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Background : Mastocytosis is a risk factor for hymenoptera venom anaphylaxis (HVA). Current guidelines recommend measuring tryptase in HVA patients and that those with mastocytosis pursue lifelong venom immunotherapy (VIT). Available data on HVA and mastocytosis largely derives from European single-center studies and the prevalence of HVA with and without mastocytosis in the United States (US) is unknown. Objective : We sought to determine the prevalence of HVA and mastocytosis in the US using an insurance claims database and evaluate the impact of mastocytosis on VIT in HVA patients in a US cohort. Methods :The IBM Watson Database, consisting of insurance claims from approximately 27 million US patients in 2018, was queried to identify patients with HVA and/or mastocytosis. Further, a retrospective study of 161 patients undergoing VIT between 2015 – 2018 at the University of Michigan (U-M) was conducted. Results :In the IBM Watson Database, the prevalence of HVA was 167 per 100,000 (0.167%) and the prevalence of mastocytosis 10 per 100,000 (0.010%) overall and 97 per 100,000 (0.097%) among those with HVA. Mastocytosis showed a 9.7-fold increase among HVA patients versus the general population. In the U-M cohort, 2.6% of VIT patients had mastocytosis. Tryptase level did not correlate with venom reaction severity but was higher in patients with systemic VIT reactions. Conclusions :We observed a lower US HVA prevalence than previously reported. Mastocytosis was more common in US HVA patients, though at lower rates than previously reported. In VIT patients there was no correlation between tryptase level and reaction severity. Key words :Tryptasevenom allergyvenom immunotherapyanaphylaxismastocytosismast cell activation syndromemast cell disease Abbreviations Hymenoptera venom allergyHVAUnited StatesUSVenom immunotherapyVITMast Cell DiseaseMCDAmerican Academy of Allergy, Asthma, and Immunology WOS:000717466600002 2-s2.0-85106369702 PMID: 33895259 Science Citation Index Expanded Q1 Article Uluslararası işbirliği ile yapılan - EVET Kasım 2021 YÖK - 2021-22

Studies have shown that patients with non-valvular atrial fibrillation (NVAF) who discontinue oral anticoagulants (OACs) are at higher risk of complications such as stroke. This analysis compared the risk of non-persistence with OACs among patients with NVAF. Adult patients with NVAF who initiated apixaban, dabigatran, rivaroxaban, or warfarin were identified using 01JAN2013–30JUN2019 data from Centers for Medicare and Medicaid Services and four US commercial claims databases. Non-persistence was defined as discontinuation (no evidence of index OAC use for ≥ 60 days from the last days’ supply) or switch to another OAC. Kaplan–Meier curves were generated to illustrate time to non-persistence along with cumulative incidences of non-persistence. Baseline and time-varying covariates were evaluated, and adjusted Cox proportional hazards models were used to evaluate non-persistence risk. In total, 363,823 patients receiving apixaban, 57,121 receiving dabigatran, 282,831 receiving rivaroxaban, and 317,337 receiving warfarin were included. Of these, 47–72% discontinued/switched OAC therapy within an average 9-month follow-up. Apixaban was associated with a lower risk of non-persistence than were dabigatran (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.61–0.62), rivaroxaban (HR 0.76; 95% CI 0.75–0.76), and warfarin (HR 0.74; 95% CI 0.74–0.75). Dabigatran was associated with a higher risk of non-persistence than were warfarin (HR 1.21; 95% CI 1.19–1.22) and rivaroxaban (HR 1.23; 95% CI 1.22–1.25), and rivaroxaban was associated with a lower risk of non-persistence than was warfarin (HR 0.98; 95% CI 0.97–0.98). Clinical events (stroke/systemic embolism and major bleeding [MB]) during follow-up were predictors of non-persistence (stroke HR 1.57; 95% CI 1.53–1.61; MB HR 2.96; 95% CI 2.92–3.00). In over one million patients with NVAF, our results suggest differences in anticoagulation treatment persistence across OAC agents, even after accounting for clinical events after OAC initiation. It is important for clinicians and patients to take these differences into consideration, especially as non-persistence to OAC therapy is associated with thromboembolic complications.

Background Patients with cancer are more likely to develop nonvalvular atrial fibrillation (NVAF). Currently there are no definitive clinical trials or treatment guidelines for NVAF patients with concurrent cancer. Objectives This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (stroke/SE) and major bleeding (MB) among NVAF patients with active cancer who were prescribed non–vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods A retrospective observational study was conducted in NVAF patients with active cancer who newly initiated apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, through September 30, 2015, with the use of Medicare and 4 U.S. commercial claims databases. Cox models were used to estimate the risk of stroke/SE and MB in the pooled propensity score–matched cohorts. Results A total of 40,271 patients were included, with main cancer types of prostate (29%), female breast (17%), genitourinary (14%), and lung (13%). Compared with warfarin, apixaban was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.45-0.78) and MB (HR: 0.58; 95% CI: 0.50-0.68); dabigatran and rivaroxaban had similar risks of stroke/SE (dabigatran: HR: 0.88 [95% CI: 0.54-1.41]; rivaroxaban: HR: 0.82 [95% CI: 0.62-1.08]) and MB (dabigatran: HR: 0.76 [95% CI: 0.57-1.01]; rivaroxaban: HR: 0.95 [95% CI: 0.85-1.06]). Risks of stroke/SE and MB varied among NOAC-NOAC comparisons, while consistent treatment effects were seen for all treatment comparisons across key cancer types. Conclusions Among this cohort of NVAF patients with active cancer, the risk of stroke/SE and MB varied among oral anticoagulants and were consistent across cancer types., Central Illustration

