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Biomedical subjects

M V Huisman

Publications and source records attributed to M V Huisman.

At least 19 recordsLinked to original sources
PubMed2006

Vascular phenotype and subclinical inflammation in diabetic Asian Indians without overt cardiovascular disease.

Although Asian Indian (AI) patients with diabetes mellitus type 2 (DM2) are at high risk for cardiovascular disease (CVD), not all patients develop CVD. The vascular phenotype of AI-DM2 without CVD has not been elucidated and may point to protective features. Using baseline data from a clinical trial we provide an initial description of vascular parameters in AI-DM2 compared to Europid Caucasian controls (ECs) matched for age and gender. Endpoints of the study were endothelial function, low-grade systemic inflammation (CRP) and carotid intima-media thickness (cIMT). AIs had longer duration of diabetes, worse glycemic control and more microangiopathy. Both groups demonstrated marked endothelial dysfunction. CRP levels were similar: 1.7 (4.9) mg/L in AIs and 2.8 (3.6) mg/L in ECs. cIMT values were significantly lower in AI-DM2 than EC-DM2 (0.655mm (0.12) versus 0.711mm (0.15), p=0.03). Multiple regression analysis showed that variability in CRP was mainly determined by waist circumference, not by ethnicity. In contrast, ethnicity was a significantly explanatory variable for cIMT. Vascular phenotype of AI-DM2 without CVD was characterized by endothelial dysfunction and relatively low levels of CRP, comparable to EC-DM2 controls. In contrast, lower cIMT values were observed in AI-DM2 despite longer duration of diabetes and worse metabolic control. We propose that mechanisms slowing its progression may have atheroprotective potential in AI-DM2.

Adult↗
PubMed2006

Macrophage low-density lipoprotein receptor-related protein deficiency enhances atherosclerosis in ApoE/LDLR double knockout mice.

OBJECTIVE: In vitro studies implicate that the low-density lipoprotein receptor (LDLR)-related protein (LRP) in macrophages has a pro-atherogenic potential. In the present study, we investigated the in vivo role of macrophage specific LRP in atherogenesis independent of its role in the uptake of lipoproteins. METHODS AND RESULTS: We generated macrophage-specific LRP-deficient mice on an apoE/LDLR double-deficient background. Macrophage LRP deletion did not affect plasma cholesterol and triglyceride levels, lipoprotein distribution, and blood monocyte counts. Nevertheless, macrophage LRP deficiency resulted in a 1.8-fold increase in total atherosclerotic lesion area in the aortic root of 18-week-old mice. Moreover, LRP deficiency also resulted in a relatively higher number of advanced lesions. Whereas macrophage and smooth muscle cell content did not differ between LRP-deficient mice and control littermates, a 1.7-fold increase in collagen content and 2.3-fold decrease in relative number of CD3+ T cells were observed in lesions from macrophage specific LRP-deficient mice. CONCLUSIONS: Our data demonstrate that independent of its role in lipoprotein uptake, absence of LRP in macrophages resulted in more advanced atherosclerosis and in lesions that contained more collagen and less CD3+ T cells. In contrast to previous in vitro studies, we conclude that macrophage LRP has an atheroprotective potential and may modulate the extracellular matrix in the atherosclerotic lesions.

Animals↗
PubMed2006

[Right-ventricular dysfunction and the pulmonary vascular obstruction index: predictable variables of the clinical course over 3 months in patients with acute lung emboli].

OBJECTIVE: To quantify right-ventricular dysfunction and the pulmonary artery obstruction index, in patients with acute pulmonary embolism, using helical CT, and to assess the prognostic value of these parameters. DESIGN: Prospective. METHOD: In 120 consecutive patients with proven acute pulmonary embolism, the extent of right-ventricular dysfunction was assessed by quantifying the ratios of the right to left-ventricular short-axis diameters (RV/LV ratio) and the extent ofobstruction ofthe pulmonary-artery circulation by using helical CT images. Regression analysis was used to correlate these parameters with patient outcome. RESULTS: Right-ventricular dysfunction (RV/LV ratio > 1.0) was seen in 69 patients (57.5%). Seven patients died as a direct result of pulmonary embolism. Both the RV/LV ratio and the obstruction index were significant risk factors for mortality within three months (p = 0.04 and 0.01 respectively). The positive predictive value for pulmonary embolism-related mortality of an RV/LV ratio > 1.0 was 10.1% (95% CI: 2.9-17.4). The negative predictive value for an uneventful outcome of an RV/LV ratio < or = 1.0 was 100% (95% CI: 94.3-100). There was a 11.2-fold risk of dying of pulmonary embolism in patients with an obstruction index > or = 40% (95% CI: 1.3-93.6). CONCLUSION: Markers of right-ventricular dysfunction and pulmonary vascular obstruction, assessed by helical CT-examination at baseline, help to predict mortality during follow-up of patients with acute pulmonary embolism.

