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OBJECTIVE To systematically evaluate the efficacy and safety of fondaparinux versus low molecular weight heparin（nadroparin，enoxaparin）in the treatment of non-ST-elevation acute coronary syndrome （NSTE-ACS）. METHODS The computer searched PubMed ，Medline，Embase，EBSCO，CNKI，Wanfang medical network ，VIP Chinese Journal Full-text Database and relevant clinical trial registration network for the clinical retrospective cohort study （RCS）of fondaparinux （as trial group）and low molecular weight heparin （natroparin，enoxaparin）（as control group ）in the treatment of NSTE-ACS. The retrieval time limit was from the establishment of the database to August 2021. Newcastle Ottawa scale （NOS）was used to evaluate the quality of literature. Outcome indicators included primary efficacy indicators （incidence of acute myocardial infarction and recurrent angina pectoris during hospitalization ），secondary efficacy indicators [revascularization of target vessels during 话：0835-2862024。E-mail：xiexingxing07@163.com hospitalization， prothrombin time （PT）， activated partial thromboplastin time （APTT）]，safety indicators （incidence of serious cardiovascular events ，severe bleeding ，slight bleeding and severe puncture site co mplications during hospitalization ），combined endpoint indicators （30 and 180 days combined endpoint）. RevMan 5.3 software was used for Meta-analysis of each effect index. RESULTS Finally，17 RCS articles were included，involving 4 946 patients with NSTE-ACS ，including 2 507 in the trial group and 2 439 in the control group.The results of NOS literature quality evaluation showed that there were 8 high-quality studies ，accounting for 47.06％ . The results of Meta-analysis showed that there was no significant difference in the incidence of acute myocardial infarction ，recurrent angina pectoris，revascularization of target vessels ，PT and serious cardiovascular events between 2 groups （P＞0.05）；there was significant difference in the APTT （MD＝1.34，95％CI of 0.22-2.45，P＜0.05），the incidence of severe bleeding （RR＝0.47， 95％CI of 0.30-0.74，P＜0.05），the incidence of slight bleeding （RR＝0.48，95％CI of 0.32-0.71，P＜0.05），the incidence of severe puncture site complications （RR＝0.48，95％CI of 0.25-0.95，P＜0.05），30 day combined endpoint （RR＝0.57，95％CI of 0.46-0.72，P＜0.05），180 days combined endpoint （RR＝0.73，95％CI of 0.54-0.98，P＜0.05）. CONCLUSIONS Fondaparinux in the treatment of NSTE-ACS in China has the same efficacy as low molecular weight heparin （nadroparin，enoxaparin），and has more obvious advantages in drug safety such as bleeding ，severe puncture site complications.
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OBJECTIVES: Cesarean section is associated with an increased risk for venous thromboembolism (VTE). The safety and efficacy of primary prophylaxis of fondaparinux, a synthetic sulfated pentasaccharide heparin analog, in women at risk after cesarean section is uncertain. METHODS: This was a retrospective study of 295 cases of pregnant women presenting to a tertiary referral center of Nara, Japan, to evaluate the usefulness of thromboprophylaxis with fondaparinux after cesarean delivery between 2011 and 2012. Patients were initially received unfractionated heparin (once 5,000 IU subcutaneously, twice a day), starting 6 hours after cesarean section for 24 hours, and then treated with fondaparinux (once 2.5 mg daily, subcutaneously) for 5 days. The primary efficacy end-point was an improvement in the incidence of symptomatic VTE or fatal post-cesarean pulmonary thromboembolism. The primary safety end-point was major bleeding during treatment. RESULTS: There were neither any episodes of symptomatic VTE cases nor maternal deaths. A total of 10 patients had a bleeding event. Major bleeding complication was observed in 2 (0.68%) of 295 patients receiving fondaparinux. Non-major bleeding into critical sites was observed in 8 patients, often at surgical sites, and recovery was not delayed. CONCLUSION: This study demonstrates the safety and efficacy of fondaparinux in women at high risk of VTE after cesarean section. Large phase trials comparing clinical outcomes with fondaparinux across a wide spectrum of patients are needed to confirm these observations.
