Bleeding Incidence Among Patients With Venous Thromboembolism: A Large US Insurance Database Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2916-2916 ◽  
Author(s):  
Xianchen Liu ◽  
Lin Xie ◽  
Hemant Phatak ◽  
Jack Mardekian ◽  
Wilson Tan ◽  
...  
Keyword(s):  
Heart Disease ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Index Date ◽  
Bleeding Risk ◽  
Employment Equity ◽  
History Of ◽  
Equity Ownership ◽  
Insurance Database

Abstract Introduction It is crucial to assess clinical benefit and bleeding risk when selecting an anticoagulant for patients with venous thromboembolism (VTE). This study examined the incidence of major bleeding and non-major bleeding and clinical predictors of major bleeding among patients with VTE in the usual clinical practice setting. Methods VTE patients aged ≥18 years were identified from the Truven Health MarketScan commercial or Medicare supplemental insurance database. Index date was defined as the first VTE diagnosis between 07/01/2006 – 12/31/2011. Patients were required to have ≥2 VTE outpatient diagnoses within a 3-week window or have 1 VTE diagnosis in an inpatient setting, have a continuous health plan enrollment for 6 months prior to the index date (baseline), and have no VTE diagnosis in the baseline period. Major bleeding was defined as any bleeding that resulted in hospitalization or blood transfusion; all other bleeds were non-major bleeding. Patients were followed until major bleeding/non-major bleeding, death, disenrollment, or end of study. Multivariate Cox regression was used to examine factors associated with major bleeding. Results Of 267,655 eligible patients, 182,972 patients were with deep vein thrombosis (DVT) only (68.4%), 69,169 with pulmonary embolism (PE) only (25.8%); and 15,514 with both (5.8%). Mean age was 61.5 years, and 53.1% were female. Mean follow-up period was 17.3 months (median=12.1). The annual incidence of major bleeding and non-major bleeding were 3.9% and 20.1%, respectively. The median time to major bleeding from index VTE diagnosis was 2.2 months. Major risk factors at baseline for major bleeding (Risk increase>20%) were history of major bleeding (HR=10.78, 95%CI=10.30-11.28) and non-major bleeding (HR=1.61, 95%CI=1.54-1.68), chemotherapy (HR=1.27, 95%CI=1.20-1.35), age ≥65 vs.≤40 years (HR=1.27, 95%CI=1.18-1.37), alcohol abuse (HR=1.26, 95%CI=1.16-1.38), cancer (HR=1.25, 95%CI=1.19-1.31), and heart disease (HR=1.23, 95%CI=1.18-1.28) (Table). Baseline hormone therapy (HR=0.74, 95%CI=0.68-0.80) and pregnancy (HR=0.59, 95%CI=0.46-0.74) were associated with reduced risk for major bleeding. Conclusions Major and non-major bleeding were common in patients with VTE. Multiple factors, especially history of bleeding, age≥65 years, alcohol abuse, cancer and heart disease, were associated with increased risk for major bleeding. Further research needs to examine bleeding risk associated with anticoagulant therapy. Disclosures: Liu: Pfizer: Employment, Equity Ownership. Xie:StatInMed: Employment, Research Funding. Phatak:BMS: Employment, Equity Ownership. Mardekian:Pfizer: Employment, Equity Ownership. Tan:Pfizer: Employment, Equity Ownership. Baser:StatInMed: Employment, Research Funding. Ramacciotti:BMS: Employment, Equity Ownership.

scholarly journals Cardiac Events in Real-World Multiple Myeloma Patients Treated with Carfilzomib: A Retrospective Claims Database Analysis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3319-3319 ◽  
Author(s):  
Ajai Chari ◽  
Sanjay K. Aggarwal ◽  
Khalid Mezzi ◽  
Kenneth Wang ◽  
Christopher Kim ◽  
...  
Keyword(s):  
Real World ◽  
Research Funding ◽  
Cardiac Event ◽  
Index Date ◽  
Hospitalized Patients ◽  
Cardiac Events ◽  
Employment Equity ◽  
Claims Database ◽  
History Of ◽  
Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a hematologic cancer that mostly affects elderly patients who are at increased risk for development of cardiac-related comorbidities due to age-, disease-, and treatment-related factors. In real world data, approximately 25-30% of MM patients are hospitalized for a cardiac event after MM diagnosis (Kistler et al. American Society Hematology 2012 Annual Meeting, poster 2916). The proteasome inhibitor, carfilzomib, is approved for treatment of patients with relapsed or refractory MM. In carfilzomib clinical trials, grade 3 or higher cardiac failure was reported for ~4% of patients (Stewart et al. NEJM 2015;372:142-52, Dimopoulos et al. Lancet Oncol 2016;17:27-38). In this retrospective analysis, we sought to evaluate the incidence rate (IR) of cardiac events in MM patients treated with carfilzomib in a real-world setting in the US and to describe differences in baseline characteristics between carfilzomib-treated MM patients who do and do not have cardiac events. Methods: Newly-diagnosed MM patients with symptomatic disease were identified in the Truven MarketScan claims database from 1/1/05 to 6/30/15 using an algorithm validated for ascertainment of MM patients in claims data (Princic et al. Blood 2015;126:4521). All carfilzomib-treated patients were included in the analysis. The first dose of carfilzomib was the index date. The baseline period was 12 months prior to the MM diagnosis date to the index date. Cardiac events (hypertension, heart failure, ischemic heart disease, arrhythmias and conduction disorders, and cardiomyopathy) were identified during baseline by inpatient (IP) or outpatient (OP) claims and after index date by primary diagnosis on IP claims (hospitalized events). Logistic regression was used to estimate baseline covariates associated with any cardiac event. Due to sample size constraints, multivariate regression was not performed. The incidence rate (IR) per 1000 patient-years (PYRs) and associated 95% confidence interval (CI) of hospitalized cardiac events during carfilzomib treatment which included 30 days after the last carfilzomib dose were calculated among patients without a history of the corresponding hospitalized event during the baseline period. Results: The cohort included 498 MM patients treated with carfilzomib; 108 (22%) patients had ≥1 cardiac event identified by both IP and OP claims and 24 (5%) had ≥1 hospitalized cardiac event. Of the 24 hospitalized patients, 14 were hospitalized during carfilzomib treatment (median days to onset = 104) and 8 were hospitalized after carfilzomib treatment (>30 days post dosing; median days to onset = 284). The median age (range) of the 24 patients with hospitalized cardiac events and those with no hospitalized cardiac claims (n=474) was 62 (37, 79) and 61 (36, 96) years, respectively (Table). Baseline medical history of any cardiac event was evident for 92% of hospitalized patients and 84% of non-hospitalized patients. Among hospitalized patients, 25% were over 75 years as compared with 13% of non-hospitalized patients. In univariate analysis, patients with baseline amyloidosis, hypertensive chronic kidney disease, and chronic kidney disease had higher odds of having a hospitalized cardiac event. No significant differences were seen in the proportion of patients with or without a hospitalized cardiac event when evaluated by line of therapy or by carfilzomib treatment regimen (monotherapy or combination). Among patients aged 75+ years, 8.7% were hospitalized, while 2.5% and 4.9% of 65-74 and 18-64 year old patients were hospitalized, respectively (Table). IR per 1000 PYRs [95% CI] among the 14 carfilzomib-treated MM patients hospitalized for any cardiac event during the carfilzomib treatment period was 89.7 (49.0; 150.5) - see Figure for IRs of specific cardiac events. Conclusions: Among carfilzomib-treated patients in a US claims database, hospitalization for a cardiac event was uncommon (~5%) and does not exceed what has been observed in MM patients. Patients at highest risk for cardiac hospitalizations had a history of amyloidosis or chronic renal failure. Additional analyses in much larger populations are needed to better understand risk factors for these events. Disclosures Chari: Array Biopharma: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Amgen Inc.: Honoraria, Research Funding; Novartis: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Pharmacyclics: Research Funding; Janssen: Consultancy, Research Funding. Aggarwal:Amgen: Employment, Equity Ownership. Mezzi:Amgen Inc.: Employment, Equity Ownership. Wang:Amgen Inc.: Employment, Equity Ownership. Kim:Amgen Inc.: Employment, Equity Ownership. Zhu:Amgen Inc.: Consultancy. Braunlin:Amgen Inc.: Employment, Equity Ownership. Werther:Amgen Inc.: Employment, Equity Ownership. Mikhael:Abbvie: Research Funding; Celgene: Research Funding; Sanofi: Research Funding; Onyx: Research Funding.

