Peak Antifactor Xa Activity Produced by Dalteparin Treatment in Patients with Renal Impairment Compared with Controls

Shprecher, Adam; Cheng-Lai, Angela; Madsen, Eileen M.; Cohen, Hillel W.; Sinnett, Mark J.; Wong, Serena; Billett, Henny H.

doi:10.1592/phco.2005.25.6.817

Cited by 29 publications

(26 citation statements)

References 25 publications

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“…In a small study of patients (N=22) treated with dalteparin, mean anti-Xa activity was similar between patients with renal impairment (mean C Cr, 26 mL/min; range, 16-38 mL/min) and those with normal renal function (C Cr >80 mL/min). 95 In a more recent study of prophylactic dalteparin in critically ill patients (N=138 evaluable) with severe renal impairment (C Cr <30 mL/min), no bioaccumulation was detected after a median of 7 days of prophylactic-dose dalteparin (5000 IU daily). 96 Treatment was not associated with excessive anticoagulation; peak anti-Xa levels were between 0.29 and 0.34 IU/mL.…”

Section: Therapies For Prophylaxis or Treatment Of Vte In Patients Wimentioning

confidence: 98%

Venous Thromboembolic Disease

Streiff¹,

Bockenstedt²,

Cataland³

et al. 2013

J Natl Compr Canc Netw

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OverviewVenous thromboembolism (VTE) is a common and life-threatening condition in patients with cancer.1,2 Results from a retrospective study of hospitalized adult patients with cancer with neutropenia (N=66,106) showed that approximately 3% to 12% of these patients, depending on the type of malignancy, experienced VTE during their first hospitalization.1 In a recent health claims database analysis of patients undergoing chemotherapy for solid tumors in the ambulatory setting (N=17,284), VTE NCCN Venous Thromboembolic Disease Clinical Practice Guidelines in Oncology AbstractVenous thromboembolism (VTE) remains a common and life-threatening complication among patients with cancer. Thromboprophylaxis can be used to prevent the occurrence of VTE in patients with cancer who are considered at high risk for developing this complication. Therefore, it is critical to recognize the various risk factors for VTE in patients with cancer. Risk assessment tools are available to help identify patients for whom discussions regarding the potential benefits and risks of thromboprophylaxis would be appropriate. The NCCN Clinical Practice Guidelines in Oncology for VTE provide recommendations on risk evaluation, diagnosis, prevention, and treatment of VTE in patients with cancer. (JNCCN 2013;11:1402-1429 NCCN Categories of Evidence and ConsensusCategory 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. These guidelines are also available on the Internet. For the latest update, visit NCCN.org.

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Section: Therapies For Prophylaxis or Treatment Of Vte In Patients Wimentioning

confidence: 98%

Venous Thromboembolic Disease

Streiff¹,

Bockenstedt²,

Cataland³

et al. 2013

J Natl Compr Canc Netw

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“…Primary objectives were peak anti-Xa levels and adjusted anti-Xa levels, adjustment being carried out for dose and body weight. Results: A total of 42 patients could be analyzed during a median of 10 days (interquartile range IQR 4-13, range [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20]. In all groups, adjusted peak anti-Xa levels were not different on day 10 compared with day 1.…”

Section: )2mentioning

confidence: 99%

Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function

Schmid

Brodmann

Fischer

et al. 2009

Journal of Thrombosis and Haemostasis

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To cite this article: Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost 2009; 7: 552-8.Summary. Background: Low-molecular-weight heparins (LMWH) have been shown to be effective and safe for prophylaxis of thromboembolic diseases. However, issues regarding safety and optimal use of LMWH arise in patients with renal insufficiency (RI). Objectives: To compare pharmacokinetic data of dalteparin for up to 3 weeks in patients with various degrees of RI. Patients and methods: Patients from general medical and surgical wards were included in this prospective cohort study and divided into three groups according to renal function: A = normal (GFR ‡ 60 mL min m )2). Dalteparin was injected s.c. once daily at a prophylactic dose. Peak anti-Xa activity levels (anti-Xa) were measured 4 ± 1 h after injection on day 1 and every third day up to 3 weeks. Primary objectives were peak anti-Xa levels and adjusted anti-Xa levels, adjustment being carried out for dose and body weight. Results: A total of 42 patients could be analyzed during a median of 10 days . In all groups, adjusted peak anti-Xa levels were not different on day 10 compared with day 1. No bioaccumulation >30% could be found up to day 10 even in patients with severe RI. Conclusion: The use of dalteparin at a prophylactic dose was not associated with a bioaccumulation >30% even in patients with severe renal insufficiency during a median follow-up of 10 days (IQR 4-13, range 1-20).