Subject(s)
Female , Humans , Pregnancy , Cesarean Section , Hemorrhage , Heparin , Incidence , Japan , Maternal Death , Pregnant Women , Pulmonary Embolism , Retrospective Studies , Tertiary Care Centers , Venous ThromboembolismABSTRACT
Objective To study the clinical efficacy of fondaparinux sodium in the treat of deep vein thromboembolism after the surgery on lower limbs.Methods 83 cases of patients with lower extremity surgery from Jan 2013 to May 2015,were randomly divided into experimental group(42 cases) and control group(41 cases),the patients in experimental group were injected subcutaneously with fondaparinux sodium 2.5 mg,one time a day,for five days and the patients of control group administrated orally with rivaroxaban 10 mg, one time a day, for five days.All patients accepted the ultrasonic examination by Doppler’ s method before the experiment, seven days and one month later after the experiment.The occurrence of deep vein thromboembolism of all patients was counted,including Proximal thrombosis,Distal thrombosis and Total venous thrombosis,and recorded the occurrence of adverse reaction-subcutaneous hemorrhage.Results One case(2.38%)of deep vein thrombosis was appeared in the experimental group,and that was significantly lower than that of the control group seven case ( 17.07%, P <0.05 ) .Meanwhile, there was no patient observed adverse reaction in experimental group, while two cases were observed in control group ( P <0.05 ) .Conclusion Fondaparinux showed better clinical efficacy than rivaoxaban,and caused fewer adverse reaction.We can conclude that it is safe and effective for the treatment of deep vein thrombosis in patients accepting the lower limbs surgery.
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La trombocitopenia inducida por heparina (TIH) es una reacción adversa inmunológica caracterizada por trombocitopenia y la asociación paradojal de trombosis arterial o venosa. Es causada por la formación de anticuerpos IgG contra el complejo multimolecular de heparina-factor plaquetario 4 (FP4). Fondaparinux es un inhibidor selectivo del factor Xa que tiene escasa afinidad por el FP4 y posee un menor potencial para inducir una respuesta inmunológica, haciendo del mismo un agente potencialmente útil en el tratamiento de la TIH. Se presenta el caso de una mujer de 73 años con TIH asociada a fenómenos trombóticos arteriales y venosos, que recibió exitosamente fondaparinux, con normalización del recuento plaquetario y sin progresión trombótica.
Heparin induced thrombocytopenia (HIT) is an immune-mediated adverse reaction characterized by thrombocytopenia and paradoxical arterial or venous thrombosis, due to the formation IgG antibodies directed to a multimolecular complex of heparin-platelet factor 4 (PF4). Fondaparinux is a selective factor Xa inhibitor with little affinity for PF4 and thus less likely to induce an immune response, making fondaparinux a potentially useful drug for the treatment of HIT. Herein we report the case of a 73 years old woman with HIT associated with arterial and venous thrombosis that was successfully treated with fondaparinux, with normalization of the platelet countand without progression of thrombosis.
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Humans , Female , Aged , Polysaccharides/therapeutic use , Thrombocytopenia/drug therapy , Heparin/adverse effects , Venous Thrombosis/drug therapy , Anticoagulants/therapeutic use , Platelet Count , Thrombocytopenia/chemically induced , Platelet Factor 4/immunology , Treatment Outcome , Venous Thrombosis/chemically induced , Fondaparinux , Anticoagulants/adverse effects , NecrosisABSTRACT
<b>Introduction</b> : Outpatient parenteral anticoagulation is not a routine practice in Japan and its experience is limited. We have treated four cases with malignancies successfully in outpatient setting with either unfractionated heparin (UFH) or fondaparinux in patients who failed warfarin or warfarin is not suitable due to frequent need of paracentesis.<br><b>Methods</b> : We reviewed four cases which was treated by outpatient parenteral anticoagulation between November 2007 to October 2012.<br><b>Cases</b> : Case 1 ; 58 year-old male with pancreatic cancer with DVT/PE was treated with intravenous UFH followed by warfarin. His DVT worsened while he was on warfarin and was switched to subcutaneous (sq) fondaparinux (5mg) with improvement of the DVT. His DVT was successfully managed with outpatient fondaparinux for 23 weeks.<br><b>Case 2</b> : 55 year-old male with lung adenocarcinoma with DVT was initially treated with UFH followed by warfarin with recurrence of DVT. Although sq UFH (20000units twice daily) improved the DVT, hemorrhage occurred when he developed thrombocytopenia due to chemotherapy. Sq fondaparinux (2.5mg) successfully treated the DVT without hemorrhage.<br><b>Case 3&4</b> : 59 year-old female with pancreatic cancer with PE and 68 year-old female with primary peritoneal carcinoma with DVT/PE who needed frequent paracentesis were treated with sq fondaparinux (2.5mg ; 17 weeks) and sq UFH (10000units twice daily ; 6 weeks). They underwent frequent paracetesis without hemorrhage by maintaining the dose on the day of the procedure. The DVT/PE were managed successfully.<br><b>Conclusion</b> : Home self-injection parenteral anticoagulation therapy seems safe in Japanese patients and would allow successful outpatient management of VTE. LMWH and fondaparinux may be preferred than sq UFH because of less hemorrhage and require no laboratory monitoring.
