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01-02-2003 | Original Research Article

Randomised Long-Term Comparison of Tinzaparin and Dalteparin in Haemodialysis

Authors: Rolinda J. R. Beijering, Hugo ten Cate, Paul Stevens, Raymond Vanholder, Wim T. Van Dorp, Rudolf W. van Olden, Björn Wickström, Dr Per Sprøgel, Jan W. ten Cate

Published in: Clinical Drug Investigation | Issue 2/2003

Abstract

Objective and design

Tinzaparin and dalteparin are low molecular weight heparins (LMWHs) with different pharmacokinetic and pharmacodynamic profiles that may lead to differences in efficacy and safety. In a long-term, multicentre, prospective, randomised trial we compared the efficacy and safety profiles of tinzaparin and dalteparin (starting doses were adjusted to comparable anti-IIa activity). The sample size was calculated to show a relative difference of 50% in unsatisfactory dialyses with a power of 80% (to prove superiority).

Patients

159 patients undergoing chronic intermittent haemodialysis were included in the study.

Main outcome measures

Efficacy was assessed by scoring the dialyser (from 1 = good, clear dialyser to 4 = total clotting of the dialyser requiring a change of the extracorporeal circuit) and bubble catcher (from 1 = no clots to 4 = severe clotting) after each dialysis. Levels of thrombin antithrombin complexes (TAT) were also determined. Safety was assessed by noting all minor and major bleeding.

Results

The mean anticoagulant dose for tinzaparin during the maintenance phase was about 10% lower than that of dalteparin: 5024 ± 2321 (range 700–12000) anti-Xa IU and 5546 ± 2395 (1875–12913) anti-Xa IU, respectively. No difference was found between treatments in clotting for either the dialyser or the bubble catcher (p = 0.59). TAT levels showed no difference between tinzaparin and dalteparin. The number of minor bleeds did not differ between treatments: 1.5% (40/2629 dialyses) for tinzaparin and 1.4% (41/2863 dialyses) for dalteparin, and one major bleed occurred in each treatment arm.

Conclusions

Dose calculation of tinzaparin and dalteparin according to anti-IIa activity resulted in equivalent efficacy and safety, although this was achieved with a 10% lower dose of tinzaparin measured in anti-Xa IU. Both LMWHs can be safely administered over a wide dosage range in patients undergoing long-term intermittent haemodialysis.

¹The use of tradenames is for product identification only and does not imply endorsement.

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Title: Randomised Long-Term Comparison of Tinzaparin and Dalteparin in Haemodialysis
Authors: Rolinda J. R. Beijering
Hugo ten Cate
Paul Stevens
Raymond Vanholder
Wim T. Van Dorp
Rudolf W. van Olden
Björn Wickström
Dr Per Sprøgel
Jan W. ten Cate
Publication date: 01-02-2003
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 2/2003
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.2165/00044011-200323020-00002

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Randomised Long-Term Comparison of Tinzaparin and Dalteparin in Haemodialysis

Abstract

Objective and design

Patients

Main outcome measures

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective and design

Patients

Main outcome measures

Results

Conclusions

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