Diagnosis and Treatment of Osteoporosis Before and After Fracture: A Side-by-Side Analysis of Commercially Insured and Medicare Advantage Osteoporosis Patients.

BACKGROUND: Although treatment for osteoporosis is recommended by U.S. clinical guidelines, a lack of diagnosis and treatment is common among patients with osteoporotic fractures. OBJECTIVE: To determine the rates of osteoporosis diagnosis and treatment before and after various types of fractures. METHODS: This was a retrospective claims analysis using data from the Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (Commercial group). Patients included in the study had a claim for a qualifying fracture occurring between January 2008 and December 2013 (the index fracture), were continuously enrolled in the health plan for ≥ 1 year before and after the index fracture, and were aged ≥ 65 years in the Medicare group or ≥ 50 years in the Commercial group at the time of the index fracture. Fragility fractures and osteoporosis diagnoses were identified from ICD-9-CM codes. Treatment for osteoporosis included oral and injectable therapies identified by National Drug Code numbers and Healthcare Common Procedure Coding System codes. Diagnosis and treatment rates were assessed during the 1-year periods before and after the index fracture. All analyses were conducted by fracture type (vertebral, hip, nonhip/nonvertebral [NHNV], and multiple), with stratification by age and sex. No comparisons were made between the Medicare and Commercial groups; rather, McNemar tests were used to compare prefracture versus postfracture diagnosis and treatment rates within each group. RESULTS: For inclusion in the Medicare group, 45,603 patients were identified, and 54,145 patients were identified for the Commercial group. In the prefracture period, the osteoporosis diagnosis rates ranged from 12.0% (NHNV) to 21.5% (vertebral) in the Medicare group and from 5.3% (NHNV) to 12.1% (vertebral) in the Commercial group. In the postfracture period, diagnosis rates significantly increased (P < 0.001)-and nearly doubled-for all fracture types but did not exceed 42.1% (vertebral) in the Medicare group and 27.7% (vertebral) in the Commercial group. Pre-index treatment rates were similarly low, ranging from 9.4% (hip) to 16.6% (vertebral) among Medicare patients, and 7.5% (NHNV) to 14.4% (vertebral) in Commercial patients. Osteoporosis treatment rates improved significantly in the postfracture year, ranging from 12.5% (NHNV) to 26.5% (vertebral) among Medicare patients, and 8.3% (NHNV) to 21.4% (vertebral) in Commercial patients. Larger increases in diagnosis rates and smaller increases in treatment rates were observed in stratified analyses of men and women and of different age groups, with women and older patients having higher overall rates of diagnosis and treatment before and after fracture. CONCLUSIONS: In men and women, osteoporosis diagnosis rates were low before the index fracture and improved substantially after the fracture, yet still remained low overall (under 50%). Osteoporosis treatment rates among patients experiencing a fracture were low before the index fracture and improved only minimally afterwards. DISCLOSURES: This study was funded by Merck & Co. Other than through the employer relationship disclosed here, Merck & Co. did not have a role in the study design, data collection, interpretation of the data, in writing of the manuscript, or in the decision to submit the manuscript for publication. Weaver is an employee of Merck & Co. Sajjan was an employee of Merck & Co. and owned stock in the company at the time of the study. Lewiecki has received consulting and/or speaker honoraria from Merck & Co., AbbVie, AgNovos Healthcare, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Radius Health, Shire, and TheraNova, along with research grant support from Merck & Co., Amgen, and Eli Lilly and Company, and serves as a board member for the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico. Harris has received consulting honoraria from Merck & Co., Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Gilead Sciences, Primus Pharmaceuticals, and Radius Health. Study concept and design were contributed by Weaver and Sajjan. Sajjan collected the data, and data interpretation was performed by all the authors. The manuscript was written and revised by Weaver, Lewiecki, and Harris.

Prevalence and Cost of Subsequent Fractures Among U.S. Patients with an Incident Fracture.

