Effects of a Low-Molecular-Weight Heparin on Thrombus Regression and Recurrent Thromboembolism in Patients with Deep-Vein Thrombosis

Breddin, H. K.; Hach-Wunderle, V.; Nakov, Roumen; Kakkar, Vijay V.

doi:10.1056/nejm200103013440902

Cited by 188 publications

(124 citation statements)

References 31 publications

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“…14,23 All but 1 study 16 blinded outcome assessors. Only 2 studies blinded data analysts, 16,21 and only 2 studies blinded patients and caregivers.…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

“…Two articles did report the cancer subgroups data. 12,13 Three other articles [14][15][16] had follow-up publications reporting the cancer subgroup data. [17][18][19][20] We contacted the authors of the remaining 19 articles to request cancer subgroup data: One author provided us with the data 21 ; another author indicated that the data were not available anymore 22 ; we used the cancer subgroup data for 7 articles, 23-29 because they were reported in 2 published systematic reviews 5,8 ; and we were not able to obtain any outcome data for the remaining studies.…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

“…Patients with cancer, as noted earlier, constituted subgroups in all studies that were included. [12][13][14][15][16]21,[23][24][25][26][27][28][29] The 13 studies recruited a total of 1016 patients with cancer and 4797 patients without cancer. None of the studies specified the type(s) of cancer of participants.…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

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Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Akl

Rohilla

Barba³

et al. 2008

Cancer

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BACKGROUND.The authors compared the relative efficacy and safety of low‐ molecular‐weight heparin (LMWH) and unfractionated heparin (UFH) for the initial treatment of venous thromboembolism (VTE) between patients with and without cancer.METHODS.By using Cochrane methodology for systematic reviews, separate meta‐analyses were conducted for subgroups of patients with and without cancer, and relative risks (RRs) were compared for statistical significance. The methodologic quality for each outcome was assessed by using the Grading of Recommendations Assessment, Development, and Evaluation approach.RESULTS.LMWH reduced mortality significantly compared with UFH in patients with cancer (RR of 0.71; 95% confidence interval [95% CI], 0.52‐0.98 [moderate‐quality evidence]) but not in patients without cancer (RR of 0.97; 95% CI, 0.65‐1.46 [low‐quality evidence]). However, the difference in the RR for the 2 subgroups did not reach statistical significance (P = .113). The difference between LMWH and UFH in the effect on recurrent VTE was not statistically significant in the subgroup with cancer (RR of 0.78; 95% CI, 0.29‐2.08 [low‐quality evidence]), in the subgroup without cancer (RR of 0.94; 95% CI, 0.60‐1.46 [low‐quality evidence]), or between the 2 subgroups (P = .367). No data were available for bleeding outcomes, thrombocytopenia, or postphlebitic syndrome.CONCLUSIONS.The current results indicated that LMWH most likely is superior to UFH in reducing mortality in the initial treatment of VTE for patients with cancer. There is a need for more and better designed trials to confirm these findings. Cancer 2008. © 2008 American Cancer Society.

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“…14,23 All but 1 study 16 blinded outcome assessors. Only 2 studies blinded data analysts, 16,21 and only 2 studies blinded patients and caregivers.…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

Section: Data Synthesis and Analysismentioning

confidence: 99%

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Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Akl

Rohilla

Barba³

et al. 2008

Cancer

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“…A range of options currently exist for thrombus resolution, including traditional anticoagulants, thrombolytic agents (such as streptokinase, urokinase, and recombinant tissue plasminogen activator), surgical embolectomy, and percutaneous catheter-directed treatment; [31][32][33] these approaches can be used alone or in combination in some cases.…”

Section: Treatment Approaches and Guidelines For Thrombus Resolutionmentioning

confidence: 99%

Overview of Current Evidence on the Impact of the Initial High Dose of the Direct Factor Xa Inhibitor Rivaroxaban on Thrombus Resolution in the Treatment of Venous Thromboembolism

Bauersachs

Koitabashi

2017

Int. Heart J.

