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Re: DewDiligence post# 60320

Friday, 03/14/2008 1:13:27 AM

Friday, March 14, 2008 1:13:27 AM

Post# of 252302
re :Alchemia vs Momenta Pharma = Alchemia is the Winner

They are not in competition with one another.

not ?

http://www.nelm.nhs.uk/Record%20Viewing/vR.aspx?id=587147

Fondaparinux more effective than enoxaparin at slowing bleeding during PCI?

Date Published 12/11/2007
Reporter initials Nicola
Reporter surname Pocock
Reporter affiliation Hospital Pharmacist
Source J Am Coll Cardiol 2007;50:1742-1751.
Resource Links
PubMed abstract
NeLM ‘In-Focus’ of OASIS-5

According to the findings of a prospectively planned analysis of the OASIS-5 trial, fondaparinux is associated with a lower risk of major bleeding than enoxaparin in patients with acute coronary syndrome (ACS) who undergo early percutaneous coronary intervention (PCI).

The OASIS-5 (Fifth Organisation to Assess Strategies in Acute Ischaemic Syndromes) trial compared the efficacy and safety of fondaparinux with enoxaparin in patients with ACS without ST-segment elevation. The full results of this study were published in NEJM in 2006, and were the subject of an ‘In Focus’ article on NeLM (see link above to view). In summary, the study found that fondaparinux had a similar efficacy to enoxaparin in the short-term, but was associated with a reduced incidence of major bleeding at day 9 (2.2% vs. 4.1%; HR 0.52; [0.44 to 0.61]; p<0.001) and a lower mortality at day 30 (2.9% vs. 3.5%; HR 0.83; [0.71 to 0.97]; p=0.02).

In this analysis, the authors focus on the outcomes of treatment in the 6,238 patients who underwent PCI. In those randomised to fondaparinux, intravenous fondaparinux was given for PCI. In the enoxaparin group, no additional anticoagulant was given if PCI was less than 6 h from last subcutaneous dose, and additional intravenous unfractionated heparin (UFH) was given if PCI was greater than 6 hours after the last dose. The main findings in this subgroup were:

• At day 9, the incidence of major bleeding was 2.4% in the fondaparinux group versus 5.1% in the enoxaparin group (hazard ratio [HR] 0.46, p < 0.00001)

• In the fondaparinux group, 6.3% of patients experienced a death, MI, or stroke by day 9, compared with 6.2% of patients in the enoxaparin group (HR 1.03, 95% CI 0.84 to 1.25, p = 0.79)

• The net clinical composite of death, MI, stroke, or major bleeding was statistically significantly lower with fondaparinux compared with enoxaparin at day 9 (8.2% vs. 10.4%, HR 0.78, p = 0.004).

• Catheter thrombus was more common in patients receiving fondaparinux (0.9%) than enoxaparin alone (0.4%), but was largely prevented by using UFH at the time of PCI, without any increase in bleeding

The authors conclude that these results were similar to those for trial participants who had not undergone PCI. They conclude that "a tailored approach of using fondaparinux in a broad range of patients with ACS as initial upstream therapy, followed by targeted therapy with UFH in those who require a PCI procedure, is an attractive strategy for the management of ACS."

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