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[A 50-year history of new drugs in Japan-the development and trends of hemostatics and antithrombotic drugs].

The developments and trends of hemostatic and antithrombotic drugs in Japan were investigated chronologically for the last 50 years after th … by injection are heparins (Na-salt, 1951; Ca-salt, 1962) and low-molecular-weight heparins such as dalteparin (1992), parnaparin (1994) and reviparin (1999). The low molecule compounds are superior to the original heparins in reducing the risk of bleeding. As oral anticoagulants, coumarin derivatives, dicumarol (1950), ethylbiscoumacetate (1954), phenylinda …

Management of thrombotic and cardiovascular disorders in the new millenium.

Anticoagulants and antithrombotic drugs have played a key role in the prophylaxis, treatment and surgica/interventional management of thromb … s gradually replaced by the low molecular weight heparins (LMWHs). LMWHs such as the Enoxaparin and Dalteparin are commonly used for the management of acute coronary syndrome. These drugs have been approved for the treatment of unstable angina and are currently undergoing rigorous trials for interventional indications. Arixtra is also developed for various s …

Cancer-associated venous thromboembolism: Treatment and prevention with rivaroxaban.

Cancer-associated venous thromboembolism (VTE) is a frequent, potentially life-threatening event that complicates cancer management. Anticoagulants are the cornerstone of therapy for the treatment and prevention of cancer-associated thrombosis (CAT); factor Xa-inhibiting direct oral anticoagulants (DOACs; apixaban, edoxaban, and rivaroxaban), which have long been recommended for the treatment of VTE in patients without cancer, have been investigated in this setting. The first randomized comparisons of DOACs against low-molecular-weight heparin for the treatment of CAT indicated that DOACs are

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… Two fatal bleeding events occurred during the study (both in the dalteparin group) and 6 intracranial hemorrhages (2 in the edoxaban group and 4 in the dalteparin group). … | Hokusai‐VTE‐Cancer 9 (edoxaban vs dalteparin) | SELECT‐D 10 (rivaroxaban vs dalteparin) | ADAM VTE 11 (apixaban vs dalteparin) N | 1050 mITT population: 522 vs 524 | 406 (203 vs 203) | 300 (150 vs 150) Design | Open‐label, multinational, noninferiority, randomized phase III trial | Open‐label, multicenter …

Cancer-associated thrombosis: prevention and treatment.

Patients with cancer are at high risk to develop venous thromboembolism, and they are also more likely to develop complications from anticoagulant treatment. Because little research has focused on the oncology population to date, the optimal methods of prophylaxis and treatment remain uncertain in some clinical situations. Currently, low molecular weight heparin and warfarin are the most frequently used pharmacologic agents; however, they have their limitations. Other therapeutic options, such as inferior caval filters, are poorly studied and remain controversial. A summary of the most recent

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… In the clot study, 676 cancer patients with acute dvt or pulmonary embolism were randomized to a 6-month course of traditional therapy with dalteparin followed by warfarin, or to dalteparin alone 53 . … To reduce the risk of bleeding in the dalteparin-only group, the dalteparin dose was reduced by 20%–25% after the first month of therapy. …

Managing thrombosis in cancer patients.

Venous thromboembolism is a major complication in cancer patients. The basis for the strong association between cancer and thrombosis remains incompletely understood, and the optimal approaches to both the treatment and the prevention of cancer-associated thrombosis are evolving. Here we review several important topics related to cancer-associated thromboembolism, including the pathogenesis, prevention, and management of this disease. Wherever possible, we include evidence from clinical trials, including the results of recently published trials that compared direct oral anticoagulants to low-m

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… The results of one such study ( NCT00876915 ) recently became available. 29 After 12 weeks of prophylactic dalteparin in cancer patients with Khorana score ≥3 undergoing chemotherapy, there was a nonsignificant reduction in the risk of VTE (12% on dalteparin vs 21% on placebo, hazard ratio [HR] of 6.9 … Study | CLOT 4 | CATCH 33 | Hokusai VTE Cancer 45 | Select‐D 47 | Daltecan 50 , a Arms | Warfarin | Dalteparin | Warfarin | Tinzaparin | Edoxaban | Dalteparin | Rivaroxaban | Dalteparin | Dalteparin Recurrent VTE | 53/336 (15.8%) | 27/336 (8.0%) | 45/451 (10.5%) | 31/449 (6.9%) | 34/522 (6.5%) | 46/524 …

The Role of Injectables in the Treatment and Prevention of Cancer-Associated Thrombosis.

