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.

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.

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.

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.

Patient initiation and persistence with allergen immunotherapy.

BACKGROUND: Allergen immunotherapy (AIT) is advised for patients with allergic rhinitis who remain symptomatic despite the use of pharmacotherapy and allergen avoidance. Several factors influence the decision to initiate and complete the AIT regimen. OBJECTIVE: To evaluate patient initiation and persistence with subcutaneous and sublingual immunotherapies (SCIT and SLIT) according to physician recommendation. METHODS: A retrospective review of electronic health records of patients with allergic rhinitis for whom AIT was recommended was conducted in a large private allergy practice in Pennsylvania. RESULTS: Of 8,790 patients advised to consider AIT, 36.2% initiated AIT (57% adults, 43% children); 78% chose SCIT and 22% chose SLIT drops. Election of AIT was significantly associated with select comorbidities, specifically chronic sinusitis (8.1% for AIT vs 10% for no AIT), allergic conjunctivitis (12.5% for AIT vs 18.5% for no AIT), and asthma (33.8% for AIT vs 37.4% for no AIT; P < .05). Choice of SCIT vs SLIT drops was significantly associated with older age, female sex, select comorbidities, and more allergy medications at initiation (P < .05). Of adults, 30.2% completed at least 3 years of recommended treatment. Median time on treatment was longer for adults on SCIT vs SLIT drops (3 vs 1.6 years). Similarly, 35.4% of children completed treatment, with a longer median time on treatment for SCIT (4.7 years) vs SLIT drops (3.5 years). CONCLUSION: A minority of patients initiated AIT according to allergist recommendation and a subset of these patients completed therapy. AIT might be an underused option that could benefit patients unable to manage allergic rhinitis symptoms by other means. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01549340.

Asthma Severity in patients initiating controller monotherapy versus combination therapy.

BACKGROUND: Asthma treatment guidelines recommend medications based on the level of asthma control. OBJECTIVE: To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. PATIENTS AND METHODS: Children (5-16 years; n = 488) and adults (17-80 years; n = 530) with asthma and no controller therapy in the prior 6 months were included. Telephone surveys were conducted within 5 days of filling a new asthma controller prescription with either the caregiver of children or the adult patient. Demographics, asthma control before therapy, and asthma-related resource use were assessed for patients initiating monotherapy (filling one asthma controller prescription) and combination therapy (filling more than one controller medication or a fixed-dose combination). RESULTS: Mean pediatric age was 10 years; 53% were male. Mean adult age was 47 years; 25% were male. There were no significant differences in asthma control score between patients receiving monotherapy and combination therapy. Children on combination therapy did not have more nighttime awakening or short-acting ß-agonist use but were more likely to have been hospitalized due to asthma attack (p = .05) and have more unscheduled (p = .0374) and scheduled (p = .009) physician visits. Adults on combination therapy were more likely to have been hospitalized due to asthma attack (p < .05) and have regular doctor visits for asthma (p < .01). CONCLUSIONS: Assessment of asthma control scores in the 4 weeks before index medication suggests that asthma severity during a treatment-free period did not differ significantly for patients initiating controller monotherapy versus combination therapy. From these findings, it appears that although physicians may not focus on asthma control when choosing the intensity of initial controller therapy, the intensity of health-care encounters may be an influence.

LDL-C goal attainment among patients newly diagnosed with coronary heart disease or diabetes in a commercial HMO.