BACKGROUND: The prevalence and cost of subsequent fractures among patients with an incident fracture are not well defined. OBJECTIVE: To assess the prevalence of, and costs associated with, subsequent fractures in the year after an incident fracture. METHODS: This was a retrospective claims database analysis using data from Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (commercial group). Patients included in the study had a claim for a qualifying fracture occurring between January 2008 and December 2013 (index fracture), were continuously enrolled in the health plan for ≥ 1 year before and after the index fracture, and were aged ≥ 65 years in the Medicare group or ≥ 50 years in the commercial group at the time of the index fracture. Subsequent fractures were identified by ICD-9-CM codes and were defined as the second fracture occurring ≥ 3 to ≤ 12 months after the index fracture (≥ 6 to ≤ 12 months for fractures at the same site as the index fracture). Rates of subsequent fractures were calculated as the number of patients who had a subsequent fracture divided by the total sample size. After propensity matching of demographic and clinical variables, we determined the total medical and pharmacy costs accrued within 1 year of the index fracture by patients with and without a subsequent fracture. Health care costs were compared between patients with and without a subsequent fracture using McNemar's test. RESULTS: A total of 45,603 patients were included in the Medicare group, and 54,145 patients were included in the commercial group. In the Medicare group, 7,604 (16.7%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture was highest among patients with multiple index fractures (26.2%, n = 905), followed by those with hip (25.5%, n = 1,280) and vertebral (20.2%, n = 1,908) index fractures. In the commercial group, 6,256 (11.6%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture paralleled those observed in the Medicare group: 24.5% (n = 808) in patients with multiple index fractures, 22.0% (n = 525) in those with hip fracture, and 14.5% (n = 841) in those with vertebral fracture. For vertebral, hip, and nonhip nonvertebral fractures, subsequent fractures were most frequently of the same type as the index fracture. The mean total health care cost (sum of medical and pharmacy costs) in the year following the incident fracture for the Medicare group was $27,844 and differed significantly between patients with and without a subsequent fracture ($34,897 vs. $20,790; P < 0.001). The mean total health care cost in the year following the incident fracture for the commercial group was $29,316 and also differed significantly between patients with and without a subsequent fracture ($39,501 vs. $19,131; P < 0.001). CONCLUSIONS: Among patients with an incident fracture, those who experienced a subsequent fracture in the following year had significantly higher health care costs than those who did not. A subsequent fracture is most likely to be of the same type as the initial fracture. DISCLOSURES: This study was funded by Merck & Co. Other than through the employer relationships disclosed here, Merck & Co did not have a role in the study design, data collection, interpretation of the data, in writing of the manuscript, or in the decision to submit the manuscript for publication. Weaver and Marvos are employees of Merck & Co. Sajjan was an employee of Merck & Co. and owned stock in the company at the time of the study. Lewiecki has received consulting and/or speaker honoraria from Merck, AbbVie, AgNovos Healthcare, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Radius Health, Shire, and TheraNova. Lewiecki has received research grant support from Merck, Amgen, and Eli Lilly and Company and serves as a board member for the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico. Harris has received consulting honoraria from Merck, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Gilead Sciences, Primus Pharmaceuticals, and Radius Health. Study concept and design were contributed by Weave and Sajjan. Lewiecki collected the data, and data interpretation was performed by all the authors. The manuscript was written and revised by Weaver, Lewiecki, and Harris.

Quality of Life and Economic Burden of Respiratory Disease in Asia-Pacific-Asia-Pacific Burden of Respiratory Diseases Study.

OBJECTIVES: Asia-Pacific Burden of Respiratory Diseases is a cross-sectional, observational study examining the burden of disease in adults with respiratory diseases across six countries. The aim of this study was to describe health care resource use (HCRU), work impairment, cost burden, and health-related quality of life (HRQOL) associated with respiratory disease in the Asia-Pacific. METHODS: Consecutive participants aged 18 years or older with a primary diagnosis of asthma, allergic rhinitis, chronic obstructive pulmonary disease, or rhinosinusitis were enrolled. Participants completed a survey detailing respiratory symptoms, HCRU, work productivity and activity impairment, and HRQOL. Locally sourced unit costs for each country were used in the calculation of total costs. RESULTS: The study enrolled 5250 patients. Overall, the mean annual cost for patients with a respiratory disease was US $4191 (SGD 8489) per patient. For patients who reported impairment at work, the mean annual cost was US $7315 (SGD 10,244), with productivity loss being the highest cost component for all four diseases (US $6310 [SGD 9100]). On average, patients were impaired for one-third of their time at work and 5% of their work time missed because of respiratory disease, which resulted in a 36% reduction in productivity. Patients with a primary diagnosis of chronic obstructive pulmonary disease had the greatest impact on HRQOL. CONCLUSIONS: In the Asia-Pacific, respiratory diseases have a significant impact on HCRU and associated costs, along with work productivity. Timely and effective management of these diseases has the potential to reduce disease burden and health care costs and improve work productivity and HRQOL.

The burden of segregated respiratory diseases in India and the quality of care in these patients: Results from the Asia-Pacific Burden of Respiratory Diseases study.

BACKGROUND: Chronic respiratory diseases such as asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), and rhinosinusitis are becoming increasingly prevalent in the Asia-Pacific region. The Asia-Pacific Burden of Respiratory Diseases study examined the disease and economic burden of AR, asthma, COPD, and rhinosinusitis across the Asia-Pacific and more specifically India. OBJECTIVES: To estimate the proportion of adults receiving care for asthma, AR, COPD, and rhinosinusitis and assess the economic burden, both direct and indirect of these chronic respiratory disease. SUBJECTS AND METHODS: Consecutive participants aged ≥18 years with a primary diagnosis of asthma, AR, COPD, or rhinosinusitis were enrolled. Surveys comprising questions about respiratory disease symptoms, healthcare resource utilization, work productivity, and activity impairment were completed by treating physicians and participants during one study visit. Costs, indirect and direct, that contributed to treatment for each of the four respiratory diseases were calculated. RESULTS: A total of 1000 patients were enrolled. Asthma was the most frequent primary diagnosis followed by AR, COPD, and rhinosinusitis. A total of 335 (33.5%) patients were diagnosed with combinations of the four respiratory diseases; the most frequently diagnosed combinations were asthma/AR and rhinosinusitis/AR. Cough or coughing up sputum was the primary reason for the current visit by patients diagnosed with asthma and COPD while AR patients reported a watery, runny nose, and sneezing; patients with rhinosinusitis primarily reported a colored nasal discharge. The mean annual cost per patient was US$637 (SD 806). The most significant driver of direct costs was medications. The biggest cost component was productivity loss. CONCLUSIONS: Given the ongoing rapid urbanization of India, the frequency of respiratory diseases and their economic burden will continue to rise. Efforts are required to better understand the impact and devise strategies to appropriately allocate resources.

