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The Lancet. Haematology Oct 2019
Topics: Anniversaries and Special Events; Anticoagulants; Dalteparin; Global Burden of Disease; Humans; Risk Factors; Thrombosis
PubMed: 31561856
DOI: 10.1016/S2352-3026(19)30172-3 -
Archives of Internal Medicine Mar 2001
Comparative Study
Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Dalteparin; Humans; Treatment Outcome; Venous Thrombosis; Warfarin
PubMed: 11231726
DOI: 10.1001/archinte.161.5.776 -
Pediatric Blood & Cancer Dec 2020On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk...
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk of recurrence in pediatric patients 1 month of age and older. Approval was primarily based on FDA review of a single-arm trial evaluating dalteparin administered subcutaneous twice daily in 38 pediatric patients with symptomatic VTE. Efficacy was based on the achievement of therapeutic plasma anti-Xa levels. The FDA concluded that dalteparin has efficacy and acceptable safety for pediatric patients.
Topics: Adolescent; Adult; Anticoagulants; Child; Child, Preschool; Dalteparin; Drug Approval; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Prognosis; United States; United States Food and Drug Administration; Venous Thromboembolism; Young Adult
PubMed: 32896942
DOI: 10.1002/pbc.28688 -
The Medical Letter on Drugs and... Dec 1995
Topics: Anticoagulants; Controlled Clinical Trials as Topic; Dalteparin; Drug Costs; Heparin; Humans; Molecular Weight; Thrombophlebitis
PubMed: 7500910
DOI: No ID Found -
PharmacoEconomics 2006In a recent randomised trial (CLOT [Comparison of Low molecular weight heparin versus Oral anticoagulant Therapy for long term anticoagulation in cancer patients with... (Comparative Study)
Comparative Study
OBJECTIVE
In a recent randomised trial (CLOT [Comparison of Low molecular weight heparin versus Oral anticoagulant Therapy for long term anticoagulation in cancer patients with venous thromboembolism]), which evaluated secondary prophylaxis of venous thromboembolism (VTE) in cancer patients, dalteparin reduced the relative risk of recurrent VTEs by 52% compared with oral anticoagulation therapy (p = 0.002). A Canadian pharmacoeconomic analysis was conducted to measure the economic value of dalteparin for this indication.
DESIGN
The study was conducted from the Canadian healthcare system. The first part of this study utilised the CLOT trial database, from which resource utilisation data were converted into Canadian cost estimates (Can dollars, year 2005 values). Univariate and multivariate regression analyses were conducted to compare the total cost of therapy between patients randomised to treatment with dalteparin or oral therapy. Health state utilities and treatment preferences were then measured in 24 oncology care providers using the time trade-off technique.
RESULTS
When all of the cost components were combined for the entire population (n = 676), patients in the dalteparin group had significantly higher overall costs than the control group (Can dollars 4162 vs Can dollars 2003; p < 0.001). The preference assessment revealed that 23 of 24 respondents (96%) selected dalteparin over warfarin, with an associated gain of 0.157 QALYs. When the incremental cost of dalteparin (Can dollars 2159 per patient) was combined with the QALY gain, the findings revealed that dalteparin was associated with a cost of approximately Can dollars 13,800 (95% CI 12,400, 15,100) per QALY gained.
CONCLUSIONS
Given the practical advantages of dalteparin in terms of convenience, improved efficacy and the acceptable economic value, this analysis suggests that long-term dalteparin therapy is a sound alternative to warfarin for the prevention of recurrent VTEs in patients with cancer.
Topics: Adult; Anticoagulants; Canada; Dalteparin; Female; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Secondary Prevention; Thromboembolism; Warfarin
PubMed: 16761906
DOI: 10.2165/00019053-200624060-00006 -
Veterinary Clinical Pathology Jun 2017Dalteparin is used to prevent thrombotic complications in dogs. Measurement of anti-factor Xa (anti-FXa) activity is currently used for monitoring therapy, but remains a...
BACKGROUND
Dalteparin is used to prevent thrombotic complications in dogs. Measurement of anti-factor Xa (anti-FXa) activity is currently used for monitoring therapy, but remains a nonfunctional test. The calibrated automated thrombogram (CAT) could be a suitable approach for functional monitoring.
OBJECTIVES
We hypothesized that the CAT will detect decreased endogenous thrombin potential (ETP) in healthy dogs receiving dalteparin.
METHODS
Twenty-four healthy adult Beagles were randomly allocated to 4 equal groups. A single subcutaneous (SC) dose of 50 U/kg, 100 U/kg, or 150 U/kg of dalteparin was given. Platelet-poor plasma (PPP) was collected over a 24-hour period and evaluated by thrombin generation (TG) via CAT, anti-FXa activity, and APTT. Analysis was performed with a repeated-measures general linear mixed model, and the treated groups were compared to a placebo group.
