A retrospective study to assess clinical characteristics and time to initiation of open-triple therapy among patients with chronic obstructive pulmonary disease, newly established on long-acting mono- or combination therapy.

INTRODUCTION: An incremental approach using open-triple therapy may improve outcomes in patients with chronic obstructive pulmonary disease (COPD). However, there is little sufficient, real-world evidence available identifying time to open-triple initiation. METHODS: This retrospective study of patients with COPD, newly initiated on long-acting muscarinic antagonist (LAMA) monotherapy or inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) combination therapy, assessed baseline demographics, clinical characteristics, and exacerbations during 12 months prior to first LAMA or ICS/LABA use. Time to initiation of open-triple therapy was assessed for 12 months post-index date. Post hoc analyses were performed to assess the subsets of patients with pulmonary-function test (PFT) information and patients with and without comorbid asthma. RESULTS: Demographics and clinical characteristics were similar between cohorts in the pre-specified and post hoc analyses. In total, 283 (19.3%) and 160 (10.9%) patients had moderate and severe exacerbations at baseline, respectively, in the LAMA cohort, compared with 482 (21.3%) and 289 (12.8%) patients in the ICS/LABA cohort. Significantly more patients initiated open-triple therapy in the LAMA cohort compared with the ICS/LABA cohort (226 [15.4%] versus 174 [7.7%]; P<0.001); results were similar in the post hoc analyses. Mean (standard deviation) time to open-triple therapy was 79.8 (89.0) days in the LAMA cohort and 122.9 (105.4) days in the ICS/LABA cohort (P<0.001). This trend was also observed in the post hoc analyses, though the difference between cohorts was nonsignificant in the subset of patients with PFT information. DISCUSSION: In this population, patients with COPD are more likely to initiate open-triple therapy following LAMA therapy, compared with ICS/LABA therapy. Further research is required to identify factors associated with the need for treatment augmentation among patients with COPD.

Assessment of Evidence-Based Standards in the Treatment of Advanced Prostate Cancer in a Community Practice.

INTRODUCTION: Although the monitoring of patients with advanced prostate cancer is essential to optimize treatment, little is known about adherence to guidelines. In this study we compared testing practices at an integrated urology/radiation oncology group practice with evidence-based guidelines and best practices. METHODS: Electronic medical records up to December 2014 from the integrated urology/radiation oncology group practice were queried to identify patients who received androgen deprivation therapy and in whom advanced disease was staged as androgen deprivation therapy sensitive, subcastration resistant (incompletely defined probable castration resistant prostate cancer) or castration resistant after April 2011 and for 6 months or more. Frequency of prostate specific antigen and testosterone level testing as well as imaging (magnetic resonance imaging, computerized tomography, positron emission tomography/computerized tomography, bone scan or x-ray) was evaluated, and compared to national guidelines and best practices. RESULTS: Overall 346 patients with androgen deprivation therapy sensitive prostate cancer, 90 with subcastration resistant prostate cancer and 102 with castration resistant prostate cancer met the study inclusion criteria. On average, prostate specific antigen was tested every 4.7, 3.7 and 3.3 months for patients with androgen deprivation therapy sensitive disease, subcastration resistant prostate cancer and castration resistant prostate cancer, respectively, compared with the 3 to 12 months and 3 months recommendations of the National Comprehensive Cancer Network and RADAR (Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence) for patients with androgen deprivation therapy sensitive disease and nonmetastatic castration resistant prostate cancer, respectively. Testosterone levels were assessed within 6 months of classification for 23% and 46% of patients with subcastration resistant prostate cancer and castration resistant prostate cancer, respectively. Finally, 28% and 46% of patients with subcastration resistant prostate cancer and castration resistant prostate cancer, respectively, underwent some type of imaging within 6 months. CONCLUSIONS: This retrospective study of patients receiving androgen deprivation therapy at a particular integrated urology/radiation oncology group practice demonstrated adherence to prostate specific antigen best practices. However, there was some room for improvement in terms of testosterone testing and imaging.