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Objective To explore the efficiency and safety of fondaparinux and low molecular weight heparin(LMWH) on the elder patients with non-ST-segnent elevation acute coronary syndromes (NSTE-ACS).Methods One hundred and forty patients over 75 years old with NSTE-ACS were randomly divided into treatment group(n =70) and control group (n =70).Patients in treatment group were given the conventional treatment combined with fondaparinux,and in control group were given the basis of conventional treatment combined with LMWH.The therapeutic efficacy,the cardiovascular events at 4 d,7 d and 30 d during the treatment and bleeding incidence rate were observed.Reslts There was no statistically significant difference between the treatment group and control group in the total effective rate (x2 =0.475,P ＞ 0.05.Meanwhile,no significant differences were found between the two groups in cardiovascular events at 4 d,7 d and 30 d (x2 =0.257,0.475 and 0.317,P ＞0.05).The incidence rate of bleeding in treatment group was obviously lower than that in control group and there was statistically significant difference (2.9％ vs.31.4％ ; x2 =20.115,P ＜0.01).Conclusion The effectiveness of fondaparinux used in elderly patients with non-ST-segment elevation acute coronary syndromes is similar with LMWH,but the incidence rate of bleeding is lower than LMWH.
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Objective To study efficiency and safety of fondaparinux and Enoxaparin in treatment of Chinese patients with acute coronary syndrome (ACS) having undergone percutaneous coronary intervention (PCI). Methods One thousand and sixty ACS patients (945 with unstable angina, 115 with AMI) having undergone PCI in Henan provincial hospital from July 2011 to July 2013 were randomized into two groups treated with fondaparinux or enoxaparin respectively. Apart from treatment with oral aspirin and clopidogrel, those in the former group were treated with fondaparinux (2.5 mg IH QD) and the latter with enoxaparin (60 mg IH Q12H) subcutaneously for 2 days before operation, both suspended for 12 h before the operation. All of the patients were given heparin (60 IU/kg) during the operation. After the operation, the therapies with fondaparinux (2.5 mg IH QD) and enoxaparin (60 mg IH Q12H) were resumed subcutaneously for 3 days. Perioperative observation and follow-ups were made in terms of hemorrhage, thrombosis and major adverse cardiac events (MACE) in the patients during the hospitalization period, 2 and 4 weeks after operation. Results Fondaparinux and enoxaparin are both effective on anticoagulation for the patients after PCI. There was no significant difference about the incidence of MACE between the two groups (P > 0.05). But, fondaparinux group had lower incidence of hemorrhage than enoxaparin group (P < 0.05). Conclusion Fondaparinux and enoxaparin both have good anticoagulant activity in Chinese patients with ACS undergoing PCI, but fondaparinux may lower the risk of hemorrhage compared to enoxaparin.