Predictors of Major Bleeding in Patients with First Venous Thromboembolism Treated with Vitamin K Antagonists in Clinical Practice in the United Kingdom

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2327-2327
Author(s):  
Alexander T Cohen ◽  
Christopher Wallenhorst ◽  
Anja Katholing ◽  
Melissa Hamilton ◽  
Sreevalsa Unniachan ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Research Funding ◽  
Vitamin K Antagonists ◽  
Medical Illness ◽  
Treatment Episode ◽  
Bleeding Events ◽  
Employment Equity ◽  
History Of ◽  
Equity Ownership ◽  
Active Cancer

Abstract Introduction: The management of venous thromboembolism (VTE) and the prevention of recurrent VTE consists of anticoagulation primarily with Vitamin K Antagonists (VKA). The main adverse effect of anticoagulation is bleeding. This study aimed to investigate the predictors of major bleeding in patients with first VTE treated with VKA. Methods: A cohort study was undertaken using the United Kingdom's Clinical Practice Research Datalink with additional data from hospitalizations and causes of death. Patients with incident first VTE between 2008-2013 treated with VKA, i.e. starting VKA treatment within 60 days after first VTE, were included in the cohort. Major bleeding was defined in accordance with the International Society of Thrombosis and Haemostasis recommendations comprising fatal bleeds, bleeds at a critical site, and bleeding events in association with anemia or blood transfusions. Patients were followed until the end of the first VKA treatment episode. Hazard ratios of potential predictors for major bleeding during the first VKA treatment episode were estimated from Cox regression models which included recognized predictors for major bleeding before the diagnosis of VTE, and a list of potential predictors during VKA treatment. Results: Among 10,118 VKA-treated VTE patients the incidence rate of major bleeding was 2.6 (95% confidence interval (CI), 2.2-3.1) per 100 person-years (145 major bleeds during 5,548 person-years of VKA use). Among baseline characteristics, predictors for major bleeding (Table) included increasing age, and history of a major bleeding and of a non-major clinically relevant bleeding. Furthermore the following events after the first VTE (80 of 145 cases) were also associated with an increased risk of major bleeding: non-major clinically relevant bleeding, HR 2.88 (95% CI, 1.85 - 4.46), active cancer 4.13 (2.48-6.89), trauma 14.05 (7.96-24.82), surgery 3.27 (1.29-8.28), and medical illness 3.03 (1.87-4.90). Additional predictors for major bleeding were new onset or history of moderate/severe liver disease, 7.44 (2.93-18.92), or renal disease, 1.73 (1.19-2.52). Conclusions: Assessment for and awareness of these predictors prior to and during VKA treatment is needed to prevent major bleeding events. Caution is warranted in patients with these independent risk factors. Table 1. Association between factors at first VTE and during VKA treatment and major bleeding Incident major bleeding after first VTE n (%) Crude hazard ratio (95%-CI) Adjusted hazard ratio (95%-CI) Total 145 (100) Age1 <60 26 (17.93) 1 1 60-69 31 (21.38) 2.03 (1.21 - 3.42) 1.83 (1.07 - 3.14) 70-79 39 (26.90) 2.56 (1.56 - 4.21) 2.19 (1.27 - 3.76) 80+ 49 (33.79) 4.52 (2.81 - 7.28) 3.28 (1.90 - 5.68) Gender Female 72 (49.66) 0.98 (0.71 - 1.35) 0.89 (0.63 - 1.25) Type of first VTE DVT 82 (56.55) 1 1 PE 63 (43.45) 0.91 (0.65 - 1.27) 0.78 (0.56 - 1.09) History of bleeding prior to first VTE Non-major clinically relevant 56 (38.62) 2.09 (1.48 - 2.95) 1.75 (1.23 - 2.49) Major bleeding 13 (8.97) 4.47 (2.48 - 8.05) 3.17 (1.73 - 5.80) Prevalence of prior events at the day of the first VTE (duration of exposure) Active cancer (90 days) 14 (9.66) 2.07 (1.20 - 3.60) 0.75 (0.37 - 1.50) Non-active cancer 14 (9.66) 1.40 (0.81 - 2.43) 0.75 (0.42 - 1.37) Trauma (90 days) 11 (7.59) 1.01 (0.54 - 1.86) 1.09 (0.58 - 2.04) Inpatient surgery (90 days) 13 (8.97) 1.00 (0.57 - 1.77) 0.90 (0.48 - 1.68) Medical illness (90 days) 11 (7.59) 1.14 (0.62 - 2.11) 0.71 (0.35 - 1.42) Liver disease Mild 4 (2.76) 1.62 (0.60 - 4.38) 1.15 (0.42 - 3.17) Moderate/severe 5 (3.45) 6.80 (2.78 - 16.64) 7.44 (2.93 - 18.92) Renal disease 50 (34.48) 2.60 (1.84 - 3.66) 1.73 (1.19 - 2.52) Bleeding after first VTE Non-major clinically relevant 27 (18.62) 3.91 (2.55 - 5.99) 2.88 (1.85 - 4.46) Events after first VTE (duration of exposure) Active cancer (90 days) 32 (22.07) 4.76 (3.19 - 7.10) 4.13 (2.48 - 6.89) Trauma (14 days) 14 (9.66) 16.63 (9.49 - 29.12) 14.05 (7.96 - 24.82) Inpatient surgery (14 days) 5 (3.45) 5.79 (2.33 - 14.37) 3.27 (1.29 - 8.28) Medical illness (90 days) 24 (16.55) 3.24 (2.06 - 5.10) 3.03 (1.87 - 4.90) Disclosures Cohen: BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; Portola: Consultancy, Honoraria, Research Funding, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Research Funding, Speakers Bureau; Jannsen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pfizer: Consultancy, Honoraria, Research Funding, Speakers Bureau; Bayer: Honoraria, Research Funding, Speakers Bureau; Boeheringer Ingelheim: Consultancy, Honoraria. Hamilton:BMS: Employment, Equity Ownership. Unniachan:BMS: Employment, Equity Ownership. Martinez:Bayer: Research Funding; CSL Behring: Research Funding; Pfizer: Research Funding; BMS: Research Funding; Boehringer Ingelheim: Consultancy; Merz Pharma: Research Funding.

