scholarly journals Fondaparinux Pre-, Peri-, and/or Postpartum for the Prophylaxis/Treatment of Venous Thromboembolism (FondaPPP)

2021 ◽  
Vol 27 ◽  
pp. 107602962110145
Author(s):  
Carl-Erik Dempfle ◽  
Jürgen Koscielny ◽  
Edelgard Lindhoff-Last ◽  
Birgit Linnemann ◽  
Irene Bux-Gewehr ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Drug Hypersensitivity ◽  
Low Molecular Weight ◽  
Premature Births ◽  
First Line ◽  
Bleeding Events ◽  
Heparin Induced Thrombocytopenia ◽  
First Line Therapy ◽  
Heparin Allergy

We analyzed data for women who received fondaparinux for ≥7 days during pregnancy. The study retrospectively included women who received fondaparinux pre-, peri- and/or postpartum for ≥7 days for prophylaxis/venous thromboembolism (VTE) treatment at German specialist centers (2004-2010). Data on pregnancy, VTE risk factors, anticoagulant treatment, pregnancy outcome and adverse events were extracted from medical records. 120 women (mean age 31.5 years) were included. Among 84 women with prior pregnancies, 41.0% had ≥1 abortion. Anticoagulation was indicated for prophylaxis in 92.5% cases, including 82.5% women with an elevated VTE risk (82.8% thrombophilia, 34.2% VTE history). All women received low-molecular-weight heparin (LMWH) as first-line therapy; 3 also unfractionated heparin. Treatment changed to fondaparinux, due to heparin allergy (41.7%) or heparin-induced thrombocytopenia (10.0%). Fondaparinux was generally well tolerated. Adverse events included bleeding events (n = 5), abortion (n = 2), premature births (n = 2), stillbirth (n = 1), arrested labors (n = 2), injection site erythema (n = 4) and unspecified drug hypersensitivity (n = 6). No VTE events or increased liver enzymes occurred during treatment. In this retrospective study, fondaparinux was effective and well tolerated. Trial registration: ClinicalTrials.gov NCT01004939.

191 Association of immune related adverse events with the efficacy of immune checkpoint inhibitors in metastatic renal cell carcinoma

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A205-A206
Author(s):  
Vasilii Bushunow ◽  
Leonard Appleman ◽  
Roby Thomas
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Checkpoint Inhibitors ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Kaplan Meier

BackgroundImmune checkpoint inhibitors (ICI) are first-line therapy for tumors including metastatic renal cell carcinoma (mRCC). Use of ICI is complicated by diverse immune-related adverse events (irAEs), which can add significant morbidity but are also associated with improved efficacy of therapy.1 2 Risk factors for development of irAE are still poorly understood. We hypothesized that patients with mRCC treated with ICI as first-line therapy have higher rates of developing irAE’s than patients previously treated with other therapies.MethodsWe conducted a single-institution, retrospective medical record review of patients with mRCC treated with immune-checkpoint inhibitors from March 2011 through April 15, 2020. We identified therapy duration, and presence, severity, and treatment of adverse events. We defined overall survival as time elapsed from date of diagnosis until death or until completion of study. We classified severity of adverse events according to CTCAE guidelines. Statistical methods included univariate Cox proportional hazards and logistic regression models, and Kaplan-Meier curves were plotted for subgroups.ResultsA total of 64 unique charts were reviewed. 18 patients (28%) of patients were treated with ICI as first-line therapy. 28 patients (44%) experienced immune-related adverse events with a total of 40 irAE’s identified. Most irAE were grade I-II (78%), with 7 (17%) grade III and 1 (2.4%) grade IV irAE’s. Most common sites were skin (29%), thyroid (20%) and gastrointestinal (15%). Patients with irAE had increased survival compared to those who did not have irAE (median survival not reached, vs 139 weeks, p=0.0004) (figure 1). This finding remained after excluding patients who had only experienced dermatologic irAE (median survival not reached in non-derm irAE subgroup, vs 144 weeks for dermatologic or no irAE, p=0.01) (figure 2). Patients treated with ICI as first line therapy had greater rates of developing irAE (72%) than those who had prior therapies (32%) (OR 5.4; p = 0.006). There was no association between histology type and rate of irAE.Abstract 191 Figure 1Kaplan-Meier survival plot of OS between patients with any irAE and those without any irAEAbstract 191 Figure 2Kaplan-Meier survival plot of OS between patients with non-dermatologic irAE and those without any irAE or only dermatologic irAEConclusionsThe development of irAE’s in patients with mRCC treated with ICI is associated with longer survival. This study joins the growing body of evidence showing that presence of irAE’s is associated with increased treatment efficacy. Use of ICI as first-line therapy is associated with higher risk of irAE. Given growing use of ICI as first-line therapy, further study to predict onset and severity of irAE’s is required.AcknowledgementsHong Wang, PhD, for statistical support.Ethics ApprovalThis study was approved by the University of Pittsburgh Institutional Review Board. Approval number STUDY19100386.ReferencesElias R, Yan N, Singla N, Levonyack N, Formella J, Christie A, et al. Immune-related adverse events are associated with improved outcomes in ICI-treated renal cell carcinoma patients. J Clin Oncol 2019;37(7):S645.Verzoni E, Cartenì G, Cortesi E, et al. Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program. J Immunother Cancer 2019;7(1):99.

