Cost-effectiveness of fondaparinux versus enoxaparin in non-ST-elevation acute coronary syndrome in Canada (OASIS-5).

BACKGROUND: Acute coronary syndrome (ACS) refers to a spectrum of life-threatening cardiac diseases usually due to coronary artery plaque rupture, subsequent thrombin generation plaque activation and thrombus formation. To date, no economic analyses have been published about the use of fondaparinux in NSTE-ACS patients in Canada. The purpose of our study is to estimate the lifetime cost-effectiveness of fondaparinux compared to enoxaparin for non-ST-elevation acute coronary syndrome (NSTE-ACS) patients in a Canadian hospital setting. METHODS: As an extension of a previous published economic analysis for US patients, an event-based decision analytic model was constructed using clinical and resource use data from OASIS-5, a randomized trial of 20,078 patients from 41 countries. A public payer perspective in the hospital setting was adopted. Resource use data from the trial were valued using Canadian costs. A cost regression model was developed to estimate the mean cost of managing the clinical events over the 180 day period. Annual costs of long-term care for ACS patients were added after 180 days until death. Long-term survival was incorporated using Canadian life tables with further adjustment for additional risks associated with NSTE-ACS. Quality-of-life (utility) decrements from published sources were applied to clinical events. Lifetime costs (2009 CAD$) and quality-adjusted life-years (QALYs), discounted annually at 5 %, were estimated for the typical patient in OASIS-5 (i.e., at mean covariate values). RESULTS: The trial data showed that fondaparinux is protective against all clinical events observed in the trial. The model showed that: over 180 days, fondaparinux dominates enoxaparin, producing similar estimates of QALYs gained and saving $439; over a patient's lifetime, fondaparinux yields an ICER of $4293/QALY. Based on PSA, the probabilities that fondaparinux dominates enoxaparin (less costly and more effective) and that is cost-effective at a $50,000 threshold were 42 % and 96 %, respectively. CONCLUSIONS: In the Canadian hospital setting, fondaparinux is cost-effective when compared to enoxaparin for the treatment of NSTE-ACS. This result holds both in the immediate post-event period and over the lifetimes of patients.

Neutralising antibodies for Mayaro virus in Pantanal, Brazil

The Pantanal hosts diverse wildlife species and therefore is a hotspot for arbovirus studies in South America. A serosurvey for Mayaro virus (MAYV), eastern (EEEV), western (WEEV) and Venezuelan (VEEV) equine encephalitis viruses was conducted with 237 sheep, 87 free-ranging caimans and 748 equids, including 37 collected from a ranch where a neurologic disorder outbreak had been recently reported. Sera were tested for specific viral antibodies using plaque-reduction neutralisation test. From a total of 748 equids, of which 264 were immunised with vaccine composed of EEEV and WEEV and 484 had no history of immunisation, 10 (1.3%) were seropositive for MAYV and two (0.3%) for VEEV using criteria of a ≥ 4-fold antibody titre difference. Among the 484 equids without history of immunisation, 48 (9.9%) were seropositive for EEEV and four (0.8%) for WEEV using the same criteria. Among the sheep, five were sero- positive for equine encephalitis alphaviruses, with one (0.4%) for EEEV, one (0.4%) for WEEV and three (1.3%) for VEEV. Regarding free-ranging caimans, one (1.1%) and three (3.4%), respectively, had low titres for neutralising antibodies to VEEV and undetermined alphaviruses. The neurological disorder outbreak could not be linked to the alphaviruses tested. Our findings represent strong evidence that MAYV and all equine encephalitis alphaviruses circulated in the Pantanal.

Perioperative venous thromboembolism in patients with gynecological malignancies: a lesson from four years of recent clinical experience.

AIM: To analyze clinical characteristics of venous thromboembolisms (VTE) in gynecological malignancies, and to find a cost-effective prophylaxis procedure for post-operative VTE. PATIENTS AND METHODS: We analyzed clinical characteristics of 751 patients who underwent definitive surgery for gynecologic malignancies, and cost-effectiveness of VTE prophylaxis. RESULTS: VTE was diagnosed preoperatively in 4.5% of ovarian cancer cases, more frequently than any other type (p<0.005). Older age and greater length of operation were independent risk factors for postoperative VTE. To prevent eight VTEs in 738 malignant cases, which occurred during day 2 to 10, $617,783, $726,185, or $994,222 were necessary for continuous VTE prophylaxis, using either unfractionated heparin (UFH), low-molecular weight heparin or fondaparinux, respectively. CONCLUSION: A strategy which might be cost-effective for post-surgical management of gynecological malignances is use of UFH three times combined with graduated compression stockings and intermittent pneumatic compression, thorough SpO2 monitoring, and perioperative measurements of the circumference of both sides of thighs and calves.