Acute Disease↗
PubMed2006

A simple diagnostic strategy in hospitalized patients with clinically suspected pulmonary embolism.

OBJECTIVES: Diagnostic strategies in patients with suspected pulmonary embolism have been extensively studied in outpatients; their value in hospitalized patients has not been well established. Our aim was to determine the safety and clinical utility of a simple diagnostic strategy in hospitalized patients with suspected pulmonary embolism. DESIGN: Prospective management study. SETTING: Twelve teaching hospitals (five academic, seven general hospitals). SUBJECT: A total of 605 hospitalized patients with clinically suspected pulmonary embolism. All patients completed the study. INTERVENTIONS: First the clinical decision rule (CDR)-score was calculated. An unlikely CDR-score in combination with a normal D-dimer excluded pulmonary embolism. All other patients underwent helical computed tomography (CT). CT either diagnosed or excluded pulmonary embolism, in which case anticoagulants were started or withheld. All patients were instructed to report symptoms of venous thrombosis. Objective tests were performed to confirm venous thromboembolism. The primary outcome was the incidence of symptomatic venous thrombosis during 3-month follow-up. RESULTS: The combination of an unlikely CDR-score and a normal D-dimer excluded pulmonary embolism in 60 patients (10% of all patients); no venous thromboembolic event occurred during follow-up (0%; 95% CI 0-6.7%). CT excluded pulmonary embolism in 380 patients; during follow-up venous thromboembolism occurred in five patients (1.4%; 95% CI 0.4-3.1%). CONCLUSIONS: An unlikely CDR-score in combination with a normal D-dimer appears to exclude pulmonary embolism safely in hospitalized patients. Before clinical implementation it is important this safety is confirmed by others. CT testing was obviated in only 10% of patients. CT can safely exclude pulmonary embolism in hospitalized patients.

Algorithms↗
PubMed2006

Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement.

BACKGROUND: Joint replacement surgery is an appropriate model for dose-ranging studies investigating new anticoagulants. OBJECTIVES: To assess the efficacy and safety of a novel, oral, direct factor Xa (FXa) inhibitor--BAY 59-7939--relative to enoxaparin in patients undergoing elective total hip replacement. METHODS: In this double-blind, double-dummy, dose-ranging study, patients were randomized to oral BAY 59-7939 (2.5, 5, 10, 20, or 30 mg b.i.d.), starting 6-8 h after surgery, or s.c. enoxaparin 40 mg once daily, starting on the evening before surgery. Treatment was continued until mandatory bilateral venography was performed 5-9 days after surgery. RESULTS: Of 706 patients treated, 548 were eligible for the primary efficacy analysis. The primary efficacy endpoint was the incidence of any deep vein thrombosis, non-fatal pulmonary embolism, and all-cause mortality; rates were 15%, 14%, 12%, 18%, and 7% for BAY 59-7939 2.5, 5, 10, 20, and 30 mg b.i.d., respectively, compared with 17% for enoxaparin. The primary efficacy analysis did not demonstrate any significant trend in dose-response relationship for BAY 59-7939. The primary safety endpoint was major, postoperative bleeding; there was a significant increase in the frequency of events with increasing doses of BAY 59-7939 (P = 0.045), but no significant differences between individual BAY 59-7939 doses and enoxaparin. CONCLUSIONS: When efficacy and safety were considered together, the oral, direct FXa inhibitor BAY 59-7939, at 2.5-10 mg b.i.d., compared favorably with enoxaparin for the prevention of venous thromboembolism in patients undergoing elective total hip replacement.

Adult↗
PubMed2006

Accuracy of clinical decision rule, D-dimer and spiral computed tomography in patients with malignancy, previous venous thromboembolism, COPD or heart failure and in older patients with suspected pulmonary embolism.