Introduction Non-valvular atrial fibrillation (NVAF) is often accompanied by multiple comorbid conditions, which increase the associated risks and complexity of patient management. This study evaluated the risk of stroke/systemic embolism (SE) and major bleeding (MB) among multimorbid patients with NVAF who were prescribed non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods A retrospective study of patients with NVAF and high multimorbidity who initiated apixaban, dabigatran, rivaroxaban, or warfarin from 1 January 2013 to 30 September 2015 was conducted using five insurance claims databases. Multimorbidity was defined as six or more comorbid conditions, and 1:1 propensity score matching (PSM) was conducted between the NOAC-warfarin and NOAC-NOAC cohorts. Cox proportional hazard models were used to evaluate the hazard ratios of stroke/SE and MB. Results Of the NVAF population (n = 466,991), 33.4% (n = 155,959) had multimorbidity, including 36,921 apixaban, 10,248 dabigatran, 45,509 rivaroxaban, and 63,281 warfarin patients. Compared to warfarin, apixaban and rivaroxaban were associated with a lower risk of stroke/SE (hazard ratio [HR] 0.63, 95% CI 0.54–0.74; HR 0.70, 95% CI 0.64–0.77, respectively). Apixaban and dabigatran were associated with a lower risk of MB (HR 0.61, 95% CI 0.56–0.67; HR 0.75, 95% CI 0.66–0.86, respectively) and rivaroxaban was associated with a higher risk of MB (HR 1.06, 95% CI 1.01–1.12) compared to warfarin. Conclusions Among patients with NVAF and six or more comorbid conditions, NOACs were associated with varying risk of stroke/SE and MB compared to warfarin and to each other. Rather than a “one drug fits all” approach, our results may be useful for appropriate OAC treatment for multimorbid patients. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01724-8.

Introduction The purpose of this study was to identify predictors of initial hospitalization and describe the outcomes of high-risk patients hospitalized with influenza. Methods Data were taken from the 5% national US Medicare database from 2012 to 2015. Patients (aged at least 13 years) were required to have at least one diagnosis for influenza and have continuous health plan enrollment for 6 months before (baseline) and 3 months (follow-up) after the date of influenza diagnosis. Patients who died during follow-up were included. Patients were categorized as initially hospitalized if hospitalized within 0–1 day of diagnosis. High-risk initially hospitalized patients were defined as patients aged at least 65 years or those that had a diagnostic code for chronic lung disease, cardiovascular or cerebrovascular disease, or weakened immune system during baseline period. Logistic regression models were developed to determine predictors of initial hospitalization. Results The study population included 8127 high-risk patients who were initially hospitalized and 16,784 who were not hospitalized. Among high-risk patients, 89.3% were diagnosed in the emergency room, whereas 7.5% and 3.2% were diagnosed in a physician’s office or other Medicare settings, respectively. Chronic obstructive pulmonary disorder, congestive heart failure, chronic kidney disease, older age, being male, other comorbidities, number of comorbidities, and baseline healthcare resource use were the predictors of hospitalization. Median length of stay for the hospitalization was 5.0 days, and the 30-day readmission rate was 14%. All-cause mortality rate was 5.1% during the inpatient stay and 9.2% within 30 days of diagnosis. Hospitalized patients with influenza incurred an increase of $16,568 per patient in total all-cause healthcare costs from pre-influenza to post-influenza diagnosis. Conclusion The study characterized the burden of hospitalization for influenza and found that hospitalized high-risk patients experience greater comorbidity burden, higher likelihood of multiple inpatient admissions, and costly medical interventions compared to patients who were not hospitalized. Electronic supplementary material The online version of this article (10.1007/s40121-020-00354-x) contains supplementary material, which is available to authorized users.

**Background:** The study investigated the economic burden of vaso-occlusive crisis (VOC) among sickle cell disease (SCD) patients, through assessment of overall utilization and costs and costs per VOC episode (regarding the number of VOC episodes and health care setting, respectively). **Methods:** Using the Medicaid Analytic Extracts database, the first SCD-related diagnosis claim (index claim) between June 1, 2009–December 31, 2012 was identified among eligible adults. Patients were required to have continuous medical and pharmacy benefits for 6 months pre- and 12 months post-index. Discrete VOC claims identified within a 3-day gap were combined as a single VOC episode. Annual all-cause and SCD-related medical resources and costs were identified and stratified by number of VOC episodes during the 1-year follow-up period. Health care costs per VOC episode were also examined, stratified by care setting. **Results:** Enrollees included 8521 eligible patients with a mean age of 32.88 years (SD=12.21). Of these, 66.5% had a Charlson Comorbidity index (CCI) score of 0 (no comorbidities) and 67.3% were female. The average total medical costs were US$34 136 (median=US$12 691) annually, and SCD accounted for 60% of the total costs (mean=US$20 206, median=US$1204). Patients with >3 episodes had the highest annual SCD-related costs (mean=US$58 950) across all settings. Health care resource utilization (HCRU) and costs increased substantially as the number of VOC episodes increased. This study was limited to observation of associations rather than causal inference, and by possible coding and identification discrepancies and the restricted generalizability of the population. **Conclusions:** VOC has a severe impact on medical resource use and costs among the adult SCD population. Further research among broader study populations is needed to facilitate the reduction of VOC episodes and thereby improve clinical and economic outcomes for SCD patients.

To compare the clinical and economic burden of treatment-resistant depression (TRD) among older adult patients with major depressive disorder (MDD) to non-TRD MDD and non-MDD patients.Retrospective cohort study using 5% Medicare data (January 1, 2012-December 31, 2015) for MDD patients aged ≥65 years who were defined as TRD if they received ≥2 antidepressant treatments in the current episode. MDD patients not meeting TRD criteria were deemed non-TRD MDD; those without an MDD diagnosis were categorized as non-MDD. All were required to have continuous health plan enrollment for ≥6 months pre- and ≥12 months postindex date (index: first antidepressant claim/random [non-MDD]). Three cohorts were matched, and generalized linear and Cox proportional hazards models were used to compare medication use, healthcare resource utilization, costs, and risks of initial hospitalization and readmission ≤30 days postdischarge from initial hospitalization.After matching, 178 patients from each cohort were analyzed. During 12 months of follow-up, TRD patients had higher use of different antidepressants and antipsychotics, higher inpatient and emergency room visits, longer inpatient stays, and higher total healthcare costs ($24,543 versus $16,059, $8,058) than non-TRD MDD and non-MDD cohorts, respectively (all p0.05). Risk of initial hospitalization was higher in the TRD (hazard ratio [HR] = 3.60, 95% confidence interval [CI] = 2.08-6.23) and non-TRD MDD cohorts (HR = 1.82, 95% CI = 1.02-3.25) than the non-MDD cohort.The burden of MDD among older adult Medicare beneficiaries is substantial, and even greater among those with TRD compared to non-TRD MDD, demonstrating the need for more effective treatments than those currently available.

Aims: Non-valvular atrial fibrillation (NVAF) prevalence increases with age. Hence, evaluating the economic burden among older-aged patients is vital. This study aimed to compare healthcare...