By-product from decoction process of Hibiscus sabdariffa L. calyces as a source of polyphenols and dietary fiber.

BACKGROUND: Dietary fiber (DF) and antioxidant compounds are widely used as functional ingredients. The market in this field is competitive and the search for new types of quality ingredients for the food industry is intensifying. The aim of this study was to evaluate the composition and antioxidant activity of by-products generated during the decoction of calyces of four Mexican Hibiscus sabdariffa L. cultivars ('Criolla', 'China', 'Rosalis' and 'Tecoanapa') in order to assess them as a source of functional ingredients. RESULTS: Some calyx components were partially transferred to the beverage during the decoction process, while most were retained in the decoction residues. These by-products proved to be a good source of DF (407.4-457.0 g kg⁻¹ dry matter) and natural antioxidants (50.7-121.8 µmol Trolox equivalent g⁻¹ dry matter). CONCLUSION: The decoction process extracted some soluble carbohydrates, ash and some extractable polyphenols. The DF content changed in the dried residues, which could be considered as high-DF materials with a high proportion of soluble DF (∼20% of total DF) and considerable antioxidant capacity. These by-products could be used as an antioxidant DF source.

Custo-efetividade de fondaparinux em pacientes com Síndrome Coronariana Aguda sem supradesnivelamento do ST / Cost-effectiveness of fondaparinux in patients with acute coronary syndrome without ST-segment Elevation

FUNDAMENTO: O uso combinado de agentes antitrombínicos, antiplaquetários e estratégias invasivas na síndrome coronariana aguda sem supradesnivelamento do ST (SCAsSST) reduz eventos cardiovasculares. O fondaparinux demonstrou equivalência à enoxaparina na redução de eventos cardiovasculares, porém com menor índice de sangramento nos pacientes que usaram fondaparinux. OBJETIVO: Avaliar o custo-efetividade de fondaparinux versus enoxaparina em pacientes com SCAsSST no Brasil a partir da perspectiva econômica do Sistema Único de Saúde (SUS). MÉTODOS: Um modelo de decisão analítico foi construído para calcular os custos e consequências resultantes dos tratamentos comparados. Os parâmetros do modelo foram obtidos do estudo OASIS-5 (N = 20.078 pacientes com SCAsSST randomizados para fondaparinux ou enoxaparina). O desfecho avaliado foi um composto de eventos cardiovasculares (isto é, morte, infarto agudo do miocárdio, isquemia refratária e sangramentos graves) nos dias 9, 30 e 180 pós-SCAsSST. Foram avaliados todos os custos diretos de tratamento e eventos relacionados à SCAsSST. O ano da análise foi 2010 e os custos foram descritos em reais (R$). RESULTADOS: No dia 9, o custo de tratamento por paciente foi R$ 2.768 para fondaparinux e R$ 2.852 para enoxaparina. Aproximadamente 80% do custo total foram associados a tratamentos invasivos. Os custos com medicamentos representaram 10% do custo total. As taxas combinadas de eventos cardiovasculares e de sangramentos maiores foram 7,3% e 9,0% para fondaparinux e enoxaparina, respectivamente. Análises de sensibilidade confirmaram os resultados iniciais do modelo. CONCLUSÃO: O fondaparinux para tratamento de pacientes com SCAsSST é superior à enoxaparina em termos de prevenção de novos eventos cardiovasculares com menor custo. (Arq Bras Cardiol. 2012; [online].ahead print, PP.0-0).