BACKGROUND: The diagnostic work-up of patients with suspected pulmonary embolism (PE) has been optimized and simplified by the use of clinical decision rules (CDR), D-dimer (DD) testing and spiral computed tomography (s-CT). Whether this strategy is equally safe and efficient in specific subgroups of patients is evaluated in this study. METHODS: A diagnostic strategy including a CDR, DD test and s-CT was evaluated in patients with malignancy, previous venous thromboembolism (VTE), chronic obstructive pulmonary disease or heart failure and in older patients. PE was ruled out by either an unlikely CDR and a normal DD or a s-CT negative for PE. The safety of these tests was assessed by the 3-month incidence rate of symptomatic VTE in those without PE at baseline. The efficiency was evaluated by calculating the numbers needed to test for the different subgroups. RESULTS: The venous thromboembolic incidence rate after the combination of an unlikely CDR and a normal DD varied from 0% (95% CI: 0-7.9%) in the 482 patients older than 75 years of age to 2% (95% CI: 0.05-10.9%) in the 474 patients with a malignancy. For s-CT these incidences varied from 0.3% to 1.8%. The number needed to test in order to rule out one patient from PE with the studied strategy was highest in cancer patients and in the elderly patients (approximately 10). CONCLUSION: It appears to be safe to rule out PE by either the combination of an unlikely CDR and a normal DD or by a negative s-CT in various subgroups of patients with suspected PE. However, the clinical usefulness of the CDR in combination with the DD as the initial step in the diagnostic process varied among these patient groups.

Adult↗
PubMed2006

Aspirin in the prevention and treatment of venous thromboembolism.

This review summarizes available evidence on effects of aspirin on incidence and outcomes of venous thromboembolism (VTE). From a pathophysiological point of view, inhibition of platelet aggregation is associated with an impaired thrombus formation both in an experimental model of venous thrombosis and in vivo. Epidemiological evidence in support of a beneficial effect of acetylsalicylic acid on VTE incidence is provided by the Antiplatelet Trialists' Collaboration meta-analysis of studies on the use of antiplatelet agents in cardiovascular risk reduction, showing a significant 25% risk reduction of pulmonary embolism. Moreover, a meta-analysis on older trials of antiplatelet agents in postsurgical VTE prevention and the large Pulmonary Embolism Prevention trial demonstrate a protective effect of the same magnitude: 25-30%. However, as low-molecular-weight heparins (LMWH) and vitamin K antagonists (VKA) have shown a superior efficacy and safety profile, and no direct comparisons have been made between aspirin, LMWH and VKA in prolonged use, the most recent guidelines advise against aspirin monotherapy for thromboprophylaxis in the surgical patient. Currently, there is no evidence to support a role for aspirin in air travel-related VTE. Regarding prevention of recurrent VTE, studies are ongoing to determine the potential role of aspirin after a first unprovoked VTE.

Aspirin↗
PubMed2005

Diagnosis of deep vein thrombosis and pulmonary embolism in pregnancy: a systematic review.

INTRODUCTION: Diagnosing deep vein thrombosis (DVT) and pulmonary embolism (PE) in pregnancy is challenging. Many of the common diagnostic tests, including compression ultrasonography (CUS), ventilation-perfusion scintigraphy (VQ scan) and helical computed tomography (hCT) that have been extensively investigated in non-pregnant patients, have not been appropriately validated in pregnancy. Extrapolating results of diagnostic studies of DVT and PE in non-pregnant patients to those who are pregnant may not be correct because during pregnancy, physiologic and anatomic changes may affect diagnostic test results, presentation and natural history of VTE. METHODS: We performed a systematic analysis of published studies addressing accurate diagnostic testing for DVT and PE in pregnancy to determine the accuracy of these tests in pregnancy. RESULTS: Our initial search yielded 530 articles of which four remained for inclusion, three studies investigating diagnostic testing in patients with a clinical suspicion of DVT or PE and one study in patients with a clinical suspicion of PE. CONCLUSIONS: From our systematic analysis of published studies investigating diagnostic testing for a clinical suspicion of DVT in pregnancy we conclude that; (i) two studies support withholding anticoagulant therapy in pregnant women with a clinical suspicion of DVT and normal results on serial IPG (impedance plethysmography), however, IPG is no longer used; (ii) one study demonstrated that a normal CUS at presentation combined with a normal D-dimer test or an abnormal D-dimer test combined with normal serial CUS appears promising for safely excluding DVT in pregnant patients, but too few patients were included in this pilot-study to draw firm conclusions; and (iii) one study investigated pregnant patients with a clinical suspicion of PE and this study concluded that in patients with normal or non-diagnostic VQ scans, withholding anticoagulant therapy might be safe, but this needs confirmation in larger studies. Recommendations on diagnostic testing of pregnant patients with a clinically suspected DVT or PE are provided.