scholarly journals Risk of Venous Thromboembolism Recurrence Among Rivaroxaban Treated Patients Who Continued Versus Discontinued Therapy: Analyses Among VTE Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 144-144
Author(s):  
Alok A. Khorana ◽  
Jeffrey S Berger ◽  
Philip S Wells ◽  
Roger Seheult ◽  
Veronica Ashton ◽  
...  
Keyword(s):  
New Jersey ◽  
Major Bleeding ◽  
Research Funding ◽  
Index Date ◽  
Bleeding Events ◽  
Employment Equity ◽  
P Values ◽  
Kaplan Meier ◽  
Increased Risk ◽  
Equity Ownership

Abstract Background: The American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) disease recommend treatment with anticoagulation for at least 3 months in patients with VTE. Moreover, the EINSTEIN-extension study assessed the effect of rivaroxaban on the risk of VTE recurrences in patients who had completed 6 to 12 months of treatment for VTE. Results showed that rivaroxaban significantly reduced the risk of VTE recurrences with a small increased risk of major bleeding. The objective of this study was to assess the risk of VTE recurrences and major bleeding associated with extended rivaroxaban treatment in a real-world setting among all VTE patients (i.e., unprovoked, provoked, and cancer related). Methods: A retrospective study was conducted using Truven Health Analytics MarketScan Databases from 02/2011 to 04/2015. The study included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and continuously used rivaroxaban for at least 3 months. The end of the initial 3-month rivaroxaban treatment was defined as the index date and patients were categorized into discontinued (treatment ended) and continued cohorts. Patients were followed from index date until end of continuous treatment for the continued cohort or end of data or re-initiation of oral anticoagulant therapy for the discontinued cohort. The outcomes included VTE recurrences identified as a primary diagnosis documented during a hospitalization and major bleeding events identified by a validated algorithm (Cunningham et al., 2011). Kaplan-Meier rates for VTE recurrences and major bleeding events at 3, 6, 9, and 12 months after the index date were compared between cohorts with adjustment for baseline confounding using the inverse probability of treatment weights (IPTW) method based on propensity score. Patients with unprovoked VTEs, defined as not having recent surgery, cancer, pregnancy or estrogen therapy, were also evaluated. Sample sizes of patients with provoked VTEs and cancer were too small to analyze these populations. A sensitivity analysis was also conducted among VTE patients receiving rivaroxaban for at least 6 months. Results: Among the 3-month treatment population, a total of 5,933 (63.4% unprovoked VTE) and 1,536 (68.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 149.3 (124.4) days in the continued cohort and 211.1 (191.6) days in the discontinued cohort. The Kaplan-Meier analysis (Figure 1) showed that patients in the continued cohort had significantly lower rates of VTE recurrences after an additional 3 months (0.70% vs. 1.70%), 6 months (1.41% vs. 2.34%), 9 months (1.82% vs. 3.01%), and 12 months (1.97% vs. 3.01%; all p-values < 0.05) of treatment. No statistically significant differences in the cumulative event rates for major bleeding (Figure 2) were observed between the continued and the discontinued cohort at 3 months (0.58% vs. 0.82%), 6 months (0.91% vs. 0.88%), 9 months (1.33% vs. 1.18%), and 12 months (1.44% vs. 1.44%; all p-values > 0.05). Among the 6-month treatment population, a total of 2,676 (65.9% unprovoked VTE) and 1,127 (70.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 158.5 (130.6) days in the continued cohort and 206.5 (171.5) days in the discontinued cohort. Patients in the continued cohort had lower rates of VTE recurrences after an additional 3 months (0.82% vs. 1.41%), 6 months (1.22% vs. 2.69%), 9 months (1.35% vs. 3.02%), and 12 months (1.72% vs. 3.70%; except at 3 months all p-values < 0.05) of treatment. No differences in the cumulative event rates for major bleeding were observed between the continued and the discontinued cohorts. Similar results were found among patients with unprovoked VTE for the 3- and 6-month analyses. The interaction term between the cohort variable (Continued vs. Discontinued) and the type of VTE (unprovoked vs. other types of VTE) was non-significant in both populations (p-value > 0.05), which suggests that the benefit of extended treatment do not depend on the type of VTE events. Conclusions: Our study results suggest that all patients with VTE who continued rivaroxaban therapy after the first 3-month and 6-month treatment periods had significantly lower risk of VTE recurrences without an increased risk of major bleeding. Disclosures Khorana: Halozyme: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding. Berger:AZ: Research Funding; Merck: Membership on an entity's Board of Directors or advisory committees. Wells:BMS/Pfizer: Research Funding; Itreas: Other: Served on a Writing Committee; Janssen Pharmaceuticals: Consultancy; Bayer Healthcare: Other: Speaker Fees and Advisory Board. Seheult:Janssen Scientific Affairs, LLC: Consultancy. Ashton:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lejeune:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Wildgoose:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Kaatz:Bristol Myer Squibb: Honoraria; Pfizer: Honoraria; CSL Behring: Honoraria; Boehringer Ingelheim: Consultancy; Pfizer: Consultancy; Janssen: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Boehringer Ingelheim: Honoraria; Janssen: Honoraria.