RESULTS
Time, dose, and time-dose interaction significantly affected ETP (P < .0001 for all effects), peak (P < .0001 for all effects), rate index (P < .0006 for all effects), and anti-FXa activity (P < .0001 for all effects). No significant time trend was detected in the control group. Dogs receiving the 100 U/kg dalteparin SC injection showed the most homogeneous response of ETP inhibition among treated groups. The % inhibition of ETP from baseline increased nonlinearly as a function of anti-FXa activity (r = .8186).
CONCLUSIONS
The CAT assay can be employed to measure the effects of dalteparin at different doses in healthy dogs, showing sensitivity to time- and dose-dependent changes in ETP and other TG variables. Further investigation of the CAT as a tool for monitoring low molecular weight heparin therapy in dogs is warranted.
Topics: Animals; Blood Coagulation Tests; Dalteparin; Dogs; Dose-Response Relationship, Drug; Female; Fibrinolytic Agents; Injections, Subcutaneous; Kinetics; Male; Thrombin
PubMed: 28430367
DOI: 10.1111/vcp.12489 -
International Journal of Pharmaceutical... 2017The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin...
The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin 1,000-units/mL syringes were prepared by adding 9 mL of 0.9% sodium chloride for injection to 1 mL of dalteparin sodium 10,000 unit/mL from commercial single-use syringes. Compounded solutions in 0.5-mL aliquots were transferred to 1-mL polypropylene syringes and sealed with a Luer lock tip cap and stored at refrigerated temperatures (2°C to 8°C) with ambient fluorescent light exposure. Syringes from three batches of dalteparin 1,000 units/mL were potency tested in duplicate by a stability-indicating high-performance liquid chromatography assay using a 0.5-mL sample at specified intervals. Visual and pH testing were performed on each batch. Samples were visually inspected for container integrity, color, and clarity. Samples for pH testing were prepared using a 1:1 dilution of dalteparin 1,000 units/mL in sterile water for injection and underwent duplicate analysis at each time point. High-performance liquid chromatography analyses showed a remaining percent of the initial dalteparin content at day 30 of 94.88% ± 2.11%. Samples remained colorless and clear with no signs of container compromise and no visual particulate matter at each time point. Throughout the 30-day study period, pH values remained within 0.3-pH units from the initial value of 5.84. Dalteparin 1,000 unit/mL in 0.9% sodium chloride for injection, packaged in 1-mL polypropylene syringes was stable for at least 30 days while stored at refrigerated conditions with ambient fluorescent light exposure.
Topics: Chromatography, High Pressure Liquid; Dalteparin; Drug Stability; Factor Xa Inhibitors; Hydrogen-Ion Concentration; Injections; Polypropylenes; Sodium Chloride; Syringes
PubMed: 29216619
DOI: No ID Found -
Journal of Gynecologic Oncology Jan 2020Two randomized, controlled studies comparing outcomes in patients treated with direct oral anticoagulants or low-molecular weight heparin for cancer-associated venous... (Comparative Study)
Comparative Study
OBJECTIVES
Two randomized, controlled studies comparing outcomes in patients treated with direct oral anticoagulants or low-molecular weight heparin for cancer-associated venous thromboembolism (VTE) have previously been performed. However, gynecologic cancers accounted for approximately 10% of the study populations. We compared the outcomes of patients with primary gynecological cancers who were treated for cancer-associated VTE with either rivaroxaban or dalteparin.
METHODS
The 162 eligible patients with gynecologic cancers who were treated with either dalteparin (n=60) or rivaroxaban (n=102) were reviewed. The primary outcome was a composite event, which included recurrence or clinically relevant bleeding events during the therapeutic period. Secondary outcomes were recurrence, clinically relevant bleeding events, and mortality.
RESULTS
During the therapeutic period, there were no significant differences between the groups in the proportion of composite events, recurrence, or clinically relevant bleeding. Multivariate analysis using the Cox proportional hazards model also showed no significant difference in the number of composite events and clinically relevant bleeding between the groups. In the rivaroxaban group, 44.0% of patients experienced gastrointestinal bleeding and 24.0% experienced urinary tract bleeding. In the dalteparin group, bleeding was most common in the urinary tract (44.4%) and at the injection site (22.2%).
CONCLUSION
In this study, although there were no significant differences in effectiveness or safety between the rivaroxaban and dalteparin groups, rivaroxaban use was associated with a higher rate of clinically relevant bleeding than dalteparin. Therefore, caution should be taken when prescribing rivaroxaban for gynecologic cancer-associated VTE and bleeding events should be carefully monitored.