Cancer-associated thrombosis (CAT) is a leading cause of death among patients with cancer. CAT can manifest itself as venous thromboembolism (VTE), in the form of deep vein thrombosis or pulmonary embolism, or arterial thromboembolism. The pathophysiology of CAT is complex and depends on cancer-, patient-, treatment- and biomarkers-related factors. Treatment of VTE in patients with cancer is complex and includes three major classes of anticoagulant agents: heparin and its derivatives, e.g., low molecular weight heparins, direct oral anticoagulants (DOACs), and vitamin K inhibitors. Given the t

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… The extended use of dalteparin was evaluated in the population with cancer in the CLOT study, that randomized patients to VKA or extended-use dalteparin [ 94 ]. … (4%) patients, in the dalteparin and in the dalteparin plus VKA arms, respectively, which was not statistically significant ( p = 0.27). …

Safety and Effectiveness of Direct Oral Anticoagulants Versus Low-Molecular-Weight Heparin for Cancer-Associated Thrombosis: A Systematic Review and Meta-analysis.

BACKGROUND: Cancer-associated thrombosis is a condition associated with high mortality rates, yet limited evidence exists regarding the safety and effectiveness of low-molecular-weight heparin (LMWH) and direct oral anticoagulants (DOACs), focusing on a fixed follow-up period based on clinical practice guideline recommendations. OBJECTIVE: This study aimed to compare the safety and effectiveness of DOACs versus LMWH in patients with cancer-associated thrombosis over a 6-month follow-up period. METHODS: PubMed, Embase, and Cochrane Library databases were systematically searched up to 30 June,

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… Rivaroxaban vs dalteparin in cancer-associated thromboembolism: a randomized trial. Chest. 2022;161(3):781–90. 17. Dong Y, Wang Y, Ma RL, Liu M, Gao JZ, Su WY, et al. … The efficacy and safety of rivaroxaban and dalteparin in the treatment of cancer associated venous thrombosis. Indian J Hematol Blood Transfus. 2018;34(3):530–4. 31. Signorelli JR, Gandhi AS. …

Cancer-Associated Thrombosis: A New Light on an Old Story.

Cancer-associated thrombosis (CAT) is a rising and significant phenomenon, becoming the second leading cause of death in cancer patients. Pathophysiology of CAT differs from thrombosis in the non-cancer population. There are additional risk factors for thrombosis specific to cancer including cancer type, histology, and treatment, such as chemotherapy. Recently developed scoring systems use these risk factors to stratify the degree of risk and encourage thromboprophylaxis in intermediate- to high-risk patients. Anticoagulation is safely used for prophylaxis and treatment of CAT. Both of these h

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… dalteparin 200 IU/kg once daily for five to seven days followed by VKA for six months. 27 (9%) patients treated with dalteparin had recurrent VTE events compared to 53 (17%) in the VKA group ( p = 0.002). … Major bleeding occurred in 22 patients (3.8%) of the apixaban group and in 23 patients (4.0%) receiving dalteparin ( p = 0.60). This study concluded that apixaban was noninferior to dalteparin for treatment of recurrent VTE. …

Venous and Arterial Thromboembolism in Patients With Cancer: JACC: CardioOncology State-of-the-Art Review.

Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, represents a major cause of morbidity and mortality in patients with cancer. Arterial thromboembolism, including myocardial infarction and stroke, is also prevalent. Risk differs in subgroups, with higher rates observed in specific cancers including pancreas, stomach, and multiple myeloma. Thromboprophylaxis is recommended for most patients with active cancer hospitalized for medical illnesses and after major cancer surgery. Outpatient thromboprophylaxis is not routinely recommended, but emerging data suggest

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… Edoxaban was noninferior to dalteparin regardless of treatment duration (HR: 0.97; 95% CI: 0.70 to 1.36; p = 0.006 for noninferiority). … The rates of recurrent VTE did not differ between the edoxaban and dalteparin groups (7.9% vs. 11.3%; HR: 0.71; 95% CI: 0.48 to 1.06; p = 0.09), whereas the rate of major bleeding was significantly higher with edoxaban compared to dalteparin (6.9% vs. 4.0%, respectively; HR: 1.77; 95% CI: 1.03 to 3.04 …

Unmet Needs and Challenges in Cancer-Associated Venous Thromboembolism.

Cancer-associated venous thromboembolism (CA-VTE) is a significant complication in oncology, contributing to morbidity, mortality, and increased healthcare utilization. Due to multiple patient- and disease-related factors, patients with cancer are at a markedly elevated risk for VTE, particularly within the first 6 months of diagnosis. The aim of this review is to provide an overview of current challenges and unmet needs in CA-VTE prediction, prevention and management. While the Khorana score remains the most widely used risk stratification tool, its limited sensitivity has prompted the develo

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… The Caravaggio trial reported that apixaban was non-inferior to dalteparin in preventing recurrent VTE, with recurrence rates of 5.6% in the apixaban group versus 7.9% with dalteparin (HR 0.63, 95% CI 0.37–1.07), demonstrating non-inferiority [ 126 ]. … ADAM-VTE trial also compared apixaban to dalteparin for CA-VTE treatment [ 125 ]. Major bleeding occurred in none of the 145 patients in the apixaban group and 1.4% of 142 patients in the dalteparin group. …

Pharmacoeconomic evaluation of direct oral anticoagulants for cancer-associated thrombosis: a systematic review.

OBJECTIVE: To synthesize pharmacoeconomic evidence of prevention and treatment of venous thromboembolism (VTE) in cancer patients with direct oral anticoagulants (DOACs) and evaluate the quality of the studies. METHODS: PubMed, Embase, Scopus, the Cochrane Library, the Center for Reviews and Dissemination Database, the Health Technology Assessment Database, and the China National Knowledge Infrastructure Database were searched to collect economic evaluations. The search covered publications from their inception until June 13, 2024. Study selection was conducted independently by two researcher

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… Author/Publication year/Country | Cost | Outcome | ICER | Subgroup analysis | WTP | Sensitivity analysis Connell, 2019; USA | Edoxaban: $6,061 Dalteparin: $19,398 | Edoxaban: 0.34 QALYs; Dalteparin: 0.35 QALYs | $1,873,535/QALY | Gastrointestinal malignancy: $694,058/QALY | $150,000/QALY | Two-way DSA … Using cheaper enoxaparin (generic) instead of dalteparin in studies can make LMWHs costs comparable to DOACs, making LMWHs more cost-effective ( 18 ). …

Guidance for the prevention and treatment of cancer-associated venous thromboembolism.

Venous thromboembolism (VTE) is a highly prevalent complication of malignancy with emerging changes in incidence, diagnosis and treatment paradigms. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance based on existing guidelines and consensus expert opinion where guidelines are lacking. We address a) the appropriate workup to search for occult malignancy in patients with idiopathic VTE, b) identification of high-risk cancer patients for primary thromboprophylaxis, c) the appropriate immediate and long-term treatment for people with cancer diagnosed with acute t

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… The CLOT trial reported by Lee et al. randomized 676 cancer patients with VTE to receive initial dalteparin followed by 6 months of either dalteparin or warfarin with target INR 2.5 [ 31 ]. … Results from a post-marketing study of extended treatment with dalteparin in patients with malignancy (DALTECAN) were recently reported. Of 334 patients, 109 (33 %) completed 12 months of dalteparin. Median treatment duration was 214 days. …

Clinical guide SEOM on venous thromboembolism in cancer patients.