Burden of Respiratory Disease in Korea: An Observational Study on Allergic Rhinitis, Asthma, COPD, and Rhinosinusitis.

PURPOSE: The Asia-Pacific Burden of Respiratory Diseases (APBORD) study is a cross-sectional, observational one which has used a standard protocol to examine the disease and economic burden of allergic rhinitis (AR), asthma, chronic obstructive pulmonary disorder (COPD), and rhinosinusitis across the Asia-Pacific region. Here, we report on symptoms, healthcare resource use, work impairment, and associated costs in Korea. METHODS: Consecutive participants aged ≥18 years with a primary diagnosis of asthma, AR, COPD, or rhinosinusitis were enrolled. Participants and their treating physician completed a survey detailing respiratory symptoms, healthcare resource use, and work productivity and activity impairment. Costs included direct medical cost and indirect cost associated with lost work productivity. RESULTS: The study enrolled 999 patients. Patients were often diagnosed with multiple respiratory disorders (42.8%), with asthma/AR and AR/rhinosinusitis the most frequently diagnosed combinations. Cough or coughing up phlegm was the primary reason for the medical visit in patients with a primary diagnosis of asthma and COPD, whereas nasal symptoms (watery runny nose, blocked nose, and congestion) were the main reasons in those with AR and rhinosinusitis. The mean annual cost for patients with a respiratory disease was US$8,853 (SD 11,245) per patient. Lost productivity due to presenteeism was the biggest contributor to costs. CONCLUSIONS: Respiratory disease has a significant impact on disease burden in Korea. Treatment strategies for preventing lost work productivity could greatly reduce the economic burden of respiratory disease.

Burden of respiratory disease in Thailand: Results from the APBORD observational study.

Asia-Pacific Burden of Respiratory Diseases (APBORD) was a cross-sectional, observational study examining the burden of respiratory disease in adults across 6 Asia-Pacific countries.This article reports symptoms, healthcare resource utilization (HCRU), work impairment and cost burden associated with allergic rhinitis (AR), asthma, chronic obstructive pulmonary disease (COPD), and rhinosinusitis in Thailand.Consecutive participants aged ≥18 years with a primary diagnosis of AR, asthma, COPD, or rhinosinusitis were enrolled at 4 hospitals in Thailand during October 2012 and October 2013. Participants completed a survey detailing respiratory symptoms, HCRU, work productivity, and activity impairment. Locally sourced unit costs were used in the calculation of total costs.The study enrolled 1000 patients. The most frequent primary diagnosis was AR (44.2%), followed by rhinosinusitis (24.1%), asthma (23.7%), and COPD (8.0%). Overall, 316 (31.6%) of patients were diagnosed with some combination of the 4 diseases. Blocked nose or congestion (17%) and cough or coughing up phlegm (16%) were the main reasons for the current medical visit. The mean annual cost for patients with a respiratory disease was US$1495 (SD 3133) per patient. Costs associated with work productivity loss were the principal contributor for AR and rhinosinusitis patients while medication costs were the highest contributor for asthma and COPD patients.The study findings highlight the burden associated with 4 prevalent respiratory diseases in Thailand. Thorough investigation of concomitant conditions and improved disease management may help to reduce the burden of these respiratory diseases.

Respiratory diseases and the impact of cough in Taiwan: Results from the APBORD observational study.

Chronic respiratory diseases such as asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), and rhinosinusitis are becoming increasingly prevalent in the Asia-Pacific region. The Asia-Pacific Burden of Respiratory Diseases (APBORD) study was a cross-sectional, observational study which examined the disease and economic burden of AR, asthma, COPD, and rhinosinusitis across Asia-Pacific using 1 standard protocol. Here we report symptoms, healthcare resource use (HCRU), work impairment, and associated cost in Taiwan.Consecutive participants aged ≥ 18 years presenting to a physician with symptoms meeting the diagnostic criteria for a primary diagnosis of asthma, AR, COPD, or rhinosinusitis were enrolled. Participants and their treating physician completed surveys detailing respiratory symptoms, HCRU, work productivity, and activity impairment. Costs including direct medical costs and indirect costs associated with lost work productivity were calculated.The study enrolled 1001 patients. AR was the most frequent primary diagnosis (31.2%). A quarter of patients presented with a combination of respiratory diseases, with AR and asthma being the most frequent combination (14.1%). Cough or coughing up phlegm was the primary reason for the medical visit for patients with asthma and COPD, whereas nasal symptoms (watery runny nose, blocked nose, and congestion) were the primary reasons for AR and rhinosinusitis. Specialists were the most frequently used healthcare resource by patients with AR (26.1%), asthma (26.4%), COPD (26.6%), and rhinosinusitis (47.3%). The mean annual cost per patient with a respiratory disease was US$4511 (SD 5395). The cost was almost double for employed patients (US$8047, SD 6175), with the majority attributable to lost productivity.Respiratory diseases have a significant impact on disease burden in Taiwan. Treatment strategies that prevent lost work productivity could greatly reduce the economic burden of these diseases.