Background This study aimed to evaluate sickle-cell disease (SCD) treatment patterns and economic burden among patients prescribed hydroxyurea (HU) in the US, through claims data. Methods SCD patients with pharmacy claims for HU were selected from the Medicaid Analytic Extracts (MAX) from January 1, 2009 - December 31, 2013. The first HU prescription during the identification period was defined as the index date and patients were required to have had continuous medical and pharmacy benefits for ≥6 months baseline and 12 months follow-up periods. Patient demographics, clinical characteristics, treatment patterns, health care utilization, and costs were examined, and variables were analyzed descriptively. Results A total of 3999 SCD patients prescribed HU were included; the mean age was 19.24 years, most patients were African American (73.3%), and the mean Charlson comorbidity index (CCI) score was 0.6. Asthma (20.3%), acute chest syndrome (15.6%), and infectious and parasitic diseases (20%) were the most prevalent comorbidities. During the 12-month follow-up period, 58.9% (N = 2357) of patients discontinued HU medication. The mean medication possession ratio (MPR) was 0.52, and 22.3% of patients had MPR ≥80%. The average length of stay (LOS) for SCD-related hospitalization was 13.35 days; 64% of patients had ≥1 SCD-related hospitalization. The mean annual total SCD-related costs per patient were $27,779, mostly inpatient costs ($20,128). Conclusions Overall, the study showed the patients had significant unmet needs manifest as poor medication adherence, high treatment discontinuation rates, and high economic burden.

OBJECTIVES Older adult patients are underrepresented in clinical trials comparing non–vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin. DESIGN Retrospective observational study. SETTING The Centers for Medicare & Medicaid Services and three US commercial claims databases. PARTICIPANTS A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015. MEASUREMENTS In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB. RESULTS The patients in the six matched cohorts had a mean follow‐up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49‐.69), dabigatran (HR = .77; 95% CI = .60‐.99), and rivaroxaban (HR = .74; 95% CI = .65‐.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54‐.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78‐1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07‐1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47‐.89; MB: HR = .60; 95% CI = .49‐.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59‐.86; MB: HR = .50; 95% CI = .45‐.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67‐.90) compared with rivaroxaban. CONCLUSION Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin. J Am Geriatr Soc 67:1662–1671, 2019

Background: Purine nucleoside analogs (PNAs) are highly effective for first-line treatment of hairy cell leukemia (HCL). In clinical trials of single PNAs, several adverse events (AEs) were reported; however, little is known regarding the costs and healthcare resource utilization (HRU) resulting from AEs in HCL patients (pts) treated with PNAs in non-clinical trial settings. Objective: Determine the costs and HRU of high incident and clinically important AEs associated with PNA therapy in HCL pts in the Truven MarketScan database. Methods: Adults (aged ≥18 years) with ≥2 HCL diagnosis codes ≥30 days apart during January 1, 2006–December 31, 2015 were included. Pts had ≥1 prescription claim for a PNA (cladribine or pentostatin ± rituximab) after HCL diagnosis date. First PNA claim date was defined as the index date. Pts had continuous health plan enrollment for ≥6 months at baseline and ≥12-months follow-up with no PNA in the baseline period. Pts were placed into cohorts based on the occurrence of myelosuppression (MSPN) and opportunistic infections (OI) as these were highest incident and clinically important AEs observed. Generalized linear models were used to compare outcomes during the 12-month follow-up. Results: Of the 219 pts with no history of MSPN, 101 developed MSPN (incidence [I]: 461 per 1000 pt-years) and of 619 pts with no history of OI, 26 developed OI (I: 42 per 1000 pt-years). Demographics were similar between pts with and without MSPN and OI. Pts who developed OI or MSPN had significantly higher inpatient admissions and costs (Table 1). Conclusions: PNA-treated HCL pts who developed MSPN or OI incurred higher HRU than those who did not develop either condition. This indicates the need for new therapeutic strategies to reduce HCL-treatment-associated toxicities.

Importance: Many patients with nonvalvular atrial fibrillation (NVAF) are at a high risk of gastrointestinal (GI) bleeding due to conditions including older age; stage III to V chronic kidney disease (CKD); HAS-BLED (hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65, drug or alcohol use) score of 3 or greater; corticosteroid, antiplatelet or nonsteroidal anti-inflammatory drug (NSAID) use; or GI conditions. Objective: To compare the risk of stroke and/or systemic embolism (SE) and major bleeding (MB) among patients with NVAF and high risk of GI bleeding who received non-vitamin K antagonist oral anticoagulants (NOACs) vs those who received warfarin. Design, Setting, and Participants: This retrospective cohort study included patients with NVAF who were 75 years and older; had stage III to V CKD; had an HAS-BLED score of 3 or greater; used corticosteroids, antiplatelets, or NSAIDs; or had GI conditions. Data were collected from the Centers for Medicare & Medicaid Services and 4 commercial insurance databases between January 1, 2012, and September 30, 2015. Data analysis was conducted from January 2012 to September 2015. Exposures: New prescription for apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and September 30, 2015 (identification period). Main Outcomes and Measures: Six propensity score-matched cohorts were created to compare between study drugs. For the primary objective, Cox models were used to estimate stroke and/or SE and MB hazard ratios (HRs). Results: A total of 381054 patients (187489 [49.2%] women) with NVAF and at least 1 high-risk GI bleeding factor were identified (HAS-BLED score ≥3: 284527 [74.7%]; aged ≥75 years: 252835 [66.4%]; corticosteroid, antiplatelet, or NSAID therapy: 107675 [28.3%]; prior GI bleeding conditions: 74818 [19.6%]; and stage III-V CKD: 56892 [14.9%]). All NOACs were associated with a lower risk of stroke and/or SE vs warfarin (apixaban: HR, 0.60; 95% CI, 0.52-0.68; dabigatran: HR, 0.75; 95% CI, 0.64-0.88; rivaroxaban: HR, 0.79; 95% CI, 0.73-0.86). Compared with warfarin, apixaban and dabigatran were associated with a lower risk of MB (apixaban: HR, 0.59; 95% CI, 0.56-0.63; dabigatran: HR, 0.78; 95% CI, 0.70-0.86), while rivaroxaban was associated with a higher risk (HR, 1.11; 95% CI, 1.05-1.16). Conclusions and Relevance: In this study of patients with NVAF and high risk of GI bleed, NOACs were associated with lower rates of stroke and/or SE, but NOACs had varying risks of MB compared with warfarin. These results may help inform treatment options in this patient population..

