Drug Study Shows Improvement in Major Orthopedic Surgery Care

By Mcmaster University, PRNE
Thursday, July 8, 2010

McMaster University Researcher Leads International Study

HAMILTON, Canada, July 9, 2010 - An ultra-low-molecular-weight heparin called semuloparin has been found
to reduce the incidence of venous thromboembolism in orthopedic surgery
patients in a large clinical program being led by a steering committee
chaired by McMaster University professor Dr. Alexander Turpie.

The follow-up analysis of three recently completed international clinical
studies on short-term venous thromboembolism (VTE) protective medicine in
patients undergoing major orthopedic surgery demonstrated that the
ultra-low-molecular-weight heparin semuloparin reduced the incidence of VTE
and all-cause death by 25 per cent compared to the commonly used therapy drug
enoxaparin (a low-molecular-weight heparin).

Patients undergoing major orthopedic surgery are at increased risk of
developing a dangerous blood clot that blocks veins, which is known as venous
thromboembolism (VTE). Without treatment, the incidence of confirmed
deep-vein thrombosis, blood clots within the veins of the legs and pelvis, is
up to 40 to 60 per cent following major orthopedic surgery.

"This is a potential advance in orthopedic surgery compared to current
VTE prophylaxis options," said Turpie, a professor of medicine at the Michael
G. DeGroote School of Medicine at McMaster.

The favourable benefit-to-risk profile observed with semuloparin compared
to enoxaparin in the classic major orthopedic surgery model supports the
further evaluation of semuloparin as VTE preventative therapy in other areas
including oncology, as VTE is a known complication in patients with cancer.
Patients suffering from cancer have a four to seven fold greater risk for
VTE.

Turpie's meta-analysis study reports results from 4,479 patients
recruited in three orthopedic surgery studies in hip replacement (SAVE HIP),
hip fracture (SAVE HIP-FRA) and knee replacement (SAVE KNEE). The objective
of the three studies was to assess once-daily preventative treatment with
semuloparin (20 mg) compared to enoxaparin (40 mg daily in hip, and 30 mg
twice-daily for knee) for seven to 10 days.

The results of the SAVE program in orthopedic surgery were presented
today at the 21st International Congress of Thrombosis in Milan, Italy, and
organized by the Mediterranean League Against Thromboembolic Diseases.

Turpie is chairing the steering committee for the SAVE program, an
international series of studies. The SAVE program is supported by
sanofi-aventis, producer of semuloparin.

Semuloparin's benefit-to-risk profile in cancer is currently being
investigated in two ongoing phase three clinical studies. SAVE ONCO evaluates
semuloparin in patients with cancer undergoing chemotherapy. SAVE ABDO
assesses the benefits of semuloparin in major abdominal surgery, mainly
cancer surgery. Semuloparin is a selectively engineered
ultra-low-molecular-weight heparin.

For more information: Veronica McGuire, Media Relations, Faculty of Health Sciences, McMaster University, +1-905-525-9140, ext. 22169, vmcguir at mcmaster.ca

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