BACKGROUND: The combined use of antithrombotic agents, antiplatelet agents and invasive strategies in acute coronary syndrome without ST-segment elevation (ACSWSTE) reduces cardiovascular events. Fondaparinux has demonstrated equivalence to enoxaparin in reducing cardiovascular events, but with a lower rate of bleeding in patients using fondaparinux. OBJECTIVE: Evaluate the cost-effectiveness of fondaparinux versus enoxaparin in patients with ACSWSTE in Brazil from the economic perspective of the Brazilian Unified Health System (SUS). METHODS: A decision analytic model was constructed to calculate the costs and consequences of the compared treatments. The model parameters were obtained from the OASIS-5 study (N = 20,078 patients with ACSWSTE randomized to fondaparinux or enoxaparin). The target outcome consisted of cardiovascular events (i.e., death, myocardial infarction, refractory ischemia and major bleeding) on days 9, 30 and 180 after ACSWSTE. We evaluated all direct costs of treatment and ACSWSTE-related events. The year of the analysis was 2010 and the costs were described in reais (R$). RESULTS: On day 9, the cost of treatment per patient was R$ 2,768 for fondaparinux and R$ 2,852 for enoxaparin. Approximately 80% of total costs were associated with invasive treatments. The drug costs accounted for 10% of the total cost. The combined rates of cardiovascular events and major bleeding were 7.3% and 9.0% for fondaparinux and enoxaparin, respectively. Sensitivity analyses confirmed the initial results of the model. CONCLUSION: The use of fondaparinux for the treatment of patients with ACSWSTE is superior to that of enoxaparin in terms of prevention of further cardiovascular events at lower cost. (Arq Bras Cardiol. 2012; [online].ahead print, PP.0-0).

Cost-effectiveness of fondaparinux in patients with acute coronary syndrome without ST-segment elevation.

BACKGROUND: The combined use of antithrombotic agents, antiplatelet agents and invasive strategies in acute coronary syndrome without ST-segment elevation (ACSWSTE) reduces cardiovascular events. Fondaparinux has demonstrated equivalence to enoxaparin in reducing cardiovascular events, but with a lower rate of bleeding in patients using fondaparinux. OBJECTIVE: Evaluate the cost-effectiveness of fondaparinux versus enoxaparin in patients with ACSWSTE in Brazil from the economic perspective of the Brazilian Unified Health System (SUS). METHODS: A decision analytic model was constructed to calculate the costs and consequences of the compared treatments. The model parameters were obtained from the OASIS-5 study (N = 20,078 patients with ACSWSTE randomized to fondaparinux or enoxaparin). The target outcome consisted of cardiovascular events (i.e., death, myocardial infarction, refractory ischemia and major bleeding) on days 9, 30 and 180 after ACSWSTE. We evaluated all direct costs of treatment and ACSWSTE-related events. The year of the analysis was 2010 and the costs were described in reais (R$). RESULTS: On day 9, the cost of treatment per patient was R$ 2,768 for fondaparinux and R$ 2,852 for enoxaparin. Approximately 80% of total costs were associated with invasive treatments. The drug costs accounted for 10% of the total cost. The combined rates of cardiovascular events and major bleeding were 7.3% and 9.0% for fondaparinux and enoxaparin, respectively. Sensitivity analyses confirmed the initial results of the model. CONCLUSION: The use of fondaparinux for the treatment of patients with ACSWSTE is superior to that of enoxaparin in terms of prevention of further cardiovascular events at lower cost.

[A retrospective study of UFT and oral leucovorin plus PSK combination adjuvant chemotherapy in patients with stage III colon cancer].

OBJECTIVE: To perform a retrospective analysis of UFT and oral leucovorin plus PSK combination adjuvant chemotherapy for stage III colon cancer in order to evaluate both treatment efficacy and toxicity. SUBJECTS: Between 2003 and 2009, 273 stage III colon cancer patients underwent surgery in our institute, and we studied 156 of them. RESULTS: Patients' median age was 72 years old; 87 men and 69 women. Of all patients, 119 had stage IIIa and 37 had stage IIIb. The 3-year disease, free survival rates for stage III, stage IIIa and stage IIIb patients were 73. 9%and 80. 6%and 51. 4%, respectively, and the 3-year overall survival rates for stage III was 97. 6%. With regard to toxicity, liver function disorder was observed in 9. 6%of the patients as the most frequent adverse event, but there was no grade 3 or 4 toxicity. CONCLUSION: UFT and oral leucovorin plus PSK combination adjuvant chemotherapy for stage III colon cancer showed a good response especially for stage III a.