Economic evaluation of crizotinib, alectinib, ceritinib, and brigatininb in anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) as second-line treatment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21104-e21104
Author(s):  
Nimer S. Alkhatib ◽  
Briana Choi ◽  
Hala Halawah ◽  
Matthias Calamia ◽  
Dexter Gulick ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Adverse Events ◽  
Incremental Cost ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Reference Drug ◽  
First Line Therapy ◽  
Line Therapy ◽  
Life Years

e21104 Background: Crizotinib, alectinib, ceritinib, and brigatinib are approved as second line treatment for ALK+ NSCLC. Crizotinib was the first ALK inhibitor for first line therapy approved by Food and Drug Administration (2011) then ceritinib (2014), alectinib (2015), and brigatinib (2017) were approved as second line drugs. Following more data, these agents were approved as the first line therapy (2017 for ceritinib and alectinib; 2020 for brigatinib). These remain as a treatment option in patients who fail the first line therapy. Cost-effectiveness/utility analyses were conducted to assess clinical efficacy with varying costs of the agents. Methods: A three state Markov model were assumed (progression free, progression and death). Progression free survival (PFS) curves were digitized and fitted with exponential function. US payer perspective, a lifetime horizon, and discount rate of 3% were applied. Drug costs were Redbook wholesale acquisition cost. Other costs included were monitoring, adverse events and disease progression from published data (US$ 2020). Adverse events reported >5% in patients were included. Measured outcomes were PFS life years (PFSLY) and quality adjusted life years (PFSQALY). Crizotinib was the reference drug. Incremental cost-effectiveness and utility ratios (ICER/ICUR) of PFSLY and PFSQALY gained (PFSLYG, PFSQALYG) and lost were estimated. Base case (BCA) and probabilistic sensitivity analyses (PSA) were conducted. Results: Crizotinib was the reference drug for the following outcomes. For alectinib, with the decremental cost of -$14,653 (-$14,712), the incremental PFSLY of 0.16 (0.16) and PFSQALY of 0.05 (0.05) resulted in an ICER / PFSLYG of -$89,337 (-$88,604) and an ICUR / PFSQALYG of -$269,835 (-$266,510). For brigatinib, with the decremental cost of -$14,975 (-$14,954), the incremental PFSLY of 0.01 (0.01) and PFSQALY of ̃0.01 (0.02) yielded an ICER / PFSLYG of -$1,982,962 (-$1,431,631) and an ICUR / PFSQALYG of -$2,140,534 (-$570,538). For ceritinib, with the incremental cost of $7,590 ($7,514), there were decremental PFSLY of -0.01 (-0.01) and PFSQALY of -0.03 (-0.03). Conclusions: As second line treatment, crizotinib, ceritinib, and brigatinib had comparable PFSLYs and PFSQALYs while alectinib had the most PFSLY and PFSQALY and the lowest cost. Therefore, alectinib is the most cost-effective treatment for treating ALK+ NSCLC as the second line therapy.[Table: see text]