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

Limited evidence is available on outcomes associated with currently available medications from the endothelin receptor antagonist drug class (bosentan, ambrisentan, and macitentan) in elderly patients with pulmonary arterial hypertension. We evaluated mortality in predominantly elderly patients with pulmonary arterial hypertension in the US taking endothelin receptor antagonists. A retrospective administrative claims study was conducted using the Centers for Medicare and Medicaid Services national Medicare database. Patients with pulmonary arterial hypertension were identified using diagnostic codes. Cohort inclusion required age ≥18 years; ≥1 claim for macitentan, ambrisentan, or bosentan between 1 January 2014 and 31 December 2015 (index date and index endothelin receptor antagonist defined by first such claim); continuous enrollment for ≥12 months before and after the index date; and ≥80% of days covered for the index endothelin receptor antagonist. Follow-up was from index date until the earliest of Medicare disenrollment, death, or 31 December 2016. Multivariable Cox proportional hazards regression models were used to estimate mortality hazard ratios with 95% confidence intervals for macitentan vs. ambrisentan or bosentan, adjusting for potential confounders. The study cohort included 1628 patients on index macitentan, 2852 on ambrisentan, and 1972 on bosentan. Overall, 69% of patients were aged ≥65 years and most were females (76%). Macitentan was associated with an 18% lower risk for mortality than ambrisentan (hazard ratio: 0.82, 95% confidence interval: 0.72–0.93; P = 0.0026) and a 39% lower risk than bosentan (hazard ratio: 0.61, 95% confidence interval: 0.53–0.71; P

Background: Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population. Objectives: This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods: This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013-30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score-matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB. Results: Amongst NVAF patients, 34% (N = 150 487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55–0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72–0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57–0.66) and dabigatran (HR: 0.79, 95% CI: 0.70–0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08–1.21) was associated with a higher risk vs warfarin. Conclusion: Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real-world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population.

This ARISTOPHANES analysis examined stroke/systemic embolism (SE) and major bleeding (MB) among a subgroup of nonvalvular atrial fibrillation (NVAF) patients with obesity prescribed warfarin or non-vitamin K antagonist oral anticoagulants (NOACs) in order to inform clinical decision making. A retrospective observational study was conducted among NVAF patients who were obese and initiated apixaban, dabigatran, rivaroxaban, or warfarin from 1 January 2013&ndash, 30 September 2015, with data pooled from CMS Medicare and four US commercial claims databases. Propensity score matching was completed between NOACs and against warfarin in each database, and the results were pooled. Cox models were used to evaluate the risks of stroke/SE and MB. A total of 88,461 patients with obesity were included in the study. Apixaban and rivaroxaban were associated with a lower risk of stroke/SE vs. warfarin (HR: 0.63, 95% CI: 0.49&ndash, 0.82 and HR: 0.84, 95% CI: 0.72&ndash, 0.98). Dabigatran was associated with a similar risk of stroke/SE compared to warfarin. Compared with warfarin, apixaban and dabigatran had a lower risk of MB (HR: 0.54, 95% CI: 0.49&ndash, 0.61 and HR: 0.75, 95% CI: 0.63&ndash, 0.91). Rivaroxaban was associated with a similar risk of MB compared to warfarin. In this high-risk population with obesity, NOACs had a varying risk of stroke/SE and MB vs. warfarin.

Background Purine nucleoside analogs (PNAs) are the recommended first-line treatment for patients with hairy cell leukemia (HCL), but they are associated with adverse events (AEs). Due to a lack of real-world evidence regarding AEs that are associated with PNAs, we used commercial data to assess AE rates, AE-related health care resource utilization (HCRU), and costs among PNA-treated patients with HCL. Adults aged ≥18 years with ≥2 claims for HCL ≥30 days apart from 1 January 2006 through 31 December 2015 were included. Included patients had ≥1 claim for HCL therapy (cladribine ± rituximab or pentostatin ± rituximab [index date: first claim date]) and continuous enrollment for a ≥ 6-month baseline and ≥ 12-month follow-up period. Patient sub-cohorts were based on the occurrence of myelosuppression and opportunistic infections (OIs). Generalized linear models were used to compare HCRU and costs. Results In total, 647 PNA-treated patients were identified (mean age: 57.1 years). Myelosuppression and OI incidence were 461 and 42 per 1000 patient-years, respectively. Adjusted results indicated that those with myelosuppression had higher rates of hospitalization (47.4% vs 12.4%; P P = .011) and total costs ($57,325 vs $34,733; P = .001) as compared with those without myelosuppression. Similarly, patients with OIs had higher rates of hospitalization (53.8% vs 30.8%; P = .025) and incurred higher mean inpatient costs ($21,494 vs $11,229; P Conclusions PNA therapy is highly effective but associated with significant toxicities that increase costs; these findings indicate a need for therapies with improved toxicity profiles and better risk stratification of patients at risk of developing myelosuppression and OIs.

Introduction Little has been published on respiratory syncytial virus (RSV) among Medicare patients at high risk (HR) of RSV complications due to age or comorbidity. Methods Adult patients (at least 18 years of age) with at least 1 diagnostic code for RSV were identified using the 5% US Medicare database from 2011 through 2015. Patients were required to have continuous health plan enrollment for 180 days pre- and 180 days post-RSV diagnosis (baseline and follow-up periods, respectively). HR was defined as diagnosis of chronic lung disease, congestive heart failure, or weakened immune system for 180 days during the baseline period. Patients were categorized as initially hospitalized if hospitalized within 1 day of RSV diagnosis. Logistic regression models were developed to determine predictors of initial hospitalization. Healthcare utilization and costs for 180 days pre- and post-RSV diagnosis were compared. Results The study included 756 HR patients who were initially hospitalized with RSV diagnoses. Among these, 61.7% were diagnosed in the emergency department vs 15.3% in a physician’s office, with hypertension (76.3%), chronic obstructive pulmonary disease (COPD) (53.7%), and high cholesterol (52.0%) observed as the most prevalent comorbidities. Of these, COPD, congestive heart failure, chronic kidney disease, and previous evidence of pneumonia were significant predictors of hospitalization. Other significant predictors of hospitalization included older age, hematological malignancies, stroke, and baseline healthcare resource use. Among both HR and non-HR hospitalized patients, there was a significant increase in healthcare resource utilization following hospitalization, including the number of inpatient admissions and longer hospital stays post-RSV diagnosis. The total mean all-cause healthcare costs among HR hospitalized patients increased by $9210 per patient (p