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“…Tincani showed that no bioaccumulation occurred after 6 days of dalteparin prophylaxis, irrespective of renal function without major bleeding events. 28 Studies performed by both Schmid et al and Shprecher et al showed no increase in anti-factor Xa level in patients with renal impairment in prophylactic or therapeutic dosing, 10,29 and a metaanalysis from 2006 notes that insufficient data exist to assess risk for major bleeding for other LMWHs such as dalteparin and tinzaparin, while still advising adjusted dose enoxaparin in CKD. 30 Strengths.…”

Section: Discussionmentioning

confidence: 99%

“…9 A single study comparing 4-h postinjection anti-Xa levels in patients with a mean glomerular filtration rate (GFR) of 26.1 (range 16-38) ml/min versus normal renal function after therapeutic doses of dalteparin did not show any difference in the assay levels in those with impaired renal function when compared to those with normal renal function. 10 Currently, little is known about bleeding risks with therapeutic doses of dalteparin in patients with renal insufficiency, and guidelines regarding dose adjustments and preference of unfractionated heparin over dalteparin in this population are not sufficiently evidence-based. 11 To our knowledge, there has not been a prospective or retrospective study in which the bleeding risk of therapeutic dose of dalteparin in patients with renal insufficiency has been examined.…”

Section: Introductionmentioning

confidence: 99%

Treatment with Dalteparin is Associated with a Lower Risk of Bleeding Compared to Treatment with Unfractionated Heparin in Patients with Renal Insufficiency

et al. 2015

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BACKGROUND: Low molecular weight heparins (LMWHs) have been cautiously used in patients with chronic kidney disease (CKD) due to fear of accumulation. Dalteparin, however, has shown minimal tendency to accumulate in patients with CKD and may be safe to use in this patient population. OBJECTIVE: We compared the incidence of clinically significant bleeding in patients with CKD receiving therapeutic doses of dalteparin to that of patients with CKD receiving therapeutic doses of UFH. DESIGN: This was a retrospective cohort study. SUBJECTS: Inpatients with CKD (GFR<60 ml/min) who were treated with therapeutic dalteparin or UFH were included in the study MAIN MEASURES: Primary outcome was major bleeding within 10 days of anticoagulation, identified by ICD-9 code and confirmed by chart review. Demographic characteristics, laboratory values, comorbidities, prior bleeding history and inpatient medications were extracted for each admission from the electronic medical record. Logistic regression models were created to examine the association between choice of anticoagulant and bleeding rates, after adjustment for demographic and clinical characteristics. KEY RESULTS: Dalteparin-treated patients were significantly less likely to experience a major bleed than patients treated with UFH (1.14 % vs. 3.49 %, p<0.001). The reduced likelihood of bleeding associated with dalteparin treatment remained significant after adjustment for patient characteristics (HR 0.39, 95 % CI: 0.21-0.70, p < 0.0001). A stratified analysis for subgroups with GFR< 30 mL/min and with GFR between 30 and 60 mL/min showed that dalteparin was still associated with lower odds of bleeding compared to treatment with unfractionated heparin, but the difference was nonsignificant for GFR< 30 (HR 0.35,), even after adjustment (OR 0.37, 95 % CI: 0.11-1.22). CONCLUSION: In patients with CKD, treatment with therapeutic dose dalteparin was associated with lower rates of bleeding than treatment with unfractionated heparin. For patients with severe CKD (GFR< 30), dalteparin was shown to be at least as safe as unfractionated heparin.KEY WORDS: dalteparin; renal insufficiency; bleed; heparin.

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Peak Antifactor Xa Activity Produced by Dalteparin Treatment in Patients with Renal Impairment Compared with Controls

Cited by 29 publications

References 25 publications

Venous Thromboembolic Disease

Venous Thromboembolic Disease

Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function

Treatment with Dalteparin is Associated with a Lower Risk of Bleeding Compared to Treatment with Unfractionated Heparin in Patients with Renal Insufficiency

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