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Objective To observe the efficacy and safety of fondaparinux sodium prolonged treatment in patients with acute myocardial infarction underwent primary percutaneous coronary intervention (PCI).Methods A total of 121 patients with acute ST segment elevation myocardial infarction (STEMI) underwent primary PCI from February 2011 to April 2012 were divided into three groups by random digits table method:40 patients in fondaparinux sodium general treatment group (A group),41 patients in fondaparinux sodium prolonged treatment group (B group) and 40 patients in enoxaparin group (C group).The basic treatment was similar among three groups.The patients in A group were given fondaparinux sodium 2.5 mg/d for 5-7 d,and the averaged time was 6.02 d.The patients in B group were given fondaparinux sodium 2.5 mg/d for 10-15 d,and the averaged time was 12.61 d.The patients in C group were given enoxaparin 5000 U/12 h for 5-7 d,and the averaged time was 6.21 d.Main outcome indexes including re-myocardial ischemia,new-myocardial infarction,death and bleeding were observed within 15 d after treatment.Results The incidence of death,re-myocardial ischemia,new-myocardial infarction and overall cardiovascular events in B group [4.9％(2/41),0,0,4.9％(2/41)] were significantly lower than those in A group [25.0％(10/40),12.5％(5/40),10.0％(4/40),47.5％(19/40)] and C group [27.5％(11/40),15.0％(6/40),12.5％ (5/40),55.0％ (22/40)],and there were significant differences among three groups (P ＜ 0.05or ＜0.01).The incidence of mild bleeding,severe bleeding and overall bleeding in C group [32.5％(13/40),15.0％ (6/40),47.5％ (19/40)] were significantly higher than those in A group [10.0％ (4/40),2.5％(1/40),12.5％(5/40)] and B group [14.6％(6/41),2.4％(1/41),17.1％(7/41)],and there were significant differences among three groups (P ＜ 0.05 or ＜ 0.01).Conclusions Fondaparinux sodium prolonged anticoagulation treatment can significantly reduce overall cardiovascular events in patients with STEMI underwent primary PCI,and does not increase bleeding.It is safe and effective.
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Introdução: Considerado um fármaco com adequado perfil de eficácia e segurança no tratamento da síndrome coronária aguda sem supradesnivelamento do segmento ST, o fondaparinux, utilizado de forma isolada, associa-se a maior ocorrência de complicações trombóticas durante a realização de procedimentos coronários invasivos, requerendo a adição de agente com atividade anti-IIa. Este estudo teve como objetivo avaliar a eficácia e a segurança da intervenção coronária percutânea (ICP) em pacientes admitidos com diagnóstico desíndrome coronária aguda sem supradesnivelamento do segmentoST, previamente tratados com fondaparinux. Métodos: Registro prospectivo, controlado, envolvendo 127 pacientes consecutivos submetidos a estratificação invasiva precoce navigência de fondaparinux, com suplementação de heparina não-fracionada intravenosa na dose de 85 U/kg no momento da ICP. Resultados: A taxa do desfecho primário, compostopor morte, infarto agudo do miocárdio, acidente vascular encefálico, trombose de stent ou revascularização miocárdicade urgência, foi de 3,2%. A incidência acumulada de sangramento grave e complicações vasculares foi de 3,2%. Não houve casos de trombose do cateter-guia ou oclusão abrupta do vaso. Conclusões: A ICP em pacientes com síndrome coronária aguda em uso de fondaparinux associa-se a baixastaxas de eventos cardiovasculares adversos isquêmicos e de complicaçõeshemorrágicas graves. A suplementação com heparina não-fracionada durante o procedimento invasivo elimina o risco de trombose do cateter.
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Humans , Male , Female , Aged , Angioplasty/methods , Angioplasty , Anticoagulants/administration & dosage , Stents , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/diagnosis , Risk FactorsABSTRACT
OBJECTIVE: To characterize the pharmacokinetics of a single dose of 2.5 mg fondaparinux sodium in Chinese patients after thoracic surgery. METHODS: Thirteen patients were enrolled in the study and were given a single dose of 2.5 mg fondaparinux sodium via a subcutaneous injection. Plasma concentrations of fondaparinux sodium were measured throughout a 24 h period. The pharmacokinetic analysis was performed using WinNonlin software. RESULTS: The following pharmacokinetic parameters were derived; t1/2(7.92 ± 3.13) (4.21-15.89) h, tmax(2.52 ± 0.93) (1.38-4) h, p-1 (0.73 ± 0.18) (0.45-1.02) mg · L-1, AUClast(6. 56 ± 2.19) (3.07-9. 75)mg · h · L-1, Vz/F(3.54 ± 1.00) (2.24-5.73) L, CL/F(0.34 ± 0.14) (0.16-0.63) L · h-1, and MRTlast (6.98 ± 2.1) h. The pearson correlation coefficient, r was 0.7283(P = 0.005) between the serum creatinine(Scr) and mean residence time(MRTlast) of fondaparinux. CONCLUSION: The disposition of fondaparinux is highly variable in patients. A statistical significant correlation between Scr and MRTlast of fondaparinux was observed. Fondaparinux sodium administered by intravenous injection is well tolerated in patients.