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SummaryIncomplete thrombus resolution in patients with venous thromboembolism (VTE) may increase the risk of recurrent thromboembolic events and other complications, such as post-thrombotic syndrome. Various options exist for thrombus resolution, including systemic thrombolytic agents, catheter-directed thrombolysis, and traditional anticoagulants such as heparins or vitamin K antagonists (VKAs). Data are accumulating on the use of non-VKA oral anticoagulants, such as rivaroxaban, and these may provide greater thrombus resolution compared with VKAs. Data from the phase III rivaroxaban studies presented here show that a 21-day intensive dosing regimen of rivaroxaban 15 mg twice daily is effective during the acute treatment phase for VTE, with similar recurrence rates and thrombus resolution to standard anticoagulation. Pooled analyses of phase III studies have also indicated that rivaroxaban 20 mg once daily monotherapy for up to 12 months after this initial intensive treatment period may provide effective prevention of recurrent VTE and a reduction in the risk of major bleeding, irrespective of clot burden. Four case studies from the Darmstadt Academic Teaching Hospital, Germany, and Gunma University Hospital, Japan, are also provided. Further clinical studies and real-world data may improve our understanding of initial intensive dose regimens, and assess the full significance of thrombus burden in VTE. (Int Heart J 2017; 58: 6-15)

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“…Unfortunately, a major disadvantage of LMWHs is that they can only be administered parenterally, due to a lack of absorption when administered orally [Breddin et al, 2001;Gran et al, 2001;Money and York, 2001]. The development of oral formulations for LMWH would have tremendous clinical importance as it would result not only in avoidance of the pain and discomfort associated with injections but would also reduce expenses associated with prolonged hospital stay and parenterals, thereby offering improved patient compliance.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the oral bioavailability of low molecular weight heparin formulated with glycyrrhetinic acid as permeation enhancer

Motlekar

Srivenugopal

Wachtel

et al. 2006

Drug Development Research

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Low molecular weight heparin (LMWH) is the agent of choice for anticoagulant therapy and prophylaxis of thrombosis and coronary syndromes. However, its therapeutic use is limited due to poor oral bioavailability. The aim of this study was to investigate the oral delivery of LMWH, ardeparin formulated with 18-β glycyrrhetinic acid (GA), as an alternative to currently used subcutaneous (sc) delivery. Drug transport through Caco-2 cell monolayers was monitored in the presence and absence of GA by scintillation counting and transepithelial electrical resistance. Regional permeability studies using rat intestine were performed using a modified Ussing chamber. Cell viability in the presence of various concentrations of enhancer was determined by MTT assay. The absorption of ardeparin after oral administration in rats was measured by an anti-factor Xa assay. Furthermore, the eventual mucosal epithelial damage was histologically evaluated. Higher ardeparin permeability (~7-fold) compared to control was observed in the presence of 0.02 % GA. Regional permeability studies indicated predominant absorption in the duodenal segment. Cell viability studies showed no significant cytotoxicity below 0.01 % GA. Ardeparin oral bioavailability was significantly increased (F relative / S.C . = 13.3%) without causing any damage to the intestinal tissues. GA enhanced the oral absorption of ardeparin both in vitro and in vivo. The oral formulation of ardeparin with GA could be absorbed in the intestine. These results suggest that GA may be used as an absorption enhancer for the oral delivery of LMWH.

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Effects of a Low-Molecular-Weight Heparin on Thrombus Regression and Recurrent Thromboembolism in Patients with Deep-Vein Thrombosis

Abstract: In acute deep-vein thrombosis, reviparin regimens are more effective than unfractionated heparin in reducing the size of the thrombus. Reviparin is also more effective than unfractionated heparin for the prevention of recurrent thromboembolism and equally safe.

Cited by 188 publications

References 31 publications

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Overview of Current Evidence on the Impact of the Initial High Dose of the Direct Factor Xa Inhibitor Rivaroxaban on Thrombus Resolution in the Treatment of Venous Thromboembolism

Evaluation of the oral bioavailability of low molecular weight heparin formulated with glycyrrhetinic acid as permeation enhancer

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