BACKGROUND Current information is scarce regarding comorbid conditions, treatment, survival, institutionalization, and health care utilization for Alzheimer's disease (AD) patients. OBJECTIVES Compare all-cause mortality, rate of institutionalization, and economic burden between treated and untreated newly-diagnosed AD patients. METHODS Patients aged 65-100 years with ≥1 primary or ≥2 secondary AD diagnoses (ICD-9-CM:331.0] with continuous medical and pharmacy benefits for ≥12 months pre-index and ≥6 months post-index date (first AD diagnosis date) were identified from Medicare fee-for-service claims 01JAN2011-30JUN2014. Patients with AD treatment claims or AD/AD-related dementia diagnosis during the pre-index period were excluded. Patients were assigned to treated and untreated cohorts based on AD treatment received post-index date. Total 8,995 newly-diagnosed AD patients were identified; 4,037 (44.8%) were assigned to the treated cohort. Time-to-death and institutionalization were assessed using Cox regression. To compare health care costs and utilizations, 1 : 1 propensity score matching (PSM) was used. RESULTS Untreated patients were older (83.85 versus 81.44 years; p

Introduction Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated. Methods Adult AD patients in the Commercial (n = 83,106), Medicare (n = 31,060), and Medi-Cal (n = 5550) databases were matched (1:1) to non-AD controls by demographic characteristics. AD patients were stratified by disease severity (higher, lower) using treatment as a surrogate measure of severity. The comorbidity burden, HCRU, and costs were evaluated during a 12-month follow-up period. Results In the Commercial, Medicare, and Medi-Cal populations, patients with AD had a significantly higher overall comorbidity burden (P

Background The ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS) study showed that non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of stroke/systemic embolism (S/SE) and variable comparative risks of major bleeding (MB) versus warfarin. Purpose To assess long-term use of non-VKA oral anticoagulants (NOACs) vs. warfarin in ARISTOPHANES by evaluating the risk of S/SE and MB among non-valvular atrial fibrillation (NVAF) patients by duration of treatment ( Methods In the ARISTOPHANES study, NVAF patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from 01/01/2013–09/30/2015 were identified from the CMS Medicare data and four US commercial claims databases, covering >180 million beneficiaries annually (∼56% of US population). After 1:1 propensity score matching (PSM) in each database between NOACs and warfarin (apixaban-warfarin, dabigatran-warfarin, and rivaroxaban-warfarin), the resulting patient records were pooled. Treatment duration was defined as time between the day after the treatment index date and discontinuation (30 days after a 30-day gap in the prescription), treatment switch, death, end of study period, or end of continuous medical and pharmacy enrollment, whichever occurred first. Matched patients with observed treatment duration Results The mean treatment duration for patients with shorter ( Conclusions Among NVAF patients with duration of treatment Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc.

Background: Prior analyses have indicated that chronic obstructive pulmonary disease (COPD) is a predictor of hospitalization among adult respiratory syncytial virus (RSV) patients. Objectives: This study examined outcomes among COPD patients with RSV diagnosis. Methods: Adult patients (≥18 years), with ≥1 diagnostic code for COPD, ≥1 diagnostic code for RSV and who had continuous health plan enrollment for 6 months pre and 6 months post first RSV diagnosis were identified using the 5% US Medicare database from 2011-2015. Results: Among COPD patients diagnosed with RSV, 406 were initially hospitalized and 253 were not. 56% of hospitalized patients were diagnosed in an emergency room vs. 17% in a physician’s office. Admitted patients had greater comorbidity burden than those not hospitalized [congestive heart failure (46% vs. 24%) and chronic kidney disease (32% vs. 11%)] and were more likely to have a prior inpatient stay (71% vs. 36%) pre-RSV diagnosis. Among hospitalized patients RSV, 47% received care in the ICU and 17% received mechanical ventilation. Median length of stay for the inpatient stay was 7 days. All-cause mortality rate was 5% during the inpatient stay and 13% within 30 days of diagnosis. Thirty-day readmission rate was 22%. The total mean all-cause healthcare costs were increased by $4,974 per patient (p=.03) in the post-RSV period vs. the pre-RSV period for hospitalized patients.

Background: The AMPLIFY randomized clinical trial showed that apixaban was associated with significantly lower major bleeding (MB) compared to warfarin for patients with venous thromboembolism (VTE). The main objective of this study was to compare the risk of major bleeding (MB), clinically relevant non-major bleeding (CRNM), and recurrent VTE among VTE patients treated with apixaban vs warfarin in the US Medicare population. Methods: Patients (aged ≥65 years) prescribed apixaban or warfarin within 30 days following a VTE event diagnosed in hospital or ambulatory setting were identified from 01SEPT2014-31DEC2016 using 100% CMS Medicare data. The first apixaban or warfarin prescription claim outside of the hospital was defined as the index date. Patients were required to have had continuous health plan enrollment for 6 months and no parenteral or oral anticoagulant use before the index VTE event. Outcomes were assessed from index date to the earliest of discontinuation, switch, health plan disenrollment, death, 6 months post-index date, or 31DEC2016. One-to-one propensity score matching (PSM) was used to balance patient characteristics. Cox proportional hazard models were used to estimate the risk of MB, CRNM bleeding, and recurrent VTE. Results: Among 37,799 patients meeting inclusion criteria, 25,284 patients initiated warfarin (66.9%) and 12,515 patients initiated apixaban (33.1%). Post-PSM, 11,363 matched pairs of apixaban-warfarin patients were identified, with a mean follow-up period of 4.0 and 4.4 months. Mean age was 78 years; nearly 37% of patients were male with a mean Charlson Comorbidity Index score of 2.9 in both groups. Apixaban was associated with a lower risk of MB (HR: 0.76; 95% CI: 0.64-0.91) and CRNM bleeding (HR: 0.77; 95% CI: 0.70-0.84) compared to warfarin. The risk of recurrent VTE was similar among apixaban and warfarin patients (HR: 1.04; 95% CI: 0.75-1.43; Figure). Conclusions: Among US Medicare patients with VTE, apixaban was associated with a lower risk of MB and CRNM bleeding and similar risk of recurrent VTE compared to warfarin. These results may be supportive in evaluating the risk-benefit ratio of apixaban for treatment of elderly VTE patients.