Female↗
PubMed2005

[Patients with lung emboli and hemodynamic stability: insufficient evidence for routine thrombolysis].

Pulmonary embolism (PE) is a common disorder requiring prompt anticoagulant treatment. As spiral CT has become the first-line test for PE diagnosis, physicians will likely be increasingly confronted with patients displaying large centrally located pulmonary emboli. Evidence from literature supporting the use ofthrombolytic drugs in patients with PE is sparse, since only one small trial has demonstrated that these drugs can reduce short-term mortality in patients with emboli and shock. Patients with PE can present without massive arterial hypotension but with signs of right ventricular dysfunction on echocardiography or CT. One recent randomised trial evaluated whether these haemodynamically stable patients would benefit from thrombolytic therapy. However, no definitive conclusions can be drawn from this study. Potentially, other prognostic markers including brain type natriuretic peptide may be better predictors of suitable candidates for thrombolytic therapy. It is concluded that based on current knowledge, patients with PE who presentwithout arterial hypotension should not routinely be treated with thrombolytic drugs, irrespective of whether they display central emboli on CT or not.

Anticoagulants↗
PubMed2005

[The diagnosis of pulmonary embolism: the best strategies according to the results of a large Dutch multicentre study].

The Dutch national guidelines for the diagnosis of patients with clinically suspected pulmonary embolism (from 1992 en 1998) are poorly followed in clinical practice, due especially to practical objections. A large multicentre trial to investigate the diagnostic accuracy of the available modalities and of recently developed techniques such as D-dimer determination, (99m)Tc-gas-scintigraphy and spiral CT scanning was started in I997. In the first phase, the diagnostic value was assessed of: spiral CT (sensitivity 69%, specificity 84%; sensitivity for segmental and larger pulmonary embolisms (PE) 86% and for subsegmental PE 21%), (99m)Tc-gas-ventilation scintigraphy (no improvement compared to conventional ventilation scintigraphy), D-dimer determination (sensitivity for segmental PE 93% and for subsegmental PE 53%, specificity 63%), clinical decision rules (in combination with D-dimer determination; sensitivity 100%, specificity 11%) and echography of the deep venous system (sensitivity 26% for segmental PE and 7% for subsegmental PE, specificity 97%). In the second phase, the feasibility of two new potentially cost-effective diagnostic algorithms was evaluated on the basis of the results obtained in the first phase and data in the literature. In 631 patients, a clinical risk estimate was made and D-dimer determination was done, followed by a ventilation-perfusion scan and serial compression echography of the leg veins. An apparent recurrence of PE occurred in 6 of 466 patients in whom no PE had been found originally (1.3%; 95% CI: 0.5-2.8). The average costs were 812 Euro,--per patient. In 510 patients, a spiral CT followed by compression echography was performed. Recurrent PE occurred in 3 of 378 patients with initial normal tests (0.8%; 95% CI: 0.2-2.3). The average costs were 883 Euro,--per patient. A combination of both strategies can be cost-effective with a cost 674 Euro,--per patient (recurrence rate: 1.9%). Both the strategy starting with a clinical-risk estimate and a D-dimer determination as well as the strategy consisting of spiral CT and serial echography were safe and cost-effective. According to the results of a survey of hospital directors, internists and pulmonologists, both are well accepted in clinical practice.

Algorithms↗
PubMed2005

Diagnostic methods in pulmonary embolism.

Diagnosing pulmonary embolism (PE) is challenging since clinical signs and symptoms are non-specific. The diagnostic tests available for demonstrating PE all have their drawbacks and are often costly and consume considerable amounts of resources. Simple tools that have become available in the last several years include clinical prediction rules and D-dimer testing. Assessment of the clinical probability, combined with a D-dimer test, can limit the need for additional diagnostic tests by 30%. For outpatients with a normal, sensitive ELISA D-dimer test and a low-to-moderate clinical probability, PE can safely be ruled out. Pulmonary angiography, though still the gold standard, is rarely used nowadays because of its invasiveness, its high costs and limited availability, and the declining experience of radiologists with the technique. Two imaging techniques--lung scintigraphy and helical CT--are the diagnostic methods of choice. A normal perfusion lung scan can safely exclude PE. However, 55-65% of patients have indeterminate lung scan results, making additional imaging tests necessary. Helical CT is increasingly being used as the first-line test because it can directly visualize a thromboembolus, it can suggest an alternative diagnosis, and there is excellent inter-observer agreement. A normal helical CT, followed by compression ultrasonography of the leg veins, can safely rule out PE. Finally, the safety of withholding anticoagulant treatment from patients with a normal multi-row detector helical CT as the sole test has not yet been demonstrated.

