared change from baseline in exacerbations, HCRU (office, emergency visits, and hospitalizations), and total costs between groups, adjusting for baseline differences.

          Results

          A total of 14,211 patients (roflumilast, n=710; non-roflumilast, n=13,501) were included. During follow-up, the rate of overall exacerbations per patient per month decreased by 11.1% in the roflumilast group and increased by 15.9% in the non-roflumilast group ( P<0.001). After controlling for baseline differences, roflumilast-treated patients experienced a greater reduction in exacerbations (0.0160 fewer exacerbations per month, P=0.01), numerically greater reductions in hospital admissions (0.003 fewer per month, P=0.57), office visits (0.46 fewer per month, P=0.26), and total costs from baseline compared with non-roflumilast patients ($116 less per month, P=0.62).

          Conclusion

          In a real-world setting, patients initiating roflumilast experienced reductions in exacerbations versus patients treated with other COPD medications.

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          Most cited references 13

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          Deaths: preliminary data for 2011.

          This report presents preliminary U.S. data on deaths, death rates, life expectancy, leading causes of death, and infant mortality for 2011 by selected characteristics such as age, sex, race, and Hispanic origin. Data in this report are based on death records comprising more than 98 percent of the demographic and medical files for all deaths in the United States in 2011. The records are weighted to independent control counts for 2011. Comparisons are made with 2010 final data. The age-adjusted death rate decreased from 747.0 deaths per 100,000 population in 2010 to 740.6 deaths per 100,000 population in 2011. From 2010 to 2011, age-adjusted death rates decreased significantly for 5 of the 15 leading causes of death: Diseases of heart, Malignant neoplasms, Cerebrovascular diseases, Alzheimer's disease, and Nephritis, nephrotic syndrome and nephrosis. The age-adjusted death rate increased for six leading causes of death: Chronic lower respiratory diseases, Diabetes mellitus, Influenza and pneumonia, Chronic liver disease and cirrhosis, Parkinson's disease, and Pneumonitis due to solids and liquids. Life expectancy remained the same in 2011 as it had been in 2010 at 78.7 years.
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            Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease.

            The oral phosphodiesterase-4 (PDE4) inhibitor, roflumilast, can improve lung function in moderate chronic obstructive pulmonary disease (COPD). Whether treatment is effective in more severe COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] stages III and IV) over a longer period is unknown. To determine whether roflumilast improves lung function and decreases exacerbation frequency over 1 year in patients with stable COPD. We conducted a randomized, placebo-controlled, double-blind, parallel-group trial for 1 year. We recruited 1,513 patients (mean post-bronchodilator FEV1 41% predicted), 760 receiving oral 500 microg roflumilast and 753 receiving placebo once daily. We recorded post-bronchodilator FEV1, exacerbation rate, St. George's Respiratory Questionnaire total score at the study end point, and number and type of reported adverse events during treatment. Post-bronchodilator FEV1 increased by 39 ml with roflumilast compared with placebo by 52 weeks (p=0.001). The mean exacerbation rate was low and comparable in both treatment groups (0.86 vs. 0.92 exacerbations/patient/yr for roflumilast and placebo, respectively). In a retrospective analysis, the exacerbation rate in patients in GOLD stage IV disease was 36% lower in patients treated with roflumilast than in those treated with placebo (1.01 vs. 1.59 exacerbations/patient/year, respectively; p=0.024). The St. George's Respiratory Questionnaire total score did not differ between treatments. The commonest adverse events related to roflumilast treatment were diarrhea, nausea, and headache, which usually subsided during continued treatment. However, roflumilast resulted in more withdrawals within the first 3 to 4 weeks of administration. In severe, stable COPD, PDE4 inhibition with roflumilast produced a modest but significant improvement in lung function without changing the exacerbation rate or health status. However, patients with very severe disease experienced fewer exacerbations with roflumilast.
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              Impact of exacerbations on health care cost and resource utilization in chronic obstructive pulmonary disease patients with chronic bronchitis from a predominantly Medicare population

              Background Exacerbations of chronic obstructive pulmonary disease (COPD) lead to significant increases in resource utilization and cost to the health care system. COPD patients with chronic bronchitis and a history of exacerbations pose an additional burden to the system. This study examined health care utilization and cost among these patients. Methods For this retrospective analysis, data were extracted from a large national health plan with a predominantly Medicare population. This study involved patients who were aged 40–89 years, had been enrolled continuously for 24 months or more, had at least two separate insurance claims for COPD with chronic bronchitis (International Classification of Diseases, Ninth Revision, Clinical Modification code 491.xx), and had pharmacy claims for COPD maintenance medications between January 1, 2007, and March 31, 2009. Two years of data were examined for each patient; the index date was defined as the first occurrence of COPD. Baseline characteristics were obtained from the first year of data, with health outcomes tracked in the second year. Severe exacerbation was defined by COPD-related hospitalization or death; moderate exacerbation was defined by oral or parenteral corticosteroid use. Adjusted numbers of exacerbations and COPD-related costs per patient were estimated controlling for demographic and clinical characteristics. Results The final study sample involved 8554 patients; mean age was 70.1 ± 8.6 years and 49.8% of the overall population had exacerbation, 13.9% had a severe exacerbation only, 29.1% had a moderate exacerbation only, and 6.8% had both a severe and moderate exacerbation. COPD-related mean annual costs were $4069 (all figures given in US dollars) for the overall population and $6381 for patients with two or more exacerbations. All-cause health care costs were $18,976 for the overall population and $23,901 for patients with history of two or more exacerbations. Severity of exacerbations, presence of cardiovascular disease, diabetes, and long-term oxygen use were associated with higher adjusted costs. Conclusions The results indicate that despite treatment with maintenance medications, COPD patients continue to have exacerbations resulting in higher costs. New medications and disease management interventions are warranted to reduce the severity and frequency of exacerbations and the related cost impact of the disease.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2015
                07 October 2015
                : 10
                : 2127-2136
                Affiliations
                [1 ]Health Economics and Modeling, Outcomes Research, Pharmerit International, Bethesda, MD, USA
                [2 ]Health Economics and Outcomes Research, Forest Laboratories, LLC, an affiliate of Actavis, Inc., Jersey City, NJ, USA
                [3 ]Pulmonary Critical Care, Washington Hospital Center and Georgetown University, Washington, DC, USA
                Author notes
                Correspondence: Xin Gao, Health Economics and Modeling, Outcomes Research, Pharmerit International, 4350 East West Highway, Suite 430, Bethesda, MD 20814, USA, Tel +1 240 821 1266, Fax +1 240 821 1296, Email cgao@ 123456pharmerit.com
                Article
                copd-10-2127
                10.2147/COPD.S80106
                4603715
                © 2015 Wan et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                health care resource utilization, pde-4 inhibitor, outcomes, copd

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