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Clinical and Experimental Pharmacology... Nov 20111. The low molecular weight heparin (LMWH) dalteparin is used, for example, to prevent primary venous thromboembolism in patients undergoing surgery or in medically ill...
1. The low molecular weight heparin (LMWH) dalteparin is used, for example, to prevent primary venous thromboembolism in patients undergoing surgery or in medically ill patients. The anticoagulant activity of dalteparin can be monitored by measuring anti-factor Xa levels and activated partial thromboplastin time (aPTT); however, aPTT is an unreliable parameter in this case. The aim of the present in vitro study was to evaluate the thrombelastograph ROTEM(®) (Tem International, Munich, Germany) with respect to determining the anticoagulant activity of dalteparin at therapeutic and supratherapeutic plasma concentrations. 2. The ROTEM(®) parameters, namely coagulation time (CT), clot formation time (CFT) and maximum clot firmness (MCF), were measured using the reagents EXTEM and INTEM (Pentapharm, Munich, Germany) at increasing concentrations of dalteparin (0.01-10 μg/mL, which corresponded to anti-factor Xa levels of 1-1000 U/mL, respectively). 3. The mean CT measured using EXTEM was found to increase from 65.4 ± 27.9 s at baseline to 173.3 ± 112.2 s and 332.2 ± 200.7 s at drug concentrations of 1 and 10 μg/mL, respectively (P < 0.0001 for both). Moreover, the mean CFT value (EXTEM) increased from 97.7 ± 21.5 s at baseline to 187.6 ± 115.2 s (P = 0.0001) at a drug concentration of 10 μg/mL, which is greater than the therapeutic anti-factor Xa concentrations for LMWH. The results obtained when INTEM was used as the reagent were similar to those obtained using EXTEM. 4. In conclusion, the results indicate that the thrombelastograph ROTEM(®) can detect the anticoagulant effects of dalteparin only at supratherapeutic levels of anti-factor Xa.
Topics: Adult; Anticoagulants; Blood Coagulation; Blood Coagulation Tests; Blood Platelets; Dalteparin; Dose-Response Relationship, Drug; Factor Xa; Factor Xa Inhibitors; Germany; Heparin, Low-Molecular-Weight; Humans; Male; Partial Thromboplastin Time; Thrombelastography
PubMed: 21883380
DOI: 10.1111/j.1440-1681.2011.05593.x -
Blood May 2001
Topics: Alopecia; Anticoagulants; Citrates; Dalteparin; Female; Humans; Renal Dialysis
PubMed: 11345088
DOI: 10.1182/blood.v97.9.2914 -
Haematologica Jul 2022The effect of renal impairment (RI) on risk of bleeding and recurrent thrombosis in cancer patients treated with direct oral anticoagulants for venous thromboembolism... (Randomized Controlled Trial)
Randomized Controlled Trial
Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial.
The effect of renal impairment (RI) on risk of bleeding and recurrent thrombosis in cancer patients treated with direct oral anticoagulants for venous thromboembolism (VTE) is undefined. We ran a prespecified analysis of the randomized Caravaggio study to evaluate the role of RI as a risk factor for bleeding or recurrence in patients treated with dalteparin or apixaban for cancerassociated VTE. RI was graded as moderate (creatinine clearance between 30-59 mL/minute; 275 patients) and mild (between 60- 89 mL/minute; 444 patients). In the 1142 patients included in this analysis, the incidence of major bleeding was similar in patients with moderate vs. no or mild RI (HR 1.06-95% CI: 0.53-2.11), with no difference in the relative safety of apixaban and dalteparin. Recurrent VTE was not different in moderate vs. no or mild RI (HR=0.67, 95% CI: 0.38-1.20); in moderate RI, apixaban reduced recurrent VTE compared to dalteparin (HR=0.27, 95% CI: 0.08-0.96; P for interaction 0.1085). At multivariate analysis, no association was found between variation of renal function over time and major bleeding or recurrent VTE. Advanced or metastatic cancer was the only independent predictor of major bleeding (HR=2.84, 95% CI: 1.20-6.71), with no effect of treatment with apixaban or dalteparin. In our study, in cancer patients treated with apixaban or dalteparin, moderate RI was not associated with major bleeding or recurrent VTE. In patients with moderate renal failure, the safety profile of apixaban was confirmed with the potential for improved efficacy in comparison to dalteparin. ClinicalTrials.gov identifier: NCT03045406.