Venous thromboembolism (VTE) is a common event in cancer patients and one of the major causes of cancer-associated mortality and a leading cause of morbidity. In recent years, the incidence rates of VTE have notably increased; however, VTE is still commonly underestimated by oncologists. VTE is considered an adverse prognostic factor in cancer patients in all settings. In 2011 the Spanish Society of Medical Oncology (SEOM) first published a clinical guideline of prophylaxis and treatment of VTE in cancer patients. In an effort to incorporate evidence obtained since the original publication, SE

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… A post hoc analysis of CLOT trial [ 35 ] showed that treatment with dalteparin was associated with improved overall survival in patients without metastatic disease (probability of death at 12 months: 20 % in the dalteparin group vs. 36 % in the VKA arm, HR 0.50; 95 % CI 0.27–0.95; p = 0.03) compared … In the largest one of these trials, the CLOT study, dalteparin was administered at a full dose for the first month followed by a 25 % reduction in the treatment dose for the remaining 5 months. …

Primary prevention of venous thromboembolism in medical and surgical oncology patients.

Recent data suggest that patients with a malignancy have a seven-fold increased risk for venous thromboembolism (VTE) compared with those without cancer, suggesting that these patients may benefit from thromboprophylaxis. Mechanisms for the prevention of thromboembolism can be divided into two broad categories: mechanical and pharmacological. Although generally used in combination with pharmacotherapy, little evidence exists for the efficacy of mechanical modalities either in the broader population of patients at risk for VTE or for patients with cancer specifically. A recent study using gradu

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… In the United Kingdom, five LMWHs are available for clinical use for specific indications, including dalteparin, enoxaparin sodium, tinzaparin, nadroparin sodium, and bemiparin. Dalteparin very recently gained a European licence for use as a thromboprophylactic in patients with cancer. … Among the 2048 patients who were evaluable for efficacy, VTE occurred in 4.6% of fondaparinux patients and 6.1% of dalteparin patients ( P =0.144). …

2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19.

The International Initiative on Thrombosis and Cancer is an independent academic working group of experts aimed at establishing global consensus for the treatment and prophylaxis of cancer-associated thrombosis. The 2013, 2016, and 2019 International Initiative on Thrombosis and Cancer clinical practice guidelines have been made available through a free, web-based mobile phone application. The 2022 clinical practice guidelines, which are based on a literature review up to Jan 1, 2022, include guidance for patients with cancer and with COVID-19. Key recommendations (grade 1A or 1B) include: (1)

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… of 142 assigned dalteparin (HR 0·099, 95% CI 0·013–0·78; p=0·0281), without any difference in overall survival at 6 months. … Rates of major bleeding (1·4% with rivaroxaban vs 3·7% with dalteparin; HR 0·36, 95% CI 0·04–3·43), major or clinically relevant non-major bleeding (12·2% with rivaroxaban vs 9·8 % with dalteparin; 1·27, 0·49–3·26) or death from any cause were similar in both groups. …

Prevention of venous thromboembolism in ambulatory patients with cancer.

Patients with cancer are at high risk of venous thromboembolic events, and this risk can be further increased in patients with certain cancer types and by cancer treatments. Guidelines on the prevention of cancer-associated thrombosis (CAT) recommend thromboprophylaxis for hospitalised patients; however, this is not routinely recommended for ambulatory patients receiving chemotherapy and is limited to specified high-risk patients. Identification of the ambulatory patients at risk of CAT who would most benefit from anticoagulant therapy is therefore critical to reduce the incidence of this comp

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… of clinically relevant bleeding (seven patients on dalteparin vs one patient on observation; HR 7.02; 95% CI 1.24 to 131.6; p=0.025). … Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial. Lancet 2014;384:1673–83. 10.1016/S0140-6736(14)60793-5 57. Ay C, Dunkler D, Marosi C, et al. …

Anticoagulant management of cancer-associated thrombosis and thrombocytopenia: a retrospective chart review.