OBJECTIVE: To address gaps in the data comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among patients with nonvalvular atrial fibrillation (NVAF) and diabetes.PATIENTS AND METHODS: A retrospective study was conducted on patients with NVAF and diabetes newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, through September 30, 2015, with Medicare data from the US Centers for Medicare & Medicaid Services and 4 other US commercial claims databases. One-to-one propensity score matching was completed between NOACs and warfarin and between NOACs in each database, and the results were pooled. Cox proportional hazards models were used to evaluate the risk of stroke/systemic embolism (SE) and major bleeding (MB).RESULTS: A total of 154,324 patients were included in the 6 matched cohorts, with a mean follow-up time of 6 to 8 months. Compared with warfarin, apixaban (hazard ratio [HR], 0.67; 95% CI, 0.57-0.77) and rivaroxaban (HR, 0.79; 95% CI, 0.71-0.89) were associated with a lower risk of stroke/SE; dabigatran (HR, 0.84; 95% CI, 0.67-1.07) was associated with a similar risk of stroke/SE. Apixaban (HR, 0.60; 95% CI, 0.56-0.65) and dabigatran (HR, 0.78; 95% CI, 0.69-0.88) were associated with a lower risk of MB; rivaroxaban (HR, 1.02; 95% CI, 0.94-1.10) was associated with a similar risk of MB compared with warfarin. Compared with dabigatran and rivaroxaban, apixaban was associated with a lower risk of MB. Compared with rivaroxaban, dabigatran was associated with a lower risk of MB.CONCLUSION: This study-the largest observational study to date of patients with NVAF and diabetes taking anticoagulants-found that NOACs were associated with variable rates of stroke/SE and MB compared with warfarin.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03087487.

ObjectivesThis study evaluated the prevalence rate of vaso-occlusive crisis (VOC) episodes, rates of uncomplicated and complicated VOC episodes, and the primary reasons for emergency room (ER) visits and inpatient admissions for sickle cell disease (SCD) patients.MethodsThe Medicaid Analytic extracts database was used to identify adult SCD patients using claims from 01JUL2009-31DEC2012. The date of the first observed SCD claim was designated as the index date. Patients were required to have continuous medical and pharmacy benefits for ≥6 months baseline and ≥12 months follow-up period. Patient demographics, baseline clinical characteristics, the rate of uncomplicated and complicated VOC (VOC with concomitant SCD complications) episodes, and reasons for ER visits and inpatient stays were analyzed descriptively.ResultsA total of 8,521 patients were included in the analysis, with a median age of 30 years. The average follow-up period was 2.7 years. The rate of VOC episodes anytime in the follow-up was 3.31 in person-years. During the first-year follow-up period, an average of 2.79 VOC episodes were identified per SCD patients, with 1.06 VOC episodes treated in inpatient setting and 0.90 VOC episodes in ER without admission. A total of 76,154 VOC episodes were identified during the entire follow-up period for the overall SCD patients. Most of the VOC episodes (70.3% [n = 53,523]) were uncomplicated episodes, and 29.7% were complicated episodes. Using primary diagnosis claims only, the most frequent complications during the VOC episode were infectious diseases (25.9%), fever (21.8%), and pulmonary disorders (16.2%). Among ER and hospitalizations related to VOC or SCD complication, ~85.0% had VOCs as the primary reason for admission; 15.0% had SCD complications as the primary reason.ConclusionIn summary, SCD and its related comorbidities and complications result in high acute health care utilization. In addition, VOC remains the primary reason for SCD patients' ER visits and inpatient admissions.

Chronic obstructive pulmonary disease (COPD) is a common condition responsible for substantial morbidity, mortality, and costs in the United States. The economic burden of COPD is driven primarily by hospitalizations, with 1 in 5 hospitalized patients experiencing a 30-day readmission. Bronchodilators, delivered via handheld inhalers or nebulizers, are the mainstay of therapy for COPD. However, differences in outcomes between short- and long-acting therapies are unclear. We examined real-world differences in 30-day readmission and exacerbation rates between Medicare beneficiaries with COPD treated with a nebulized long-acting betaTruven MarketScan Hospital Drug Database and Medicare files were probabilistically matched between 2009 and 2013 to identify beneficiaries who were aged ≥65 years and discharged from a hospital with a primary COPD diagnosis or a secondary COPD diagnosis and a primary diagnosis for another respiratory condition. Matching was performed by using COPD hospitalization date (±7 days) and source, length of stay (±1 day), discharge date and destination, and hospital region. After applying additional inclusion/exclusion criteria, 2 cohorts were created: nebulized ARF users (n = 953) and nebulized SABA users (n = 6939). Logistic regression analyses were used to examine 30-day readmission (all-cause and COPD related) and exacerbation rates. Odds ratios (ORs), 95% CIs, and P values were computed.On average, nebulized SABA users had more comorbidities than nebulized ARF users, including diabetes, atrial fibrillation, renal disease, musculoskeletal disease, myocardial infarction, and cognitive impairment (all, P 0.0001). However, nebulized ARF users had a higher average COPD severity score than nebulized SABA users (49.5 v. 38.0; P 0.001). COPD therapies at baseline were similar in both cohorts and included systemic corticosteroids (≥65%), short-acting bronchodilators (≥33%), and inhaled corticosteroids + long-acting betaNebulized ARF users had lower 30-day readmission rates, greater COPD severity, and fewer comorbidities than nebulized SABA users. In this population, maintenance treatment with ARF reduced costly COPD outcomes.

Background: Gastrointestinal (GI) bleeding is the most common type of major bleeding associated with oral anticoagulant (OAC) treatment. Patients with major bleeding are at an increased risk of a stroke if an OAC is not reinitiated. Methods: Non-valvular atrial fibrillation (NVAF) patients initiating OACs were identified from the Centers for Medicare and Medicaid Services ( CMS) Medicare data and four US commercial claims databases. Patients who had a major GI bleeding event (hospitalization with primary diagnosis of GI bleeding) while on an OAC were selected. A control cohort of patients without a major GI bleed during OAC treatment was matched to major GI bleeding patients using propensity scores. Stroke/systemic embolism (SE), major bleeding, and mortality (in the CMS population) were examined using Cox proportional hazards models with robust sandwich estimates. Results: A total of 15,888 patients with major GI bleeding and 833,052 patients without major GI bleeding were included in the study. Within 90 days of the major GI bleed, 58% of patients discontinued the initial OAC treatment. Patients with a major GI bleed had a higher risk of stroke/SE [hazard ratio (HR): 1.57, 95% confidence interval (CI): 1.42–1.74], major bleeding (HR: 2.79, 95% CI: 2.64–2.95), and all-cause mortality (HR: 1.29, 95% CI: 1.23–1.36) than patients without a major GI bleed. Conclusion: Patients with a major GI bleed on OAC had a high rate of OAC discontinuation and significantly higher risk of stroke/SE, major bleeding, and mortality after hospital discharge than those without. Effective management strategies are needed for patients with risk factors for major GI bleeding.

