title: [Safety and efficacy of sodium enoxaparin in anti-thrombotic prophylaxis and treatment].
abstract: OBJECTIVE
  Use of low molecular weight heparins (LMWH), either prophylactic or therapeutic, is of most importance in several syndromes and diseases in daily clinical practice. Our objective in this clinical trial was to evaluate safety and efficacy of test sodium enoxaparin (ENOX-T) compared to the reference drug (ENOX-R).
  
  
  METHODS
  We conducted a prospective, randomized, comparative, unicentric and open-labeled trial including patients with either prophylactic or therapeutic anti-thrombotic indications. A total of 100 patients were enrolled in two branches: prophylactic (n=50) and therapeutic (n=50) and two groups for each branch (group 1: ENOX-R and group 2: ENOX-T). We analyzed clinical and laboratory data in each segment. Anti-factor Xa was measured in three different moments: baseline (1st evaluation); 1st or 2nd day (2nd evaluation) and 5th to 7th day (3rd evaluation). Doppler-sonography of inferior limbs was performed on all patients in prophylactic group on 2nd or 3rd evaluation.
  
  
  RESULTS
  The data showed that both branches (prophylactic and therapeutic) were homogenous in regard of sex, age, body mass index (BMI), serum creatinine and APACHE II severity score at admission. Anti-factor Xa results, in both prophylactic and therapeutic branches, showed expected efficacy to both drugs, without any clinical or statistical difference between them. Adverse events incurred in both groups in a similar way, without any clinical or statistical difference between them. In prophylactic branch, Doppler-sonography of inferior limbs added useful information on drugs efficacy.
  
  
  CONCLUSIONS
  We conclude that test sodium enoxaparin (ENOX-T) was effective and safe in our patient's cohort and equivalent to reference drug (ENOX-R).
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Silvia G
authors.initials: SG
authors.lastname: Lage
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Ricardo T
authors.initials: RT
authors.lastname: Carvalho
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Liliane
authors.initials: L
authors.lastname: Kopel
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Jaime F
authors.initials: JF
authors.lastname: Bastos
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Marcelo A
authors.initials: MA
authors.lastname: Ribeiro
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Antonio Ap
authors.initials: AA
authors.lastname: Fagundes Junior
authors.affiliation: Unidade de Terapia Intensiva, Instituto do Coração, HC, FMUSP.
authors.forename: Helia Beatriz N
authors.initials: HB
authors.lastname: Araujo
authors.affiliation: Laboratório de Análises Clínicas, Instituto do Coração, HC, FMUSP.
authors.forename: Célia C
authors.initials: CC
authors.lastname: Strunz