High rate of non-treatment among osteoporotic women enrolled in a US Medicare plan.

OBJECTIVE: To estimate the rate of non-treatment among elderly women with osteoporosis (OP) and to examine the association between patient characteristics and receiving treatment. RESEARCH DESIGN AND METHODS: This cross-sectional, retrospective, observational study utilized patient information and claims from the Humana database to identify Medicare covered women aged ≥65 years old and continuously enrolled with evidence of either an OP diagnosis or an OP-related fracture during 2007-2011. The main outcome was receipt of pharmacological treatment of OP during 2012 (follow-up). The percentage of non-treatment was calculated and a stepwise selection logistic regression model was employed to estimate the association between baseline demographic and clinical characteristics and receiving treatment. RESULTS: A total of 109,829 patients were included. Mean age was 75.7 years and 79.4% were identified with OP through OP diagnosis codes and did not have evidence of a prior fracture. Approximately one-third (32%) of patients had used OP medications during the baseline period, and 39% had experienced at least one gastro-intestinal event during baseline. Among all patients, 71.4% did not receive OP therapy during follow-up. The strongest factor associated with receiving treatment was prior use of OP therapy (odds ratio [OR] = 31.3; p < .001). Among the subgroup of patients with baseline fractures, 75.9% did not receive OP therapy during follow-up and the strongest factor associated with receiving treatment remained prior use of OP therapy (OR = 20.4; p < .001). Those with high comorbidity burden were less likely to receive treatment in both the overall cohort and within the subgroup with baseline fractures. CONCLUSIONS: Among Medicare-eligible women aged ≥65 identified with OP between 2007 and 2011, 71.4% did not receive OP treatment during 2012, including 75.9% of the subgroup of patients with a prior fracture. The use of diagnosis and procedures codes to identify patients with osteoporosis is subject to variation in coding.

Proportion and Characteristics of Patients in Sweden Remaining at High Risk of Fracture Despite Prior Treatment.

PURPOSE: Fragility fractures are a clinical consequence of osteoporosis (OP). Evidence suggests however, current OP treatments may be inadequate in reducing fracture risk. The purpose of this study was to estimate the proportion and characteristics of Swedish patients who remain at high risk of fracture after 2 years of treatment, as evidenced by osteoporotic bone mineral density (BMD), a decrease in BMD, or the occurrence of new fractures. METHODS: This was a retrospective, descriptive analysis of a subset of participants obtained from a Swedish osteoporosis patient registry from 1991 to 2009. Patients were required to be osteoporotic, to be treatment naive at baseline, to have returned for at least 1 follow-up visit, and to have reported osteoporosis treatment use for ≥2 years after the baseline visit with a BMD T score. Two overlapping cohorts remaining at high risk of fracture were defined using the BMD T score measured after 2 years of treatment from baseline. The osteoporosis cohort comprised patients who remained osteoporotic, whereas the BMD decrease cohort included patients whose total hip or lumbar spine T score decreased by ≥3%. FINDINGS: A total of 3292 osteoporotic patients were identified in the registry, of whom 392 met the study inclusion criteria. The mean (SD) patient age was 68.3 (8.5) years, with most patients being female (92.3%). Among all patients, 297 (75.8%) remained osteoporotic after at least 2 years of treatment, 90 (23.0%) experienced a BMD decrease of ≥3%, and 23 (5.9%) reported an incident fracture between the baseline and first follow-up visit. More than three-quarters (76.8%) of all patients reported taking bisphosphonates, whereas only 72.4% and 47.8% reported this in the osteoporosis and BMD decrease cohorts, respectively. Raloxifene was the only nonbisphosphonate used, with 24.2% of all patients reportedly taking it. IMPLICATIONS: This study highlighted that despite 2 years of osteoporosis treatment, a high percentage of patients remain at high risk of fracture. There is a need for improved treatment strategies that reduce fracture risk and improve patient outcomes in the real-world setting.

Association between gastrointestinal events and osteoporosis treatment initiation in women diagnosed with osteoporosis in France: a retrospective analysis.