Objectives The study aimed to assess the burden of RA among the US Medicare population (aged ≥65 years) by comparing co-morbidities, health-care resource utilization (HCRU) and costs against matched non-RA Medicare patients. Methods Data were obtained from the Medicare fee-for-service claims database from 2010 to 2013. RA Medicare patients were identically matched with Medicare patients without RA (controls) based on demographics. Bivariate analyses were conducted to examine differences between cohorts for co-morbidities, HCRU and costs. A generalized linear model was used to test relationships between patient-level characteristics, HCRU and costs. Results The study population included 115 867 RA patients and 115 867 age-, sex-, race- and region-matched non-RA controls. Mean age was 75.2 years; 79.4% were female. Co-morbidities were greater in RA vs non-RA patients [Charlson Co-morbidity Index (excluding RA): 1.86 vs 1.00; P

The prevalence of rheumatoid arthritis has risen in recent years, resulting in substantial increases in rheumatoid arthritis-associated disability, cost, and mortality1-3. Furthermore, rheumatoid arthritis is increasingly concentrated among elderly individuals, and nearly 50% of patients who are newly diagnosed with rheumatoid arthritis are sixty-five years of age and older4. Although there is no cure for rheumatoid arthritis, early treatment with disease-modifying antirheumatic drugs (DMARDs) can slow disease progression and has rapidly become the standard of care for patients with newly diagnosed disease5. Unlike young individuals, elderly patients with rheumatoid arthritis are less likely to receive treatment with DMARDs6,7, are more likely to suffer from multiple comorbid conditions requiring additional medications, and may be more sensitive to drug interactions and polypharmacy8-10. Additionally, complications from potent immunosuppressive medications may be more difficult for elderly individuals to tolerate; drug metabolism may be markedly different among older individuals11,12. Rheumatoid arthritis-related joint and soft-tissue reconstructive procedures can predictably correct deformity, avoid flexion contraction, alleviate pain, and improve function and quality of life13,14. Furthermore, surgical reconstruction for the upper extremity can often be performed on an outpatient basis under regional anesthetic, minimizing the physiologic stress of surgery. However, surgery is often considered only in the late stage of rheumatoid arthritis for patients who have developed severe pain, joint destruction, or function loss with failure to respond to pharmaceutical therapy13,15,16. Moreover, the patient and provider factors that influence the timing of surgery are not well understood. Given the aging population in the United States, defining the epidemiology of rheumatoid arthritis-related procedures among elderly patients can identify potential areas of unmet need and systematic differences in treatment. In this context, we examined the incidence of upper and lower extremity procedures performed for rheumatoid arthritis-related deformities among a cohort of Medicare beneficiaries in the United States. Our purpose was to define the timing and rates of upper and lower limb reconstructive procedures performed following the diagnosis of rheumatoid arthritis. We hypothesized that overall rates of upper and lower limb reconstruction decline with age and are significantly associated with sociodemographic factors and regional density of specialists.

Objective.To examine the rate and variation in rheumatoid arthritis (RA)-related hand and wrist surgery among Medicare (elderly) beneficiaries in the United States, and to identify the patient and provider factors that influence surgical rates.Methods.Using the 2006–2010 100% Medicare claims data of beneficiaries with RA diagnosis, we examined rates of rheumatoid hand and wrist arthroplasty, arthrodesis, and hand tendon reconstruction in the United States. We used multivariate logistic regression models to examine variation in receipt of surgery by patient and regional characteristics (density of providers, intensity of use of biologic disease-modifying antirheumatic drugs).Results.Between 2006 and 2010, the annual rate of RA-related hand and wrist arthroplasty or arthrodesis was 23.1 per 10,000 patients, and the annual rate of hand tendon reconstruction was 4.2 per 10,000 patients. The rates of surgery varied 9-fold across hospital referral regions in the United States. Younger patient age, female sex, white race, higher socioeconomic status (SES), and rural residence were associated with a higher likelihood of undergoing arthroplasty and arthrodesis. We observed a significant decline in rate of arthroplasty and arthrodesis with increasing density of rheumatologists. Tendon reconstruction was not influenced by provider factors, but was correlated with age, race, SES, and rural status of the patients.Conclusion.Surgical reconstruction of rheumatoid hand deformities varies widely across the United States, driven by both regional availability of subspecialty care in rheumatology and individual patient factors.

To compare all-cause health care utilization and costs between patients with schizophrenia treated with once monthly paliperidone palmitate (PP1M; Invega SustennaThis was a retrospective claims-based analysis among adult California Medicaid (Medi-Cal) patients with schizophrenia having ≥2 claims for PP1M or OAT from 1 July 2009 to 31 December 2013 and continuous health plan enrollment for ≥1 year pre- and post-index date (PP1M or OAT initiation date). Baseline characteristics were reported descriptively. Propensity score matching with a 1:1 greedy match method was used to create two matched cohorts. Treatment patterns, all-cause health care utilization, and costs for the 12 month follow-up period were compared between the two matched cohorts.Two well matched cohorts of 722 patients were produced with similar baseline characteristics. During the 12 month follow-up period, PP1M patients were significantly less likely to discontinue treatment (30.6% vs. 39.5%, p .001) or switch to a new therapy (21.6% vs. 27.7%, p = .007). PP1M patients had fewer inpatient visits (5.0 vs. 7.9, p .001), lower mean hospitalization days (15.0 vs. 27.7 days, p .001) and inpatient costs ($5060 vs. $10,880, p .001). While pharmacy costs were significantly higher in the PP1M cohort ($16,347 vs. $9115, p .001), total costs were not significantly different between the matched cohorts ($25,546 vs. $25,307, p = 0.853).Patients with schizophrenia treated with PP1M had significantly fewer inpatient hospitalizations and associated costs with no significant difference in the total costs between the two cohorts. This study is subject to limitations associated with claims data such as miscoding, inability to examine clinical severity, etc.