scholarly journals Association of Bleeding Severity with Mortality with in-Hospital and Extended Thromboprophylaxis in the Medically Ill in the Magellan Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2441-2441
Author(s):  
Alex C. Spyropoulos ◽  
Gary E. Raskob ◽  
Alexander T Cohen ◽  
Walter Ageno ◽  
Jeffrey I. Weitz ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Events ◽  
Employment Equity ◽  
Advisory Committees ◽  
Increased Risk ◽  
Bayer Healthcare ◽  
Equity Ownership

Background: Venous thromboembolism (VTE) is common after hospitalization in acutely ill medical patients, yet extended thromboprophylaxis has not been widely implemented due to concerns about bleeding. The MAGELLAN study (NCT00571649) evaluated whether rivaroxaban (10 mg QD for 35±4 days) compared with enoxaparin (40 mg QD for 10±4 days) followed by placebo could prevent asymptomatic deep vein thrombosis, symptomatic VTE, and VTE-related death. Through Day 35, rivaroxaban was superior to enoxaparin/placebo in the modified intent-to-treat population (4.4% vs 5.7%, RR 0.77, 95%CI, 0.62 to 0.96, p=0.02), but there was an increase in clinically relevant bleeding, the composite of major and non-major clinically relevant (NMCR) bleeding (4.1% vs 1,7%, RR 2.5, 95%CI 1.85-3.25, p<0.001). Although major bleeding has been associated with increased mortality, the relationship between NMCR bleeding and all-cause mortality (ACM) is not established. We hypothesized that subjects in the MAGELLAN trial with major bleeding but not those with NMCR bleeding, would be at an increased risk of ACM irrespective of treatment group. Methods: We evaluated all bleeding events in subjects taking at least one dose of study drug from randomization until 2 days after the last dose (safety population) and their association with ACM through the Day 90 visit in 3 mutually exclusive groups: (1) subjects with no major or NMCR bleeding; (2) subjects whose first event was NMCR bleeding; and (3) subjects whose first event was major bleeding. Subjects only developing minimal or trivial bleeding were grouped with those who had no clinically relevant bleeding. Using a Cox proportional hazards model that included the bleeding group variable and baseline covariates significantly associated with ACM at p<0.05 (age, BMI, history of cancer, history of anemia, inflammatory disease, acute ischemic stroke, and acute respiratory insufficiency), we compared the risk of ACM in subjects with and without bleeding events. Results: The incidence of ACM for subjects who had NMCR bleeding was numerically higher but not significantly increased compared with subjects with no bleeding (20/176, 11.4% vs 468/7763, 6.0%, HR 1.41 95%CI 0.88, 2.25, p=0.151), while subjects with major bleeding were at a significantly increased risk of death (28/59, 47.5% vs 468/7763, 6.0%, HR 7.74 95%CI 5.16, 11.59, p<0.0001). Results of landmark analyses from the first bleeding event or end of treatment + 2 days to ACM for the three groups are displayed (Figure). Limitations: This analysis was post hoc and may have been underpowered to detect differences in ACM associated with NMCR bleeding. Conclusion: Major bleeding was associated with a significantly increased risk of ACM but NMCR bleeding was not. This suggests that a modest increase in NMCR bleeding associated with extended thromboprophylaxis with rivaroxaban may be acceptable to prevent VTE. Strategies to better select patients at lower risk of bleeding may improve the benefit risk profile of extended thromboprophylaxis with rivaroxaban. Disclosures Spyropoulos: Daiichi Sankyo: Consultancy; Boehringer Ingelheim: Consultancy, Research Funding; Portola: Consultancy; Bayer Healthcare: Consultancy; ATLAS (Colorado Prevention Center): Consultancy; Janssen R&D, LLC: Consultancy. Raskob:Janssen R&D, LLC: Consultancy, Honoraria; Novartis: Consultancy; Tetherex: Consultancy; Daiichi Sankyo: Consultancy, Honoraria; Anthos: Consultancy; Boehringer Ingelheim: Consultancy; Pfizer: Consultancy, Honoraria; Portola: Consultancy; Bayer Healthcare: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Eli Lilly: Consultancy. Cohen:Boston Scientific: Consultancy; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boehringer-Ingelheim: Consultancy, Speakers Bureau; GLG: Consultancy; AbbVie: Consultancy; ACI Clinical: Consultancy; Aspen: Consultancy, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; Temasek Capital: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism. Ageno:Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees, Other: conference and travel support; Bayer: Membership on an entity's Board of Directors or advisory committees, Other: research support,travel support ; BMS Pfizer: Other: travel support; Aspen: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Portola: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Sanofi: Membership on an entity's Board of Directors or advisory committees, Other: travel support. Weitz:Janssen R&D, LLC: Consultancy; Bayer Healthcare: Consultancy, Honoraria; Boehringer Ingelheim: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Daiichi-Sankyo: Consultancy, Honoraria; Ionis: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Portola: Consultancy, Honoraria. Spiro:Bayer U.S. LLC: Employment, Equity Ownership. Lu:Janssen R&D, LLC: Employment, Equity Ownership. Lipardi:Janssen Research and Develompent: Employment, Equity Ownership. Barnathan:Janssen Research and Development LLC: Employment, Equity Ownership. OffLabel Disclosure: Rivaroxaban is a Factor Xa inhibitor. It is currently under review by FDA for approval as thromboprophylaxis in acutely ill medical patients at risk for venous thromboembolism.

Analysis of Second Primary Malignancies in Lenalidomide-Treated Patients with IPSS Low- or Int-1-Risk Myelodysplastic Syndromes

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1704-1704 ◽  
Author(s):  
Aristoteles Giagounidis ◽  
Azra Raza ◽  
Alan F. List ◽  
Pierre Fenaux ◽  
Bouchra Benettaib ◽  
...  
Keyword(s):  
Research Funding ◽  
Prior History ◽  
Second Primary ◽  
Employment Equity ◽  
Phase 3 ◽  
Advisory Committees ◽  
Increased Risk ◽  
History Of ◽  
Equity Ownership ◽  
Rbc Transfusion