Safety and efficacy of direct oral anticoagulants for venous thromboembolism and stroke prophylaxis in patients with hematologic malignancies

2019 ◽  
Vol 26 (2) ◽  
pp. 351-360 ◽  
Author(s):  
Stephanie Kim ◽  
Jennifer Namba ◽  
Aaron M Goodman ◽  
Thi Nguyen ◽  
Ila M Saunders
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hematologic Malignancies ◽  
Low Molecular Weight ◽  
Direct Oral Anticoagulant ◽  
Low Molecular Weight Heparins ◽  
Bleeding Events

Purpose Low-molecular-weight heparins are currently the recommended antithrombotic therapy for treatment and prevention of malignancy-related venous thromboembolism. Currently, the evidence evaluating direct oral anticoagulants versus low-molecular-weight heparins or a vitamin K antagonist in cancer patients with hematologic malignancies is limited. We evaluated the safety and efficacy of direct oral anticoagulants for venous thromboembolism treatment or stroke prevention for non-valvular atrial fibrillation in patients with hematologic malignancies. Methods This was a retrospective evaluation of adult patients with hematologic malignancies who received at least one dose of the Food and Drug Administration-approved direct oral anticoagulant for venous thromboembolism treatment or stroke prevention. We determined the frequency of major bleeding events, non-major bleeding events, stroke, systemic embolism, appropriateness of initial direct oral anticoagulant doses, holding practices prior to procedures, and the rate of all-cause mortality. An analysis was also performed to compare the incidence of bleeding between patients with a history of hematopoietic stem cell transplant to non-transplant patients. Results A total of 103 patients were identified, with the majority of patients receiving rivaroxaban for venous thromboembolism treatment. Major bleeding events occurred in four patients and no fatal bleeding events occurred. Non-major bleeding occurred in 29 patients, most commonly epistaxis and bruising. Two patients experienced a systemic embolism while on direct oral anticoagulant therapy. Conclusion Direct oral anticoagulants may be a safe and effective alternative for anticoagulation therapy in patients with hematologic malignancies. However, larger prospective studies comparing direct oral anticoagulants to low-molecular-weight heparins or vitamin K antagonists are warranted to compare efficacy and safety outcomes in this patient population.

Low molecular heparin for cancer-associated venous thromboembolism – still the “CATCH of the day“?

Phlebologie ◽  
2015 ◽  
Vol 44 (05) ◽  
pp. 256-260
Author(s):  
A. Matzdorff
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Controlled Trial ◽  
Vitamin K Antagonists ◽  
Secondary Prophylaxis ◽  
Guideline Recommendation ◽  
Low Molecular Weight ◽  
Bleeding Events ◽  
Extended Treatment

SummaryIn December 2014 the CATCH study was presented at the annual meeting of the American Society of Hematology. CATCH is a randomized controlled trial comparing the low molecular weight heparin tinzaparin with warfarin for 6 months extended treatment (=secondary prophylaxis) of cancer-associated venous thromboembolism (VTE). 6.9 % of patients in the tanzaparin arm experienced recurrent symptomatic and asymptomatic VTE compared with 10 % in the warfarin arm, this difference was statistically not significant. The difference became significant when only symptomatic VTEs were compared. There was no difference in the incidence of major bleeding events, but significantly fewer patients experienced clinically relevant non-major bleeding with tinzaparin than warfarin. The CATCH study is so far the largest study on extended treatment of cancer-associated VTE. It supports the guideline recommendation that low molecular weight heparins should be preferred to vitamin K antagonists for anticoagulation of cancer-associated VTE.

