Topic
Ardeparin
About: Ardeparin is a research topic. Over the lifetime, 28 publications have been published within this topic receiving 1030 citations.
Papers
TL;DR: In this paper, the authors performed a double-blind, randomized clinical trial to compare the efficacy and safety of three different subcutaneous (SC) low molecular weight heparin doses (ardeparin sodium 25, 35, or 50 anti-X a U/kg twice daily [BID]) to adjusted-dose warfarin (international normalized ratio [INR] = 2.0 to 3.0), as venous thromboembolism prophylaxis after total knee replacement surgery.
Abstract: We performed a double-blind, randomized clinical trial to compare the efficacy and safety of three different subcutaneous (SC) low molecular weight heparin doses (ardeparin sodium 25, 35, or 50 anti-X a U/kg twice daily [BID]) to adjusted-dose warfarin (international normalized ratio [INR] = 2.0 to 3.0), as venous thromboembolism prophylaxis after total knee replacement surgery. The primary endpoint was total venous thromboembolism prevalence, defined as deep vein thrombosis discovered at postoperative venography of the operated leg, or symptomatic, objectively-documented pulmonary embolism. Of 860 patients randomized, 680 (79%) had an evaluable venogram or pulmonary embolism. The total venous thromboembolism prevalence was significantly greater among patients prophylaxed with warfarin compared to ardeparin 50 BID (38% vs 27%, p = 0.019); the prevalence among ardeparin 25 BID (37%) and 35 BID (28%) patients was similar to warfarin and ardeparin 50 BID patients, respectively. Overt bleeding occurred in 22 (7.9%) ardeparin 50 BID patients compared to 12 (4.4%) warfarin patients (p = 0.08), and in seven ardeparin 25 and 35 BID patients each (5.2% and 5.0%, respectively). Compared to the warfarin group, blood loss was significantly greater in the ardeparin 50 and 25 BID groups, and not different in the ardeparin 35 BID group. Conclusions: Postoperative, unmonitored, fixed-dose ardeparin 50 anti-X a U/kg SC BID is significantly more effective than adjusted-dose warfarin for this indication. Although overt bleeding among warfarin and ardeparin 50 BID patients did not differ significantly, ardeparin 50 BID patients had significantly greater blood loss. Ardeparin 35 anti-X a U/kg SC BID may provide efficacy similar to ardeparin 50 anti-X a U/kg SC BID but with reduced bleeding.
94 citations
TL;DR: In this article, the authors evaluated the effect of sodium caprate as an oral penetration enhancer for low molecular weight heparin (LMWH), ardeparin in rats.
Abstract: The primary objective of this study was to evaluate sodium caprate as an oral penetration enhancer for low molecular weight heparin (LMWH), ardeparin. In vitro studies using Caco-2 cell monolayer indicated that 0.0625% of sodium caprate gave approximately 2-fold enhancement of ardeparin compared to negative control with almost 100% cell survival as evaluated by MTT cytotoxicity assay. In vivo studies in rats with ardeparin (1,200 IU/kg) and sodium caprate (100 mg/kg) led to a relative bioavailability of 27% with plasma anti-factor Xa levels within the therapeutic range (>0.2 IU/ml). Moreover, under these conditions, histological examination provided evidence that there was no damage to the gastrointestinal wall. Regional permeability studies using rat intestine indicated the colon as the region of maximum permeation. These results suggest that, at the dose administered, sodium caprate acts as a relatively safe and efficient absorption enhancer in the quest for alternatives for the oral delivery of LMWH.
46 citations
TL;DR: There is insufficient evidence for determining the therapeutic equivalence of low-molecular-weight heparins (LMWHs), and they are being considered as alternatives to UFH or warfarin, and there is potential for therapeutic interchange.
Abstract: OBJECTIVE:To review the recent literature on the approved uses of enoxaparin, dalteparin, ardeparin, and tinzaparin and the evidence for therapeutic equivalence.DATA SOURCES:A MEDLINE search (1993–January 2001) was conducted to identify English-language literature available on enoxaparin, dalteparin, ardeparin, and tinzaparin.STUDY SELECTION:All controlled trials evaluating low-molecular-weight heparins (LMWHs) versus standard therapy powered to detect a significant difference were reviewed.DATA EXTRACTION:Agents were reviewed with regard to safety and efficacy.DATA SYNTHESIS:As a class, LMWHs have chemical, physical, and clinical similarities. LMWHs have greater bioavailability, longer half-lives, a more predictable pharmacologic response, possible improved safety, and similar or greater efficacy compared with unfractionated heparin (UFH). Because of this, enoxaparin, dalteparin, ardeparin, and tinzaparin are being considered as alternatives to UFH or warfarin, and there is potential for therapeutic inte...
43 citations
TL;DR: The Heptest results at 12 hours after ardeparin administration indicated that the global anticoagulant effects produced by LMWH are sustained for many hours after subcutaneous dosing.
Abstract: This prospective, uncontrolled trial explored the relationship between varying dosages of a low molecular weight heparin (LMWH) preparation, ardeparin sodium (Normiflo, Wyeth-Ayerst, Philadelphia, PA), and anticoagulant effects, monitored by an amidolytic anticoagulation factor Xa (aXa) assay and by global coagulometric methods, including the activated partial thromboplastin time (APTT) and the Heptest (Haemachem, St. Louis, MO). Thirty-three patients undergoing elective unilateral total hip or knee replacement received subcutaneous ardeparin prophylaxis initiated 12 to 18 hours following surgery, administered at a fixed 40-mg dose twice daily, 50 aXa U/kg twice daily or 90 aXa U/kg once daily for up to 14 days. The target antithrombotic aXa levels, determined by amidolytic assay in plasma 6 hours after each ardeparin injection, were most optimally attained and maintained by twice-daily dosing based on body weight and correlated well with incremental increases in Heptest values measured chronometrically. The Heptest results at 12 hours after ardeparin administration indicated that the global anticoagulant effects produced by LMWH are sustained for many hours after subcutaneous dosing.
35 citations
TL;DR: Tinzaparin is a group of important medications with total sales reaching nearly 2.5 billion dollars with expanded indications reaching far beyond the initial indications for the prophylaxis of post-surgical DVT.
Abstract: Standard unfractionated heparin (UFH) has been in clinical use for over 50 years. The commercial use of low molecular weight heparins (LMWHs) began in the mid 1980s for hemodialysis and the prophylaxis of deep vein thrombosis (DVT). Initially, the clinical development of LMWHs was concentrated on the European continent. Subsequently, LMWHs were introduced in North America as well. In the initial stages of development of these drugs only nadroparin, dalteparin and enoxaparin were used. Subsequently, several other LMWHs such as ardeparin, tinzaparin, reviparin and parnaparin were introduced. LMWHs constitute a group of important medications with total sales reaching nearly 2.5 billion dollars with expanded indications reaching far beyond the initial indications for the prophylaxis of post-surgical DVT. This review highlights the pharmacology of tinzaparin. Unlike other LMWHs, tinzaparin is prepared by enzymatic hydrolysis with heparinase, while various chemical depolymerization methods are used for the synthesis of other LMWHs. As compared with the standard heparin, LMWHs have different pharmacodynamic, and pharmacokinetic properties; they also differ in clinical benefits.
33 citations
Related Topics (5)
Performance Metrics
| Year | Papers |
|---|---|
| 2020 | 1 |
| 2018 | 1 |
| 2017 | 1 |
| 2010 | 1 |
| 2006 | 3 |
| 2005 | 1 |