Abstract Abstract 1704 Background: Lenalidomide (LEN) is approved in the US for the treatment of RBC transfusion-dependent patients with IPSS Low- or Int-1-risk myelodysplastic syndromes (MDS) with del(5q), with or without other cytogenetic abnormalities. In a phase 3 trial, treatment with LEN 5 mg and 10 mg resulted in RBC transfusion independence (TI) for ≥ 26 weeks in 43% and 56% of such patients, cytogenetic response in 25% and 50%, and a significant improvement of health-related quality of life (p <.05 for both 5 mg and 10 mg). Achievement of RBC-TI ≥ 8 weeks was associated with a significantly reduced risk of AML progression and death (p <.05 for both) (Fenaux P et al. Blood 2011;doi: 10.1182/blood-2011-01-330126). In newly diagnosed multiple myeloma patients, results of phase 3 trials showed a numerical imbalance in the occurrence of second primary malignancies (SPMs) between patients treated with LEN (in combination with melphalan or immediately after high-dose melphalan therapy and stem cell transplantation) and control cohorts. SPMs were analyzed in clinical trials of LEN across indications, including MDS. Methods: This was a single arm analysis of SPM data retrieved from RBC transfusion-dependent patients with IPSS Low- or Int-1-risk MDS with or without del(5q) who received LEN as monotherapy in 5 studies (MDS-001, -002, -003, -004, and -007). The cutoff date was February 28, 2011. SPMs were defined using MedDRA (Medical Dictionary for Regulatory Activities) categories of invasive SPMs (hematologic malignancies and solid tumors) and non-melanoma skin cancers (NMSC). Acute myeloid leukemia (AML) is considered part of the natural history of disease progression in MDS. Although further follow-up is needed, results of a phase 3 study showed no obvious evidence for an increased risk of AML progression in LEN-treated RBC transfusion-dependent patients with IPSS Low- or Int-1-risk MDS and del(5q) (Fenaux P et al. Blood 2011;doi: 10.1182/blood-2011-01-330126). AML was not included in the present analysis. The overall number of SPMs (invasive malignancies and NMSC), and the number and incidence rate (IR) of all invasive SPMs were evaluated, with IR defined as the number of new events per 100 person-years (pys). The IR of invasive SPMs was compared with the IR of new events of invasive cancer as reported from the SEER (Surveillance, Epidemiology, and End Results) cancer registry (2.1/100 pys for persons aged ≥ 65 years) (Howalder N et al. National Cancer Institute, 2011). Results: The combined population of all 5 studies comprised 557 LEN-treated patients. The median age was 71 years (range 27–95 years) and 72% of patients were aged ≥ 65 years. 88 patients (15.8%) had a prior history of cancer including malignant melanoma, meningioma, breast cancer, lung cancer, squamous cell carcinoma, and basal cell carcinoma. A total of 28 patients (5.0%) developed ≥ 1 SPM, including 17 (3.1%) with an invasive SPM and 12 (2.2%) with NMSC; 1 patient had both an invasive malignancy and a NMSC. Two of the 17 patients with invasive SPMs had a B-cell malignancy and 15 had solid tumors of heterogeneous type. Of the 28 patients with SPMs in total, 5 patients had a prior history of cancer. The IR of invasive SPMs was 2.60/100 pys (95% confidence interval 1.56–4.07), which is consistent with the IR reported in the SEER database among patients in this age group (2.1/100 pys for persons aged ≥ 65 years). The median time to onset of SPMs was 13.5 months (range 0.3–48.6 months). Conclusion: There was no clear evidence to associate LEN treatment with an increased risk of developing SPMs in patients with Low- or Int-1-risk MDS with or without del(5q). The IR of invasive SPMs among these LEN-treated patients is what would be expected from population-based estimates of invasive cancer incidence among persons in this age group. The collection of data on SPMs in LEN-treated patients including post-marketing information is ongoing. Disclosures: Giagounidis: Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. List:Celgene Corporation: Consultancy, Honoraria, Research Funding. Fenaux:Merck: Honoraria; Johnson & Johnson: Honoraria; Amgen: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Celgene Corporation: Honoraria, Research Funding; Cephalon: Honoraria; Novartis: Honoraria. Benettaib:Celgene Corporation: Employment, Equity Ownership. Brown:Celgene Corporation: Employment, Equity Ownership. Zhong:Celgene Corporation: Employment, Equity Ownership. Brandenburg:Celgene Corporation: Employment, Equity Ownership. Mufti:Celgene Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Is Adherence to the American College of Chest Physicians Recommended Anticoagulation Treatment Duration Associated with Different Outcomes Among Patients with Venous Thromboembolism?

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1126-1126 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Ron Preblick ◽  
Jackie Kwong ◽  
Melissa Lingohr-Smith ◽  
Jay Lin
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Duration ◽  
Bleeding Risk ◽  
Patient Characteristics ◽  
Baseline Period ◽  
Employment Equity ◽  
Minimum Duration ◽  
Study Population ◽  
Equity Ownership

Abstract Introduction: Venous thromboembolism (VTE) represents a major clinical and economic burden. The American College of Chest Physicians (ACCP) Guideline 9th Edition on the treatment of VTE recommends a minimum duration of anticoagulation (AC) therapy depending on patient risk profiles. The objectives of this study were to evaluate the clinical and economic outcomes associated with adherence to the AC treatment duration recommendation among VTE patients in the real world setting. Methods: Adult patients (≥18 years of age) with at least 1 inpatient diagnosis or 2 outpatient diagnoses on two different dates of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), based on ICD-9-CM codes, were identified from the IMS Pharmetrics Plus database during 1/1/2009 through 3/31/2013. The first VTE diagnosis was defined as the index event. Study patients were required to have continuous insurance coverage during the 12 months before (baseline) and after (follow-up) the index event and no prior VTE diagnosis in the baseline period. They were also required to have received at least one outpatient anticoagulant treatment within 30 days of the initial VTE diagnosis with a minimum medication days of supply of 30 days. ACCP recommend that patients with provoked VTE or unprovoked VTE and high bleeding risks receive AC treatment for at least 3 months and that patients with unprovoked VTE and low or moderate bleeding risks or patients with cancer receive AC treatment for at least 6 months. Patient records in the database including ICD-9-CM codes and RIETE bleeding risk scores were used to group patients into 2 cohorts, one comprised of patients who received AC treatment for a duration as recommended by the ACCP (adherent group, AD) and the other comprised of patients who received AC treatment for a duration less than that recommended by the ACCP (non-adherent group, non-AD). Patient demographics and clinical characteristic were evaluated during the baseline period. Healthcare resource utilization, including hospital admissions, outpatient medical services, and prescription drug usage, were measured during the baseline and follow-up periods. VTE recurrence, defined as hospitalization or ER visit with a VTE diagnosis code, was also measured during the follow-up period. Multivariate regression analysis was utilized to compare clinical and economic outcomes of study cohorts while controlling for key patient characteristics. Results: The study population included 81,827 patients with a mean age (standard deviation) of 55.3 (13.8) years. For the index VTE event, 61% had DVT only, 26% had PE only, and 13% had DVT/PE. Of the study population, the minimum ACCP recommended AC treatment durations were 3 and 6 months for 27% (n=22,157) and 73% (n=59,670) of patients, respectively. Among all patients, 74% (n=60,550) received AC therapy for the ACCP recommended duration. The proportion of patients with VTE risks, including recent hospitalization (17% vs. 9%, p<0.001), recent surgery (9% vs. 6%, p<0.001), index diagnosis of PE only (28% vs. 20%, p<0.001), and index diagnosis of DVT/PE (15% vs. 8%, p<0.001) was greater in the AD cohort than in the non-AD cohort. Furthermore, mean Charlson Comorbidity Index score (1.67 vs. 1.59, p<0.001) and RIETE bleeding risk score (RIETE ≥1: 66% vs. 55%, p<0.001) were higher for the AD cohort compared to the non-AD cohort. The most prevalent anticoagulants used for treatment were warfarin (89% vs. 96%, p<0.001) and low molecular weight heparin (58% vs. 59%, p<0.01). After controlling for key patient characteristics, risks for all-cause hospitalization (Odds ratio (OR): 0.80, confidence interval (CI): 0.77-0.83, p<0.001) and VTE recurrence (OR=0.91, CI: 0.86-0.95, p<0.001) were lower among VTE patients in the AD cohort vs. the non-AD cohort, as were differences in all-cause total healthcare payments (-$3,416, p<0.001) and VTE-related healthcare payments (-$2,139, p<0.001) during the follow-up period. Conclusions: Approximately a quarter of the study population with VTE did not receive treatment with AC therapy for the minimum duration as recommended by the ACCP guideline. Patients who did not receive outpatient AC therapy for the recommended duration had more VTE recurrences, utilized more inpatient services, and had higher healthcare costs than patients who received AC therapy for the ACCP recommended duration. Disclosures Spyropoulos: Daiichi Sankyo, Inc.: Consultancy. Preblick:Daiichi Sankyo, Inc.: Employment, Equity Ownership. Kwong:Daiichi Sankyo, Inc.: Employment, Equity Ownership. Lingohr-Smith:Chimerix, Inc.: Consultancy; Bristol-Myers Squibb: Consultancy; Daiichi Sankyo, Inc: Consultancy; Novosys Health: Employment. Lin:Chimerix, Inc.: Consultancy; Daiichi Sankyo, Inc: Consultancy; Bristol-Myers Squibb: Consultancy; Novosys Health: Employment.

