Dalteparin sodium 100,000units/4ml solution for injection vials

PurposeTo analyze the costs of high thromboembolic risk patients who require low molecular weight heparins (LMWHs) as a thromboprophylaxis strategy.MethodsCost analysis was conducted to assess LMWHs (enoxaparin versus comparators: nadroparin and dalteparin) as thromboprophylaxis for hospitalized patients with high thromboembolic risk in Oncology, General or Orthopedic Surgery, and Internal Medicine services from the healthcare provider's perspective in Colombia. A decision tree was developed, and the health outcomes considered in the analysis were deep vein thrombosis, major bleeding, pulmonary thromboembolism, and chronic pulmonary hypertension. Clinical inputs were obtained from a systematic review of the literature and the economic parameters from micro-costing. Inputs were validated by three clinical experts. Costs were expressed in 2020 US dollars (USD).ResultsIn a hypothetical cohort of 10,000 patients with a thromboprophylaxis use rate of 40%, the use of enoxaparin was less costly than that of dalteparin in Oncology (difference of USD 624,669), Orthopedic Surgery (difference of USD 275,829), and Internal Medicine (difference of USD 109,119) patients. For these services, using enoxaparin was more efficient than using nadroparin (cost differences of USD 654,069, USD 416,927, and USD 92,070, respectively). Sensitivity analysis showed an important influence of the number of patients undergoing thromboprophylaxis, as well as the unit cost, and the risk of events (DVT, PTE, and CTEPH).ConclusionEnoxaparin is the least expensive health technology for thromboprophylaxis in most of the medical contexts analyzed in Colombia due to its efficacy and the lower risk of complications than dalteparin and nadroparin.

Abstract licence: CC BY-NC

Venous thromboembolism (VTE) is a serious postoperative complication in patients undergoing total hip or knee arthroplasty, with both pulmonary embolisms and deep vein thromboses being major causes of preventable morbidity and mortality. Low-molecular-weight heparins such as enoxaparin and dalteparin are widely used for thromboprophylaxis, but direct comparative data are limited. We aimed to do a systematic review of the literature to compare the efficacy and safety of enoxaparin and dalteparin in preventing VTE following total hip or knee replacement surgery. A systematic literature search was conducted in MEDLINE, PubMed, Embase, and the Cochrane Library. After deduplication, 145 studies were screened, 28 full texts were assessed, and three papers were included. Eligible studies were randomised controlled trials (RCTs) or observational studies comparing enoxaparin and dalteparin in adult patients undergoing hip or knee arthroplasty, reporting VTE rates as the primary outcome. Risk of bias (ROB) was assessed using the Cochrane RoB 2 tool for randomised trials and the Newcastle-Ottawa Scale for observational studies. Three studies - one RCT and two retrospective cohort studies with a total of 1,167 patients - met the inclusion criteria. Across all studies, VTE incidence was low with no significant difference between enoxaparin and dalteparin. Some evidence suggested dalteparin may be associated with fewer bleeding events and lower transfusion rates, with one study also reporting cost savings. ROB was moderate in the observational studies, with some concerns in the RCTs. Enoxaparin and dalteparin appear similarly effective for VTE prevention after hip or knee arthroplasty. However, dalteparin may be associated with a lower bleeding risk and reduced transfusion rates, with potential cost savings. Current evidence is limited by the small number and quality of studies. Further high-quality randomised trials are needed to confirm these findings and inform clinical decision-making.

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Background and aimsTraditionally, low molecular weight heparin, such as dalteparin, has been the first-line treatment for cancer-associated venous thromboembolism (VTE). However, recent studies suggest that rivaroxaban, a direct oral anticoagulant, may offer comparable efficacy with the convenience of oral administration. This systematic review and meta-analysis aim to evaluate and compare the efficacy and safety of rivaroxaban versus dalteparin in managing cancer-associated VTE, focusing on recurrence rates, bleeding events, and patient adherence.MethodsThis review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines, systematically retrieving data from PubMed and Cochrane databases using structured search terms related to cancer, VTE, and anticoagulation. Data on recurrent VTE, major bleeding, and patient outcomes were extracted. Statistical analyses were performed using a random-effects model to account for heterogeneity.ResultsNine studies were analyzed, encompassing a range of study designs across multiple countries. The findings show no significant difference in major bleeding risk between rivaroxaban and dalteparin (risk ratio: 0.91, P = 0.69), nor in bleeding-related mortality (odds ratio [OR]: 4.00, P = 0.36). Rivaroxaban was associated with a significant reduction in deep vein thrombosis (DVT) recurrence (OR: 0.75, P = 0.04) and a marginally nonsignificant reduction in pulmonary embolism recurrence (OR: 0.73, P = 0.05). Nonsignificant bleeding events were slightly higher with rivaroxaban but did not reach statistical significance.ConclusionRivaroxaban presents a viable alternative to dalteparin for treating cancer-associated VTE, showing comparable safety regarding major bleeding and potential efficacy in reducing DVT recurrence. This study supports the potential for more standardized guidelines that include rivaroxaban as a feasible option in cancer-associated VTE management.