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JUSTIFICATIVA E OBJETIVOS: As síndromes coronarianas agudas (SCA) estão entre as principais causas de admissão em unidades de terapia intensiva (UTI). Novos fármacos vêem sendo desenvolvidos para o manuseio das SCA. O uso combinado destes medicamentos tem reduzido de forma considerável a morbimortalidade desta síndrome, no entanto seus efeitos adversos ou mesmo seu manuseio incorreto podem levar à maior incidência de sangramento. O objetivo deste estudo foi apresentar os principais aspectos terapêuticos, indicações e manuseio dos fármacos em síndromes coronárias agudas. MÉTODO: Foi realizada uma busca por artigos originais cruzando os unitermos acute coronary syndromes e antitrombotic therapy na base de dados -MedLine; busca de artigos e diretrizes nacionais e internacionais no endereço eletrônico: http://sumsearch.uthscsa.edu. RESULTADOS: No tratamento de angina instável e infarto sem supradesnivelamento de ST, a enoxaparina mostrou-se tão eficaz quanto à heparina não fracionada (HNF) e de manuseio mais simples (estudos SYNERGY e A a Z). Neste cenário, o fondaparinux também não foi inferior à enoxaparina e; no entanto, promoveu menor taxa de sangramento (OASIS-5), a bivalirudina também foi não inferior combinada ou não à GPIIB/IIIa comparada a outras heparinas (ACUITY). No infarto com supradesnivelamento do segmento ST, a enoxaparina foi superior à HNF em pacientes submetidos à trombólise (EXTRACT TIMI 25), e no estudo OASIS 6, o fondaparinux foi superior à HNF em pacientes submetidos à trombólise e os não submetidos à reperfusão. CONCLUSÕES: A correta administração das doses dos antitrombóticos e a escolha individualizada da combinação de fármacos são imprescindíveis para a redução de óbito e eventos cardiovasculares maiores, reduzindo o desconfortável risco de sangramento adicional.
BACKGROUND AND OBJECTIVES: Acute coronary syndromes (ACS) are one of the most common causes of ICU admissions. New drugs have been developed for management of ACS. These drugs reduced morbidity and mortality; however their adverse effects or their incorrect use may cause excessive bleeding. The objective of this review is to present the principal peculiarities, doses, and indications of these drugs in ACS settings. METHODS: Original articles were retrieved crossing the terms acute coronary syndromes and antithrombotic therapy in the MedLine database as well as search for Brazilian and international guidelines in http://sumsearch.uthscsa.edu. RESULTS: In the treatment of acute coronary syndromes with non-ST-segment elevation enoxaparin was as efficient as UFH, but with a simpler management (SYNERGY and A to Z studies). In this same setting, fondaparinux was non inferior to enoxaparin and had lesser bleedings (OASIS 5), bivalirudin, combined or not with GPIIbIIIa blockers, was not inferior when compared with other heparins (ACUITY). In ST-segment elevation ACS, enoxaparin was superior to HNF in patients treated with fibrinolysis (EXTRACT TIMI 25); in OASIS 6 fondaparinux was superior to UFH in patients treated with thrombolytic therapy and not submitted to reperfusion. CONCLUSIONS: The correct management and individual combination of antithrombotic drugs are mandatory for decreased mortality and of major cardiovascular events, reducing the undesirable risk of additional bleeding.
Subject(s)
Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Acute Coronary Syndrome/drug therapyABSTRACT
Our objectives were to discuss a general overview on the description and recognition of heparin–induced thrombocytopenia (HIT) and present a critical review of the traditional and most recent advances in its pharmacotherapy. Computerized searches were done on MEDLINE and Iowa Drug Information Service (IDIS) databases from June 2001 until June 2007 and from May 2005 until May 2007, respectively. Search terms used included ‘heparin-induced thrombocytopenia’, ‘heparin-associated thrombocytopenia’, therapeutics, HIT, HAT. We largely selected publications within the timeframe above, but did not exclude commonly referenced and highly regarded older publications. The commonly referenced published articles were obtained through manual searches derived from bibliographic citations and retrievals from the authors’ personal files. Pertinent literatures (89 key articles) that were thought to have substantially contributed new information to the therapeutics of HIT within the last 6 years were identified, reviewed and presented. The following limits were used for the MEDLINE and IDIS searches: ‘human’, drug therapy’, ‘review’, ‘meta-analysis’, ‘clinical trial’, and case reports. The therapeutics of HIT is rapidly evolving and needs to consider an evidence – based approach. It is imperative that practitioners be aware of the associated risk and be up-to-date with the current advances in the management of this fatal clinical condition.