Journal Article↗
PubMed2005

The metabolic syndrome: a vascular perspective.

The metabolic syndrome (MS) is a clustering of cardiovascular risk factors. Current definitions of MS use hypertension, waist circumference, fasting glucose, triglyceride and HDL-cholesterol levels as defining variables. The prevalence of MS is increasing in our society due to lifestyle changes that result in decreased physical activity and increased body weight. Patients with MS have a three times greater risk of coronary heart disease and stroke, and a two to four times greater risk of dying from atherosclerotic coronary heart disease than those without MS. Imaging studies have shown an increased burden and progression of atherosclerosis. Also, MS patients seem to be more vulnerable to events at comparable levels of atherosclerosis. First-line treatment for MS is therapeutic lifestyle intervention, including exercise and weight reduction. Medical intervention strategies using blood pressure-lowering medication, statins, fibrates and metformin seem the most appropriate to date. The effects of thiazolidinediones on cardiovascular endpoints have not been studied to a large extent in the setting of MS. Evidence regarding risk assessment and optimal medical strategies will be an important aspect of vascular research in the coming years.

Journal Article↗
PubMed2005

C-reactive protein and D-dimer with clinical probability score in the exclusion of pulmonary embolism.

This study evaluated the diagnostic value of C-reactive protein (CRP) combined with a clinical decision rule in the exclusion of pulmonary embolism (PE) and compared this with D-dimer. In 363 consecutive outpatients CRP and D-dimer test were performed and clinical probability of PE was assessed. Patients with D-dimer levels<500 microg/l and clinical probability indicating 'PE unlikely' were followed for 3 months. Ventilation-perfusion scan or spiral computerized tomography was performed in patients with D-dimer levels>or=500 microg/l or clinical probability indicating 'PE likely'. The CRP had a sensitivity of 95.7% [95% confidence interval (CI): 90-100] and negative predictive value (NPV) of 98.4% (96-100). CRP<5 mg/l with clinical probability score indicating 'PE unlikely' (n=108, 30%), had a sensitivity of 96.7% (90-100), a specificity of 43.0% (37-49) and NPV of 99.1% (97-100). D-dimer<500 microg/l with clinical probability score indicating 'PE unlikely' (n=170, 51%), had a sensitivity of 96.7% (90-100), a specificity of 67.9% (62-74) and NPV of 99.4% (98-100). Based on retrospective data it was concluded that a standard CRP test can potentially be used to safely exclude PE, either as a sole test or combined with clinical probability assessment. Prospective studies are needed to confirm these findings.

Adolescent↗
PubMed2005

Accuracy of single-detector spiral CT in the diagnosis of pulmonary embolism: a prospective multicenter cohort study of consecutive patients with abnormal perfusion scintigraphy.

BACKGROUND: Spiral computed tomography (CT) has emerged as a potentially conclusive diagnostic test to exclude pulmonary embolism (PE) in patients with non-high probability scintigraphy and is already widely used-sometimes as the sole primary diagnostic test in the diagnosis of suspected PE. Its true sensitivity and specificity has, however, not been evaluated previously in a large cohort of consecutive patients. METHODS: In a multicenter prospective study 627 consecutive patients with clinically suspected PE were studied. Patients with normal perfusion scintigraphy were excluded from further analysis. Single-detector spiral CT scanning and ventilation scintigraphy were then performed in all patients to diagnose PE, while pulmonary angiography was performed as the gold standard. The only exceptions were those patients who had both a high-probability VQ scan and a CT scan positive for PE: these patients were considered to have PE and did not undergo additional pulmonary angiography. All imaging tests were read by independent expert panels. RESULTS: Five hundred and seventeen patients were available for complete analysis. The prevalence of PE was 32%. Spiral CT correctly identified 88 of 128 patients with PE, and 92 of 109 patients without PE, for a sensitivity and specificity of 69%[95% confidence interval (CI) 63-75] and 84% (95% CI 80-89), respectively. The sensitivity of spiral CT was 86% (95% CI 80-92) for segmental or larger PE and 21% (95% CI 14-29) in the group of patients with subsegmental PE. CONCLUSION: The overall sensitivity of spiral CT for PE is too low to endorse its use as the sole test to exclude PE. This holds true even if one limits the discussion to patients with larger PE in segmental or larger pulmonary artery branches. We conclude that, in patients with clinically suspected PE and an abnormal perfusion scintigraphy, single-slice detector spiral CT is not sensitive enough to be used as the sole test to exclude PE.