Preliminary phase II study results of capecitabine (X) + irinotecan (I) + bevacizumab (A) as first-line therapy for patients (pts) with metastatic colorectal cancer (MCRC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14502-14502
Author(s):  
S. Beslija ◽  
M. Banjin ◽  
S. Jungic ◽  
N. Obralic ◽  
G. Kecman-Malcic ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Response Rate ◽  
Early Stage ◽  
Progression Free Survival ◽  
Disease Stage ◽  
First Line ◽  
Open Label ◽  
First Line Therapy ◽  
Study Results

14502 Background: The oral fluoropyrimidine X (Xeloda®) has improved efficacy, safety and convenience compared with 5-FU/LV in MCRC [Van Cutsem et al. Br J Cancer 2004] and early-stage colon cancer [Twelves et al. NEJM 2005]. A recent study showed that I + X q2w is active and well tolerated [Garcia-Alfonso et al. ESMO 2006]. The humanized monoclonal antibody A (Avastin®) targets VEGF and limits tumor angiogenesis. The addition of A to 5-FU/LV/I (IFL regimen) results in significant improvements in survival among pts with MCRC [Hurwitz et al. NEJM 2004]. Replacing 5-FU/LV with X in this combination is a logical step forward. Here we report data from an open-label phase II trial of XIA in MCRC. Methods: Pts with untreated, histologically confirmed MCRC received I 175 mg/m2 i.v. d1, X 1000 mg/m2 orally bid d2–8, and A 5 mg/m2 d1. Treatment was repeated q2w x12 cycles in the absence of disease progression or unacceptable toxicity. Pts without progressive disease after 12 cycles of XIA continued on the same dose of A + X 1500 mg/m2 bid d2–8, q2w. The primary endpoint was progression-free survival (PFS); secondary endpoints were response rate (RECIST), overall survival (OS), safety, and quality of life. Results: 24 out of a planned total of 32 pts have been enrolled. Baseline characteristics are: M/F 50%/50%; median age 53 years (range 30–70); disease stage at initial diagnosis IIIA/IIIB/IV 29%/21%/50%; no. of metastatic sites 1/>1 50%/50%; most common metastatic site liver; prior adjuvant therapy 33% (Mayo 5-FU/LV). Pts received a median of 12 cycles (range 1–18) of XIA. All 24 pts are evaluable for safety and 22 for efficacy. The overall response rate is 77% (4 CR, 13 PR); 2 pts (9%) have stable disease and 3 have progressed. One pt has died. Median PFS and median OS have not yet been reached. The only grade 3 adverse events are diarrhea (13%), fatigue (4%), mucositis (4%), enteritis (4%), ileus (4%); there is one report of grade 4 leucopenia. All other adverse events are mild-to-moderate. Conclusions: The XIA combination appears to be highly active and well tolerated as first-line treatment for MCRC, providing support for further evaluation of this combination. No significant financial relationships to disclose.

Combining cetuximab with FOLFOX regimen as the first-line therapy of KRAS wild-type advanced gastric cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 157-157
Author(s):  
Yung-Sung Yeh
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Large Scale ◽  
Direct Sequencing ◽  
Radical Resection ◽  
Wild Type ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

157 Background: Gastric cancer is one of the most common cancers worldwide with a high incidence in Asian countries, including Taiwan. For patients with recurrent or non-resectable advanced gastric cancer (AGC), chemotherapy or the combination of target and chemotherapy was chosen for therapy in AGC patients. We prospectively analyzed the safety and efficacy of cetuximab combined with FOLFOX4 as the first-line setting in patients with AGC. Methods: From January 2010 to January 2013, a total of 20 patients with histologically confirmed unresectable advanced/recurrent gastric cancer were enrolled into this study. Direct sequencing of KRAS mutation status was performed before the treatment. All patients received cetuximab 500 mg/m2every 2 weeks, and chemotherapy was administered with FOLFOX regimen of oxaliplatin at 85 mg/m2 plus leucovorin 200 mg/m2 on the first day of treatment, followed by 5-fluorouracil (5-FU) via a 24-hour continuous infusion of 1000 mg/ m2 5-FU on days 1-2 biweekly. Therapy was continued until disease progression or intolerable adverse events or receiving surgical resection. Results: All tumor tissues of 20 AGC patients were KRAS wild-type. With the median therapy of 6 cycles (4-8 cycles), clinical efficacy, according to RECIST criteria, showed an overall response rate of 55% (11/20), and 20% (4/20) of patients exhibited stable disease as well as 25% (5/20) who had progressive disease. Radical resection could be obtained in 30% (3/10) of unresectable patients as the neoadjuvant therapy. The median time to progress (TTP) was 8.3 months and the median overall survival (OS) was 12.2 months. The grade III-IV adverse events was observed in 4 of 20 (20%) patients, including 15% of neutropenia (3/20), 5% of skin rash (1/20), 10% of nausea and vomiting (2/20) as well as 15% of asthenia (3/20). Conclusions: Cetuximab combined with FOLFOX as the first-line therapy for KRAS wild-type AGC patients appears to have favorable efficacy and safety, and the possibility of conversion to radical resection. Grade 3-4 adverse events were relatively uncommon. Despite this preliminary favorable outcome; however, a long-term result and large scale clinical trial is mandatory to verify it.

Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4001-4001 ◽  
Author(s):  
Ann-Lii Cheng ◽  
Richard S. Finn ◽  
Shukui Qin ◽  
Kwang-Hyub Han ◽  
Kenji Ikeda ◽  
...  
Keyword(s):  
Growth Factor ◽  
Adverse Events ◽  
Growth Factor Receptors ◽  
Phase Iii ◽  
Type I ◽  
Fibroblast Growth Factor Receptors ◽  
First Line ◽  
Phase Iii Trial ◽  
First Line Therapy ◽  
Line Therapy

4001 Background: SOR is the only approved agent in uHCC and new options are needed. LEN, an inhibitor of vascular endothelial growth factor receptors 1‒3, fibroblast growth factor receptors 1‒4, platelet derived growth factor receptor α, RET, and KIT, showed activity in uHCC in a phase II trial. We report a phase III trial of LEN vs SOR as first-line therapy for uHCC. Methods: In this randomized, open-label, noninferiority (NI) study, pts had uHCC, ≥ 1 measurable target lesion, Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, ECOG PS ≤ 1, and no prior systemic therapy. Pts were randomized 1:1 to LEN (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8 mg/day) or SOR 400 mg twice daily. The primary endpoint was overall survival (OS). The OS hazard ratio (HR) and its 95% CI were estimated with a stratified Cox proportional hazard model. The predefined NI margin was 1.08. Secondary efficacy endpoints were progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR) by modified RECIST. Type I error rates for secondary efficacy endpoints were controlled with a fixed sequence procedure at 2-sided α = 0.05 after OS NI was claimed. Results: 954 Pts enrolled (LEN: 478; SOR: 476). Efficacy outcomes are shown in the table. A similar number of pts in both arms had treatment-emergent adverse events (TEAEs). Most common LEN TEAEs were hypertension (42%), diarrhea (39%), decreased appetite (34%), decreased weight (31%), and fatigue (30%). Median (range) treatment duration was 5.7 mos (0−35.0) for LEN and 3.7 mos (0.1−38.7) for SOR. 13% Of LEN-treated and 9% of SOR-treated pts discontinued due to adverse events. 33% Of LEN-treated and 39% of SOR-treated pts received second-line therapy. Conclusions: LEN is noninferior in OS, and achieves statistically significant and clinically meaningful improvements in PFS, TTP, and ORR, as first line therapy for uHCC. TEAEs were consistent with the known LEN safety profile. Clinical trial information: NCT01761266. [Table: see text]

scholarly journals Recurrent Venous Thromboembolism (VTE), Major Bleeding (MB), and Associated Cost of Treatment with Low Molecular Weight Heparin (LMWH) or Direct Oral Anticoagulant (DOAC) in High Risk Patients with Gastrointestinal (GI) Malignancies: Retrospective Real-World Analysis at a Comprehensive Cancer Center