Utilization of seafood processing by-products: medicinal applications.

Large amount of underutilized by-products are generated from the seafood processing plants annually. Consequently, researches have been initiated to investigate those discarded materials and have identified a number of bioactive compounds including bioactive peptides, collagen and gelatin, oligosaccharides, fatty acids, enzymes, calcium, water-soluble minerals, and biopolymers. Bioactive peptides derived from fish by-products have shown various biological activities including antihypertensive and antioxidant activities and hence may be a potential material for biomedical and food industries. Collagen and gelatin are currently used in diverse fields including food, cosmetic, and biomedical industries. Other than that, they are promising drug carriers for the treatment of cancer. Many studies have reported that chitin, chitosan, and their derivatives possess biologically active polysaccharides and hence they are potential agents for many applications. Further, those compounds have also showed potential activities such as antioxidant, antibacterial, antiviral, antihypertensive, anticancer, etc. Hence, seafood by-products are valuable natural resources that show range of functionalities and hence potential materials for biomedical and nutraceutical industries.

[Safety and economics of fondaparinux administration in the laparoscopic surgery].

BACKGROUND: The factor Xa inhibitor, fondaparinux was used for prevention of venous thromboembolism in the clinical setting. We evaluated the antithrombotic effect, complications and economic aspects of this agent in the patients undergoing laparoscopic surgery. METHODS: Forty one patients scheduled for laparoscopic abdominal surgery were divided into two groups. In group F (N = 33), patients received once-daily subcutaneous injection of fondaparinux (2.5 mg x day(-1)) for 4 postoperative days. In group E (N = 8), patients did not receive therapy. In group F, general anesthesia with transversus abdominis plane (TAP) block was administered during surgery, and general anesthesia with epidural anesthesia was performed in group E. We evaluated incidence of DVT (deep vein thrombosis), abnormal bleeding, other postoperative complications, and economic benefit to the hospital. RESULTS: In both groups, no patient developed DVT Abnormal bleeding was observed in 7 patients of group E. Postoperative complications and pain were not different between the two groups. The revenue in group F was 34,434 yen/patient lower than that of group E due to Japanease insulance system. CONCLUSIONS: No patients developed DVT and severe complications of fondaparinux after laparoscopic abdominal cancer surgery. However, revenue to the hospital decreased 34,434 yen/patient by use of analgestic method. We must consider cost-benefit in use of fondaparinux.

Structural characterization and antioxidant activities of 2 water-soluble polysaccharide fractions purified from tea (Camellia sinensis) flower.

UNLABELLED: The water-soluble crude polysaccharide tea flower polysaccharide (TFP), obtained from tea (Camellia sinensis) flower by boiling-water extraction and ethanol precipitation, was fractionated by Sephadex G-100 column chromatography, giving 2 polysaccharide fractions termed TFP-1 and TFP-2. The structural features of TFP-1 and TFP-2 were investigated by high-performance liquid chromatography (HPLC), gel-permeation chromatography (GPC), rheometer, infrared (IR) spectra, nuclear magnetic resonance (NMR) spectroscopy, atomic force microscope (AFM), and scanning electron microscope (SEM). Results indicated that TFP-1 was composed of glucose: xylose: rhamnose: galactose=1.0:1.2:0.81:0.98 with a molecular weight of 167.5 KDa, while TFP-2 comprised glucose: xylose: rhamnose: arabinose=1.0:0.76:2.3:2.3 with a molecular weight of 10.1 KDa. The 1H NMR revealed that TFP-1 contained α-L-Rhap, α-D-Galp, α-D-GalpNAc, α-D-Xylp, α-D-Glcp, and ß-D-Glcp residues, while TFP-2 was illustrated to have α-L-Rhap, α-L-Arap, α-D-Xylp, α-D-Glcp, and α-D-GlcpNAc residues. Antioxidant activities of these fractions were investigated using various in vitro assay systems compared with ascorbic acid. In conclusion, TFP-2 exhibited the higher antioxidant activities and could be explored as a novel potential antioxidant. PRACTICAL APPLICATION: At present, commonly low-grade tea is preferred to extract the tea polysaccharide, to take full advantage of tea flower resource to extract polysaccharides can greatly reduce the cost of tea products. Thus, the search for plant-derived biomaterials from this study could generate natural value-added products from underutilized tea plant waste and used as a medicinal agent against chronic health problems, such as cancers, aging, and atherosclerosis caused by reactive free radicals that produced from oxidation.