BACKGROUND: Patients beginning treatment with lipid-modifying drugs should have their serum lipid levels monitored and, if necessary, their drug therapy adjusted to reach and maintain their treatment goals. Patients with coronary heart disease or diabetes are at high risk of coronary events and are particularly important target groups for monitoring and dose adjustment of lipid-modifying drug therapy. OBJECTIVE: to determine from administrative claims the rates of lipid testing, treatment with low-density lipoprotein cholesterol (LDL-C)-lowering drug therapy, and LDL-C goal attainment defined as LDL-C < 100 mg per DL in the time period after a new diagnosis of coronary heart disease or diabetes among patients who had not previously received lipid-modifying drug therapy. METHODS: an index date was defined by a new diagnosis of coronary heart disease or diabetes between January 1, 1999 and December 31, 2000, preceded by a 12-month pre-index period without lipid-modifying drug treatment in a commercial health maintenance organization (HMO) database for the southeastern united states. coronary heart disease (CHD) was defined by a diagnosis code for myocardial infarction (International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] code 410.xx) or angina/ischemic heart disease (411.xx), or a procedural code for angioplasty (icd-9-cM 36.1x-36.3x; Current Procedural Terminology [CPT] 92980-92984, 92995-92996) or coronary artery bypass graft (icd-9-cM 36.01, 36.02, 36.05, 36.09; CPT 33510-33545). diabetes was identified either by an icd-9-cM diagnosis code 250.xx or a pharmacy claim for an antihyperglycemic medication. Patients were followed in the post-index period until loss of eligibility or a maximum of 42 months (mean = 26 months, range=12-42 months). We calculated the proportion of patients with lipids treated and at LDL-C goal (defined as V < 100 mg per DL) in months 1-6 after the index date. among those not at goal in months 1-6, we estimated the proportion treated to goal in months 7-12 and in month 7 to the end of the post-index period. Logistic regression was used to estimate the odds of goal attainment in months 7-12 and in month 7 to the end of the post-index period among patients who were not at goal in months 1-6. RESULTS: Laboratory lipid values were available for 4,676 (40.4%) of 11,552 patients who had not previously received lipid-modifying drug therapy in months 1-6 after the index date, of whom 72.7% (n = 3,400) had an LDL-C > or =100 mg per DL (63.5% for CHD and 76.7% for diabetes). Of 1,245 patients tested and treated with lipid-modifying therapy in months 1-6, 485 (39.0%) were at LDL-C goal in months 1-6 (48.2% of CHD and 28.8% of diabetes patients), and 760 (61.0%) were not at LDL-C goal (51.8% of those with CHD and 71.2% of those with diabetes). Goal attainment (cumulative) among those treated improved to 50.1% in months 7-12 and 58.4% in month 7 to the end of the post-index period. Patients not attaining goal in months 1-6, and who continued treatment in months 7-12 and month 13 to the end of the post-index period, had a 48.8% (95% confidence interval [CI], 44.0%-53.6%) predicted probability of attaining their goals. The odds of goal attainment in month 7 to the end of post-index period (among those not at goal in months 1-6) were greater for (a) age e 65 years (odds ratio [or] = 2.45, 95% CI, 1.62-3.72), (b) history of hypertension (or = 1.91, 95% CI, 1.20-3.03), (c) greater number of distinct medications (or = 1.07, 95% CI, 1.01-1.14 per additional medication), (d) months of observation post-index (or = 1.04, 95% CI = 1.01-1.08 per additional month), and (e) months supply of lipid-modifying medication (or = 1.04, 95% CI, 1.01-1.07 per additional month), and were lower for LDL-C > or = 130 mg per DL in months 1-6 (or = 0.53, 95% CI, 0.35-0.82) and a history of dyslipidemia (or = 0.54, 95% CI, 0.35-0.83). The odds of LDL-C goal attainment were not affected by diagnosis (CHD vs. diabetes), gender, statin titration (34% of patients), lipid-modifying drug switching (39% of patients), or treatment with a high-potency LDL-C-lowering drug dosage (one of sufficient strength to reduce LDL-C by > 40%). CONCLUSION: of patients receiving lipid testing and lipid drug treatment in the 6 months after an initial diagnosis of CHD or diabetes, 61% were not at the LDL-C goal of < 100 mg per DL. Among those not at LDL-C goal in the first 6 months of treatment, only about half who continued treatment subsequently attained their LDL-C goal, despite statin titration or switching of their lipid-modifying drug therapy.

Factors influencing the acceptance of changes in antiretroviral therapy among HIV-1-infected patients.

Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower.

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.

Impact of recent fracture on health-related quality of life in postmenopausal women.