BACKGROUND: A substantial portion of women diagnosed with osteoporosis (OP) do not initiate pharmacotherapy to reduce fracture risk. In clinical practice, gastrointestinal (GI) events have been linked with OP therapy discontinuation. However, there is limited research examining GI events as barrier to treatment initiation following an OP diagnosis. The objective of this study was to examine the association between gastrointestinal (GI) events and osteoporosis (OP) treatment initiation among post-menopausal women diagnosed with osteoporosis in France. METHODS: A retrospective claims analysis of the Mediplus France database during 1997 to 2010 identified women aged ≥ 55 with an OP diagnosis and without prior OP treatment (first diagnosis date was defined as the index date). GI events were identified during the 1 year pre-index and up to 1 year post-index. OP treatment initiation post-index was identified based on the presence of claims for any bisphosphonate (BIS) or non-BIS OP medication within 1 year post-index. Multivariate models (logistic regression, Cox proportional hazards regression and discrete choice) adjusted for pre-index patient characteristics were used to assess the association of pre- and post-index GI events with the likelihood of initiating OP treatment, and the type of treatment initiated (BIS vs. non-BIS). RESULTS: A total of 10,292 women (mean age 70.3 years) were identified; only 25% initiated OP treatment. Post-index GI events occurred in 11.5% of patients, and were associated with a 75.7% lower likelihood of initiating OP treatment. Among treated patients, a discrete choice model estimated that patients with post-index GI events were 34.6% less likely to receive BIS vs non-BIS as compared to patients without post-index GI events. CONCLUSION: Among women aged ≥ 55 years with an OP diagnosis, post-index GI events were associated with a lower likelihood of OP treatment initiation.

Relationship Between Gastrointestinal Events and Compliance With Osteoporosis Therapy: An Administrative Claims Analysis of the US Managed Care Population.

PURPOSE: A large proportion of women with osteoporosis do not comply with current osteoporosis therapies, resulting in diminished therapeutic effect. Noncompliance may be due to the occurrence of gastrointestinal (GI) events during the course of therapy. The objective of this study was to estimate the rate of GI events among women taking oral bisphosphonates and to determine the association between GI events and compliance with bisphosphonate therapy. METHODS: This was a retrospective analysis of data from a US Medicare claims database (HUMANA). The study period was from January 2007 to June 2013. The index date was the date of the first oral bisphosphonate prescription (alendronate, ibandronate, or risedronate) occurring between January 2008 and June 2012. The pre- and postindex periods were the 1-year periods before and after the index date, respectively. The analysis included women 65 years of age and older who were naïve to all osteoporosis treatments before the index date. GI events included nausea/vomiting; dysphagia; esophagitis; esophageal reflux; esophageal, gastric, duodenal, and peptic ulcer; stricture, perforation, or hemorrhage of the esophagus; acute gastritis; and GI hemorrhage. GI events were assessed during the preindex period and at 3, 6, and 12 months in the postindex period. Compliance was defined as a medication possession ratio of ≥80%. The medication possession ratio was calculated as the total days׳ supply of bisphosphonate in the postindex period divided by 365 days. The association of postindex GI events with compliance was assessed using multivariate logistic regression. FINDINGS: The analysis included 37,886 women initiating oral bisphosphonate therapy. In the preindex year, 37.5% of the women experienced a GI event, and in the postindex year, 38.9% had a GI event. Patients with preindex GI events had numerically higher rates of postindex GI events than patients without preindex GI events (61.8% vs 25.1% at 12 months postindex). Patients who experienced postindex GI events were less likely to be compliant with bisphosphonate therapy, with odds of compliance of 0.76 (95% CI, 0.72-0.80) after 12 months. IMPLICATIONS: Among US women who were prescribed oral bisphosphonates, on-treatment GI events were associated with decreased compliance at 1 year.

Respiratory disease in the Asia-Pacific region: Cough as a key symptom.

BACKGROUND: Respiratory diseases represent a significant impact on health care. A cross-sectional, multicountry (India, Korea, Malaysia, Singapore, Taiwan, and Thailand) observational study was conducted to investigate the proportion of adult patients who received care for a primary diagnosis of asthma, allergic rhinitis (AR), chronic obstructive pulmonary disease (COPD), or rhinosinusitis. OBJECTIVE: To determine the proportion of patients who received care for asthma, AR, COPD, and rhinosinusitis, and the frequency and main symptoms reported. METHODS: Patients ages ≥18 years, who presented to a physician with symptoms that met the diagnostic criteria for a primary diagnosis of asthma, AR, COPD, or rhinosinusitis were enrolled. Patients and physicians completed a survey that contained questions related to demographics and respiratory symptoms. RESULTS: A total of 13,902 patients with a respiratory disorder were screened, of whom 7030 were eligible and 5250 enrolled. The highest percentage of patients who received care had a primary diagnosis of AR (14.0% [95% confidence interval {CI}, 13.4-14.6%]), followed by asthma (13.5% [95% CI, 12.9-14.1%]), rhinosinusitis (5.4% [95% CI, 4.6-5.3%]), and COPD (4.9% [95% CI, 5.0-5.7%]). Patients with a primary diagnosis of COPD (73%), followed by asthma (61%), rhinosinusitis (59%), and AR (47%) most frequently reported cough as a symptom. Cough was the main reason for seeking medical care among patients with a primary diagnosis of COPD (43%), asthma (33%), rhinosinusitis (13%), and AR (11%). CONCLUSION: Asthma, AR, COPD, and rhinosinusitis represent a significant proportion of respiratory disorders in patients who presented to health care professionals in the Asia-Pacific region, many with concomitant disease. Cough was a prominent symptom and the major reason for patients with respiratory diseases to seek medical care.