Extended prophylaxis of venous thromboembolism with fondaparinux in patients undergoing major orthopaedic surgery in Italy: a cost-effectiveness analysis.

Enoxaparin is the most frequently used low-molecular weight heparin in the world, given in order to prevent venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery (MOS). Fondaparinux is an effective and safe alternative. The aim of our study was to compare the cost-effectiveness of enoxaparin and fondaparinux in the extended thromboprophylaxis of patients undergoing MOS in Italy. A decision-tree model was developed: probabilities of symptomatic events were derived from the published trials; use of resources in Italy was evaluated by means of a questionnaire administered to a panel of experts. Only the direct costs of VTE (acute treatment of events and of complications) were considered. Cost units were derived from the current cost of drugs, and from the Italian National Healthcare tariffs in 2007. Incremental cost-effectiveness ratios were analysed at three time points: 30 days, 1 year and 5 years. The higher cost of fondaparinux was counterbalanced by reduced rates of early DVT, early PE and prophylaxis-related major bleeding. If compared with enoxaparin, after 30 days of extended prophylaxis, fondaparinux is associated with a savings of 48.83 per patient; at the end of the first year, the savings increased to 72.13, and after 5 years, the savings are 74.36. One-way sensitivity analysis shows that the results are robust to the variation in unit costs for VTE-related care, or in event rates for both treatments. In conclusion, our model shows that, when administered for extended prophylaxis of VTE following MOS, fondaparinux is more effective and cost saving than enoxaparin.

Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a single technology appraisal.

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of dabigatran etexilate (DBG) for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip and knee surgery based upon a review of the manufacturer's submission to the NICE as part of the single technology appraisal (STA) process. The submission's evidence came from three reasonable-quality trials comparing DBG with enoxaparin, and a comparison of DBG with fondaparinux based on the relative efficacy and safety as derived from a mixed treatment comparison (MTC) meta-analysis. DBG (220 mg and 150 mg once daily) is not inferior to enoxaparin (40 mg once daily and 30 mg twice daily) in terms of major VTE or VTE-related events (secondary outcome). Meta-analysis shows that 220 mg DBG is not inferior to enoxaparin (40 mg once daily or 30 mg twice daily) in reducing total VTE and all-cause mortality (primary outcome) in total hip or knee replacement, whereas there is uncertainty around the clinical effectiveness of 150 mg DBG for this outcome. In the MTC analysis DBG compared favourably with the other interventions, with the exception of extended enoxaparin and fondaparinux. The adverse event profile was not significantly different in those receiving DBG and those receiving enoxaparin. The submitted two-phase economic model compares DBG with enoxaparin and fondaparinux in total hip and knee replacement. The model structure is appropriate and the model assumptions are reasonable. The health states, costs, utilities and recurrence rates used are considered to be appropriate for the required analysis. The model estimated that at the licensed dose of 220 mg once daily DBG dominates enoxaparin in both total hip replacement and total knee replacement and that at the lower dose of 150 mg once daily DBG dominates enoxaparin in total hip replacement and enoxaparin dominates DBG in total knee replacement. DBG is less cost-effective than fondaparinux in total hip replacement at both doses; the cost per quality-adjusted life-year of fondaparinux versus DBG is 11,111 pounds and 6857 pounds for the higher and lower doses of DBG respectively. In total knee replacement, both DBG doses are dominated by fondaparinux. For DBG versus all comparators in all cases the cost-effectiveness results are based on small incremental cost and health benefits. Weaknesses of the submitted evidence include that methods used for screening studies, data extraction and applying quality assessment criteria to included studies, as well as key details of trials included in the MTC, were not adequately described. In addition, some input parameters into the modelling process are incorrect. The ERG was unable to correct all of these mistakes and the impact on the model results is therefore unknown. The National Institute for Health and Clinical Excellence guidance issued as a result of the STA states that DBG is recommended as an option for the primary prevention of VTE events in adults who have undergone elective total hip or knee replacement surgery.