UNLABELLED: The effect of fractures other than hip and spine on HRQoL in younger and older women has not been extensively studied. In a cohort of 86,128 postmenopausal women, we found the impact of recent osteoporosis-related fractures on HRQoL to be similar between women < 65 compared with those > or = 65 years of age. The impact of spine, hip, or rib fractures was greater than that of wrist fractures in both age groups. INTRODUCTION: Health-related quality of life (HRQoL) after vertebral and hip fractures has been well studied. Less is known about HRQoL after fractures at other sites. We studied the effect of recent clinical fractures on HRQoL, using Short Form-12 (SF-12). MATERIALS AND METHODS: This study included 86,128 postmenopausal participants in the National Osteoporosis Risk Assessment (NORA) who responded to two follow-up surveys during a 2-year interval. At each survey, they completed the SF-12 HRQoL questionnaire and reported new fractures of the hip, spine, wrist, and rib. The effect of recent fracture on HRQoL was assessed by comparing Physical Component Score (PCS) and Mental Component Score (MCS) means for women with and without new fractures at the second survey. Analyses were by fracture type and by age group (50-64 and 65-99) and were adjusted for PCS and MCS at the first survey. RESULTS: New fractures (320 hip, 445 vertebral, 657 rib, 835 wrist) occurring during the interval between the first and second follow-up surveys were reported by 2257 women. The PCS was poorer in both older and younger women who had fractured the hip, spine, or rib (p < or = 0.001). Wrist fractures had an impact on PCS in women < or = 65 years of age (p < 0.001), but not older women (p > 0.10). These differences in PCS by fracture status were similar to those reported for other chronic diseases such as asthma, chronic obstructive pulmonary disease (COPD), and osteoarthritis. MCS was less consistently changed by fracture status, but younger and older women with vertebral fracture (p < 0.004), older women with hip fracture (p < 0.004), and younger women with rib fracture (p < 0.004) had poorer MCS compared with those who did not fracture within their age cohort. CONCLUSIONS: Recent osteoporosis-related fractures have significant impact on HRQoL as measured by SF-12. The impact of recent fracture on HRQoL was similar for older and younger postmenopausal women. Fracture prevention and postfracture interventions that target the subsequent symptoms are needed for postmenopausal women of any age.

Patterns of asthma-related health care resource use in children treated with montelukast or fluticasone.

OBJECTIVE: To examine the impact of controller monotherapy with montelukast or fluticasone on asthma-related health care resource use among children aged 2-14 years old. DESIGN AND METHODS: A retrospective claims-based analysis of asthmatic children, 2-14 years old, receiving a prescription (index) for montelukast or fluticasone between January 1, 1999 and June 30, 2000 was conducted. Children were matched by age and propensity score to obtain comparable treatment groups. The propensity score was derived using patient demographics, pre-existing respiratory conditions, and asthma-related pharmacy and health service utilization (i.e. ambulatory visits, emergency department visits and hospitalizations). Claims for asthma-related emergent care and medication use were examined for the 12-month periods before and after the index prescription. Treatment group comparisons of asthma-related resource use were conducted for the total pediatric population and separately for children 2-5 years and 6-14 years. Persistent controller medication use was assessed at 6 and 12 months post-index. RESULTS: A total of 2034 children were matched (1017 in each treatment group). Post-index rates of asthma-related resource use were similar among children treated with montelukast or fluticasone. Among children 2-5 years old, fewer emergency department visits were observed with montelukast versus fluticasone (relative risk = 0.52, 95% confidence interval [CI]: 0.28-0.96); no significant difference was observed among children 6-14 years old. No significant differences between montelukast and fluticasone cohorts in hospitalizations or rescue medication fills were noted in either age group. Evidence of at least one medication refill was significantly greater with montelukast at both 6 and 12 months post-index. CONCLUSIONS: Similar levels of resource use were achieved by children 2-14 years initiating montelukast or fluticasone, as indicated by use of asthma-related emergent care and rescue/acute medications. Subgroup analyses suggest a differential effect of age on the relationship between treatment and asthma-related resource use, with children 2-5 years observed to have less resource use while on montelukast.

Trends in lipid management among patients with diabetes.