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5057-5057 ◽  
Author(s):  
Alejandro Recio Boiles ◽  
Ali McBride ◽  
Hani M. Babiker ◽  
Nimer Alsaid ◽  
Ivo Abraham ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
High Risk ◽  
Adverse Events ◽  
Healthcare Costs ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Major Bleed ◽  
Recurrent Vte ◽  
Event Rates

Abstract Introduction: Cancer patients who experienced a venous thromboembolism (VTE) are at high risk for poor clinical outcomes; hence VTE recurrence prevention is salient. Low molecular weight heparin (LMWH) has been the preferred treatment for cancer-related VTE; however, direct oral anticoagulants (DOACs) have been prescribed empirically in cancer due to patient convenience. Although the recent HOKUSAI and SELECT-D trials have confirmed the non-inferiority of DOACs to LMWH in the management of recurrent VTE in cancer patients, there remain a continued safety concern for major bleeds (MB). Recurrent VTE and MB complications during anticoagulation treatment of GI cancer (GICA) patients are increased as compared to other cancer types. The incremental health care costs associated with VTE recurrences and MB episodes are significant and steadily increasing. In this retrospective analysis, we aimed (1) to evaluate for differences in the VTE recurrence rate and MB events based on anticoagulation therapy (LMWH or DOAC) prescribed with a prior VTE and (2) to calculate the associated healthcare costs for six months of treatment. Methods: We reviewed the medical records of patients with biopsy-proven GICA and imaging documented VTE treated with DOAC or LMWH from November 2013 to February 2017. Patients were excluded if anticoagulation was given for another treatment indication or cancer diagnosis. Adverse events of recurrent VTE and MB criteria were defined per the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Costs of LMWH and DOAC t was sourced from Medicare Reimbursement 2018. Hospital admission and adjusted 6-month ambulatory cots were sourced from Economic Evaluations of Anticoagulation Outcomes in the U.S. by Amin et al 2015. Costs were inflation-adjusted to 2018 cost levels using the Medical Care component of the Consumer Price Index. The Chi-squared test was used for overall and the Fisher exact test for pairwise comparisons of the proportions of patients experiencing VTE and MB events. Results: Our analysis included 106 patients on enoxaparin (N=40), rivaroxaban (N=37) and apixaban (N=29). Recurrent VTE outcomes at 6 months were 3 (7.5%) for enoxaparin, 1 (2.7%) for rivaroxaban, and 2 (6.8%), for apixaban (all p=n.s.) (Table 1). Major bleeding events at 6 months were 2 (5%) for enoxaparin, 2 (6.8%) for apixaban, and a significantly higher 8 (21.6%) for rivaroxaban (overall p=0.048; v. LMWH pairwise p=0.042; all other p=n.s.). The estimated composite costs associated with the observed recurrent VTE event rates were $173,130 for enoxaparin, $57,710 for rivaroxaban, and $115,420 for apixaban. The estimated composite costs associated with the observed MB event rates were $117,146 for enoxaparin and apixaban, versus $468,558 for rivaroxaban. The estimated total 6-months healthcare costs for recurrent VTE, MB and prescriptions were $293,784 for enoxaparin, $529,336 for rivaroxaban, and $235,634 for apixaban. Conclusion: Our real-world retrospective analysis corroborates a non-inferiority of DOACs to LMWH in preventing recurrent VTE in GICA patients at 6 months but a higher incidence of MB in rivaroxaban v. LMWH treated patients. The higher MB rate for rivaroxaban mainly accounts for the higher overall costs of this DOAC v. LMWH and apixaban. In absolute total costs, apixaban prevails over LMWH and rivaroxaban, and LMWH prevails over rivaroxaban in cost-efficiency in this analysis of anticoagulation in selected high-risk GICA patients. Rivaroxaban significantly increases medical costs, mainly driven by the total number of major bleed adverse events in GICA patients, confirming previously published evidence. The subpopulation of GICA patients at high risk of VTE/MB warrants an additional prospective clinical trial for primary safety major bleed outcomes of DOACs with an accompanying cost-effectiveness analysis. This may eventually reduce the healthcare economic burden. Disclosures Abraham: Sandoz: Consultancy.

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