Economic and clinical evaluation of fondaparinux vs. enoxaparin for thromboprophylaxis following general surgery.

PURPOSE: Patients undergoing general surgical procedures are at increased risk for venous thromboembolism (VTE). Compliance rates with established guidelines for VTE thromboprophylaxis in patients at moderate-to-high risk are notably low. Recent literature has demonstrated that fondaparinux is associated with lower costs and fewer VTEs than enoxaparin in patients undergoing major orthopedic surgery (MOS), but data are limited in patients undergoing general surgery. This study was conducted to evaluate the cost implications and relative real-world effectiveness of fondaparinux vs. enoxaparin in general surgery patients. METHODS: Data were obtained from inpatient billing records from over 500 hospitals using Premier's Perspective Comparative Database. Patients hospitalized for general surgery between July 1, 2003 and January 31, 2006 were eligible for inclusion. Eligible patients were included if they received fondaparinux or enoxaparin after their general surgery date. Patients were excluded if they received both anticoagulants on their first day of therapy, were <18 years of age on the surgery date, or did not have data 6 months prior and 1 month post hospitalization. Included patients were stratified into two cohorts based on their first anticoagulant, fondaparinux or enoxaparin. Patients were matched in each group on 1:1 case-control matching based on propensity scores. RESULTS: A total of 5364 patients were included (n = 2682 for each cohort) from 326 unique hospitals. Average total costs per patient for the fondaparinux group were significantly lower than the enoxaparin group ($15 156 vs. 17 741, p < 0.0001). Patients receiving fondaparinux were significantly less likely to experience a VTE (2.80 vs. 3.77%, p = 0.046, a 35% relative risk reduction). No significant differences in bleeding events between the cohorts were observed (p = 0.6047), and no significant differences in all-cause inpatient death were noted (p = 0.3673). CONCLUSION: Fondaparinux was associated with significantly lower costs and fewer VTEs compared to enoxaparin without an increase in bleed rates or all-cause inpatient mortality. The findings from this study are limited by the retrospective study design and should only be generalized to a similar patient population.

Fondaparinux for the prevention or treatment of venous thromboembolism related to lower limb trauma: evidence today.

Patients with lower limb and pelvic trauma, or undergoing major orthopaedic surgery represent one of the highest risk groups for the development of venous thromboembolism (VTE). A significant number of pharmacological and mechanical agents have been used for the prophylaxis and treatment of VTE. Fondaparinux is a relative new pharmacological agent that selectively binds to antithrombin, and represents a new class of synthetic selective inhibitors of activated factor X. Eleven percent of the fondaparinux-related English language literature, between 2001 and 2007, refers to orthopaedic trauma, and was the sample assessed for this critical analysis review. The clinical studies evaluating the safety, efficacy, and financial implications associated with lower limb orthopaedic trauma show that fondaparinux has comparable results with the well-established use of enoxaparin. However, the scientific community has raised several issues regarding mostly fondaparinux's safety, timing of its 1(st) dose, bleeding side effects, duration of administration and lack of a reliable reversing agent. Further trials are necessary focusing on the safety and efficacy of this drug mostly in relation to clinical relevant outcomes and to different fields of trauma surgery (pelvis, long bone fractures and polytrauma patients).

Comparison of cost, effectiveness, and safety of injectable anticoagulants used for thromboprophylaxis after orthopedic surgery.

PURPOSE: The cost, effectiveness, and safety of injectable anticoagulants used for thromboprophylaxis after orthopedic surgery were compared. METHODS: This retrospective, observational, cross-sectional, cohort analysis of inpatient billing data was conducted from the institutional perspective. Patients who received dalteparin, enoxaparin, fondaparinux, or unfractionated heparin after orthopedic surgery were included in the analysis. The primary outcome measure was the mean aggregated cost per patient treated with each injectable anticoagulant. Secondary outcomes included the percentages of patients in each treatment group who had a venous thromboembolism (VTE) or major bleeding episode. RESULTS: Mean total adjusted costs were significantly lower for fondaparinux ($18,019) compared with other anticoagulants, with unfractionated heparin being the most costly ($20,835). Relative adjusted cost differences were 1.4% (p = 0.0127), 1.8% ( p = 0.0105), and 14.6% (p < 0.0001) higher for enoxaparin, dalteparin, and unfractionated heparin, respectively, compared with fondaparinux. Significantly fewer fondaparinux-treated patients had a VTE event compared with the other treatment groups. The use of dalteparin was associated with fewer major bleeding events, and no significant differences in the rate of major bleeding events were observed among groups treated with fondaparinux, enoxaparin, or unfractionated heparin. CONCLUSION: A retrospective analysis of inpatient billing data showed that, among orthopedic surgery patients, fondaparinux was associated with lower institutional cost and a lower frequency of VTE than were dalteparin, enoxaparin, and unfractionated heparin. Dalteparin was associated with a lower rate of major bleeding events than was fondaparinux, but there were no significant differences in such events among fondaparinux, enoxaparin, and unfractionated heparin.