Hospital length of stay of nonvalvular atrial fibrillation patients who were administered Rivaroxaban versus Warfarin with and without pretreatment parenteral anticoagulants therapies.

BACKGROUND: Warfarin has been the only anticoagulant used for decades to prevent strokes and systemic embolisms in nonvalvular atrial fibrillation (NVAF) patients. Compared with rivaroxaban, warfarin has a narrow therapeutic range and many genetic and food-drug interactions that could potentially prolong hospital length of stay (LOS). OBJECTIVE: To compare hospital LOS between NVAF patients who were administered rivaroxaban versus warfarin with and without pretreatment of parenteral anticoagulant agents in a population of rivaroxaban-treated patients. METHODS: A retrospective matched-cohort analysis was conducted using the Premier Perspective Comparative Hospital Database from November 2010 to September 2012. Adult patients were included in the study if they had a hospitalization for NVAF. Rivaroxaban users were matched with up to 4 warfarin users based on propensity score analyses. Patients with and without pretreatment of parenteral anticoagulant agents were evaluated separately. Hospital LOS was compared between treatment groups using generalized estimating equations. RESULTS: The matched cohorts' characteristics were well balanced. Among the matched rivaroxaban and warfarin users who were administered parenteral agents, the mean age of the cohorts was 70 years and 47% of patients were female, whereas in the sample of patients who were not administered parenteral agents, the mean age was 72 years and 50% of patients were female. In the sample of patients who were administered parenteral agents, rivaroxaban users had significantly shorter hospital LOS (LOS difference: 1.38 days, P < 0.001) compared with warfarin users among rivaroxaban-treated patients. No significant difference in LOS was found in the sample of patients who were not administered parenteral anticoagulant agents (P = 0.169). CONCLUSION: In the study sample of NVAF patients who were administered parenteral anticoagulant agents, rivaroxaban was associated with a significantly shorter hospital LOS compared with warfarin. The difference in LOS was not statistically significant in the sample of patients who were not administered parenteral anticoagulant agents.

Is rivaroxaban associated with lower inpatient costs compared to warfarin among patients with non-valvular atrial fibrillation?

BACKGROUND: Warfarin has been the mainstay treatment used by patients with a moderate-to-high risk of stroke due to non-valvular atrial fibrillation (NVAF). Unlike rivaroxaban, laboratory monitoring to allow the attainment of the prothrombin time international normalized ratio goal is required with warfarin, thereby potentially increasing a patient's hospitalization costs. OBJECTIVE: To compare hospitalization costs between hospitalized NVAF patients using rivaroxaban versus warfarin in a real-world setting. METHODS: A retrospective claims analysis was conducted using the Premier Perspective Comparative Hospital Database from November 2010 to September 2012. The study included adult patients hospitalized for NVAF after November 2011. Patients using rivaroxaban during hospitalization were matched with up to four warfarin users by propensity score analyses. Hospitalization costs were compared between the matched cohorts using generalized estimating equations. A sub-analysis was performed for patients who were first administered their treatment on day three or later of their hospital stay. Sensitivity analyses were conducted on matched cohorts with a primary diagnosis of AF. RESULTS: The matched cohorts' (2809 rivaroxaban and 11,085 warfarin users) characteristics were well balanced. The mean age of cohorts was 71 years and 49% of patients were female. The average hospitalization cost of rivaroxaban users was $11,993 compared to $13,255 for warfarin users. The cost difference was significantly lower by $1284 (P < 0.001). Patients who were administered rivaroxaban treatment on day three or after incurred significantly lower hospitalization costs (cost difference: $4350; P < 0.001) compared to warfarin users. Rivaroxaban users with a primary diagnosis of AF also had significantly lower costs compared to warfarin users. LIMITATIONS: These included possible inaccuracies or omissions in diagnoses, completeness of baseline characteristics, and a study population that included patients newly initiated on and patients who continued anticoagulant therapy. CONCLUSION: Hospitalization costs for rivaroxaban were significantly lower than those for warfarin in NVAF patients treated with rivaroxaban.

Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients.

BACKGROUND: Rivaroxaban was shown to be effective in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) in a randomized controlled trial setting. OBJECTIVE: To assess real-world safety, effectiveness, and persistence associated with rivaroxaban and warfarin in nonvalvular AF patients. METHODS: Healthcare claims from Symphony Health Solutions' Patient Transactional Datasets from May 2011 to July 2012 were analyzed. Adult patients newly initiated on rivaroxaban or warfarin, with ≥2 AF diagnoses (ICD-9-CM: 427.31) and a CHADS2 score ≥1 during the 180 day baseline period were included. Cohorts were matched 1:4 using propensity score methods. Study outcomes were major bleeding, intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding, composite stroke and systemic embolism, and venous thromboembolism (VTE) events. Cox proportional hazard models were used to compare event and persistence rates. RESULTS: The matched sample included 3654 rivaroxaban and 14,616 warfarin patients. Matching was adequate, with all standardized differences in patient characteristics <10%. No significant differences were observed for bleeding and composite stroke and systemic embolism outcomes, although rivaroxaban users were associated with significantly fewer VTE events (hazard ratio [HR] = 0.36, 95% confidence interval [CI]: 0.24-0.54, p < 0.0001) compared to warfarin users. Rivaroxaban was also associated with a significantly lower risk of treatment non-persistence (HR = 0.66; 95% CI: 0.60-0.72, p < 0.0001). LIMITATIONS: Claims data may have contained inaccuracies, and mortality and laboratory data were not available. Confounding may still have been possible even after propensity score matching. Early use pattern of medications may have changed over time. CONCLUSION: This analysis suggests that rivaroxaban and warfarin do not differ significantly in real-world rates of composite stroke and systemic embolism and major, intracranial, or GI bleeding. Rivaroxaban, however, was associated with significantly fewer VTE events and significantly better treatment persistence compared with warfarin.

Hospital length of stay: is rivaroxaban associated with shorter inpatient stay compared to warfarin among patients with non-valvular atrial fibrillation?

BACKGROUND: Warfarin has been the mainstay treatment for prevention of stroke among patients with non-valvular atrial fibrillation (NVAF). Unlike rivaroxaban, warfarin requires laboratory monitoring to allow the attainment of the prothrombin time (PT) international normalized ratio (INR) goal, thereby potentially prolonging a patient's hospital length of stay (LOS). OBJECTIVE: To compare hospital LOS between hospitalized NVAF patients using rivaroxaban versus warfarin in a real-world setting. METHODS: A retrospective claims analysis was conducted using the Premier Perspective Comparative Hospital Database from 11/2010 to 9/2012. Adult patients were included in the study if they had a hospitalization for NVAF. Patients using rivaroxaban during hospitalization were matched with up to four warfarin users by propensity score analyses. Patients who were first administered their oral anticoagulants on day 3 or later of their hospital stay were also evaluated. Comparison of hospital LOS was assessed using generalized estimating equations. RESULTS: The characteristics of the matched cohorts were well balanced. Among the matched rivaroxaban and warfarin users (2809 and 11,085 patients, respectively), the mean age of the cohorts was 71 years and 49% of patients were female. The average (median) hospital LOS for rivaroxaban patients was 4.46 (3) days, compared to 5.27 (4) days for the warfarin cohort. The mean difference in hospital LOS of 0.81 days (19.44 hours) was found to be significant at P < 0.001. Patients who were administered rivaroxaban on day 3 of their hospital stay or later also had a significantly lower LOS compared to warfarin users. LIMITATIONS: These included inaccuracies or omissions in diagnoses, completeness of baseline characteristics, and a study population that included patients newly initiated on and patients who continued anticoagulant therapy. CONCLUSION: The study sample of NVAF patients receiving rivaroxaban was associated with a significantly shorter hospital length of stay compared to the sample of patients receiving warfarin.