Topics: Anticoagulants; Dalteparin; Hemorrhage; Humans; Kidney; Neoplasms; Pyrazoles; Pyridones; Venous Thromboembolism
PubMed: 34382385
DOI: 10.3324/haematol.2021.279072 -
The Journal of Supportive Oncology Mar 2006The increased risk of thrombosis-related morbidity and mortality in patients with cancer remains, even in the face of anticoagulant therapy. Moreover, recurrent venous... (Review)
Review
The increased risk of thrombosis-related morbidity and mortality in patients with cancer remains, even in the face of anticoagulant therapy. Moreover, recurrent venous thromboembolism (VTE) complicates the management of cancer and adversely affects quality of life and survival. Until recently, initial therapy with unfractionated heparin or low-molecular-weight heparin (LMWH) followed by long-term therapy with an oral anticoagulant was the standard of care for the secondary prevention of acute thromboembolism in most patients. However, according to the results of the CLOT trial (Randomized Comparison of Low-Molecular-Weight Heparin Versus Oral Anticoagulant Therapy for the Prevention of Recurrent VTE in Patients With Cancer), extended LMWH therapy with dalteparin represents an alternative to standard oral anticoagulation. In terms of efficacy, the incidence of recurrent VTE in patients receiving dalteparin was half that of those receiving warfarin (27 of 336 patients vs 53 of 336 patients, respectively), for a 52% relative risk reduction. The incidence of major bleeding in this trial was not significantly different in the two arms. Although this LMWH regimen is supported by the latest practice guidelines of the American College of Chest Physicians, the question of whether long-term treatment with LMWH in cancer patients actually affects survival apart from the benefits of thromboprophylaxis remains to be answered.
Topics: Anticoagulants; Dalteparin; Evidence-Based Medicine; Humans; Neoplasms; Thromboembolism; Venous Thrombosis
PubMed: 16553136
DOI: No ID Found -
Journal of Thrombosis and Haemostasis :... Jan 2009The role of anticoagulants for the prevention of placental-mediated pregnancy complications is uncertain. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The role of anticoagulants for the prevention of placental-mediated pregnancy complications is uncertain.
OBJECTIVES
Our aim was to investigate the effectiveness of dalteparin, a low-molecular-weight heparin, in preventing the recurrence of these complications in women without thrombophilia.
PATIENTS/METHODS
Between August 1 2000 and June 20 2007, 116 pregnant women with: (i)
dalteparin (n = 58) or no dalteparin (n = 58). The primary outcome was a composite of one or more of: severe pre-eclampsia, newborn weight RESULTS
Among the 110 women included in the final analysis, dalteparin was associated with a lower rate of the primary outcome [5.5% (n = 3/55) vs. 23.6% (n = 13/55), adjusted odds ratio (OR) 0.15, 95% confidence interval (CI) 0.03-0.70]. Secondary outcomes were not statistically different between the groups. Bleeding problems or thrombocytopenia did not occur.
CONCLUSION
In this pilot study, dalteparin is effective in decreasing the recurrence of placental-mediated complications in women without thrombophilia. Our results require confirmation in further randomized trials.