scholarly journals Safety of Anticoagulant Therapies for Treatment of Venous Thromboembolism in Patients with Cancer

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1178-1178 ◽  
Author(s):  
Michael Streiff ◽  
Dejan Milentijevic ◽  
Keith McCrae ◽  
Daniel Yannicelli ◽  
Jonathan Fortier ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Major Bleeding ◽  
Research Funding ◽  
Hazard Ratio ◽  
Control Cohort ◽  
Bleeding Events ◽  
Employment Equity ◽  
Patients With Cancer ◽  
Equity Ownership ◽  
Major Bleeding Events

Abstract Introduction: Anticoagulation is effective for the treatment of venous thromboembolism (VTE) in cancer patients, but it is also associated with an increased risk of bleeding. Previous clinical trials (e.g., CLOT and CATCH) of LMWH and warfarin for the treatment of VTE in cancer patients reported major bleeding in 3% to 6% of treated patients. The objective of this observational study was to compare the risk of major bleeding in cancer patients treated with anticoagulants for VTE in a real world setting. Methods: Medical and pharmacy claims from the Humana Database from 1/1/2013 to 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis, and with ≥1 dispensing of an anticoagulant within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban (other agents not included due to low utilization). Inverse probability of treatment weights based on propensity score were used to adjust for differences between treatment cohorts for the following comparisons: LMWH vs. rivaroxaban, LMWH vs. warfarin, and rivaroxaban vs. warfarin. Patients were followed up until the earliest event, either treatment non-persistence (gap > 60 days between the end of the days of supply of a dispensing and the start date of the next dispensing), or end of data availability. Major bleeding events were identified using validated criteria (Cunningham et al., 2011). Kaplan-Meier rates at 3 and 6 months and Cox proportional hazards models were used to compare the risk of bleeding between different treatment cohorts. To better understand the risk of major bleeding in cancer patients unrelated to anticoagulation, a cohort of patients with cancer who did not have VTE and did not receive an anticoagulant was added as a control cohort. Results: A total of 2,428 patients (LMWH: n=660; warfarin: n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced among treatment cohorts. Median duration of therapy with LMWH was shorter than rivaroxaban (1.0 vs. 3.0 months, p<.0001) and warfarin (1.0 vs. 3.5 months, p<.0001). Rates of major bleeding for LMWH and rivaroxaban were 8.3% and 8.2%, respectively at 6 months with a hazard ratio (HRs [95% CI]) of 1.03 (0.64-1.65; Figure 1A). In the comparison between LMWH and warfarin cohorts, major bleeding rates were 8.5% and 8.6%, respectively at 6 months with hazard ratio (HRs [95% CI]) of 1.04 (0.69-1.57; Figure 1B). The risk of major bleeding was also similar for rivaroxaban and warfarin cohorts, 9.0% and 8.7%, respectively at 6 months with a hazard ratio (HR [95% CI]) of 1.01 (0.71-1.43; Figure 1C). For the control cohort of cancer patients without VTE and not receiving anticoagulation median follow-up was 5.6 months. Rates of major bleeding events for the control cohort were 2.6% and 4.2 % at 3 and 6 months, respectively. Conclusion: This real world study of cancer patients treated for VTE found that the risk of major bleeding was similar for the 3 most widely prescribed anticoagulants in current clinical practice: LMWH, warfarin, and rivaroxaban. The observed rates of major bleeding were generally higher than what has been reported for LMWH and warfarin in the CLOT and CATCH trials. Patient characteristics such as older age (average age 73 years) could have contributed to the higher major bleeding rate seen in this study compared to the CLOT and CATCH trials, respectively. Figure 1 Rates of Major Bleeding Events LMWH vs. rivaroxaban cohorts Figure 1. Rates of Major Bleeding Events. / LMWH vs. rivaroxaban cohorts Figure 2 LMWH vs. warfarin cohorts Figure 2. LMWH vs. warfarin cohorts Figure 3 rivaroxaban vs. warfarin cohorts Figure 3. rivaroxaban vs. warfarin cohorts Disclosures Streiff: Portola: Research Funding; Janssen: Consultancy, Research Funding; Roche: Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Yannicelli:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Nelson:Janssen Scientific Affairs: Employment, Equity Ownership. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Roche: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.

scholarly journals Real-World Analysis of Ruxolitinib Treatment Patterns and Outcomes Among Patients with Myelofibrosis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4750-4750 ◽  
Author(s):  
Tanya Burton ◽  
Kejal Parikh ◽  
Manish Patel ◽  
Kevin Sundquist ◽  
Lincy S. Lal ◽  
...  
Keyword(s):  
Health Plan ◽  
Research Funding ◽  
Index Date ◽  
Myeloproliferative Neoplasm ◽  
Treatment Patterns ◽  
Systemic Steroid ◽  
Administrative Claims ◽  
Employment Equity ◽  
Oncology Research ◽  
Equity Ownership