Patient frailty is associated with adverse health outcomes and increased risk of mortality. This ARISTOPHANES study subgroup analysis used multiple data sources to evaluate stroke/systemic embolism (S/SE) and major bleeding (MB) among frail nonvalvular atrial fibrillation (NVAF) patients prescribed

Obesity has an important impact on general health outcomes and is prevalent in nonvalvular atrial fibrillation (NVAF) patients. This study evaluated stroke/systemic embolism (SE) and major bleeding (MB) among obese NVAF patients using non-vitamin K antagonist oral anticoagulants (NOACs) in the

The prevalence of obesity in nonvalvular atrial fibrillation (NVAF) patients is apparent in trials and real-world studies; however, there is limited data on the effectiveness and safety of anticoagulation specific to this population. This study evaluated stroke/systemic embolism (SE) and major

Non-valvular atrial fibrillation (NVAF) prevalence increases with age. Hence, evaluating the health care resource utilization (HRU) and expenditures among elderly patients is vital. HRU and expenditures were compared among newly-diagnosed elderly NVAF patients who initiated treatment with oral anti

Patient frailty is associated with adverse health outcomes and increased risk of mortality. This subgroup analysis of the ARISTOPHANES study used multiple data sources to evaluate stroke/systemic embolism (S/SE) and major bleeding (MB) among frail non-valvular atrial fibrillation (NVAF) patients

Introduction: Purine nucleoside analogs (PNAs) are the recommended first-line treatment in patients with hairy cell leukemia (HCL) owing to their efficacy. However, because of the rarity of this disease, little is known about clinically significant adverse events (AEs) outside of previously performed clinical trials. This retrospective claims-based study of patients treated in the current era of improved supportive care assessed the incidence and prevalence rates of AEs associated with PNA use and healthcare resource utilization (HRU) among patients with HCL enrolled in the Truven MarketScan Commercial Claims and Encounters and the Medicare Supplemental databases. Methods: Adults (≥18 years old) diagnosed with HCL (≥2 medical claims ≥30 days apart) between January 1, 2006 and December 31, 2015 were included in the study. All patients had ≥1 claim for PNA therapy (cladribine or pentostatin ± rituximab) after the HCL diagnosis date and the 1st prescription claim was defined as the index date. Continuous health plan enrollment for ≥6 months pre- (baseline period) and ≥12 months post-index date (follow-up period) was required. Patients treated with a PNA during the baseline period were excluded. Incidence rate was defined as the number of new cases of an AE during the follow-up period divided by the number of patients at risk (patients without any evidence of the adverse event in the 6-month baseline period). Prevalence rate was defined as the number of all AEs (existing cases during the baseline period and new cases during the follow-up period) divided by the total number of patients. Incidence and prevalence rates were calculated as rate per 1000 patient-years at risk. To evaluate the HRU, PNA-treated patients with HCL were categorized based on occurrence of highest AE during the follow-up period. Generalized linear model (GLM) compared HRU during the 12-month follow-up, adjusting for demographic, clinical characteristics, and baseline total healthcare costs. Results: In total, 647 PNA-treated patients with HCL were identified. Mean age (standard deviation) was 57.1 (12.2) years. Most patients were men (81.5%) and resided in the southern USA (32.2%). Over the 12-month follow-up period, 87.2% of the PNA-treated patients developed at least one AE. PNA-related AEs with the highest incidence rate were myelosuppression, anemia, and skin toxicities. The prevalence rate showed a similar trend for PNA-related AEs. Infectious complications including opportunistic infections were seen at a high rate (Table 1). The incidence and prevalence of infectious complications overall were 23.5% and 39.3% (235 and 393 per 1000 patient-years), respectively. Patients who developed myelosuppression had a higher rate of hospitalization compared with those who did not (47.4% vs 12.2%; p Conclusion: This large claims-based dataset of patients with HCL treated with PNAs shows that a substantial proportion of patients developed AEs, including myelosuppression (most frequent) and infectious complications. Because of the nature of the data set, information regarding mortality is not currently available. However, infections due to myelo- and immunosuppression are known to be the most frequent causes of death in this patient population. These findings indicate a need for larger studies evaluating the outcomes of patients with HCL treated with approved therapies to understand better their short- and long-term toxicities, as well as for the development of therapies with lower risks of myelo- and immunosuppression. Disclosures Pavilack: AstraZeneca: Employment. Olufade:AstraZeneca: Equity Ownership; AstraZeneca: Employment. Bashyal:STATinMED: Employment. Li:STATinMED: Employment. Andritsos:HCLF: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy.

We identified the cost of care and clinical events using dipyridamole versus adenosine in pharmacological stress (ST)/single-photon-emission computed tomography (SPECT) myocardial perfusion testing.Commercial health plan members received adenosine or dipyridamole as an adjunct to ST/SPECT testing during the period January 1, 2006, through November 30, 2008. Propensity score matching techniques were used to compare risk-adjusted, test-related complications, symptoms and costs.A total of 12,351 patients underwent ST/SPECT testing with dipyridamole and 59,969 with adenosine. Risk-adjusted outcomes analysis showed that patients receiving dipyridamole had a higher number of emergency room (ER) visits (0.65 vs. 0.23%, p0.001) and angina pectoris episodes (7.11 vs. 6.01%, p0.001). The likelihood of shortness of breath was significantly higher (6.63 vs. 5.77%, p0.001) in the adenosine group. One-day risk-adjusted, office-visit, outpatient hospital and other utilization costs for same day ST/SPECT testing were higher for the adenosine group. Risk-adjusted ER visit costs were higher for the dipyridamole group ($1276 vs. $1095, p0.001).First the presence of a claim for a filled prescription does not indicate that the medication was consumed or taken as prescribed. Second, medications filled over-the-counter or provided as samples will not be observed in the claims data. Third, presence of diagnosis codes on medical claims are not positive presence of disease, as diagnosis codes may be incorrectly coded or included as rule-out criteria rather than actual disease. Finally, certain information is not readily available in claims data that could have an effect on study outcomes, such as certain clinical and disease-specific parameters.Differences in complications and symptoms may help identify a better-tolerated vasodilator drug (VD) for use in pharmacologic stress testing based on a patient's history and symptoms. Implementation of a data-based strategy for the selection of the most appropriate stress-testing adjunctive agent may be a cost-effective step for institutions and health plans.