SANOFI-SYNTHELABO ARIXTRA® 1

ARIXTRA® (fondaparinux sodium)

in the prevention of venous thromboembolism after hip-fracture surgery

BI Eriksson, BI Eriksson, KA Bauer, MR Lassen, and AGG TurpieKA Bauer, MR Lassen, and AGG Turpieon behalf of the Steering Committees on behalf of the Steering Committees

of the Pentasaccharide Orthopaedic Prophylaxis Studiesof the Pentasaccharide Orthopaedic Prophylaxis Studies

SANOFI-SYNTHELABO ARIXTRA 2

PENTHIFRA: OBJECTIVE AND DESIGN

To compare the efficacy and safety of o.d. s.c. injections of Arixtra® 2.5 mg with enoxaparin 40 mg in preventing venous thromboembolism (VTE) in patients undergoing surgery for hip fracture.

A multicenter, randomized, double-blind, two-parallel-group comparative trial in 1711 patients.

SANOFI-SYNTHELABO ARIXTRA 3

PENTHIFRA: DESIGN

ArixtraArixtra®®

2.5 mg o.d.2.5 mg o.d.

EnoxaparinEnoxaparin40 mg o.d. 40 mg o.d. start pre-opstart pre-op

start 6 ± 2 hrs post-opstart 6 ± 2 hrs post-op

Venogram Day 5–11Venogram Day 5–11 Follow up Follow up Day 42 ± 7Day 42 ± 7

Treatment 7 ± 2 DaysTreatment 7 ± 2 Days

RR

SANOFI-SYNTHELABO ARIXTRA® 4

PENTHIFRA: ENDPOINTS

Primary efficacy: VTE up to day 11 deep-vein thrombosis (DVT) detected by mandatory

bilateral venography, or documented symptomatic DVT, or pulmonary embolism.

Primary safety: Major bleeding.

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PENTHIFRA: EFFICACY RESULTS

1250 (73.1%) patients included in the primary efficacy analysis

Arixtra® also reduced the incidence of:

any DVT by 58.2% (p<0.001), any proximal DVT by 78.7%

(p<0.001) distal-only DVT by 55.4%

(p<0.001).

SANOFI-SYNTHELABO ARIXTRA® 6

Arixtra® N=831n (%)

EnoxaparinN=842n (%)

Fatal bleeding 0 1 (0.1)

Bleeding in critical organ 0 0

Bleeding leading to reoperation 3 (0.4) 2 (0.2)

Bleeding with a bleeding index* 2 15 (1.8) 16 (1.9)

PENTHIFRA: SAFETY RESULTS

*The bleeding index was calculated as follows: [number of units of packed red blood cells or whole blood transfused] + [(pre-bleeding) - (post-bleeding) hemoglobin (g/dl) values]

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PENTHIFRA: CONCLUSION

In patients undergoing surgery for hip fracture,

Arixtra® was significantly more effective than enoxaparin in preventing VTE

and was equally safe