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Background: Venous thromboembolism (VTE), particularly in the context of cancer-associated thrombosis (CAT), is a major cause of morbidity and mortality in patients with malignancy. While apixaban has emerged as a potential alternative to low-molecular-weight heparins (LMWHs), uncertainty remains regarding the consistency of its safety profile across different LMWH agents. Methods: This systematic review and meta-analysis was conducted in accordance with PRISMA guidelines. A comprehensive literature search was performed across PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials. Results: Six randomized controlled trials were included. Apixaban was associated with a reduced risk of recurrent VTE (RR 0.66, 95% CI 0.45-0.96). However, safety outcomes varied depending on the LMWH comparator. Compared with dalteparin, apixaban was associated with a higher risk of clinically relevant non-major bleeding (CRNMB) (log RR 0.38; 95% CI 0.02 to 0.75), whereas, compared with enoxaparin, it was associated with a lower risk (log RR -0.49; 95% CI -0.96 to -0.02). Conclusions: These findings suggest potential differences in safety profiles across individual LMWH agents. However, given the limited number of included trials and clinical heterogeneity, the results should be interpreted cautiously. Further large-scale studies are required to confirm these observations.

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BackgroundThe Hokusai Venous Thromboembolism (VTE) Cancer trial demonstrated that edoxaban was noninferior to dalteparin for the treatment of cancer-associated venous VTE.ObjectivesWe reanalyzed the trial using the win ratio, an approach that evaluates a composite of outcomes in a hierarchical order.MethodsForty-nine thrombosis experts ranked 10 outcomes in order of clinical importance from all-cause death (most important) to clinically relevant nonmajor bleeding (least important). We performed unmatched pairwise comparisons between participants on edoxaban and those on dalteparin at 6- and 12-month follow-up. Within each pair, edoxaban was assigned a win, loss, or tie according to the hierarchy of outcomes. We calculated the win ratio (total wins divided by total losses among edoxaban patients), with more wins than losses indicating the benefit of edoxaban, and the win difference (total wins minus total losses).ResultsAmong 273 528 pairs (522 × 524 participants), edoxaban was associated with a win in 34.9%, a loss in 38.5%, and a tie in 26.6%. The win ratio was 0.91 (95% CI, 0.76-1.08), with a win difference of -3.55% (95% CI, -9.9% to 2.9%) at 12 months. The win ratio remained unchanged at 6 months (0.91; 95% CI, 0.75-1.11). The findings were consistent with a hierarchy of only death, recurrent VTE, and major bleeding (win ratio, 0.92; 95% CI, 0.76-1.11), or when replacing all-cause death with VTE-related death or fatal bleeding (win ratio, 0.83; 95% CI, 0.65-1.06).ConclusionWe observed no significant difference between edoxaban and dalteparin for the treatment of cancer-associated VTE when using the win ratio approach with a hierarchy of 10 prioritized outcomes.

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BackgroundThe management of recurrent venous thromboembolism (VTE) despite anticoagulant treatment in patients with cancer is uncertain. To address this, we used data from the Hokusai VTE Cancer trial, which compared edoxaban with dalteparin to treat cancer-associated VTE.ObjectivesTo characterize and evaluate anticoagulant treatment strategies during and after on-treatment recurrent VTE, including the type and dose of anticoagulant.MethodsIn this post hoc analysis, all patients with adjudicated on-treatment recurrent VTE within 12 months after randomization were included. Outcomes were second recurrent VTE and major bleeding within 3 months after the first recurrent VTE.ResultsA total of 67 patients developed on-treatment recurrent VTE while receiving therapeutic-dose edoxaban (31%), therapeutic-dose low-molecular-weight heparin (LMWH) (34%), maintenance-dose LMWH (21%), or other therapies (14%). After the recurrent event, 28 patients (42%) received an increased dose, 35 (52%) a comparable dose, and 4 (6%) a reduced dose or stopped anticoagulants. Common treatment regimens included supratherapeutic-dose LMWH (21%), therapeutic-dose LMWH (51%), direct oral anticoagulants (16%), or another treatment strategy (12%). In the 3 months after recurrent VTE, 6 (9%) patients had a second recurrence and 7 (10%) had major bleeding.ConclusionTreatment strategies for recurrent VTE in patients with cancer are heterogeneous. The risk of a second recurrence and major bleeding are considerable. More studies are needed to determine the optimal treatment strategy for recurrent cancer-associated thrombosis.

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