Topics: Adult; Dalteparin; Female; Fetal Death; Humans; Infant, Low Birth Weight; Infant, Newborn; Pilot Projects; Placenta; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Secondary Prevention
PubMed: 19036070
DOI: 10.1111/j.1538-7836.2008.03230.x -
The New England Journal of Medicine Jul 2003
Topics: Anticoagulants; Dalteparin; Humans; Neoplasms; Pulmonary Embolism; Risk Factors; Secondary Prevention; Thrombosis; Venous Thrombosis
PubMed: 12853582
DOI: 10.1056/NEJMp030086 -
Surgery For Obesity and Related... 2010
Topics: Anticoagulants; Bariatric Surgery; Dalteparin; Enoxaparin; Humans; Obesity; Postoperative Complications; Practice Guidelines as Topic; United Kingdom; Venous Thromboembolism
PubMed: 20655034
DOI: 10.1016/j.soard.2010.05.007 -
American Journal of Cardiovascular... 2009Deep vein thrombosis (DVT) and pulmonary embolism (PE) are manifestations of venous thromboembolic events (VTEs). Patients undergoing major surgical procedures such as...
BACKGROUND
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are manifestations of venous thromboembolic events (VTEs). Patients undergoing major surgical procedures such as total hip replacement (THR), total knee replacement (TKR), and hip fracture surgery (HFS) are at an elevated risk for VTEs. The American College of Chest Physicians' (ACCP) guidelines recommend that such patients receive thromboprophylaxis for at least 10 days. In patients undergoing THR or HFS, extended prophylaxis for up to 28-35 days is the recommended approach for those at high risk of thromboembolic events. The NAFT (North American Fragmin Trial) compared the prophylactic efficacy of dalteparin with that of warfarin during the in-hospital period, and with that of placebo during the period of hospital discharge until day 35 postsurgery, in patients who underwent total hip arthroplasty. During both the in-hospital and the postdischarge time periods, dalteparin significantly reduced the occurrence of DVT. Given the clinical relevance of these results, the low specificity of the ACCP recommendations regarding optimal prophylaxis duration, and the importance of optimizing the efficiency of DVT prophylaxis in the practice setting, a cost-utility analysis was conducted comparing dalteparin 10-day and 35-day (extended) with a warfarin 10-day protocol, in patients undergoing major orthopedic surgeries such as THR, TKR, or HFS.
DESIGN AND SETTING
A three-arm decision model was developed using the prevalence of symptomatic DVT from NAFT publications, epidemiologic studies, and published meta-analyses. Healthcare resource use was abstracted from a survey of clinicians and from the economic literature. Utility estimates were obtained by interviewing a sample of 24 people from the general public using the time trade-off technique. The clinical, economic and utility data were then used to estimate the cost per quality-adjusted life-year (QALY) gained with dalteparin for 10 or 35 days relative to 10 days of warfarin.
STUDY PERSPECTIVE
Canadian provincial healthcare system.
MAIN OUTCOME MEASURES AND RESULTS
The cost per QALY gained with 10 days of dalteparin was below $Can1000 for all the surgeries evaluated (all costs are reported in 2007 Canadian dollars [$Can1 = $US1, as of December 2007]). In the case of extended prophylaxis, the incremental cost per QALY gained with 35 days of dalteparin over warfarin was $Can40 100, $Can46 500, and $Can31 200 for patients undergoing THR, TKR, and HFS, respectively. Reducing the duration of prophylaxis from 35 to 28 days generated ratios that were below $Can35 000 for all three surgeries evaluated.
CONCLUSION
Ten days of dalteparin following major orthopedic surgery is a clinically and economically attractive alternative to warfarin for DVT prophylaxis. In the case of the 35-day dalteparin protocol, the results also indicated acceptable economic value to a publicly funded healthcare system, particularly in the settings of HFS and THR. In addition, reducing the duration of prophylaxis to 28 days postsurgery would be associated with a more favorable return on public healthcare expenditures.
Topics: Anticoagulants; Canada; Cost-Benefit Analysis; Dalteparin; Drug Administration Schedule; Humans; Meta-Analysis as Topic; Models, Economic; Orthopedic Procedures; Postoperative Complications; Prevalence; Quality-Adjusted Life Years; Venous Thromboembolism; Warfarin
PubMed: 19178131
DOI: 10.2165/00129784-200909010-00005 -
Journal of Pharmacy Practice Apr 2012This study compared the effectiveness of a change from enoxaparin to dalteparin for the prophylaxis of patients at risk of venous thromboembolism (VTE). (Comparative Study)
Comparative Study
PURPOSE
This study compared the effectiveness of a change from enoxaparin to dalteparin for the prophylaxis of patients at risk of venous thromboembolism (VTE).