Cost-effectiveness of extended prophylaxis with fondaparinux compared with low molecular weight heparin against venous thromboembolism in patients undergoing hip fracture surgery.

A model was developed to estimate costs and clinical effectiveness of fondaparinux compared with enoxaparin after hip fracture surgery in Sweden. Outcomes and costs of venous thromboembolism (VTE)-related care from a health care perspective were incorporated, with symptomatic deep-vein thrombosis and pulmonary embolism, recurrent VTE, post-thrombotic syndrome, major haemorrhage and all-cause death being included. Event probabilities were derived from fondaparinux clinical trial data and published data. VTE-related resource use and associated costs as well as costs of prophylaxis were based on local Swedish data. Extended prophylaxis with fondaparinux could avoid an additional 28 symptomatic VTE per 1,000 patients compared with extended prophylaxis with enoxaparin in hip fracture surgery patients. Although the prophylaxis costs were higher in the fondaparinux group, these were offset by the lower costs associated with treating fewer VTE, which thus indicates that extended fondaparinux prophylaxis is the dominant alternative when compared with enoxaparin in hip fracture surgery.

Cost-effectiveness of fondaparinux compared with enoxaparin as prophylaxis against venous thromboembolism in patients undergoing hip fracture surgery.

OBJECTIVE: To evaluate the cost-effectiveness of fondaparinux relative to enoxaparin as prophylaxis against venous thromboembolism (VTE) in patients undergoing hip fracture surgery. METHODS: A decision analysis model was created to simulate the impact of fondaparinux 2.5 mg once daily relative to enoxaparin 30 mg twice daily on patient outcomes and costs over various time points up to 5 years after surgery. Probabilities for the analysis were estimated for a hypothetical cohort of 1000 patients undergoing hip fracture surgery in the United States receiving either fondaparinux or enoxaparin according to comparative trial results. Resource use and costs (2003 dollars) were obtained from large health-care databases. Outcome measures were rates of symptomatic VTE events, health-care costs, and incremental cost-effectiveness ratios. RESULTS: Fondaparinux is estimated to prevent an additional 30 VTE events (per 1000 patients) at 3 months compared with enoxaparin, producing savings of 103 dollars at discharge, 290 dollars over 1 month, 361 dollars over 3 months, and 466 dollars over 5 years. The results remain robust to clinically plausible variation in input parameters and assumptions. CONCLUSIONS: Fondaparinux improves outcomes and is cost-saving over a broad range of assumptions compared with enoxaparin for prophylaxis of VTE after hip fracture surgery.

Review of fondaparinux sodium injection for the prevention of venous thromboembolism in patients undergoing surgery.

The antithrombin binding sequence of heparin, a pentasaccharide, has been synthesized as fondaparinux, an indirect, selective, and reversible factor Xa inhibitor. It can be administered subcutaneously, is well absorbed, and has a half-life of c. 17 hours permitting once-daily injection. It has been evaluated in an extensive study program in major orthopedic surgery, including hip fracture, and in major abdominal surgery with a large proportion of surgery for cancer. The effect is at least as effective as for low-molecular-weight heparins and it has also been shown effective for extended prophylaxis in hip fracture patients. Several thousands of patients have been studied and the substance is safe, although a slightly higher frequency of bleedings is found than in patients on low-molecular-weight heparins. There is no specific antidote but if necessary, recombinant activated factor VII can be used. Other side-effects are rare. Fondaparinux is cost saving and sometimes cost neutral when compared with enoxaparin.