PMID- 15159264
OWN - NLM
STAT- MEDLINE
DCOM- 20040615
LR  - 20061115
IS  - 0003-9926 (Print)
IS  - 0003-9926 (Linking)
VI  - 164
IP  - 10
DP  - 2004 May 24
TI  - Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose 
      low-molecular-weight heparin in the initial treatment of venous thromboembolism.
PG  - 1077-83
AB  - BACKGROUND: Few reports have addressed the value of unfractionated heparin (UFH) 
      or low-molecular-weight heparin in treating the full spectrum of patients with 
      venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism. 
      METHODS: In an open, multicenter clinical trial, 720 consecutive patients with 
      acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with 
      pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to 
      treatment with subcutaneous UFH with dose adjusted by activated partial 
      thromboplastin time by means of a weight-based algorithm (preceded by an 
      intravenous loading dose), or fixed-dose (adjusted only to body weight) 
      subcutaneous nadroparin calcium. Oral anticoagulant therapy was started 
      concomitantly and continued for at least 3 months. We recorded the incidence of 
      major bleeding during the initial heparin treatment and that of recurrent VTE and 
      death during 3 months of follow-up. RESULTS: Fifteen (4.2%) of the 360 patients 
      assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) 
      of the 360 patients assigned to nadroparin (absolute difference between rates, 
      0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH 
      (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major 
      bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% 
      to 1.7%). Overall mortality was 3.3% in each group. CONCLUSIONS: Subcutaneous UFH 
      with dose adjusted by activated partial thromboplastin time by means of a 
      weight-based algorithm is as effective and safe as fixed-dose nadroparin for the 
      initial treatment of patients with VTE, including those with pulmonary embolism 
      and recurrent VTE.
FAU - Prandoni, Paolo
AU  - Prandoni P
AD  - Department of Medical and Surgical Sciences, University of Padua, Via Ospedale 
      Civile 105, 35128 Padua, Italy. paoloprandon@tin.it
FAU - Carnovali, Marino
AU  - Carnovali M
FAU - Marchiori, Antonio
AU  - Marchiori A
CN  - Galilei Investigators
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arch Intern Med
JT  - Archives of internal medicine
JID - 0372440
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
SB  - IM
CIN - Rev Med Chil. 2004 Sep;132(9):1140-3. PMID: 15543773
MH  - Adult
MH  - Aged
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Heparin/*administration & dosage/adverse effects
MH  - Heparin, Low-Molecular-Weight/administration & dosage/adverse effects
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Embolism/diagnosis/*drug therapy/mortality
MH  - Recurrence
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Single-Blind Method
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Venous Thrombosis/diagnosis/*drug therapy/mortality
EDAT- 2004/05/26 05:00
MHDA- 2004/06/16 05:00
CRDT- 2004/05/26 05:00
PHST- 2004/05/26 05:00 [pubmed]
PHST- 2004/06/16 05:00 [medline]
PHST- 2004/05/26 05:00 [entrez]
AID - 164/10/1077 [pii]
AID - 10.1001/archinte.164.10.1077 [doi]
PST - ppublish
SO  - Arch Intern Med. 2004 May 24;164(10):1077-83. doi: 10.1001/archinte.164.10.1077.