Topics: Aged; Dalteparin; Factor Xa Inhibitors; Female; Genital Neoplasms, Female; Hemorrhage; Humans; Middle Aged; Proportional Hazards Models; Republic of Korea; Rivaroxaban; Venous Thromboembolism
PubMed: 31789000
DOI: 10.3802/jgo.2020.31.e10 -
Journal of Thrombosis and Thrombolysis Oct 2019Malignancy is a well-established risk factor for venous thromboembolism and while low-molecular-weight heparin therapy has been standard of care for cancer-associated... (Comparative Study)
Comparative Study
Malignancy is a well-established risk factor for venous thromboembolism and while low-molecular-weight heparin therapy has been standard of care for cancer-associated thrombosis for many years, many patients find injection therapy burdensome. The direct oral anticoagulant edoxaban has been shown to be noninferior to dalteparin for the treatment of cancer-associated thrombosis. In a Markov simulation model, edoxaban with 6-month time horizon and a United States societal perspective with 2017 US dollars, edoxaban was the preferred strategy in the general cancer population (6-month cost $6061 with 0.34 quality adjusted life years) and in a subgroup of patients with gastrointestinal malignancy (6-month cost $7227 with 0.34 quality adjusted life years). The incremental cost effectiveness ratio of dalteparin compared to edoxaban was $1,873,535 in the general oncology population and $694,058 in the gastrointestinal malignancy population.
Topics: Anticoagulants; Cost-Benefit Analysis; Dalteparin; Gastrointestinal Neoplasms; Humans; Markov Chains; Models, Theoretical; Neoplasms; Pyridines; Quality-Adjusted Life Years; Thiazoles; Thrombosis; United States
PubMed: 31228036
DOI: 10.1007/s11239-019-01903-z -
PharmacoEconomics 2005Patients undergoing abdominal surgeries face substantial risk of experiencing venous thromboembolic events in the perioperative period. The low-molecular-weight heparin...
INTRODUCTION
Patients undergoing abdominal surgeries face substantial risk of experiencing venous thromboembolic events in the perioperative period. The low-molecular-weight heparin dalteparin sodium is clinically effective in reducing the incidence of venous thromboembolism (VTE) in these patients. Dalteparin may be used in low (2500 units [U]) and high (5000 U) once-daily doses for this indication. However, the cost effectiveness of dalteparin 5000 U compared with dalteparin 2500 U and unfractionated heparin (UFH) for this indication has not been studied.
OBJECTIVE
To conduct a cost-utility analysis to evaluate the cost effectiveness of dalteparin compared with UFH for preventing VTE in patients undergoing elective abdominal surgery.
METHODS
A Markov model, from a healthcare perspective, was constructed to evaluate the cost effectiveness of dalteparin 5000 U and dalteparin 2500 U compared with UFH. A 69-year-old mixed sex patient population was studied using pooled probabilities of clinical outcomes from randomised, controlled trials. Cost data were mostly derived from Medicare reimbursement, in year 2002-03 values. Cost effectiveness was measured as cost per QALY gained over the patient's lifetime.
RESULTS
Total costs for patients given UFH, dalteparin 2500 U and dalteparin 5000 U were US45,855 dollars, US45,882 dollars and US46,308 dollars, respectively, while QALYs were 9.5603, 9.5632 and 9.5811, respectively. Hence, the incremental cost effectiveness of dalteparin 5000 U over dalteparin 2500 U and UFH was US23,799 dollars/QALY and US21,779 dollars/QALY gained, respectively. Similarly, cost effectiveness for dalteparin 2500 U over UFH was US9310 dollars/QALY gained. Univariate sensitivity analysis showed that dalteparin 5000 U maintained its cost effectiveness (incremental cost-effectiveness ratio [ICER]
dalteparin 5000 U would achieve cost effectiveness for 90% of patients at values close to US230,000 dollars/QALY. Dalteparin 2500 U was less effective than UFH for patients aged <63 years. CONCLUSION
Even though our base-case analysis seems to show that dalteparin 5000 U is cost effective compared with dalteparin 2500 U and UFH for prophylaxis of VTE in patients undergoing abdominal surgery, Monte Carlo simulation demonstrated that this was the case for only about 50% of the patients if the threshold for cost effectiveness is set at US50,000 dollars per QALY gained. Furthermore, there was substantial uncertainty in the cost-effectiveness results. To ensure that > or =90% patients receive the benefit of the medication, policy makers would need to commit substantially more resources than suggested by the baseline ICERs.
Topics: Abdomen; Aged; Aged, 80 and over; Anticoagulants; Cost-Benefit Analysis; Dalteparin; Female; Humans; Male; Models, Economic; Thromboembolism; Venous Thrombosis
PubMed: 16153135
DOI: 10.2165/00019053-200523090-00005