Treatment persistence among patients with immune-mediated rheumatic disease newly treated with subcutaneous TNF-alpha inhibitors and costs associated with non-persistence.

The main objective of this study was to describe real-world treatment persistence with subcutaneous tumor necrosis factor-alpha inhibitors (SC-TNFi) in patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis [collectively immune-mediated rheumatic disease, (IMRD)] in Sweden. A secondary objective was to describe potential effects on health care resource utilization (HCRU) cost from non-persistence. Patients were identified through filled prescriptions for adalimumab (ADA), etanercept (ETA), certolizumab pegol (CZP), and golimumab (GLM) between 5/6/2010 and 12/31/2012 from the Swedish Prescribed Drug Register. Persistence was estimated using survival analysis. Costs were derived from HCRU and comprised specialized outpatient care, inpatient care and non-disease-modifying antirheumatic drug medications. A total of 4903 patients were identified (ADA: 1823, ETA: 1704, CZP: 622, GLM: 754). Comparisons over 3 years showed that GLM had significantly higher persistence than ADA (p = 0.022) and ETA (p = 0.004). The mean difference in non-biologic HCRU costs between persistent and non-persistent patients was higher after compared to before the start of biologic therapy. SC-TNFi-naïve IMRD patients initiating treatment with GLM had significantly higher persistence rates than patients initiating treatment with ADA or ETA in Sweden. Furthermore, persistence rates observed in the study were lower than those observed in clinical trials, highlighting the need for an all-party (provider-patient-payer-drug manufacturer) engagement and development of programs to increase persistence rates in clinical practice, thus leading to improved clinical outcomes. In addition, the results of this study indicate that persistence to treatment with SC-TNFi may be associated with cost offsets in terms of non-biologic costs.

Association of gastrointestinal events with osteoporosis treatment initiation and treatment compliance in Germany: An observational study.

BACKGROUND: Gastrointestinal (GI) events are common in postmenopausal women treated for osteoporosis. The influence of GI events on treatment initiation and treatment compliance is the subject of ongoing research. OBJECTIVE: The objectives of this study were (i) to determine the association of GI events with receipt of treatment in patients newly diagnosed with osteoporosis, and (ii) among treated patients, to determine the association of GI events with treatment compliance. METHODS: This was a retrospective analysis of claims data carried out in Germany using the Mediplus database. Data were collected from January 1992 through December 2010. The dual-objective study design required two distinct cohorts. Cohort 1 comprised women aged ≥ 55 with a diagnosis of osteoporosis. GI events were recorded for the 12 month periods before and after the date of diagnosis. Time-varying Cox regression and discrete choice models were used, respectively, to assess the association of post-diagnosis GI events with the initiation of pharmacologic treatment (yes versus no) and the type of treatment initiated (bisphosphonates versus non-bisphosphonates). Cohort 2 comprised women aged ≥ 55 who initiated an oral bisphosphonate (alendronate, ibandronate, or risedronate). GI events were recorded for the 12 month periods before and after the date of bisphosphonate initiation, and a logistic regression model was employed to determine if pre-treatment or post-treatment GI events were associated with patient compliance, defined as a medication possession ratio (MPR) of ≥ 60%, with sensitivity analyses at MPR ≥ 80%. RESULTS: In cohort 1 (N = 18,813), 13.8% of patients had GI events in the pre-diagnosis period, and 14.8% had GI events in the post-diagnosis period. Among the patients with post-diagnosis GI events, 93.2% remained untreated during the post-index year, 6.2% were treated with bisphosphonates, and 0.6% received non-bisphosphonates. The respective percentages in patients without post-diagnosis GI events were 81.3%, 16.7%, and 1.9%. A post-diagnosis GI event decreased the likelihood of receiving any osteoporosis treatment (versus no treatment) by 83% (HR 0.17, 95% CI 0.14-0.20) and also decreased the likelihood of receiving a bisphosphonate (versus a non-bisphosphonate) by 39% (OR 0.61, 95% CI 0.54-0.68). In cohort 2 (N = 6040), 17.1% of patients had GI events in the year before treatment initiation, and 19.1% had GI events in the year after treatment initiation. At 12 months post-treatment initiation, GI events were more frequent in patients with pre-treatment GI events (53.2%) than in those without pre-treatment GI events (12.0%). Post-treatment GI events decreased the likelihood of attaining compliance defined as an MPR ≥ 60% (OR 0.84, 95% CI 0.73-0.97) but not an MPR ≥ 80% (OR 0.91, 95% CI 0.79-1.06). CONCLUSIONS: In German women newly diagnosed with osteoporosis, GI events decreased the likelihood of receiving treatment and were associated with the choice of treatment. In women initiating oral bisphosphonates, post-treatment GI events were associated with reduced patient compliance.