OBJECTIVE: To examine trends in lipid management (cholesterol testing, treatment, and goal attainment) among patients with diabetes and to analyze the factors associated with initiation of lipid-lowering therapy. METHODS: We conducted a longitudinal, retrospective study of patients with diabetes identified during a 24-month baseline period (January 1, 1995, to December 31, 1996) and for whom follow-up was continued for 5 years (1997 to 2001). Generalized estimating equations were used to test for time trend effects in lipid management. We modeled the days from baseline to the first lipid-lowering prescription fill date with a multivariate Cox proportional hazards regression model. RESULTS: Rates of lipid testing, treatment, and goal attainment significantly improved (P<0.001) during the 5-year study period: from 37% to 67% for lipid testing; from 19% to 41% for treatment with a lipid-lowering agent; from 22% to 37% for achievement of low-density lipoprotein cholesterol (LDL-C) levels < 100 mg/dL; and from 54% to 75% for achievement of LDL-C levels < 130 mg/dL. The relative likelihood (hazard rate) of treatment with lipid-lowering agents was greater for patients with LDL-C levels > or = 100 mg/dL relative to patients with LDL-C concentrations < 100 mg/dL. Treatment with lipid-lowering agents of patients with a cardiovascular event during follow-up was approximately 3 times more likely relative to those without such an event. CONCLUSION: We found that rates of lipid testing, treatment, and goal attainment improved significantly between 1997 and 2001. Nevertheless, ample room for improvement of these rates continues to exist. Particular attention may be warranted to ensure that patients with diabetes receive lipid-lowering agents not only after a cardiovascular event but also before such an event occurs.

Administrative claims analysis of asthma-related health care utilization for patients who received inhaled corticosteroids with either montelukast or salmeterol as combination therapy.

OBJECTIVE: To compare asthma-related health care resource utilization among a matched cohort of asthma patients using inhaled corticosteroids (ICSs) plus either montelukast (MON) or salmeterol (SAL) as combination therapy for asthma, during a time prior to the availability of fixed-dose combinations of ICS/SAL. METHODS: A retrospective analysis using the PHARMetrics patient-centric claims database was conducted for the period preceding the market introduction of combination fluticasone-SAL in September 2000. Patients had to meet the following criteria for inclusion in the study: they had to be between the ages of 4 and 55 years; they had to have been continuously enrolled for 2 years; they had to have initiated ICS/MON or ICS/SAL therapy between July 1, 1998, and June 30, 1999; and they had to have had either (a) a diagnosis of asthma (based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes of 493.xx) for 2 outpatient visits, 1 or more emergency department (ED) visits, or 1 or more hospitalizations within 1 year or (b) pharmacy claim records that contained a National Drug Code for an antiasthma medication (betaagonist, theophylline, ICS, cromolyn, or leukotriene) 2 or more times within 1 year. ICS/MON and ICS/SAL patients were matched 1 to 1 on age and propensity score. Outcomes included asthma-related hopitalizations and ED visits with ICD-9-CM codes of 493.xx, and oral corticosteroid (OCS) fills and short-acting beta-agonist (SABA) fills. Multivariate regression analyses were performed. Subgroup analyses based on sequential or concurrent initiation of combination therapy were also conducted. RESULTS: A total of 1,216 patients were matched (ICS/MON = 608; ICS/SAL= 608). Decreased odds of ED visits and/or hospitalizations were observed with ICS/MON (adjusted odds ratio [OR] = 0.58; 95% confidence interval [CI], 0.35- 0.98) versus ICS/SAL. The odds of postindex OCS fills were not different for ICS/MON and ICS/SAL patients (adjusted OR = 1.04; 95% CI, 0.79-1.38). Postindex pharmacy claims for SABAs were significantly higher among ICS/MON patients versus ICS/SAL patients (adjusted relative risk [RR] = 1.33; 95% CI, 1.17-1.52), and this difference remained regardless of prior use or no prior use of ICSs. In subgroup analyses, mean change in SABA fills varied by how combination therapy was initiated, with sequential addition of asthma controllers leading to a reduction in SABA fills in both groups. For patients with concurrent initiation of combination therapy, the odds of ED visits/hospitalizations were significantly lower in patients initiating ICS/MON (adjusted OR = 0.25; 95% CI, 0.08-0.79). CONCLUSION: In this matched cohort, use of ICS/MON compared with ICS/SAL resulted in similar odds of OCS fills, decreased odds of ED visits and asthmarelated hospitalizations, but higher utilization of SABA.

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.

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.

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.

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.

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.