BACKGROUND: Patients with cancer-associated thrombosis (CAT) are at an increased risk of recurrent thrombosis and bleeding, especially if there is treatment- or disease-related thrombocytopenia. While direct oral anticoagulants (DOACs) are used in the management of CAT, low molecular weight heparin (LMWH) continues to be recommended for CAT with thrombocytopenia. OBJECTIVES: This study aimed to identify the rates of recurrent venous thromboembolism (VTE) and bleeding in patients with CAT and thrombocytopenia treated with DOACs compared with LMWH. METHODS: A retrospective review of patients w

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… Apixaban was the most common type of DOAC used initially ( n = 12; 75.0%), while the most common type of LMWH was dalteparin ( n = 18; 94.7%). Several anticoagulant and dose changes took place across the 90-day follow-up period. … The patient was not thrombocytopenic and was receiving dalteparin at 150 units/kg once daily as per the CLOT trial regimen [ 17 ]. Dalteparin dose reduction occurred 1 week prior to VTE recurrence. …

Anticoagulation for Cancer Patients in Special Situations: A Narrative Review of Guidelines and Literature.

Cancer-associated thrombosis (CAT) is a major cause of morbidity and mortality in patients with cancer. The management of special situations-including recurrent venous thromboembolism (VTE), thrombosis at unusual sites, and central venous catheter-associated thrombosis (CVC-AT)-remains particularly challenging because of the limited availability of high-quality evidence. This narrative review synthesizes recommendations from major international and Spanish clinical practice guidelines and expert consensus documents, including those from SEOM, ESMO, ASCO, NCCN, ITAC and SEMI, to provide a struc

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… Initial dose reduction is advised in cases of enoxaparin and bemiparin, but not for dalteparin. … Dalteparin: The SmPC only states that dalteparin should be used with caution in patients with severe hepatic impairment, as a factor for a greater risk of bleeding [ 66 ]. Tinzaparin: Hepatic impairment is not mentioned as a specific concern in the SmPC [ 62 , 63 ]. …

Aspirin Versus LMWH for Thromboprophylaxis Following Hip or Knee Arthroplasty-Clinical Implications and Budget Impact.

Venous thromboembolism (VTE) remains a significant concern for patients undergoing hip or knee arthroplasty, with a need to balance effective thromboprophylaxis and bleeding risk. We aimed to compare the efficacy, safety, and budget impact of aspirin versus low-molecular-weight heparin (LMWH) as sole thromboprophylactic agents initiated immediately postoperatively in this population. First, we conducted a systematic review of randomized controlled trials (RCTs) from Ovid MEDLINE, Embase, and Cochrane CENTRAL databases, assessing clinical outcomes and healthcare costs. Subsequently, a simplifie

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… All patients received an initial 10‐day course of dalteparin [5000 IU subcutaneously (s.c.)] thromboprophylaxis before being randomized to either 28 days of dalteparin or aspirin (81 mg/day orally) [ 10 ]. … Then three groups received oral rivaroxaban at 10 mg, subcutaneous Dalteparin at 2500 IU, and oral aspirin at 100 mg. …

Multidisciplinary Care for the Prevention and Treatment of Venous Thromboembolism in Patients with Cancer-Associated Thrombosis (CAT): Impact of Educational Interventions on CAT-Related Events and on Patients' and Clinicians' Awareness.

Cancer is a leading cause of death. Venous thromboembolism (VTE) is an often-overlooked cause of morbidity and mortality in cancer patients that can be readily prevented and treated. Actions are needed to reduce the morbidity and mortality of patients with cancer-associated thrombosis (CAT). There is a need to increase awareness of the impact of CAT on cancer patients' morbidity and mortality, on their quality of life and to understand the importance of more effective preventions and treatments of VTE in cancer patients. Moreover, it is of great importance to systematically assess the risk of

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… In all trials, DOACs were shown to be as effective and safe as dalteparin. … The single-arm DALTECAN trial considered extended treatment with dalteparin on 334 cancer patients with VTE; among them 109 completed 12 months of dalteparin. The risk of major bleeding and of recurrent VTE was the greatest during the first month of treatment [ 51 ]. …