Adult↗
PubMed2005

Helical computed tomography and alternative diagnosis in patients with excluded pulmonary embolism.

OBJECTIVE: A clinical diagnosis of pulmonary embolism (PE) is confirmed objectively in 20-30% of patients. Helical computed tomography (CT) can allow an alternative diagnosis to be made. The frequency and validity of alternative diagnoses on helical CT in consecutive patients presenting with clinically suspected PE was assessed. PATIENTS AND METHODS: In all 512 prospectively analyzed patients helical CT scan was performed, and apart from presence or absence of PE, pathologic changes in lung parenchyma, mediastinum, cardiovascular system, pleura and skeleton were recorded. When possible an alternative diagnosis was given and compared with the final diagnosis after 3 months follow-up. RESULTS: In 130 patients (25.4%) PE was excluded and an alternative diagnosis considered likely. In 123 of the 130 patients (94.6%) this diagnosis was unchanged at 3 months follow-up. The diagnoses included pneumonia (n = 67), malignancy (n = 22), pleural fluid (n = 10), cardiac failure (n = 10), COPD (n = 6) and a variety of other causes (n = 15). The diagnosis changed at follow-up in seven patients (5.4%). An initial diagnosis of pneumonia changed to malignancy in two patients and to pleuritis and cardiac failure in one patient each. In two other patients malignancy and chronic obstructive pulmonary disease (COPD) were ruled out and the diagnosis changed to pneumonia. In one patient the final diagnosis remained unknown after an initial suspicion of malignancy. CONCLUSION: In clinically suspected PE helical CT allows a reliable alternative diagnosis to be made in 25.4% of patients. This feature is an unique advantage in comparison with other diagnostic tests and supports the decision of taking helical CT as first line test in suspected PE.

Algorithms↗
PubMed2004

Pentasaccharides in the prophylaxis and treatment of venous thromboembolism: a systematic review.

PURPOSE OF REVIEW: The aim of this review is to perform a critical analysis of all completed studies evaluating pentasaccharides-synthetically derived, selective inhibitors of activated factor X-in prophylaxis in major orthopedic surgery and the treatment of venous thromboembolism. RECENT FINDINGS: Venous thromboembolism is a disorder with considerable morbidity when left untreated. New antithrombotic agents have been developed that selectively inhibit components of the coagulation system, thereby avoiding the difficulties associated with current anticoagulants. The pentasaccharides fondaparinux and idraparinux are the first of a new class of synthetic selective inhibitors of activated factor X. Fondaparinux has been extensively investigated in two areas: orthopedic surgery and venous thromboembolism. It is clear from four thromboprophylaxis studies in major orthopedic surgery that fondaparinux is 50% more effective in reducing venous thromboembolism than enoxaparin. This superior efficacy led to an overall increase in major bleeding, which was however primarily due to more fondaparinux-treated patients with bleeding indexes of 2 or greater. The incidence of fatal bleeding, critical organ bleeding, or bleeding leading to reoperation did not differ significantly between the two groups. In the initial treatment of patients with proximal vein thrombosis and pulmonary embolism, fondaparinux was equally effective as low molecular weight heparins and unfractionated heparin, respectively, without a different incidence in major bleeding in fondaparinux and comparator heparin groups. SUMMARY: Fondaparinux, one of the first of a new class of synthetic selective factor Xa inhibitors, is overall 50% more effective in reducing venous thromboembolism than enoxaparin in major orthopedic surgery, with an overall 1% increased rate of major bleeding, when compared with enoxaparin. The incidence of fatal bleeding, critical organ bleeding, or bleeding leading to reoperation did not differ significantly between the two treatment groups. Fondaparinux is equally effective as low molecular weight heparins and unfractionated heparin in the initial treatment of patients with proximal vein thrombosis and pulmonary embolism, respectively. Finally, as with any new drug, fondaparinux should be used cautiously and only in patients who reflect the population of the clinical trials in which the drug was evaluated.

Clinical Trials as Topic↗