Background: Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by bone marrow fibrosis, splenomegaly, cytopenias, and poor survival. Ruxolitinib (RUX) is the only approved treatment for Intermediate or High-risk MF. In a previous study, we have shown almost 1 in 3 patients initiating RUX had dose modifications during the first 3 months of treatment (Burton T et al. HemaSphere 2019). The objective of this study was to assess RUX treatment patterns among patients with MF. Methods: This retrospective analysis used administrative claims data from a large US health plan to identify adults (aged ≥ 18 years) with ≥ 1 claim for RUX and ≥ 2 non-diagnostic medical claims for primary (International Classification of Diseases [ICD] 9th or 10th Revision [9/10]: 238.76, D47.4) or secondary MF (ICD-9/10: 289.83, D75.81) from January 1, 2012 to June 30, 2018. The first RUX claim on or after the first MF claim defined the index date. Included patients were continuously enrolled in a commercial or Medicare Advantage health plan for 3 months before the index date (pre-index period) and 6 months on or after the index date (post-index period). Clinical characteristics, MF-related treatments, health care resource utilization (HCRU), and costs were assessed during the pre- and post-index periods. Costs were adjusted to 2018 US dollars using the medical component of the Consumer Price Index. Cohorts were created based on the maximum (max) RUX daily dose observed during the 6-month post-index period: suboptimal max < 30 mg/day (SUB); and optimal max ≥ 30 mg/day (OPT). All variables were analyzed descriptively. Results: Among 495 eligible patients, mean (SD) age was 69.4 (10.3) years; 54.1% were male; and 25% had a primary MF diagnosis code. Median initial RUX dose was 30 mg/day and patients continued with this dose for a mean (SD) of 70.0 (45.8) days. RUX dose was modified for 19.4% of patients during the 6-month post-index period, and the distribution of max RUX daily doses was: < 15 mg (13.7%), 15-29 mg (24.9%), 30-40 mg (55.8%), and > 40 mg (5.7%). Two groups based on max RUX dosing were further analyzed: 191 (38.6%) in the SUB cohort (< 30 mg), and 304 (61.4%) in the OPT cohort (≥ 30 mg). Patients in the SUB cohort were older than patients in the OPT cohort (SUB: mean 70.8 [SD 10.1] years; OPT: mean 68.5 [SD 10.3] years; P = 0.013), but the mean Charlson Comorbidity Index scores did not differ (SUB: mean 1.6 [SD 1.8]; OPT: mean 1.5 [SD 1.8]; P = 0.601). Rates of anemia were higher at baseline for the SUB cohort than the OPT cohort (SUB: 64.9%; OPT: 53%; P = 0.009). During the 6-month post-index period, compared with patients in the OPT cohort, patients in the SUB cohort had a higher proportion of thrombocytopenia (SUB: 31.4%; OPT: 22.7%; P = 0.03). Nearly half (45.5%) the sample used a supportive agent such as an androgen, systemic steroid, or erythropoiesis-stimulating agent during the post-index period (SUB: 48.2%; OPT: 43.8%; P = 0.34). With respect to HCRU and costs, the SUB cohort had a higher proportion of emergency department (ED) visits than the OPT cohort during baseline (SUB: 31.4%; OPT: 23.4%; P = 0.048); and baseline total mean (SD) all-cause costs were USD 18,079 (21,876) overall, USD 18,908 (24,411) for the SUB cohort, and USD 17,559 (20,145) for the OPT cohort (P = 0.523). During the 6-month follow-up period, 31.1% of patients had ≥ 1 ED visit (SUB: 35.1%; OPT: 28.6%; P = 0.131), 22.8% had ≥ 1 inpatient (IP) hospitalization (SUB: 24.6%; OPT: 21.7%; P = 0.455), and total mean (SD) all-cause costs were USD 94,498 (97,391) overall (SUB: USD 93,289 [115,418]; OPT: USD 95,258 [84,315]; P = 0.839). Conclusion: In this study, patients with MF treated with RUX experienced significant disease burden and high costs, regardless of dose. Both anemia and thrombocytopenia were observed along with nearly half of patients using a supportive agent. Given the large proportion of patients with a dose adjustment, suboptimal dosing, and an IP hospitalization, there continues to be a need for additional therapeutic options for patients with MF. Disclosures Parikh: Celgene Corporation: Employment, Equity Ownership. Patel:Celgene Corporation: Employment, Equity Ownership. Sundquist:Optum: Employment, Equity Ownership. Lal:Optum: Employment. Copher:Celgene Corporation: Employment. Gerds:Roche: Research Funding; Incyte: Consultancy, Research Funding; Sierra Oncology: Research Funding; CTI Biopharma: Consultancy, Research Funding; Imago Biosciences: Research Funding; Celgene Corporation: Consultancy, Research Funding; Pfizer: Consultancy.

scholarly journals Reduced Costs and Length-of-Stay Associated with Rivaroxaban As Compared to Parenteral Bridging and Warfarin in Pulmonary Embolism Patients Managed in Observation Status

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2337-2337
Author(s):  
Christine G Kohn ◽  
Erin R Weeda ◽  
W Frank Peacock ◽  
Gregory J Fermann ◽  
Christopher W. Baugh ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
New Jersey ◽  
Major Bleeding ◽  
Research Funding ◽  
Hospital Costs ◽  
Advisory Board ◽  
Hospital Treatment ◽  
Total Hospital ◽  
Employment Equity ◽  
Equity Ownership