Association between gastrointestinal events and compliance with osteoporosis therapy.

PURPOSE: The aim of this study was to estimate the rate of gastrointestinal (GI) events, and association between GI events and compliance with osteoporosis therapy among osteoporotic women. METHODS: A retrospective cohort study using a large administrative claims database in the United States from 2001 through 2010 was conducted. We studied women ≥ 55 years old who were continuously enrolled in a health plan for at least 2 years, a baseline year before and a follow-up year after the date of the first prescription of oral bisphosphonate as the first oral osteoporosis treatment. Compliance with osteoporosis therapy was measured using the medication possession ratio (MPR), with compliance defined as MPR ≥ 0.8. Multivariate logistic regression was used to assess the association between occurrence of GI events and compliance with osteoporosis therapy after controlling for demographic and clinical characteristics. RESULTS: A sample consisting of 75,593 women taking at least one oral bisphosphonate with mean (SD) age of 64 (8) years was identified. A total of 21,142 (28%) patients experienced at least one GI event during the follow-up period. Only 31,306 (41%) patients were compliant with osteoporosis therapy. Patients who experienced GI events after initiation of oral bisphosphonates were 29% less likely to adhere to osteoporosis therapy as compared to patients who did not experience GI events (odds ratio [95% CI], 0.71 [0.69-0.74]; P < .001). CONCLUSIONS: Less than half of the patients were compliant with osteoporosis therapy within one year after initiating oral bisphosphonates, and the likelihood of compliance was significantly lower by 29% among women with GI events.

Gastrointestinal events and association with initiation of treatment for osteoporosis.

BACKGROUND: Preexisting gastrointestinal (GI) events may deter the use of pharmacologic treatment in patients diagnosed with osteoporosis (OP). The objective of this study was to examine the association between preexisting GI events and OP pharmacotherapy initiation among women diagnosed with OP. METHODS: The study utilized claims data from a large US managed care database to identify women aged ≥55 years with a diagnosis code for OP (index date) during 2002-2009. Patients with a claim for pharmacologic OP treatment in the 12-month pre-index period (baseline) were excluded. OP treatment initiation in the post-index period was defined as a claim for bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), calcitonin, raloxifene, or teriparatide. During the post-index period (up to 12 months), GI events were identified before treatment initiation. A time-dependent Cox regression model was used to investigate the likelihood of initiating any OP treatment. Among patients initiating OP treatment, a discrete choice model was utilized to assess the relationship between post-index GI events and likelihood of initiating with a bisphosphonate versus a non-bisphosphonate. RESULTS: In total, 65,344 patients (mean age 66 years) were included; 23.7% had a GI event post diagnosis and before treatment initiation. Post-index GI events were associated with a 75% lower likelihood of any treatment initiation (hazard ratio 0.25; 95% confidence interval 0.24-0.26). Among treated patients (n=23,311), those with post-index GI events were 39% less likely to receive a bisphosphonate versus a non-bisphosphonate (odds ratio 0.61; 95% confidence interval 0.54-0.68). CONCLUSION: GI events after OP diagnosis were associated with a decreased likelihood of OP treatment initiation and an increased likelihood of treatment initiation with a non-bisphosphonate versus a bisphosphonate.

History of cardiovascular events and cardiovascular risk factors among patients initiating strontium ranelate for treatment of osteoporosis.

PURPOSE: To estimate the proportion of osteoporosis patients in whom initiating strontium ranelate treatment, under new EMA guidelines, should be contraindicated because of a history of cardiovascular events or risk for cardiovascular events. MATERIALS AND METHODS: This was a retrospective analysis of medical and pharmacy claims using the Clinical Practice Research Datalink database. Patients were included if they had ≥1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged ≥50 as of the index date (the date of the first ever strontium ranelate prescription), and had ≥1 year of medical records pre-index. Cardiovascular events occurring any time pre-index were identified, which included ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral arterial disease. Cardiovascular risk factors assessed included 1) diabetes or hypertension any time pre-index; 2) hyperlipidemia in the 12 months pre-index; or 3) obesity in the 12 months pre-index. RESULTS: A total of 7,474 patients were included: 90.4% were women, with an average age of 76.5 years, and 84.5% used osteoporosis therapy, either bisphosphonates or non-bisphosphonates, prior to strontium initiation. A total of 23.6% of patients experienced ≥1 cardiovascular event prior to strontium initiation; the rate was lower among female patients than in male patients (22.4% vs 35.3%, P<0.01). A total of 45.9% had risk factors for cardiovascular events (without cardiovascular event history). CONCLUSION: More than one-fifth of osteoporosis patients in the UK who used strontium had a cardiovascular event history, and one-half had cardiovascular risk factors prior to strontium initiation.

Association Between Gastrointestinal Events and Health Care Resource Utilization Among Patients with Osteoporosis: Analysis of a U.S. Managed Care Population.

