title: [Prevention of venous thromboembolic events by fondaparinux 2.5 mg in general practice. ArchiMed Ville].
abstract: OBJECTIVE
  To evaluate the mean duration of treatment course with fondaparinux 2.5 mg (ARIXTRA(®)) in the setting of ambulatory general medicine, with respect to its indication in thromboprophylaxis for medically ill patients and to describe the population treated.
  
  
  METHODS
  Observational, prospective, national, multicenter, pharmaco-epidemiological study, performed in France, at the request of the Transparency Commission (a division of the French Health Regulatory Authority). The general practitioners had to include the first three adult patients, considered as patients at high risk of venous thromboembolic events and immobilized for acute medical illness, treated with initiation of thromboprophylaxis by fondaparinux 2.5 mg.
  
  
  RESULTS
  Two hundred and seventeen general practitioners included 840 patients. The mean age of patients was 63.6±18.1 years, and 63% of patients (n=520/831) were females. The real total administration duration of the treatment by fondaparinux 2.5 mg was known for 797 patients and was 15.8±12.4 days on average (range: 1-90 days, median: 10 days). In 40% of patients, the duration ranged from 6 to 14 days [duration consistent with the summary of product characteristics (SmPC)]. Among the 834 patients analyzed, 569 (68%) suffered from at least one acute illness and had at least one risk factor for venous thromboembolism (VTE). The indication did fully comply with the summary of product characteristics of fondaparinux 2.5 mg in 52% of the patients (n=434/834 patients).
  
  
  CONCLUSIONS
  The results of the ArchiMed study support that the thromboprophylaxis treatment with fondaparinux 2.5 mg in ambulatory general medicine, and the associated medical conditions were usually consistent with the SmPC or guidelines. However, a difference was found for the duration and the initial indication, in situations that may be regarded as presenting a risk by the prescriber.
authors.affiliation: EA 7334 méthodologies et société (REMES), hôpital Louis-Mourier, université Paris 7, AP-HP, 178, rue des Renouillers, 92700 Colombes, France.
authors.forename: I
authors.initials: I
authors.lastname: Mahé
authors.affiliation: IURC de Montpellier, 641, avenue du Doyen-Gaston-Giraud, 34093 Montpellier cedex, France; CHU de Nîmes, 30029 Nîmes, France.
authors.forename: J-P
authors.initials: JP
authors.lastname: Daurès
authors.affiliation: Département de médecine générale, UFR Tours, 10, boulevard Tonnellé, BP 3223, 37032 Tours cedex 1, France.
authors.forename: D
authors.initials: D
authors.lastname: Pouchain
authors.affiliation: Hôpital Saint-Eloi, CHRU de Montpellier, 80, avenue Augustin-Fliche, 34295 Montpellier cedex 5, France.
authors.forename: I
authors.initials: I
authors.lastname: Quéré
authors.affiliation: Laboratoire GlaxoSmithKline, 100, route de Versailles, 78160 Marly-le-roi, France.
authors.forename: C
authors.initials: C
authors.lastname: Aubin
authors.affiliation: Kappa Santé, 4, rue de Cléry, 75002 Paris, France.
authors.forename: J
authors.initials: J
authors.lastname: Doussaint
authors.affiliation: Kappa Santé, 4, rue de Cléry, 75002 Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Schück
authors.affiliation: Département de médecine interne et de pneumologie, université européenne de Bretagne, CHU de la Cavale-Blanche, boulevard Tanguy-Prigent, 29609 Brest cedex, France. Electronic address: Christophe.leroyer@chu-brest.fr.
authors.forename: C
authors.initials: C
authors.lastname: Leroyer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000628:therapy; D001510:Bed Rest / Q000009:adverse effects; D003404:Creatinine / Q000097:blood; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D058006:General Practice; D006801:Humans; D007103:Immobilization / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D012307:Risk Factors; D011795:Surveys and Questionnaires; D019851:Thrombophilia / Q000188:drug therapy / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D014947:Wounds and Injuries / Q000628:therapy; D055815:Young Adult
chemical_list: D065427:Factor Xa Inhibitors; D011134:Polysaccharides; D003404:Creatinine; D000077425:Fondaparinux
keywords: Drug utilization; Epidemiology; Thrombose veineuse; Utilisation médicament; Venous thrombosis; Épidémiologie