Abstract Background: Observation stays are intended to assess patients for short periods (i.e., <2-midnights) to determine need for inpatient admission or discharge. Unlike rivaroxaban, treatment of pulmonary embolism (PE) with parenteral bridging to warfarin requires frequent coagulation monitoring and dosing adjustments that may prolong length-of-stay (LOS) and increase hospital treatment costs. Objective: To compare LOS, hospital treatment costs, and readmissions in PE patients managed through observation stays treated with either rivaroxaban or parenterally-bridged warfarin. Methods: US Premier Hospital claims data spanning 11/2012-9/2015 was used to identify patients with a primary diagnosis code for PE (415.1x) managed through an observation stay and having ³1 claim for a PE-related diagnostic test on day 0-2. Rivaroxaban users, allowing ²2 days of prior parenteral therapy, were 1:1 propensity-score matched to patients parenterally bridged to warfarin. LOS, the proportion of encounters lasting >2-midnights, total hospital costs and risk of readmission for venous thromboembolism (VTE) or major bleeding during the same month or 2 months subsequent to the index event were compared between propensity-score-matched treatment cohorts. Results: A total of 401 rivaroxaban patients were matched to 401 patients receiving parenteral bridging to warfarin.Rivaroxaban use was associated with a shorter LOS (-0.25 days), fewer encounters lasting >2 midnights (21.1% vs. 32.7%) and lower total hospital costs (-$240) vs. parenteral bridging to warfarin (p²0.03 for all) (Table). Readmission was similar between cohorts (p>0.99 for both VTE and major bleeding readmission). Conclusion: Shorter LOS and lower hospital costs occurred with rivaroxaban vs. parenteral bridging to warfarin in PE observation stay patients. This was achieved without increasing short-term risk of VTE or major bleeding readmission. Table Table. Disclosures Peacock: Portola: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding. Fermann:Janssen Pharmaceuticals: Other: Advisory Board, Speakers Bureau; Pfizer: Research Funding. Baugh:Janssen Pharmaceuticals: Consultancy; Roche Diagnostics: Other: Advisory Board. Wells:Janssen Pharmaceuticals: Consultancy; Bristol Myers Squib: Research Funding; Pfizer: Research Funding; Bayer Healthcare: Other: Advisory Board, Speakers Bureau; Itreas: Other: Writing Committee. Ashton:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Wildgoose:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Coleman:Boehringer-Ingelheim Pharmaceuticals, inc.: Consultancy, Research Funding; Bayer Pharmaceuticals AG: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding.

Disease and Clinical Characteristics of Patients with Polycythemia Vera: An Early View of the Reveal Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2813-2813
Author(s):  
Brady Stein ◽  
Alison Moliterno ◽  
Ralph V. Boccia ◽  
Ahmad B. Naim ◽  
Joseph A. Cordaro ◽  
...  
Keyword(s):  
Research Funding ◽  
Clinical Characteristics ◽  
Thromboembolic Event ◽  
Employment Equity ◽  
Advisory Committees ◽  
Reveal Study ◽  
Patient Reported ◽  
The Us ◽  
History Of ◽  
Equity Ownership

Abstract Background: Patients with polycythemia vera (PV) have an increased symptom burden (eg, fatigue, pruritus, and splenomegaly-related symptoms) and an increased risk of mortality compared with the general population, often resulting from thrombotic events, disease transformation to myelofibrosis, or secondary malignancies. There are limited data regarding PV burden and treatment patterns in a contemporary, real-world US setting. REVEAL is an ongoing observational study being conducted to describe contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and healthcare resource utilization among patients with PV in the US. The objective of this assessment is to describe the clinical characteristics at enrollment among patients currently enrolled in REVEAL (enrollment from July 22, 2014 to June 9, 2015). Methods: REVEAL is a multicenter, noninterventional, nonrandomized, prospective, observational study. Eligible patients are ≥18 years of age with a PV diagnosis and currently under active management by a physician in the US. Data regarding disease and clinical characteristics, patient-reported outcomes, and health resource utilization are being collected at usual-care visits over a planned 36-month observation period. Analyses of these preliminary data were descriptive. Results: At data cutoff, 865 patients were enrolled (total planned enrollment, n=2000) from 174 sites (academic, n=27; community, n=147). Median (range) age at enrollment was 67 (22-95) years, 55.5% were male, 89.5% were white, and 45.4% had a history of smoking. Most patients (99.4%) had health insurance, including Medicare (56.0%), PPO (24.3%), or HMO (11.6%). Fifty-two percent were retired, 29.6% were employed, and 4.5% were unable to work or disabled. A total of 40.2% of patients completed a college/graduate degree, 19.9% had some college, and 32.5% completed high school or the equivalent. Documented major World Health Organization diagnostic criteria included JAK2V617F mutation in 50.9% of patients, elevated hemoglobin in 52.3%, and red cell mass in 5.5%. A bone marrow biopsy was conducted in 24.0% of patients, approximately half of whom (52.4% of the 24.0%) had trilineage myeloproliferation. Erythropoietin levels were abnormal in 19.7% of patients. Approximately half (46.6%) of patients had physician-reported PV-related symptoms at diagnosis, most frequently fatigue (25.2%) and pruritus (14.0%). At enrollment, median disease duration was 52.6 months; 42.3% of patients were diagnosed ≥5 years before enrollment. The most common comorbidities were hypertension (51.3%), obesity (14.2%), dyspnea (13.4%), myalgia (11.2%), and diabetes mellitus (11.1%). Mean hematocrit was 44.9%, hemoglobin was 14.5 g/dL, white blood cell count was 11.4×109/L, platelet count was 363.7×109/L, and absolute neutrophil count was 363.7×109/L. Twenty-one percent of patients had a history of thrombotic events, with 13.1% and 8.6% of patients experiencing ≥1 venous or arterial thromboembolic event, respectively. Of the 261 reported thrombotic events, 43.7% occurred after diagnosis of PV. The most common PV symptoms recorded at enrollment (using the Myeloproliferative Neoplasm Symptom Assessment Form) were fatigue (37.1%), pruritus (24.0%), headache (18.6%), insomnia (17.0%), dizziness (13.2%), bone pain (10.5%), and blurred vision (7.9%); 19.7% of 518 evaluable patients had palpable splenomegaly. Fewer than half of patients were receiving aspirin at enrollment (47.7%). The most common PV treatments ± aspirin were phlebotomy (PBT; 63.5%), hydroxyurea (HU; 42.2%), watchful waiting (5.3%), and ruxolitinib (3.1%); 23.0% of patients received PBT + HU. Conclusion: The REVEAL study is unique in that it captures data from both academic and community centers, and therefore includes a broader segment of the PV population typically not described in the literature. REVEAL can provide novel insights into questions related to the contemporary demographics of PV, practice patterns regarding diagnosis and therapy, and the real-world burden of PV and its impact on patients' quality of life and work productivity. Preliminary descriptive data from this early subset of patients suggest that a high proportion of patients report having PV-related symptoms at diagnosis, fewer patients are treated with aspirin than expected, and that thromboembolic event rates remain high after diagnosis. Disclosures Stein: Incyte Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moliterno:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Boccia:Incyte Corporation: Honoraria. Naim:Incyte Corporation: Employment, Equity Ownership. Cordaro:Incyte Corporation: Employment, Equity Ownership. Peng:Incyte Corporation: Employment, Equity Ownership. Sun:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Mesa:Promedior: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; NS Pharma: Research Funding; CTI Biopharma: Research Funding; Gilead: Research Funding; Pfizer: Research Funding; Incyte Corporation: Research Funding; Genentech: Research Funding.

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