BACKGROUND: Among patients on osteoporosis therapy, including oral bisphosphonates (BIS), upper gastrointestinal (GI) conditions have been linked with lower adherence to treatment and increased treatment discontinuation in clinical practice. Patients who are nonadherent to treatment have a higher risk of osteoporotic fractures and, consequently, have greater use of health care services. The burden of upper gastrointestinal events on health care resource utilization (HCRU) among women initiating oral BIS has not been well investigated. OBJECTIVE: To examine the association of upper GI events and HCRU in women initiating oral BIS.  METHODS: Using a U.S. national claims database, this retrospective study identified women aged ≥ 55 years who were prescribed oral BIS during 2001-2011 and had no history of GI events 12 months prior to treatment initiation. Patients with medical claims for an upper GI event ≤ 4 months posttreatment initiation were cases; all others were controls. The date of the first upper GI event among cases and a randomly assigned date ≤ 4 months posttreatment initiation among controls was the index date. Cases were matched 1:1 to controls by propensity scores derived from logistic regression of pre-index patient characteristics. Outcomes were all-cause and osteoporosis (OP)-related HCRU in the 6-month post-index period. Differences were assessed using McNemar's test. RESULTS: Of the 62,863 eligible patients, 4,751 (7.6%) experienced an upper GI event ≤ 4 months posttreatment initiation (cases); 4,739 cases were matched with 4,739 controls. Compared with controls, cases had higher rates of all-cause HCRU (outpatient: 99.3% vs. 87.8%; inpatient: 20.2% vs. 6.4%; emergency room [ER]: 12.5% vs. 7.4%; all P less than 0.0001) and OP-related HCRU (outpatient: 24.6% vs. 18.2%; inpatient: 3.4% vs. 1.0%; ER: 0.7% vs. 0.4%; all P less than 0.05). CONCLUSIONS: Patients with upper GI events had higher rates of all-cause and OP-related health care utilization. Upper GI events may pose an incremental HCRU burden among patients initiating BIS.

Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada.

OBJECTIVES: The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS-EU) was designed to better understand the rate and burden of gastrointestinal (GI) events on clinical and health care outcomes among postmenopausal women with osteoporosis. METHODS: MUSIC OS-EU is a prospective, multinational, observational cohort study of postmenopausal women ≥50 years of age diagnosed with osteoporosis and enrolled in physician clinics in six countries: France, Italy, the Netherlands, Sweden, the United Kingdom, and Canada. The MUSIC OS-EU study has three components: (i) a physician survey to describe their management of osteoporotic patients with GI events; (ii) a retrospective chart survey to describe the receipt and type of osteoporosis medication prescribed; and (iii) a prospective cohort study including untreated and treated patients diagnosed with osteoporosis to investigate the rate of GI events and association with osteoporosis medication use patterns, health-related quality of life, treatment satisfaction and resource utilisation among postmenopausal women with osteoporosis. RESULTS: Physicians at 97 sites completed the physician questionnaire and data for 716 patients were abstracted for the retrospective chart review. Enrolment and the baseline data collection for the prospective cohort study were conducted between March 2012 and June 2013 for 292 untreated and 2,959 treated patients, of whom 684 were new users and 2,275 were experienced users of oral osteoporosis medications. CONCLUSIONS: The results of MUSIC OS-EU will illuminate the association of GI events with the management of osteoporosis and with patient-reported outcomes among postmenopausal women with osteoporosis in Europe and Canada.

Prospective Study on the Relationship of Obesity to Asthma Impairment and Risk.

BACKGROUND: Although studies consistently show an association between obesity and increased asthma incidence, the role of obesity in asthma control is less clear. OBJECTIVE: The objective of this study was to evaluate the association between baseline body mass index (BMI) and measures of subsequent asthma control in a large real-world cohort of adults with persistent asthma. METHODS: In Kaiser Permanente Southern California (KPSC), a large managed care organization, we identified adults with persistent asthma in 2006, continuous health plan enrollment in 2007 and 2008, and a BMI measurement in 2006 or 2007. Each patient's last BMI measure in 2006 or 2007 was categorized into a BMI group: normal (<25 kg/m(2)), overweight (25-29.9 kg/m(2)), or obese (≥30 kg/m(2)). Asthma control outcomes in 2008 included asthma hospitalizations or emergency department visits (EDHO), oral corticosteroid dispensings linked to an asthma encounter (OCS), and dispensing of ≥7 short-acting beta-agonist canisters (SABA7). Multivariable analyses were conducted to assess the relationships of BMI categories with the risk of the asthma control outcomes after controlling for potential confounders. RESULTS: In the 10,233 eligible adults-after adjusting for potential demographic, comorbidity, and prior utilization confounders-we found an increased relative risk (RR) of EDHO in overweight and obese (RR 1.40, 95% CI 1.10-1.78) individuals. Only obesity was associated in adjusted analyses with a significant increased relative risk of SABA7 (RR 1.27, 95% CI 1.15-1.40). CONCLUSIONS: Elevated BMI, particularly obesity, is associated with subsequent poor asthma control, especially in the risk domain (exacerbations). These findings further support the importance of facilitating weight loss in overweight and obese adults with asthma.