METHODS
A retrospective cohort study identified hospitalized patients with VTE risk admitted at Wellmont Health System between August 1, 2008 and July 31, 2009. On February 1, 2009, a therapeutic interchange from enoxaparin to dalteparin occurred. All patient records were reviewed from billing data collected 6 months prior and following conversion. Statistical tests of heterogeneity compared distributions of demography between study cohorts and Cochran tests were used to compare pre- versus postchange in the outcomes.
RESULTS
A total of 3557 and 3465 patient discharges were analyzed in the 6 months prior and following the interchange, respectively. Of these discharges, 1870 were administered enoxaparin and 1639 dalteparin. VTE rates were similar between the 2 groups. Data showed no significant difference in-hospital length of stay (LOS), readmittance, and bleeding rates in the populations. The system achieved a $40 788 savings over 6 months following the conversion using approved prophylactic dosing per patient indication.
CONCLUSIONS
Dalteparin is similarly effective as enoxaparin and an alternative for the prophylaxis of VTE in a hospital setting while providing cost savings.
Topics: Aged; Aged, 80 and over; Anticoagulants; Cohort Studies; Dalteparin; Data Interpretation, Statistical; Enoxaparin; Female; Hospitalization; Humans; Length of Stay; Male; Middle Aged; Postoperative Complications; Retrospective Studies; Venous Thromboembolism
PubMed: 21987527
DOI: 10.1177/0897190011418514 -
Blood Coagulation & Fibrinolysis : An... Apr 2024Venous thromboembolism (VTE) is a preventable cause of significant morbidity and mortality in hospitalized patients world-wide. In Australia, the low-molecular weight... (Observational Study)
Observational Study
Venous thromboembolism (VTE) is a preventable cause of significant morbidity and mortality in hospitalized patients world-wide. In Australia, the low-molecular weight heparins (LMWHs) enoxaparin or dalteparin are usually used as first-line prophylaxis for VTE, though there is uncertainty whether dalteparin has the same effectiveness as enoxaparin in real-world settings. This is relevant because dalteparin is less renally cleared and may be more cost effective than enoxaparin. The aim of this study was to explore VTE event incidence in a general cohort of hospitalized adult inpatients who were prescribed enoxaparin or dalteparin for VTE prophylaxis. A retrospective observational study was conducted at a quaternary hospital in Brisbane, Australia, of patients who had experienced a hospital-acquired VTE from 1 September 2021 to 1 March 2023. Patients were identified from routinely collected data following an in-hospital VTE event, and further data was retrieved retrospectively from the integrated electronic Medical Record (ieMR). Incidence and type of VTE events, LMWH-prescribing patterns, and risk factors were assessed. The incidence of VTE events were similar across the dalteparin and enoxaparin cohorts (42.1 events/10 000 patients vs. 34.4 events/10 000 patients, respectively), although patients prescribed enoxaparin had a higher number of risk factors, particularly obesity and active cancer. Our research indicates comparable incidence of VTE in patients prescribed dalteparin compared with enoxaparin in an Australian hospital general cohort of adult inpatients. Dalteparin may be as effective as enoxaparin for VTE prophylaxis in a real-world cohort of patients, and as such dalteparin may be considered a suitable alternative to enoxaparin for VTE prophylaxis. Further research including large randomized controlled trials are required to confirm these results.
Topics: Adult; Humans; Dalteparin; Enoxaparin; Venous Thromboembolism; Heparin, Low-Molecular-Weight; Retrospective Studies; Australia; Anticoagulants
PubMed: 38358899
DOI: 10.1097/MBC.0000000000001281